JEMPERLI 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

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.

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

Talk 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.

Possible side effects

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 Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 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; citric acid monohydrate;

L-arginine hydrochloride; sodium chloride; polysorbate 80; 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 UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

UK

Manufacturer

GlaxoSmithKline Trading Services Ltd.

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Jemperli

Reference number: 19494/0297

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in April 2021

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

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.