tocilizumab: package leaflet

RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.

RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough. RoActemra is usually given in combination with methotrexate. However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.

RoActemra can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.

RoActemra is used to treat children with sJIA. RoActemra is used for children aged 2 years and over who have active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash. RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.

RoActemra is used to treat children with pJIA. RoActemra is used for children aged 2 years and over with active polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more joints. RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.

RoActemra is used to treat adults and children aged 2 years and over with severe or life-threatening cytokine release syndrome (CRS), a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.


RoActemra is used to treat adults with coronavirus disease 2019 (COVID-19), receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.

You are not to be given RoActemra
 if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in Section 6).
 if you have an active, severe infection (with the exception of COVID-19).
If any of these applies to you, tell the doctor or nurse giving you the infusion.
Warnings and precautions
Talk to your doctor or nurse before you are given RoActemra.

If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light- headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.

If you have any kind of infection, short- or long-term, or if you often get infections. Tell your doctor immediately if you feel unwell. RoActemra can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.

If you have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

If you have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.

If you have liver disease, tell your doctor. Before you use RoActemra, your doctor may do a blood test to measure your liver function.

If any patient has recently been vaccinated (either adult or child), or is planning a vaccination, tell your doctor. All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with RoActemra, unless urgent treatment initiation is required. Certain types of vaccines should not be used while receiving RoActemra.

If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.

If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving RoActemra.

If you have moderate to severe kidney function problems, your doctor will monitor you.

If you have persistent headaches.
Your doctor will perform blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

Children and adolescents
RoActemra is not recommended for use in children under 2 years of age.
If a child has a history of macrophage activation syndrome, (activation and uncontrolled proliferation of specific blood cells), tell your doctor. Your doctor will have to decide if they can still be given RoActemra.
Other medicines and RoActemra
Tell your doctor if you are taking any other medicines (or your child is, if they are the patient), or have recently taken any. This includes medicines obtained without a prescription. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:
 methylprednisolone, dexamethasone, used to reduce inflammation
 simvastatin or atorvastatin, used to reduce cholesterol levels
 calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure  theophylline, used to treat asthma  warfarin or phenprocoumon, used as a blood thinning agents  phenytoin, used to treat convulsions  ciclosporin, used to suppress your immune system during organ transplants  benzodiazepines (e.g. temazepam), used to relieve anxiety.
Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA or pJIA.
Pregnancy, breast-feeding and fertility
RoActemra is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Stop breast-feeding if you are to be given RoActemra, and talk to your doctor. Leave a gap of at least 3 months after your last treatment before you start breast-feeding. It is not known whether RoActemra is passed into breast milk.
The data available so far does not suggest any effect on fertility from this treatment.
Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
RoActemra contains sodium
After dilution with 0.9 % sodium chloride solution, this medicinal product contains 230.6 mg sodium per maximum dose of 800 mg equivalent to 11.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
RoActemra contains polysorbate 80 (E 433)
This medicine contains 5 mg of polysorbate 80 in each 200 mg/10 mL vial, 10 mg of polysorbate 80 in each 400 mg/20 mL vial, and 2 mg of polysorbate 80 in each 80 mg/4 mL vial, which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.

This medicine is subject to restricted medical prescription by your doctor.

RoActemra will be given to you as a drip into a vein, by a doctor or a nurse. They will dilute the solution, set up the intravenous infusion and monitor you during and after the treatment.
Adult patients with RA
The usual dose of RoActemra is 8 mg per kg of body weight. Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Children with sJIA (aged 2 and over)
The usual dose of RoActemra depends on your weight.

If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight  If you weigh 30 kg or more: the dose is 8 mg for every kilogram of body weight The dose is calculated based on your body weight at each administration.
Children with sJIA will be given RoActemra once every 2 weeks through a drip in the vein (intravenous infusion) over one hour.
Children with pJIA (aged 2 and over)
The usual dose of RoActemra depends on your weight.

If you weigh less than 30 kg: the dose is 10 mg for every kilogram of body weight  If you weigh 30 kg or more: the dose is 8 mg for every kilogram of body weight The dose is calculated based on your body weight at each administration.
Children with pJIA will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Patients with CRS
The usual dose of RoActemra is 8 mg for every kg of body weight if you weigh 30 kg or more.
The dose is 12 mg for every kg of body weight if you weigh less than 30 kg.
RoActemra can be given alone or in combination with corticosteroids.
Patients with COVID-19
The usual dose of RoActemra is 8 mg for every kg of body weight. A second dose may be required.
If you are given more RoActemra than you should
Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much.
However, if you are worried, talk to your doctor.
If you miss a dose of RoActemra
Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose. However, if you are worried, talk to your doctor or nurse.
If you stop being given RoActemra
You should not stop using RoActemra without discussing with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, RoActemra can cause side effects, although not everybody gets them. Side effects could occur at least up to 3 months after your last dose of RoActemra.
Possible serious side effects
Tell your doctor immediately if you experience any of the following side effects:

These are common: may affect up to 1 in 10 people
Allergic reactions during or after infusion:
 difficulty with breathing, chest tightness or light-headedness
 rash, itching, hives, swelling of the lips, tongue or face
Signs of serious infections:
 fever and chills
 mouth or skin blisters
 stomach ache
Signs and symptoms of liver toxicity:
These are rare: may affect up to 1 in 1 000 people
 tiredness
 abdominal pain
 jaundice (yellow discolouration of skin or eyes)
List of other possible side effects
If you notice any of these, tell your doctor as soon as possible:
Very common side effects:
These may affect more than 1 in 10 people
 upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache  high blood fat (cholesterol) levels Common side effects:
These may affect up to 1 in 10 people
 lung infection (pneumonia)
 shingles (herpes zoster)
 cold sores (oral herpes simplex), blisters
 skin infection (cellulitis) sometimes with fever and chills
 rash and itching, hives
 allergic (hypersensitivity) reactions
 eye infection (conjunctivitis)
 headache, dizziness, high blood pressure
 mouth ulcers, stomach pain
 fluid retention (oedema) in the lower legs, weight increase
 cough, shortness of breath
 low white blood cell counts shown by blood tests (neutropenia, leucopenia)
 abnormal liver function tests (increased transaminases)
 increased bilirubin shown by blood tests
 low fibrinogen levels in the blood (a protein involved in blood clotting)
Uncommon side effects:
These may affect up to 1 in 100 people
 diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
 red swollen areas in the mouth
 high blood fat (triglycerides)
 stomach ulcer
 kidney stones
 underactive thyroid

Rare side effects:
These may affect up to 1 in 1 000 people

Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)  fatal allergic reactions (anaphylaxis)  inflammation of the liver (hepatitis), jaundice Very rare side effects:
These may affect up to 1 in 10 000 people
 low counts for white blood cells, red blood cells and platelets in blood tests  liver failure Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Children with sJIA
In general, side effects in sJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.
Children with pJIA
In general, side effects in pJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.

What RoActemra contains

The active substance is tocilizumab.
Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).

The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections (see section 2 ‘RoActemra contains sodium’ and ‘RoActemra contains polysorbate 80 (E 433)’).
What RoActemra looks like and contents of the pack
RoActemra is a concentrate for solution for infusion. The concentrate is a clear to opalescent, colourless to pale yellow liquid.

RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion. Pack size of 1 and 4 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
България
Рош България ЕООД
Тел: +359 2 474 5444
Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799
Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111
Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500
Danmark
Roche Pharmaceuticals A/S
Tlf.: +45 - 36 39 99 99
Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140
Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00
Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739
Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100
Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
España
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
France
Roche
Tél: +33 (0) 1 47 61 40 00
România
Roche România S.R.L.
Tel: +40 21 206 47 01

Hrvatska
Roche d.o.o
Tel: +385 1 47 22 333
Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00
Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700
Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201
Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000
Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:
Instructions for dilution prior to administration
Parenteral medicinal products must be inspected visually for particulate matter or discolouration prior to administration. Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted. Use a sterile needle and syringe to prepare RoActemra.
RA, COVID-19 and CRS adult patients ( ≥ 30 kg)
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of 100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
Use in the paediatric population sJIA, pJIA and CRS patients ≥ 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of 100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
sJIA and CRS patients < 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of 50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
pJIA patients < 30 kg
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.5 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of 50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
RoActemra is for single-use only.
Any unused product or waste material should be disposed of in accordance with local requirements.

RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. RoActemra is used to treat:
 adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
 adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
RoActemra is usually given in combination with another medicine for RA called methotrexate.
However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
 adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body’s largest arteries, especially those that supply blood to the head and neck. Symptoms include headache, fatigue and jaw pain. Effects can include strokes and blindness.

RoActemra can reduce pain and swelling in the arteries and veins in your head, neck and arms.
GCA is often treated with medicines called steroids. They are usually effective, but can have side effects if used at high doses for a long time. Reducing the steroid dose can also lead to a flare-up of the GCA. Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA.
 children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
RoActemra is used to improve the symptoms of sJIA. It can be given in combination with methotrexate or alone.
 children and adolescents, aged 2 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease that causes pain and swelling in one or more joints.
RoActemra is used to improve the symptoms of pJIA. It can be given in combination with methotrexate or alone.

Do not use RoActemra
 if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
 if you or a child patient you look after have an active, severe infection.
If either of these applies to you, tell a doctor. Do not use RoActemra.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using RoActemra.

If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light- headedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.

Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.

If you have any kind of infection, short- or long-term, or if you often get infections. Tell your doctor immediately if you feel unwell. RoActemra can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.

If you have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.

If you have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.


If you have liver disease, tell your doctor. Before you use RoActemra, your doctor may do a blood test to measure your liver function.

If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor. All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra. Certain types of vaccines should not be given while receiving RoActemra.

If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.

If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving RoActemra.

If you have moderate to severe kidney function problems, your doctor will monitor you.

If you have persistent headaches.
Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Children and adolescents
RoActemra subcutaneous injection is not recommended for use in children under 1 year of age.
RoActemra must not be given to children with sJIA weighing less than 10 kg.
If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor. Your doctor will have to decide if they can still be given RoActemra.
Other medicines and RoActemra
Tell your doctor if you are taking any other medicines, or have recently taken any. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:
 methylprednisolone, dexamethasone, used to reduce inflammation
 simvastatin or atorvastatin, used to reduce cholesterol levels
 calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure  theophylline, used to treat asthma  warfarin or phenprocoumon, used as a blood thinning agents  phenytoin, used to treat convulsions  ciclosporin, used to suppress your immune system during organ transplants  benzodiazepines (e.g. temazepam), used to relieve anxiety Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA or GCA.
Pregnancy, breast-feeding and fertility
RoActemra is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Stop breast-feeding if you are to be given RoActemra, and talk to your doctor. Leave a gap of at least 3 months after your last treatment before you start breast-feeding. It is not known whether RoActemra is passed into breast milk.

Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
RoActemra contains polysorbate 80 (E 433)
This medicine contains 0.18 mg of polysorbate 80 in each 162 mg/0.9 mL PFS which is equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
The recommended dose
The dose for RA or GCA for adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Children and adolescents with sJIA (aged 1 year and over)
The usual dose of RoActemra depends on the patient’s weight.

If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks  If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe) once every week Children and adolescents with pJIA (aged 2 and over) The usual dose of RoActemra depends on the patient’s weight.

If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe), once every 3 weeks  If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe), once every 2 weeks.
RoActemra is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject RoActemra. However, your doctor may decide that you may inject RoActemra yourself. In this case you will get training on how to inject RoActemra yourself. Parents and carers will get training on how to inject RoActemra for patients who cannot inject themselves, such as children.
Talk to your doctor if you have any questions about giving yourself or a child patient you look after an injection. You will find detailed “Instructions for administration” at the end of this leaflet.
If you use more RoActemra than you should
Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much.
However, if you are worried, talk to your doctor, pharmacist or nurse.
If an adult with RA or GCA or a child or adolescent with sJIA misses or forgets a dose It is very important to use RoActemra exactly as prescribed by your doctor. Keep track of your next dose.

If you miss your weekly dose within 7 days, take your dose on the next scheduled day.

If you miss your once every other week dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.

If you miss your weekly or once every other week dose by more than 7 days, or you are not sure when to inject RoActemra, call your doctor or pharmacist.

If a child or adolescent with pJIA misses or forgets a dose
It is very important to use RoActemra exactly as prescribed by the doctor. Keep track of the next dose.

If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.

If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.
If you stop using RoActemra
You should not stop using RoActemra without discussing with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Side effects could occur 3 months or more after your last dose of RoActemra.
Possible serious side effects
Tell your doctor immediately if you experience any of the following side effects:
These are common: they may affect up to 1 in 10 people
Allergic reactions during or after injection:
 difficulty with breathing, chest tightness or light-headedness
 rash, itching, hives, swelling of the lips, tongue or face
Signs of serious infections:
 fever and chills
 mouth or skin blisters
 stomach ache
Signs and symptoms of liver toxicity:
These are rare: may affect up to 1 in 1 000 people
 tiredness
 abdominal pain
 jaundice (yellow discolouration of skin or eyes)
List of other possible side effects
If you notice any of these, tell your doctor as soon as possible:
Very common side effects:
These may affect 1 in 10 people or more
 upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache  high blood fat (cholesterol) levels  injection site reactions Common side effects:
These may affect up to 1 in 10 people
 lung infection (pneumonia)
 shingles (herpes zoster)
 cold sores (oral herpes simplex), blisters
 skin infection (cellulitis) sometimes with fever and chills
 rash and itching, hives
 allergic (hypersensitivity) reactions

 eye infection (conjunctivitis)
 headache, dizziness, high blood pressure
 mouth ulceration, stomach pain
 fluid retention (oedema) in the lower legs, weight increase
 cough, shortness of breath
 low white blood cell counts shown by blood tests (neutropenia, leucopenia)
 abnormal liver function tests (increased transaminases)
 increased bilirubin shown by blood tests
 low fibrinogen levels in the blood (a protein involved in blood clotting)
Uncommon side effects:
These may affect up to 1 in 100 people
 diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
 red swollen areas in the mouth
 high blood fat (triglycerides)
 stomach ulcer
 kidney stones
 underactive thyroid
Rare side effects:
These may affect up to 1 in 1 000 people

Stevens-Johnson Syndrome (skin rash, which may lead to severe blistering and peeling of the skin)  fatal allergic reactions (anaphylaxis)  inflammation of the liver (hepatitis), jaundice Very rare side effects:
These may affect up to 1 in 10 000 people
 low counts for white blood cells, red blood cells and platelets in blood tests  liver failure Side effects in children and adolescents with sJIA or pJIA Side effects in children and adolescents with sJIA or pJIA are generally similar to those in adults.
Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Once removed from the refrigerator, the pre-filled syringe can be stored up to 2 weeks at or below 30 °C.
Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.

Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled syringe appears to be damaged.
The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.

What RoActemra contains

The active substance is tocilizumab.
Each pre-filled syringe contains 162 mg tocilizumab in 0.9 mL.

The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L- Arginine/L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections (see section 2 ‘RoActemra contains polysorbate 80 (E 433)’).
What RoActemra looks like and contents of the pack
RoActemra is a solution for injection. The solution is colourless to slightly yellowish.
RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection. Each pack contains 4 pre-filled syringes with multipacks containing 12 (3 packs of 4) pre- filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
България
Рош България ЕООД
Тел: +359 2 474 5444
Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799
Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111
Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf.: +45 - 36 39 99 99
Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140
Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00
Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739
Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100
Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
España
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
France
Roche
Tél: +33 (0) 1 47 61 40 00
România
Roche România S.R.L.
Tel: +40 21 206 47 01
Hrvatska
Roche d.o.o.
Tel: +385 1 47 22 333
Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00
Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700
Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201
Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000
Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.

What do I need to know to use my RoActemra pre-filled syringe safely?
It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly. These instructions do not replace training from your healthcare provider.
Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time. Ask your healthcare provider any questions you may have. Do not attempt to administer an injection until you are sure that you understand how to use the RoActemra syringe.
Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine. It is important to remain under your healthcare provider's care while using RoActemra.
Important Information:

Do not use the syringe if it appears to be damaged

Do not use if medicine is cloudy, hazy, discoloured or contains particles

Do not try to take apart the syringe at any time

Do not remove the needle-cap until you are ready to inject

Do not inject through clothing covering the skin

Never re-use the same syringe

Do not touch the syringe trigger fingers as this may damage the syringe
Storage
Keep the RoActemra syringe and all medicines out of the sight and reach of children. Always store the syringe in a refrigerator at a temperature of 2 °C – 8 °C. Once removed from the refrigerator, the pre- filled syringe can be stored for a total time of up to 2 weeks at or below 30 °C, but not exceeding the original expiry date (EXP). Mark the relevant date on the carton. The prefilled syringe must always be kept in the carton. Protect the syringe from freezing and from light. Keep the syringes dry.
Pre-filled syringe parts
You will need the following to give your injection:
Included in the box:
●
Pre-filled Syringe
Not included in the box:
●
Alcohol pad
●
Sterile cotton ball or gauze
●
Puncture-resistant container or sharps container for safe disposal of needle-cap and used syringe

A place to prepare your supplies:
●
Find a well-lit, clean, flat surface such as a table
Step 1. Visually check the syringe
●
Take the box containing the syringe out of the refrigerator and open the box. Do not touch the trigger fingers on the syringe as this may damage the syringe.
●
Remove the syringe from the box and visually examine the syringe, as well as the medicine in the syringe. This is important to ensure that the syringe and medicine are safe to use.
●
Check the expiry date on the box and syringe (See Fig. A) to make sure that it has not passed (expired). Do not use the syringe if the expiry date has passed. This is important to ensure that the syringe and medicine are safe to use.
Dispose of the syringe and do not use if:
● the medicine is cloudy
● the medicine contains particles
● the medicine is any colour besides colourless to yellowish
● any part of the syringe appears to be damaged
Step 2. Allow the syringe to adjust to room temperature
●
Do not remove the needle-cap on your syringe until Step 5. Early removal of the needle-cap can cause the medication to dry out and block the needle.
●
Place the syringe on a clean flat surface and allow the syringe to come to room temperature (18 °C - 28 °C) for about 25-30 minutes to warm up. Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger.
●
Do not warm up the syringe in any other way.
Step 3. Clean your hands
●
Wash your hands with soap and water.
Step 4. Choose and prepare an injection site
●
The recommended injection sites are the front and middle of your thighs and the lower part of the abdomen below the navel (belly button) except for the five centimeter area directly around the navel. (See Fig. B) ● If a caregiver is giving the injection, the outer area of the upper arms may also be used. (See Fig. B)

●
You should use a different place each time you give yourself an injection, at least three centimeters from the area you used for your previous injection.
●
Do not inject into areas that could be bothered by a belt or waistband. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
●
Clean the chosen injection site area using the alcohol pad (See Fig. C), to reduce the risk of infection.
●
Let the skin dry for approximately 10 seconds.
●
Be sure not to touch the cleaned area prior to the injection. Do not fan or blow on the clean area.
Step 5. Remove needle-cap
●
Do not hold the syringe by the plunger while removing the needle-cap.
●
Hold the needle-shield of the syringe firmly with one hand and pull off the needle-cap with the other hand. (See Fig. D) If you cannot remove the needle cap you should request the help of a caregiver or contact your healthcare provider.

●
Do not touch the needle or let it touch any surface.
●
There may be a small air bubble in the RoActemra prefilled syringe. You do not need to remove it.
●
You may see a drop of liquid at the end of the needle. This is normal.
●
Throw away the needle-cap in the puncture resistant container or sharps container.
NOTE: Once the needle-cap is removed, the syringe must be used immediately.
●
If it is not used within 5 minutes of cap removal, the syringe must be disposed of in the puncture resistant container or sharps container and a new syringe must be used. If the needle cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle.
●
Never reattach the needle-cap after removal.
Step 6. Give the injection
●
Hold the syringe comfortably in your hand.
●
To be sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the clean injection site with your free hand. Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could result in an uncomfortable injection.
●
Do not hold or push on the plunger while inserting the needle into the skin.
●
Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick, firm action. (See Fig. E).
It is important to choose the correct angle to ensure the medication is delivered under the skin (into fatty tissue), otherwise the injection could be painful and the medication may not work.
●
Then keep the syringe in position and let go of the pinch of skin.
●
Slowly inject all of the medicine by gently pushing the plunger all the way down. (See Fig.
F). You must press the plunger all the way down to ensure that you get the full dose of medication and to ensure the trigger fingers are completely pushed to the side. If the plunger is not fully depressed the needle shield will not extend to cover the needle when it is removed. If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.

●
Once the plunger is pushed all the way down, keep pressing down on the plunger to be sure all of the medicine is injected before taking the needle out of the skin.
●
Keep pressing down on the plunger while you take the needle out of the skin at the same angle as inserted. (See Fig. G) ● If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2). If you still experience difficulty, you should consult your healthcare provider.
●
Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle. (See Fig. H) ● If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for approximately 10 seconds.
●
Do not rub the injection site.
Step 7. Dispose of the syringe
●
Do not try to re-cap your syringe.

●
Throw away used syringes in a puncture-resistant container or sharps container. Ask your healthcare provider or pharmacist for information about where you can get a "sharps" container or what other types of puncture-resistant containers you can use to safely dispose of your used syringes, if you do not have one. (See Fig. I) Check with your healthcare provider for instructions about the right way to throw away used syringes.
There may be local or state laws about how to throw away used syringes.
Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.
●
Dispose of the full container as instructed by your healthcare provider or pharmacist.
●
Always keep the puncture-resistant container out of the sight and reach of children.
Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe) If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoActemra injection you should seek emergency care immediately.
Patient advice regarding early recognition and treatment to limit risk of a serious infection Be alert for the first signs of infection such as:
● body aches, fever, chills
● cough, chest discomfort/tightness, shortness of breath
● redness, heat, unusual swelling of skin or joint
● abdominal pain/tenderness and/or change in bowel function
Call your doctor and seek medical attention without delay if you think you might be developing an infection.
If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.

RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. RoActemra is used to treat:
 adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
 adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
RoActemra helps to reduce RA symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
RoActemra is usually given in combination with another medicine for RA called methotrexate.
However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
 adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body’s largest arteries, especially those that supply blood to the head and neck. Symptoms include headache, fatigue and jaw pain. Effects can include strokes and blindness.

RoActemra can reduce pain and swelling in the arteries and veins in your head, neck and arms.
GCA is often treated with medicines called steroids. They are usually effective, but can have side effects if used at high doses for a long time. Reducing the steroid dose can also lead to a flare-up of the GCA. Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA.
 children and adolescents, aged 12 years and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
RoActemra is used to improve the symptoms of sJIA. It can be given in combination with methotrexate or alone.
 children and adolescents, aged 12 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease that causes pain and swelling in one or more joints.
RoActemra is used to improve the symptoms of pJIA. It can be given in combination with methotrexate or alone.

Do not use RoActemra
 if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
 if you or a child patient you look after have an active, severe infection.
If either of these applies to you, tell a doctor. Do not use RoActemra.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using RoActemra.

If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light- headedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.

Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.

If you have any kind of infection, short- or long-term, or if you often get infections. Tell your doctor immediately if you feel unwell. RoActemra can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.

If you have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.

If you have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.


If you have liver disease, tell your doctor. Before you use RoActemra, your doctor may do a blood test to measure your liver function.

If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor. All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra. Certain types of vaccines should not be given while receiving RoActemra.

If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.

If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving RoActemra.

If you have moderate to severe kidney function problems, your doctor will monitor you.

If you have persistent headaches.
Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Children and adolescents
RoActemra pre-filled pen is not recommended for use in children under 12 years of age. RoActemra must not be given to children with sJIA weighing less than 10 kg.
If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor. Your doctor will have to decide if they can still be given RoActemra.
Other medicines and RoActemra
Tell your doctor if you are taking any other medicines, or have recently taken any. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:
 methylprednisolone, dexamethasone, used to reduce inflammation
 simvastatin or atorvastatin, used to reduce cholesterol levels
 calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure  theophylline, used to treat asthma  warfarin or phenprocoumon, used as a blood thinning agents  phenytoin, used to treat convulsions  ciclosporin, used to suppress your immune system during organ transplants  benzodiazepines (e.g. temazepam), used to relieve anxiety Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA, or GCA.
Pregnancy, breast-feeding and fertility
RoActemra is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Stop breast-feeding if you are to be given RoActemra, and talk to your doctor. Leave a gap of at least 3 months after your last treatment before you start breast-feeding. It is not known whether RoActemra is passed into breast milk.

Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
RoActemra contains polysorbate 80 (E 433)
This medicine contains 0.18 mg of polysorbate 80 in each 162 mg/0.9 mL PFP which is equivalent to 0.2 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
The recommended dose
The dose for RA or GCA for adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Adolescents with sJIA (aged 12 years and over)
The usual dose of RoActemra depends on the patient’s weight.

If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled pen) once every 2 weeks  If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen) once every week The pre-filled pen should not be used to treat children less than 12 years of age.
Adolescents with pJIA (aged 12 years and over)
The usual dose of RoActemra depends on the patient’s weight.

If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled pen), once every 3 weeks  If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen), once every 2 weeks.
The pre-filled pen should not be used to treat children less than 12 years of age.
RoActemra is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject RoActemra. However, your doctor may decide that you may inject RoActemra yourself. In this case you will get training on how to inject RoActemra yourself. Parents and carers will get training on how to inject RoActemra for patients who cannot inject themselves.
Talk to your doctor if you have any questions about giving yourself or an adolescent patient you look after an injection. You will find detailed “Instructions for administration” at the end of this leaflet.
If you use more RoActemra than you should
Because RoActemra is given in one pre-filled pen, it is unlikely that you will receive too much.
However, if you are worried, talk to your doctor, pharmacist or nurse.
If an adult with RA or GCA or an adolescent with sJIA misses or forgets a dose
It is very important to use RoActemra exactly as prescribed by your doctor. Keep track of your next dose.

If you miss your weekly dose within 7 days, take your dose on the next scheduled day.

If you miss your once every other week dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.

If you miss your weekly or once every other week dose by more than 7 days, or you are not sure when to inject RoActemra, call your doctor or pharmacist.

If an adolescent with pJIA misses or forgets a dose
It is very important to use RoActemra exactly as prescribed by the doctor. Keep track of the next dose.

If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.

If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.
If you stop using RoActemra
You should not stop using RoActemra without discussing with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Side effects could occur 3 months or more after your last dose of RoActemra.
Possible serious side effects:
Tell your doctor immediately if you experience any of the following side effects:
These are common: they may affect up to 1 in 10 people
Allergic reactions during or after injection:
 difficulty with breathing, chest tightness or light-headedness
 rash, itching, hives, swelling of the lips, tongue or face
Signs of serious infections:
 fever and chills
 mouth or skin blisters
 stomach ache
Signs and symptoms of liver toxicity:
These are rare: may affect up to 1 in 1 000 people
 tiredness
 abdominal pain
 jaundice (yellow discolouration of skin or eyes)
List of other possible side effects
If you notice any of these, tell your doctor as soon as possible:
Very common side effects:
These may affect 1 in 10 people or more
 upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache  high blood fat (cholesterol) levels  injection site reactions Common side effects:
These may affect up to 1 in 10 people
 lung infection (pneumonia)
 shingles (herpes zoster)
 cold sores (oral herpes simplex), blisters
 skin infection (cellulitis) sometimes with fever and chills
 rash and itching, hives

 allergic (hypersensitivity) reactions
 eye infection (conjunctivitis)
 headache, dizziness, high blood pressure
 mouth ulceration, stomach pain
 fluid retention (oedema) in the lower legs, weight increase
 cough, shortness of breath
 low white blood cell counts shown by blood tests (neutropenia, leucopenia)
 abnormal liver function tests (increased transaminases)
 increased bilirubin shown by blood tests
 low fibrinogen levels in the blood (a protein involved in blood clotting)
Uncommon side effects:
These may affect up to 1 in 100 people
 diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
 red swollen areas in the mouth
 high blood fat (triglycerides)
 stomach ulcer
 kidney stones
 underactive thyroid
Rare side effects:
These may affect up to 1 in 1 000 people

Stevens-Johnson Syndrome (skin rash, which may lead to severe blistering and peeling of the skin)  fatal allergic reactions (anaphylaxis)  inflammation of the liver (hepatitis), jaundice Very rare side effects:
These may affect up to 1 in 10 000 people
 low counts for white blood cells, red blood cells and platelets in blood tests  liver failure Side effects in children and adolescents with sJIA or pJIA Side effects in children and adolescents with sJIA or pJIA are generally similar to those in adults.
Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Once removed from the refrigerator, the pre-filled pen can be stored up to 2 weeks at or below 30 °C Keep the pre-filled pens in the outer carton in order to protect from light and moisture.

Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled pen appears to be damaged.
The pen should not be shaken. After removing the cap the injection must be started within 3 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled pen is not used within 3 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre- filled pen.
If following pressing the activation button the purple indicator does not move, you must dispose of the pre-filled pen in a puncture resistant container. Do not try to re-use the pre-filled pen. Do not repeat the injection with another pre-filled pen. Call your healthcare provider for help.

What RoActemra contains

The active substance is tocilizumab.
Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL.

The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L- Arginine/L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections (see section 2 ‘RoActemra contains polysorbate 80 (E 433)’).
What RoActemra looks like and contents of the pack
RoActemra is a solution for injection. The solution is colourless to slightly yellowish.
RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection. Each pack contains 4 pre-filled pens with multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
България
Рош България ЕООД
Тел: +359 2 474 5444
Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111
Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500
Danmark
Roche Pharmaceuticals A/S
Tlf.: +45 - 36 39 99 99
Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050
Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140
Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00
Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739
Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100
Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
España
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
France
Roche
Tél: +33 (0) 1 47 61 40 00
România
Roche România S.R.L.
Tel: +40 21 206 47 01
Hrvatska
Roche d.o.o.
Tel: +385 1 47 22 333
Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00
Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700
Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201
Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000
Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.

What you need to know to use your RoActemra pre-filled pen (ACTPen) safely.
Read and follow the Instructions for Use that come with your RoActemra pre-filled pen before you start using it and each time you get a prescription refill. Before you use the RoActemra pre-filled pen for the first time, make sure your healthcare provider shows you the right way to use it.
Important: Keep your unused pre-filled pens in the original carton and keep in the refrigerator at 2 °C to 8 °C. Do not freeze.
Once removed from the refrigerator, the pre-filled pen can be stored for a total time of up to 2 weeks at or below 30 °C, but not exceeding the original expiry date (EXP). Mark the relevant date on the carton. Always keep the pre-filled pens in the outer carton in order to protect from light and moisture.
●
Do not remove the pre-filled pen cap until you are ready to inject RoActemra.
●
Do not try to take apart the pre-filled pen at any time.
●
Do not reuse the same pre-filled pen.
●
Do not use the pre-filled pen through clothing.
●
Do not leave the pre-filled pen unattended.
●
Keep out of the reach of children.
Parts of your RoActemra pre-filled pen (See Figure A).
Figure A

Supplies needed for an injection using your RoActemra pre-filled pen (See Figure B):
●
1 RoActemra pre-filled pen
●
1 Alcohol pad
●
1 Sterile cotton ball or gauze
●
1 Puncture-resistant container or sharps container for safe disposal of pre-filled pen cap and used pre-filled pen (see Step 4 “Dispose of the pre-filled pen”) Figure B Step 1. Preparing for a RoActemra Injection Find a comfortable space with a clean, flat, working surface.
●
Take the box containing the pre-filled pen out of the refrigerator.
●
If you are opening the box for the first time, check to make sure that it is properly sealed. Do not use the pre-filled pen if the box looks like it has already been opened.
●
Check that the pre-filled pen box is not damaged. Do not use RoActemra pre-filled pen if the box looks damaged.
●
Check the expiry date on the pre-filled pen box. Do not use the pre-filled pen if the expiry date has passed because it may not be safe to use.
●
Open the box, and remove 1 single-use RoActemra pre-filled pen from the box.
●
Return any remaining pre-filled pens in the box to the refrigerator.
●
Check the expiry date on the RoActemra pre-filled pen (See Figure A). Do not use it if the expiry date has passed because it may not be safe to use. If the expiry date has passed, safely dispose of the pre-filled pen in a sharps container and get a new one.
●
Check the pre-filled pen to make sure it is not damaged. Do not use the pre-filled pen if it appears to be damaged or if you have accidentally dropped the pre-filled pen.
●
Place the pre-filled pen on a clean, flat surface and let the pre-filled pen warm up for 45 minutes to allow it to reach room temperature. If the pre-filled pen does not reach room temperature, this could cause your injection to feel uncomfortable and it could take longer to inject.
●
Do not speed up the warming process in any way, such as using the microwave or placing the pre-filled pen in warm water.
●
Do not leave the pre-filled pen to warm up in direct sunlight.
Do not remove the green cap while allowing your RoActemra pre-filled pen to reach room temperature.
●
Hold your RoActemra pre-filled pen with the green cap pointing down (See Figure C).

Figure C
●
Look in the clear Window area. Check the liquid in the RoActemra pre-filled pen (See Figure C). It should be clear and colourless to pale yellow. Do not inject RoActemra if the liquid is cloudy, discoloured, or has lumps or particles in it because it may not be safe to use.
Safely dispose of the pre-filled pen in a sharps container and get a new one.
●
Wash your hands well with soap and water.
Step 2. Choose and Prepare an Injection Site
Choose an Injection Site
●
The front of your thigh or your abdomen except for the 2-inch (5cm) area around your navel are the recommended injection sites (See Figure D).
●
The outer area of the upper arms may also be used only if the injection is being given by a caregiver. Do not attempt to use the upper arm area by yourself (See Figure D).
Rotate Injection Site
●
Choose a different injection site for each new injection at least 1-inch (2.5cm) from the last area you injected.
●
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Figure D
Prepare the Injection Site
●
Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection. Do not touch the injection site again before giving the injection.

●
Do not fan or blow on the clean area.
Step 3. Inject RoActemra
●
Hold the RoActemra pre-filled pen firmly with one hand. Twist and pull off the green cap with the other hand (See Figure E). The green cap contains a loose fitting metal tube.
●
If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider.
Figure E
Important: Do not touch the needle shield which is located at the tip of the pre-filled pen below the window area (see Figure A), to avoid accidental needle stick injury.
●
Throw away the green cap in a sharps container.
●
After you remove the green cap, the pre-filled pen is ready for use. If the pre-filled pen is not used within 3 minutes of the cap removal, the pre-filled pen should be disposed of in the sharps container and a new pre-filled pen should be used.
●
Never reattach the green cap after removal.
●
Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).
Figure F
●
Use your other hand to gently pinch the area of skin you cleaned, to prepare a firm injection site (See Figure G). The pre-filled pen requires a firm injection site to properly activate.
●
Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could cause the injection to feel uncomfortable.

Figure G
●
Do not press the green activation button yet.
●
Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See Figure H).
●
It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful and the medicine may not work.
Figure H
●
To use the pre-filled pen, you first have to unlock the green Activation button.
●
To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I).

Figure I
●
Continue to keep the needle-shield pushed in.
●
If you don’t keep the needle-shield completely pushed against the skin, the green Activation button will not work.
●
Continue to pinch the skin while you keep the pre-filled pen in place.
●
Press the green Activation button to start the injection. A “click” sound indicates the start of the injection. Keep the green button pressed in and continue holding the pre-filled pen pressed firmly against your skin (See Figure J). If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider.
Figure J
●
The purple indicator will move along the Window area during the injection
(See Figure K).
●
Watch the purple indicator until it stops moving to be sure the full dose of medication is injected.
Figure K
●
The injection may take up to 10 seconds.
●
You may hear a second “click” during the injection but you should continue to hold the pre- filled pen firmly against your skin until the purple indicator stops moving.
●
When the purple indicator has stopped moving, release the green button. Lift the pre-filled pen straight off of the injection site at a 90° angle to remove the needle from the skin. The needle-shield will then move out and lock into place covering the needle (See Figure L).

Figure L
●
Check the Window area to see that it is filled with the purple indicator (See Figure L).
●
If the Window area is not filled by the purple indicator then:
●
The needle-shield may not have locked. Do not touch the needle-shield of the pre-filled pen, because you may stick yourself with the needle. If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
●
You may not have received your full dose of RoACTEMRA. Do not try to re-use the pre-filled pen. Do not repeat the injection with another pre-filled pen. Call your healthcare provider for help.
After the Injection
●
There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
●
Do not rub the injection site.
●
If needed, you may cover the injection site with a small bandage.
Step 4. Dispose of the pre-filled pen
●
The RoActemra pre-filled pen should not be reused.
●
Put the used pre-filled pen into your sharps container (see “How do I dispose of used pre- filled pens?”) ● Do not put the cap back on the pre-filled pen.
●
If your injection is given by another person, this person must also be careful when removing the pre-filled pen and disposing of it to prevent accidental needle stick injury and passing infection.
How do I dispose of used pre-filled pens?
●
Put your used RoActemra pre-filled pen and green cap in a sharps disposal container right away after use (See Figure M).
●
Do not throw away (dispose of) the pre-filled pen and the green cap in your household trash and do not recycle them.

Figure M
●
Dispose of the full container as instructed by your healthcare provider or pharmacist.
●
Always keep the puncture-resistant container out of the sight and reach of children.
Keep the RoActemra pre-filled pen and disposal container out of the reach of children.
Record your Injection
●
Write the date, time, and specific part of your body where you injected yourself. It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.
If you have any questions or concerns about your RoActemra pre-filled pen, talk to your healthcare provider familiar with RoActemra.

These pictograms are displayed on the left side of the printed Package Leaflet
Push against skin to unlock. Do Not push green button yet.
Then press green button to inject.
Refer to Instructions for Use