Jemperli - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

JEMPERLI 500 mg concentrate for solution for infusion

dostarlimab

VThis medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – Your doctor will provide you with a Patient Card. Be sure to keep this Card with you while undergoing treatment with JEMPERLI.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse.This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What JEMPERLI is and what it is used for

• 2. What you need to know before you are given JEMPERLI

• 3. How JEMPERLI is given

• 4. Possible side effects

• 5. How to store JEMPERLI

• 6. Contents of the pack and other information

1. What JEMPERLI is and what it is used for

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 has spread, or cannot be taken out by surgery, and has progressed on or following prior treatment.

2. What you need to know before you are given JEMPERLI

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

alk to your doctor or nurse before you are given JEMPERLI if you have:

• immune system problems;
• lung or breathing problems;
• liver or kidney problems;
• serious rash;
• any other medical problems.

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.

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. Rarely, polysorbates can cause severe allergic reactions. If you have breathing difficulty or swelling or you feel faint, get medical help at once.

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.

• 3. How JEMPERLI is given

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

The recommended dose of JEMPERLI is 500 mg every 3 weeks for 4 doses, followed by 1000 mg every 6 weeks for all cycles 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.

4. Possible side effects

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 due to inflammation. If you develop symptoms of inflammation, 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.

Inflammation of	Possible symptoms
Lungs	shortness of breath chest pain new or worse cough (pneumonitis)
Intestines (colitis)	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)
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

Inflammation of	Possible symptoms
	bleeding or bruising more easily than normal
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
Kidneys (nephritis)	changes in amount or colour of urine swelling of the ankles loss of appetite blood in the urine
Skin	rash, itching, peeling or skin sores ulcers in the mouth, nose, throat or genital area
Eyes	changes in eyesight
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 dostarlimab 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;
• 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;
• muscle or joint 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 pituitary gland, in the base of the brain;
• inflammation of the thyroid gland;
• Type 1 diabetes or diabetic complications (diabetic ketoacidosis);
• 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.

• ^ 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.

5. How to store JEMPERLI

Dostarlimab 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 24 hours at 2 °C to 8 °C or 6 hours at room temperature (up to 25 °C) from the time of preparation/di­lution until the end of administration.

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.

6. Contents of the pack and other information

What JEMPERLI looks like and contents of the pack

dk-info@gsk. com

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 (Ireland) Limited Tel: + 372 8002640	Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00
EZ/.döa GlaxoSmithKline Movonpóo^nq A.E.B.E. T|k + 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	Portugal GlaxoSmithKline – Produtos Farmacéuticos, Lda. Tel: + 351 21 412 95 00 FI.PT@gsk. com
Hrvatska GlaxoSmithKline (Ireland) Limited Tel: +385 800787089	Romanía GlaxoSmithKline (Ireland) Limited Tel: + 40 800672524
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000	Slovenija GlaxoSmithKline (Ireland) Limited Tel: + 386 80688869
Ísland Vistor hf. Sími: + 354 535 7000	Slovenská republika GlaxoSmithKline (Ireland) 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
Kúnpog GlaxoSmithKline (Ireland) Limited T|k + 357 80070017	Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.
Latvija GlaxoSmithKline (Ireland) Limited Tel: + 371 80205045	United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221441 customercontac­tuk@gsk. com

This leaflet was last revised in

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

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

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.
• 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.
• For the 1,000 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 2 mg/mL and 10 mg/mL.
• 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. The prepared

dose may be stored either:

• – At room temperature up to 25 °C for no more than 6 hours from the time of dilution until the end of infusion.

• – Under refrigeration at 2 °C – 8 °C for no more than 24 hours from time of dilution until end of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

• JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes by a health care practitioner.
• JEMPERLI must not be administered as an intravenous push or bolus injection.
• Do not co-administer other medicinal products through the same infusion line.