JEMPERLI 500 mg CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

JEMPERLI 500mg concentrate for solution for infusion

dostarlimab

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• Your doctor will give you the Patient Information Card. Make sure to carry the Patient Information Card with you while you are being treated with JEMPERLI.
• If you have any further questions, ask your doctor or nurse.
• If you experience side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is JEMPERLI and what is it used for
2. What you need to know before you are given JEMPERLI
3. How JEMPERLI is given
4. Possible side effects
5. Storage of JEMPERLI
6. Contents of the pack and further information

1. What is JEMPERLI and what is it used for

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

JEMPERLI works by helping your immune system fight cancer.

JEMPERLI is used in adults to treat a type of cancer called endometrial cancer(cancer of the lining of the uterus). JEMPERLI is given when the tumor is first diagnosed, has spread, or cannot be removed by surgery, or the patient has progressed during or after previous treatment.

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

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

JEMPERLI must not be given to you:

• if you are allergic to dostarlimab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• problems with your immune system;
• breathing or lung problems;
• liver or kidney problems;
• severe skin rash;
• other medical problems.

Symptoms to look out for

JEMPERLI may cause some serious side effects, which in some cases can be life-threatening and may cause death. These side effects may occur at any time during treatment, or even after your treatment has ended. You may have more than one side effect at the same time.

You should be aware of the possible symptoms, so that your doctor can give you treatment for the side effects if needed.

• Read the informationunder ‘Symptoms of serious side effects’ in section 4. Ask your doctor or nurse if you have any questions or concerns.

Children and adolescents

JEMPERLI must not be used in children and adolescents under 18 years.

Other medicines and JEMPERLI

Tell your doctor or nurseif you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way JEMPERLI works:

• medicines that weaken your immune system – for example, corticosteroids, such as prednisone.

• Tell your doctorif you are taking any of these medicines.

However, once you receive treatment with JEMPERLI, your doctor may give you corticosteroids to reduce the side effects you may have.

Pregnancy

• JEMPERLI must not be given to you if you are pregnantunless 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 may harm or kill the unborn baby.
• If you are a woman who could become pregnant, you must use an effective contraceptive methodwhile 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 doctorbefore you are given this medicine.
• Do not breast-feedwhile you are being treated and for at least 4 months after your last dose of JEMPERLI.
• It is not known if the active substance in JEMPERLI passes into breast milk.

Driving and using machines

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

JEMPERLI contains polysorbate 80

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

JEMPERLI contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”. However, before JEMPERLI is given to you, it is mixed with a solution that may contain sodium. Ask your doctor if you are on a low-sodium diet.

3. How JEMPERLI is given

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

When JEMPERLI is given alone, the recommended dose of JEMPERLI is 500 mg every 3 weeks for 4 doses, followed by 1000 mg every 6 weeks for subsequent doses.

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 subsequent doses.

Your doctor will give you JEMPERLI into a vein by infusion (intravenous infusion) over about 30 minutes.

Your doctor will decide how many treatments (cycles) you need.

If you miss an appointment to receive JEMPERLI

• Contact your doctor or hospital immediatelyto reschedule your appointment.

It is very importantthat you do not miss any dose of this medicine.

If you stop treatment with JEMPERLI

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

Patient Information Card

Important information from this leaflet can be found on the Patient Information Card that your doctor gave you. It is important that you keep this Patient Information 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some of the adverse effects can be serious, and it is necessary for you to pay attention to the symptoms.

Symptoms of Serious Adverse Effects

JEMPERLI can cause serious adverse effects. If you experience symptoms, you mustinform 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 skip a dose of JEMPERLI or interrupt treatment completely.

Infusion-Related Reactions

Some people may have allergic reactions when receiving an infusion. They usually occur within minutes or hours, but can occur up to 24 hours after treatment.

The symptoms include:

• shortness of breath or wheezing;
• itching or rash;
• flushing (redness of the skin);
• dizziness;
• chills or shaking;
• fever;
• drop in blood pressure (feeling of loss of consciousness).

Rejection of Solid Organ Transplants and Other Complications, Including Graft-Versus-Host Disease (GVHD), in People Who Have Received a Bone Marrow Transplant (Stem Cell Transplant) Using Donor Stem Cells (Allogeneic).These complications can be serious and life-threatening. These complications can occur if you have had a transplant before or after receiving treatment with JEMPERLI. Your doctor will monitor you for these complications.

• Seek medical attention immediatelyif you think you may be having a reaction.

The following adverse effects have been reported with JEMPERLI in monotherapy.

Very Common Adverse Effects– (may affect more than 1 in 10people):

• decrease in the number of red blood cells (anemia);
• reduced activity of the thyroid gland;
• diarrhea; nausea and vomiting;
• redness or rash on the skin; blisters on the skin or mucous membranes; itching of the skin;
• joint pain;
• high temperature, fever;
• increase in liver enzyme levels in the blood.

• Consult the tableabove for symptoms of possible serious adverse effects.

Common Adverse Effects– (may affect up to 1 in 10people):

• overactive thyroid gland;
• decreased secretion of adrenal hormones (adrenal insufficiency);
• inflammation of the lung;
• inflammation of the intestinal mucosa (colon);
• inflammation of the pancreas;
• inflammation of the stomach;
• inflammation of the liver;
• muscle pain;
• chills;
• infusion reaction;
• hypersensitivity reaction to the infusion.

• Consult the tableabove for symptoms of possible serious adverse effects.

Uncommon Adverse Effects– (may affect up to 1 in 100people):

• inflammation of the brain;
• destruction of red blood cells (autoimmune hemolytic anemia);
• inflammation of the pituitary gland, located at the base of the brain;
• inflammation of the thyroid gland;
• type 1 diabetes or diabetic complications (diabetic ketoacidosis);
• inflammation of the esophagus;
• a condition where the muscles weaken and rapid muscle fatigue occurs (myasthenia gravis);
• inflammation of the joints;
• inflammation of the muscles;
• inflammation of the eye – of the iris (colored part of the eye) and the ciliary body (area around the iris);
• inflammation of the kidneys.

• Consult the tableabove for symptoms of possible serious adverse effects.

Other Adverse Effects That Have Been Reported(frequency not known):

• Celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods that contain gluten);
• Absence or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency).

The following adverse effects have been reported with JEMPERLI when administered in combination with carboplatin and paclitaxel.

• Very Common Adverse Effects– (may affect more than 1 in 10people):
• reduced activity of the thyroid gland;
• skin rash;
• dry skin;
• high temperature, fever;
• increase in liver enzyme levels in the blood.

• Consult the tableabove for symptoms of possible serious adverse effects.

• Common Adverse Effects– (may affect up to 1 in 10people):
• overactive thyroid gland;
• inflammation of the lung;
• inflammation of the intestinal mucosa (colon);
• inflammation of the pancreas.

• Consult the tableabove for symptoms of possible serious adverse effects.

• Uncommon Adverse Effects– (may affect up to 1 in 100people):
• inflammation of the thyroid gland;
• decreased secretion of adrenal hormones (adrenal insufficiency);
• type 1 diabetes;
• a condition where the muscles weaken and rapid muscle fatigue occurs (myasthenia gravis);
• inflammation of the nerves that can cause 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 esophagus, stomach, or intestine;
• inflammation of the eye;
• inflammation of the joints;
• inflammation of the muscles;
• generalized inflammation of the body.

• Consult the tableabove for symptoms of possible serious adverse effects.

Other Adverse Effects That Have Been Reported(frequency not known):

• Celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods that contain gluten);
• Absence or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency).

• Contact your doctor or nurse as soon as possibleif you develop any of these symptoms.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of JEMPERLI

JEMPERLI will be administered to you in a hospital or clinic, and 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 expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

If the prepared infusion is not used immediately, it can be stored for up to 24 hours between 2°C and 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 this medicine if you observe visible particles.

Do not store unused medicine for reuse. Any unused medicine or residual material must be disposed of according to local requirements. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of JEMPERLI

• The active ingredient is dostarlimab.

• A 10 ml vial of concentrate for solution for infusion (sterile concentrate) contains 500 mg of dostarlimab.

• Each ml of concentrate for solution for infusion contains 50mg of dostarlimab.

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

Appearance of the Product and Package Contents

JEMPERLI is a clear to slightly opalescent solution, colorless to yellow, essentially free of visible particles.

It is available in packages containing one glass vial.

Marketing Authorization Holder

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Trading Services Ltd.

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma, Italy

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.