dostarlimab: package leaflet

JEMPERLI contains the active substance dostarlimab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.

JEMPERLI works by helping your immune system fight your cancer.

JEMPERLI is used in adults to treat a kind of cancer called endometrial cancer (cancer of the lining of the womb). It is given when cancer is first diagnosed, has spread or cannot be taken out by surgery, or has progressed on or following prior treatment.

JEMPERLI may be given in combination with other anticancer medicines. It is important that you also read the package leaflets for the other anticancer medicines you may be receiving. If you have any questions about these medicines, ask your doctor.

You should not be given JEMPERLI:
- if you are allergic to dostarlimab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before you are given JEMPERLI if you have:

• severe skin rash or peeling, blistering and/or mouth sores;
• immune system problems;

• lung or breathing problems;
• liver or kidney problems;
• any other medical problems.

Warnings and precautions - Take special care with JEMPERLI:
This medicine can cause serious skin reactions. Stop using JEMPERLI and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Symptoms you need to look out for
JEMPERLI can have serious side effects, which can sometimes become life-threatening and can lead to death. These side effects may happen at any time during treatment, or even after your treatment has ended.
You may get more than one side effect at the same time.

You need to be aware of possible symptoms, so your doctor can give you treatment for side effects if necessary.

➔Read the information under ‘Symptoms of serious side effects’ in section 4. Talk to your doctor or nurse if you have any questions or worries.

Children and adolescents
JEMPERLI should not be used in children and adolescents below 18 years of age. The safety and efficacy of JEMPERLI have not been established in this age group.

Other medicines and JEMPERLI
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Some medicines may interfere with the effect of JEMPERLI:
- medicines that make your immune system weak — for example, corticosteroids, such as prednisone.

→ Tell your doctor if you are taking any of these.

However, once you are treated with JEMPERLI, your doctor may give you corticosteroids to reduce any side effects that you may have.

Pregnancy
- You must not be given JEMPERLI if you are pregnant unless your doctor specifically recommends it.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
- JEMPERLI can cause harmful effects or death to your unborn baby.
- If you are a woman who could become pregnant, you must use effective contraception while you are being treated with JEMPERLI and for at least 4 months after your last dose.

Breast-feeding
- If you are breast-feeding, ask your doctor for advice before you are given this medicine.
- You must not breast-feed during treatment and for at least 4 months after your last dose of JEMPERLI.
- It is not known if the active ingredient of JEMPERLI passes into your breast milk.

Driving and using machines
JEMPERLI is unlikely to affect your ability to drive and use machines. However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.

JEMPERLI contains polysorbate 80
This medicine contains 2 mg of polysorbate 80 in each dosage unit. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

JEMPERLI contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free.’ However, before JEMPERLI is given to you, it is mixed with a solution that may contain sodium. Talk to your doctor if you are on a low salt diet.

JEMPERLI will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.

When JEMPERLI is given on its own, the recommended dose of JEMPERLI is 500 mg every 3 weeks for 4 doses, followed by 1000 mg every 6 weeks for all doses thereafter.

When JEMPERLI is given in combination with carboplatin and paclitaxel, the recommended dose of JEMPERLI is 500 mg every 3 weeks for 6 doses, followed by 1000 mg every 6 weeks for all doses thereafter.

Your doctor will give you JEMPERLI as a drip into a vein (intravenous infusion) for about 30 minutes.

Your doctor will decide how many treatments you need.

If you forget an appointment to receive JEMPERLI

➔ Contact your doctor or hospital immediately to reschedule your appointment.

It is very important that you do not miss a dose of this medicine.

If you stop receiving JEMPERLI
Stopping your treatment may stop the effect of the medicine. Do not stop treatment with JEMPERLI unless you have discussed this with your doctor.

Patient Card
Important information from this Package Leaflet can be found in the Patient Card you have been given by your doctor. It is important that you keep this Patient Card and show it to your partner or caregivers.

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

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

Some of the side effects can be serious, and you need to know what symptoms to look out for.

Symptoms of serious side effects
JEMPERLI can cause serious side effects. If you develop symptoms you must tell your doctor or nurse as soon as possible. Your doctor may give you other medicines to prevent more serious complications and

reduce your symptoms. Your doctor may decide that you should miss a dose of JEMPERLI, or stop your treatment altogether.

Conditions
Possible symptoms
Inflammation of lungs
(pneumonitis)
- shortness of breath
- chest pain
- new or worse cough
Inflammation of intestines
(colitis, enteritis, vasculitis gastrointestinal)
- diarrhoea, or more bowel movements than usual
- black, tarry, sticky stools; blood or mucus in stools
- severe stomach pain or tenderness
- feeling sick (nausea), being sick (vomiting)
Inflammation of food pipe and stomach (oesophagitis, gastritis)
- trouble swallowing
- decreased appetite
- burning in the chest (heartburn)
- chest or upper belly pain
- feeling sick (nausea), being sick (vomiting)
Inflammation of liver
(hepatitis)
- feeling sick (nausea), being sick (vomiting)
- loss of appetite
- pain on the right side of the abdomen (stomach)
- yellowing of the skin or the whites of the eyes
- dark-coloured urine
- bleeding or bruising more easily than normal
Inflammation of hormone glands (especially thyroid, pituitary, adrenal, pancreas)
- rapid heartbeat
- weight loss or weight gain
- increased sweating
- hair loss
- feeling cold
- constipation
- abdominal pain
- deeper voice
- muscle aches
- dizziness or fainting
- headache that will not go away or unusual headache
Type 1 diabetes, including diabetic ketoacidosis (acid in the blood produced from diabetes)
- feeling more hungry or thirsty than usual
- needing to urinate more often including at night
- weight loss
- feeling sick (nausea), being sick (vomiting)
- stomach pain
- feeling tired
- unusual sleepiness
- having difficulty thinking clearly
- breath that smells sweet or fruity
- deep or fast breathing
Inflammation of kidneys
(nephritis)
- changes in amount or colour of urine
- swelling of the ankles
- loss of appetite
- blood in the urine
Inflammation of skin
(pemphigoid, Stevens-Johnson syndrome)
- rash, itching, skin blistering
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes; these serious skin rashes can be preceded by fever and flu-like symptoms

Conditions
Possible symptoms
Inflammation of heart muscle
(myocarditis)
- trouble breathing
- dizziness or fainting
- fever
- chest pain and chest tightness
- flu like symptoms
Inflammation of brain and nervous system (myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, encephalitis)
- neck stiffness
- headache
- fever, chills
- vomiting
- eye sensitivity to light
- weakness of eye muscles, drooping eyelids
- dry eyes and blurred vision
- difficulty swallowing, dry mouth
- impaired speech
- confusion and sleepiness
- dizziness
- numbness, pricking, or pins and needles sensations in the hands and feet
- pain
- aching muscles
- difficulty walking or lifting objects
- abnormal heart beat/rate or blood pressure
Inflammation of spinal cord
(myelitis)
- pain
- numbness
- tingling, or weakness in the arms or legs
- bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation Inflammation of eyes
- changes in eyesight
Inflammation of other organs
- severe or persistent muscle or joint pains
- severe muscle weakness
- swollen or cold hands or feet
- feeling tired

Infusion-related reactions
Some people may have allergic-like reactions when they receive an infusion. These usually develop within minutes or hours but may develop up to 24 hours after treatment.

Symptoms include:
- shortness of breath or wheezing;
- itching or rash;
- flushing;
- dizziness;
- chills or shaking;
- fever;
- drop in blood pressure (feeling like passing out).

Solid organ transplant rejection and other complications, including graft-versus-host disease (GvHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may

happen if you underwent transplantation either before or after being treated with JEMPERLI. Your healthcare provider will monitor you for these complications.

➔ Seek medical attention immediately if you think you may be having a reaction.

The following side effects have been reported with JEMPERLI alone.

Very common side effects - (may affect more than 1 in 10 people):
- decrease in the number of red blood cells (anaemia);
- reduced thyroid gland activity;
- diarrhoea; feeling sick (nausea); being sick (vomiting);
- skin redness or rash; blistering of the skin or mucous membranes; itchy skin;
- joint pain;
- high temperature; fever;
- increased liver enzyme levels in the blood.
➔ Check the table above for symptoms of possible serious side effects.

Common side effects - (may affect up to 1 in 10 people):
- overactive thyroid gland;
- decreased secretion of adrenal hormones (adrenal insufficiency);
- inflammation of the lung;
- inflammation of the lining of the bowel (colon);
- inflammation of the pancreas;
- inflammation of the stomach;
- inflammation of the liver;
- muscle pain;
- chills;
- reaction to the infusion;
- hypersensitivity reaction to the infusion.
➔ Check the table above for symptoms of possible serious side effects.

Uncommon side effects - (may affect up to 1 in 100 people):
- inflammation of the brain;
- destruction of red blood cells (Autoimmune haemolytic anaemia);
- inflammation of the pituitary gland, in the base of the brain;
- inflammation of the thyroid gland;
- Type 1 diabetes or diabetic complications (diabetic ketoacidosis);
- inflammation of the food pipe;
- inflammation of the skin (pemphigoid, Stevens-Johnson syndrome);
- a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis);
- inflammation of the joints;
- inflammation of the muscles;
- inflammation of the eye — the iris (the coloured part of the eye) and the ciliary body (area around the iris);
- inflammation of the kidneys.
➔ Check the table above for symptoms of possible serious side effects.

Other side effects that have been reported (frequency not known):
- Coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and bloating after consuming gluten-containing foods);
- Lack or reduction of digestive enzymes made by the pancreas (pancreatic exocrine insufficiency).

The following side effects have been reported with JEMPERLI when given in combination with carboplatin and paclitaxel.

Very common side effects - (may affect more than 1 in 10 people):
- underactive thyroid gland;
- skin rash;
- dry skin;
- high temperature; fever;
- increased liver enzyme levels in the blood.
➔ Check the table above for symptoms of possible serious side effects.

Common side effects - (may affect up to 1 in 10 people):
- overactive thyroid gland;
- inflammation of the lung;
- inflammation of the lining of the bowel (colon);
- inflammation of the pancreas.
➔ Check the table above for symptoms of possible serious side effects.

Uncommon side effects - (may affect up to 1 in 100 people):
- inflammation of the thyroid gland;
- decreased secretion of adrenal hormones (adrenal insufficiency);
- Type 1 diabetes;
- a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenic syndrome);
- inflammation of the nerves that can result in pain, numbness, muscle weakness and difficulty walking (Guillain-Barré syndrome);
- inflammation of the heart muscle;
- inflammation of the stomach;
- inflammation of the blood vessels in the food pipe, stomach or bowel;
- inflammation of the eye;
- inflammation of the joints;
- inflammation of the muscles;
- inflammation throughout the body.
➔ Check the table above for symptoms of possible serious side effects.

Other side effects that have been reported (frequency not known):
- Coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and bloating after consuming gluten-containing foods);
- Lack or reduction of digestive enzymes made by the pancreas (pancreatic exocrine insufficiency).

➔ Contact your doctor or nurse as soon as possible if you develop any of these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor 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.

JEMPERLI will be given to you in a hospital or clinic and the healthcare professionals will be responsible for its storage.

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 and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect from light.

If not used immediately, the prepared infusion may be stored for up to 96 hours at 2 °C to 8 °C followed by 6 hours at room temperature (up to 25 °C) from the time of preparation/dilution until the end of administration. Do not freeze. From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, or 6 hours at room temperature (up to 25 °C), unless dilution has taken place in controlled and validated aseptic conditions. If refrigerated, the prepared infusion must be allowed to come to room temperature prior to use.

Do not use if this medicine contains visible particles.

Do not store any unused medicine for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements. These measures will help protect the environment.

What JEMPERLI contains

The active substance is dostarlimab.

One vial of 10 mL concentrate for solution for infusion (sterile concentrate) contains 500 mg of dostarlimab.

Each mL of concentrate for solution for infusion contains 50 mg of dostarlimab.

The other ingredients are trisodium citrate dihydrate (E331); citric acid monohydrate (E330);
L-arginine hydrochloride; sodium chloride; polysorbate 80 (E433); and water for injection (see section 2).

What JEMPERLI looks like and contents of the pack

JEMPERLI is a clear to slightly opalescent colourless to yellow solution, essentially free from visible particles.

It is available in cartons containing one glass vial.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24

Ireland
D24 YK11

Manufacturer
GlaxoSmithKline Trading Services Ltd.
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma, Italy

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

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Lietuva
GlaxoSmithKline Trading Services Limited
Tel: + 370 80000334

България
GlaxoSmithKline Trading Services Limited
Teл.: + 359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com
Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 80065004
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Nederland
GlaxoSmithKline BV
Tel: + 31 (0) 33 2081100
Eesti
GlaxoSmithKline Trading Services Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700 es-ci@gsk.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44 diam@gsk.com

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
FI.PT@gsk.com
Hrvatska
GlaxoSmithKline Trading Services Limited
Tel: +385 800787089

România
GlaxoSmithKline Trading Services Limited
Tel: + 40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
GlaxoSmithKline Trading Services Limited
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: + 354 535 7000

Slovenská republika
GlaxoSmithKline Trading Services Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045

This leaflet was last revised in

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

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The following information is intended for healthcare professionals only:

Preparation/dilution, storage and administration of the solution for infusion:
- Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. JEMPERLI is a slightly opalescent colourless to yellow solution. Discard the vial if visible particles are observed.

• JEMPERLI is compatible with an IV bag made of polyvinyl chloride (PVC) with or without di(2- ethylhexyl) phthalate (DEHP), ethylene vinyl acetate, polyethylene (PE), polypropylene (PP) or polyolefin blend (PP+PE), and a syringe made from PP.
• For the 500 mg dose, withdraw 10 mL of JEMPERLI from a vial and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9 %) solution for injection or glucose 50 mg/mL (5 %) solution for injection. The final concentration of the diluted solution should be between 2 mg/mL and 10 mg/mL. The total volume of the infusion solution must not exceed 250 mL. This may require withdrawing a volume of diluent from the IV bag prior to adding a volume of JEMPERLI into the IV bag.
• For example, if preparing a 500 mg dose in a 250 mL diluent IV bag, to achieve a 2 mg/mL concentration would require withdrawing 10 mL of diluent from the 250 mL IV bag. Then, 10 mL of JEMPERLI would be withdrawn from the vial and transferred into the IV bag.
• For the 1000 mg dose, withdraw 10 mL of JEMPERLI from each of two vials (withdraw 20 mL total) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9 %) solution for injection or glucose 50 mg/mL (5 %) solution for injection. The final concentration of the diluted solution should be between 4 mg/mL and 10 mg/mL. The total volume of the infusion solution must not exceed 250 mL. This may require withdrawing a volume of diluent from the IV bag prior to adding a volume of JEMPERLI into the IV bag.
• For example, if preparing a 1000 mg dose in a 250 mL diluent IV bag, to achieve a 4 mg/mL concentration would require withdrawing 20 mL of diluent from the 250 mL IV bag. Then, 10 mL of JEMPERLI would be withdrawn from each of two vials, totaling 20 mL, and transferred into the IV bag.
• Mix diluted solution by gentle inversion. Do not shake the final infusion bag. Discard any unused portion left in the vial.
• Store in the original carton until time of preparation in order to protect from light. For storage of the prepared dose, see storage time of the prepared infusion described in section 5.
• JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes by a health care practitioner.
• Tubing should be made of PVC, platinum cured silicon or PP; fittings made from PVC or polycarbonate and needles made from stainless steel.
• A 0.2 or 0.22 micron in-line polyethersulfone (PES) filter must be used during administration of JEMPERLI.
• JEMPERLI must not be administered as an intravenous push or bolus injection.
• Do not co-administer other medicinal products through the same infusion line.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.