ruxolitinib: package leaflet

Jakavi contains the active substance ruxolitinib.

Jakavi is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer.

Jakavi is also used to treat adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

Jakavi is also used to treat:
- children aged 28 days and older and adults with acute graft versus host disease (GvHD).
- children aged 6 months and older and adults with chronic GvHD.
There are two forms of GvHD: an early form called acute GvHD that usually develops soon after the transplantation and can affect skin, liver and gastrointestinal tract, and a form called chronic GvHD, which develops later, usually weeks to months after the transplantation. Almost any organ can be affected by chronic GvHD.

How Jakavi works
Enlargement of the spleen is one of the characteristics of myelofibrosis. Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged. By blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss in patients with myelofibrosis. Jakavi can help reduce the risk of serious blood or vascular complications.

Polycythaemia vera is a disorder of the bone marrow, in which the marrow produce too many red blood cells. The blood becomes thicker as a result of the increased red blood cells. Jakavi can relieve

the symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), thus potentially reducing the risk of serious blood or vascular complications.

Graft versus host disease is a complication which occurs after transplantation when specific cells (T cells) in the donor’s graft (e.g. bone marrow) do not recognise the host cells/organs and attack them.
By selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces signs and symptoms of the acute and the chronic forms of graft-versus-host disease leading to disease improvement and survival of the transplanted cells.

If you have any questions about how Jakavi works or why this medicine has been prescribed for you, ask your doctor.

Follow all your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.

Do not take Jakavi
- if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breast-feeding (see section 2 “Pregnancy, breast-feeding and contraception”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Jakavi if:
- you have any infections. It may be necessary to treat your infection before starting Jakavi.
- you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis or any other infections.
- you have ever had hepatitis B.
- you have kidney problems or you have or have ever had liver problems because your doctor may need to prescribe a different dose of Jakavi.
- you have ever had cancer, in particular skin cancer.
- you have or have had heart problems.
- you are 65 years of age or older. Patients aged 65 years and older may be at increased risk of heart problems, including heart attack, and some types of cancer.
- you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during your treatment with Jakavi if:
- you experience fever, chills or other symptoms of infections.
- you experience chronic coughing with blood-tinged sputum, fever, night sweats and weight loss (these can be signs of tuberculosis).
- you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
- you develop painful skin rash with blisters (these are signs of shingles).
- you have any skin changes. This may require further observation, as certain types of skin cancer (non-melanoma) have been reported.
- you experience sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm as these can be signs of blood clots in the veins.

Children and adolescents
This medicine is not intended for use by children or adolescents aged below 18 years, who have the disease myelofibrosis or polycythaemia vera because it has not been studied in this age group.

For the treatment of graft-versus-host disease, Jakavi can be used in patients 28 days and older.

Other medicines and Jakavi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. While you are taking Jakavi you should never start a new medicine without checking first with the doctor who prescribed Jakavi. This includes prescription medicines, non-prescription medicines and herbal or alternative medicines.

It is particularly important that you mention medicines containing any of the following active substances, as your doctor may need to adjust the Jakavi dose:
- Some medicines used to treat infections:
- medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole)
- antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
- medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
- medicines to treat hepatitis C (boceprevir, telaprevir).
- A medicine to treat depression (nefazodone).
- Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness or pain (chronic angina pectoris) (mibefradil or diltiazem).
- A medicine to treat heartburn (cimetidine).
- A medicine to treat heart disease (avasimibe).
- Medicines used to stop seizures or fits (phenytoin, carbamazepine or phenobarbital and other anti-epileptics).
- Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
- A herbal product used to treat depression (St. John’s wort (Hypericum perforatum)).
Talk to your doctor if you are not sure if the above applies to you.

Pregnancy, breast-feeding and contraception
Pregnancy
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breast-feeding
- Do not breastfeed while taking Jakavi (see section 2 “Do not take Jakavi”). Ask your doctor for advice.

Contraception
- Taking Jakavi is not recommended for women who could become pregnant and who are not using contraception. Talk to your doctor about how to use appropriate contraception to avoid becoming pregnant during treatment with Jakavi.
- Talk to your doctor if you become pregnant while using Jakavi.

Driving and using machines
If you experience dizziness after taking Jakavi, do not drive or use machines.

Jakavi contains lactose and sodium
Jakavi contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before you start treatment with Jakavi and during treatment, your doctor will do blood tests to find the best dose, to see how you are responding to the treatment and whether Jakavi is having an unwanted effect. Your doctor may need to adjust the dose or stop treatment. Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi.

Myelofibrosis
- Adults: The recommended starting dose is 5 to 20 mg twice daily. The maximum dose is 25 mg twice daily.

Polycythaemia vera
- Adults: The recommended starting dose is 10 mg twice daily. The maximum dose is 25 mg twice daily.

Acute and chronic graft versus host disease
- Children 6 years to less than 12 years old: The recommended starting dose is 5 mg twice daily.
- Children 12 years and older and adults: The recommended starting is 10 mg twice daily.
An oral solution is available if you have difficulty swallowing the whole tablet and for children less than 6 years old.

You should take Jakavi every day at the same time, either with or without food.

Your doctor will always tell you exactly how many Jakavi tablets to take.

You should continue taking Jakavi for as long as your doctor tells you to.

If you take more Jakavi than you should
If you accidentally take more Jakavi than your doctor prescribed, contact your doctor or pharmacist immediately.

If you forget to take Jakavi
If you forget to take Jakavi simply take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the side effects of Jakavi are mild to moderate and will generally disappear after a few days to a few weeks of treatment.

Myelofibrosis and polycythaemia vera

Some side effects could be serious
Seek medical help immediately prior to taking the next scheduled dose if you experience the following serious side effects:
Very common (may affect more than 1 in 10 people):
- any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood
- unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections - possible symptoms of blood disorder
- painful skin rash with blisters - possible symptoms of shingles (herpes zoster)
- fever, chills or other symptoms of infections
- low level of red blood cells (anaemia), low level of white blood cells (neutropenia) or low level of platelets (thrombocytopenia)

Common (may affect up to 1 in 10 people):
- any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis

Other side effects
Other possible side effects include the following listed below. If you experience these side effects, talk to your doctor or pharmacist.

Very common (may affect more than 1 in 10 people):
- high level of cholesterol or fat in the blood (hypertriglyceridaemia)
- abnormal liver function test results
- dizziness
- headache
- urinary tract infections
- weight gain
- fever, cough, difficult or painful breathing, wheezing, pain in chest when breathing - possible symptoms of pneumonia
- high blood pressure (hypertension), which may also be the cause of dizziness and headaches
- constipation
- high level of lipase in the blood

Common (may affect up to 1 in 10 people):
- reduced number of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
- frequently passing wind (flatulence)

Uncommon (may affect up to 1 in 100 people):
- tuberculosis
- recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown- colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).

Graft-versus-host disease (GvHD)

Some side effects could be serious
Seek medical help immediately prior to taking the next scheduled dose if you experience the following serious side effects:
Very common (may affect more than 1 in 10 people):
- signs of infections with fever associated with:
- muscle pain, skin redness, and/or difficulty breathing (cytomegalovirus infection)
- pain when urinating (urinary tract infection)
- fast heart rate, confusion and rapid breathing (sepsis, which is a condition associated with an infection and widespread inflammation)
- frequent infections, fever, chills, sore throat or mouth ulcers
- spontaneous bleeding or bruising - possible symptoms of thrombocytopenia which is caused by low levels of platelets

Other side effects
Very common (may affect more than 1 in 10 people):
- headache
- high blood pressure (hypertension)
- abnormal blood test results, including:
- high level of lipase and/or amylase
- high level of cholesterol
- abnormal liver function
- increased level of a muscle enzyme (increased blood creatine phosphokinase)
- increased level of creatinine, an enzyme which may indicate that your kidneys are not functioning properly
- low counts of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
- feeling sick (nausea)
- tiredness, fatigue, pale skin - possible symptoms of anaemia which is caused by low level of red blood cells

Common (may affect up to 1 in 10 people):
- fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold or difficulty breathing - possible symptoms of infection with BK virus
- weight gain
- constipation

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 carton or blister after “EXP”.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Jakavi contains
- The active substance of Jakavi is ruxolitinib.
- Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
- Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
- Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
- Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
- The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate (see section 2), povidone, hydroxypropylcellulose, lactose monohydrate (see section 2).

What Jakavi looks like and contents of the pack
Jakavi 5 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L5” debossed on the other side.
Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side.
Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.

Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets

Not all packs may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

to avoid any potential contamination.
If Jakavi oral solution gets on your skin, immediately wash the area well with soap and water.
If Jakavi oral solution gets in your eyes, immediately rinse your eyes well with cool water.

Do not give Jakavi oral solution if the tamper evident seal is broken or the expiry date has passed.

Remove the child-resistant cap by pushing down on the cap and turning it in the direction of the arrow (anti-clockwise).

Write the date of the first opening on the bottle label.
2 reuseable oral syringes (1 ml size with 0.1 ml graduations)

1 bottle adapter
1 bottle containing Jakavi oral solution
Tip
Barrel
Plunger
Black stopper
Dose markings

firmly. With your other hand, insert the adapter into the bottle using your thumb or palm.

Important: Inserting the adapter may require a high force. Push hard until it is fully inserted.
The adapter should be fully flush with the bottle, and you should not be able to see any ridges.

the bottle adapter.

Push down to ensure the syringe is securely attached.

7.
Carefully turn the bottle upside down and pull down on the plunger until the top of the black stopper lines up with your prescribed dose on the syringe barrel.

Note: Small air bubbles are ok.
8.
Continue to hold the syringe in place and carefully turn the bottle back upright.

Remove the syringe from the bottle by gently pulling straight up.

9.
Check again to be sure that the top of the black stopper is at your prescribed dose.

If not, repeat measuring steps again.
10.
Make sure the child is sitting upright or standing.

Place the end of the syringe inside the mouth with the tip touching inside of either cheek.

Slowly push the plunger all the way down to give the prescribed dose of Jakavi oral solution.

WARNING: Administering to the throat or pushing the plunger too fast may cause choking.

11.
Check there is no Jakavi oral solution left in the syringe. If there is any Jakavi oral solution left in the syringe, administer it.

The child can be given a drink of water after administration to ensure that the whole dose of Jakavi oral solution is swallowed.

Note: If the prescribed dose requires using the syringe twice, repeat the administration steps until the prescribed dose has been administered.

12.
Do not remove the bottle adapter.

Place the child-resistant cap back on the bottle and turn it clockwise to close it.

Make sure the cap is securely attached onto the bottle.

Cleaning the syringe

Note: keep your oral syringe separate from your other kitchen items in order to keep it clean.

1.
Fill a glass with warm water.

2.
Place the syringe into the glass with the warm water.

Pull up and then push down on the plunger to pull the water in and out of the syringe 4 to 5 times.

3.
Remove the plunger from the barrel.

Rinse the glass, plunger and barrel under warm tap water.

4.
Leave the plunger and barrel on a dry surface to air dry before next use.

Always keep the syringe out of reach of children.

Administration via feeding tube
- Always talk to your healthcare provider before administering Jakavi oral solution via a feeding tube. Your healthcare provider should show you how to administer Jakavi oral solution via a feeding tube.
- Jakavi oral solution can be administered via a Nasogastric (NG) or Gastric (G) feeding tube of size French 4 (or greater) and not exceeding 125 cm in length.
- You may need an ENFIT adapter (not included in pack) to connect the 1 ml syringe to the feeding tube.
- Flush the feeding tube according to the manufacturer’s instructions immediately before and after administering Jakavi oral solution.

Opzelura contains the active substance ruxolitinib. It belongs to a group of medicines called Janus kinase inhibitors.

Opzelura is used on the skin to treat vitiligo with facial involvement in adults and adolescents from 12 years. Vitiligo is an autoimmune disease, where the body’s immune system attacks the cells that produce the skin pigment melanin. This causes a loss of melanin, leading to patches of pale pink or white skin. In vitiligo, ruxolitinib reduces the immune system’s activity against the melanin-producing cells, allowing the skin to produce pigment and regain its normal colour.

Opzelura is used on the skin to treat moderate atopic dermatitis, also known as atopic eczema, in adult patients who are inadequately controlled with, or for whom topical corticosteroids and calcineurin inhibitors are inappropriate. Ruxolitinib decreases the inflammation which plays a major role in causing the symptoms of atopic dermatitis. By lowering the inflammation, ruxolitinib can improve your atopic dermatitis, reducing the area of the skin impacted and decreasing the related itching, rash and redness.

Do not use Opzelura
- if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Opzelura.

Opzelura is not for use on the lips, in the eyes, mouth or vagina. If cream accidentally gets into these areas, thoroughly wipe off and/or rinse off the cream with water.

Talk to your doctor or pharmacist before and during treatment with Opzelura if you have ever had a herpes infection (shingles) because Opzelura may allow it to come back. Tell your doctor if you get a painful skin rash with blisters as this can be a sign of shingles.

Children
- Do not give Opzelura to children with vitiligo below the age of 12 years, because it has not been studied in this age group.
- Do not give Opzelura to children with moderate atopic dermatitis below the age of 18 years because its safety and efficacy have not been established in this age group.

Other medicines and Opzelura
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Using Opzelura at the same time as other medicines on the affected skin is not recommended, as it has not been studied.

After applying Opzelura, wait at least 2 hours before applying other medicines, sunscreen or body creams/oils to the same skin area.

Pregnancy and breast-feeding
Opzelura should not be used by pregnant or breast-feeding women as this has not been investigated. If you are a woman of childbearing age, you should use an effective contraception during treatment and during 4 weeks after applying Opzelura for the last time.

It is not known if ruxolitinib passes into breast milk after applying it to the skin. The effects of this medicine in breastfed infants are unknown; therefore, Opzelura should not be used if you are breast-feeding or planning to breastfeed. You may start breast-feeding approximately four weeks after applying Opzelura for the last time.

Driving and using machines
Opzelura is unlikely to have an effect on your ability to drive and use machines.

Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, butylated hydroxytoluene and polysorbate 20
- This medicine contains 150 mg propylene glycol (E1520) in each gram of cream, which may cause skin irritation.
- Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
- Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
- Butylated hydroxytoluene (E321) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
- Polysorbates can cause allergic reactions.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using Opzelura in vitiligo

Recommended dose
- Apply a thin layer of cream twice daily to affected areas of your skin. Wait at least 8 hours between applications.
- The cream should not be used on more than 10% (one tenth) of your body. This surface area represents the equivalent to ten times the palm of one hand with the five fingers.

Method of administration
- This medicine is for use on the skin only.
- Do not apply to skin surfaces other than the ones instructed by your doctor. The medicine should be used at the smallest skin area necessary.
- Wash your hands after applying this medicine, unless you are treating your hands. If someone applies this medicine to you, they should wash their hands after application.
- Avoid washing treated skin for at least 2 hours after application of Opzelura.

Duration of use
Your doctor will decide how long you should use the cream for.
A minimum duration of 6 months is recommended but satisfactory treatment may require over 12 months. If you achieve satisfactory repigmentation of treated areas, consult your doctor to discuss if treatment of those areas could be stopped. Consult your doctor if you experience loss of repigmentation after stopping treatment.

Do not use more than two 100 gram tubes a month.

Using Opzelura in atopic dermatitis

Recommended dose
−
Apply a thin layer of cream twice daily to affected areas of your skin. Wait at least 8 hours between applications.
−
The cream should not be used on more than 20% (one fifth) of your body.

Method of administration
−
This medicine is for use on the skin only.
−
Do not apply to skin surfaces other than the ones instructed by your doctor. The medicine should be used at the smallest skin area necessary.
−
Wash your hands after applying this medicine, unless you are treating your hands. If someone applies this medicine to you, they should wash their hands after application.
−
Avoid washing treated skin for at least 2 hours after application of Opzelura.

Duration of use
Your doctor will decide how long you should use the cream for.
Use every day until lesions of atopic dermatitis have cleared. If your lesions of atopic dermatitis have not cleared after 8 weeks of continuous treatment, consult your doctor.

For the first 8 weeks, do not use more than four 100 gram tubes a month. As the extent of the lesions decreases with treatment, the number of tubes required should decrease accordingly.

If you use more Opzelura than you should
Wipe off the excess cream if this occurs.

If you forget to use Opzelura
If you forget to apply the cream at the scheduled time, do it as soon as you remember, then continue your normal dosing schedule. However, if the next scheduled dose is due within 8 hours, skip the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Opzelura:
Common (may affect up to 1 in 10 people)
- acne at application site

Uncommon (may affect up to 1 in 100 people)
- shingles (herpes zoster): symptoms can include a painful skin rash with blisters

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 tube and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30 ºC.

Once the tube has been opened, use the cream within 6 months but not after the expiry date.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Opzelura contains
- The active substance is ruxolitinib.
One gram of cream contains 15 mg of ruxolitinib.
- The other ingredients are butylated hydroxytoluene (E321), cetyl alcohol, dimeticone (E900), disodium edetate (E385), glyceryl stearate, paraffin (E905), macrogol, medium chain triglycerides, methyl parahydroxybenzoate (E218), phenoxyethanol, phosphoric acid (E338), polysorbate 20 (E432), propylene glycol (E1520), propyl parahydroxybenzoate, purified water, stearyl alcohol, xanthan gum (E415).

See section 2 “Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, butylated hydroxytoluene and polysorbate 20”.

What Opzelura looks like and contents of the pack
Opzelura cream is coloured white to off-white, supplied in tubes containing 5 g and 100 g cream.
There is one tube per carton.

Marketing Authorisation Holder and Manufacturer
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu