Jemperli 500 mg concentrado para solucion para perfusion

Prospect: information for the patient

JEMPERLI 500mg concentrate for solution for infusion

dostarlimab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to refer to it again.
• Your doctor will provide you with a Patient Information Leaflet. Make sure to carry the Patient Information Leaflet with youwhile undergoing treatment with JEMPERLI.
• If you have any questions, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

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

JEMPERLI acts by helping your immune system to fight cancer.

JEMPERLI is used in adults to treat a type of cancer calledendometrial cancer(cancer of the uterine lining). JEMPERLI is administered when the tumor is diagnosed for the first time, has spread, or cannot be removed by surgery, or the patient has progressed during or after a previous treatment.

JEMPERLI may be administered in combination with other cancer medications. It is essential that you also read the leaflets of the other cancer medications you may be receiving. If you have any questions about these medications, consult your doctor.

You should not receive JEMPERLI:

• if you are allergic to dostarlimab or any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Consult your doctor or nurse before receiving JEMPERLI if you have:

• immunological problems;
• respiratory or pulmonary problems;
• liver or kidney problems;
• severe rash;
• other medical problems.

Symptoms to watch for

JEMPERLI may cause some serious side effects, which in some cases may put your life at risk and cause death. These side effects may occur at any time during treatment, or even after 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 necessary.

??Read the informationunder ‘Serious side effect symptoms’ in section4. Consult your doctor or nurse if you have any questions or concerns.

Children and adolescents

JEMPERLIshould not be used in children and adolescents under 18years.

Other medications and JEMPERLI

Inform your doctor or nurseif you are taking, have taken recently, or may need to take any other medication.

Some medications may affect the effect of JEMPERLI:

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

??Inform your doctorif you are taking any of these medications.

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

Pregnancy

• You should not receive JEMPERLI if you are pregnantunless your doctor specifically recommends it.
• If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before receiving this medication.
• JEMPERLI may cause harmful effects or death of the fetus.
• If you are a woman who may become pregnant, you must use an effectivecontraceptivemethod while receiving treatment with JEMPERLI and for at least 4months after your last dose.

Breastfeeding

• If you are breastfeeding,consult your doctorbefore receiving this medication.
• You should not breastfeedwhile receiving treatment and for at least 4months after your last dose of JEMPERLI.
• The active ingredient in JEMPERLI is unknown to pass into breast milk.

Driving and operating machinery

It is unlikely that JEMPERLI will affect your ability to drive and operate machinery. However, if you have side effects that affect your concentration and reaction, you should be careful when driving or using machinery.

JEMPERLI contains sodium

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

JEMPERLI will be administered in a hospital or clinic under the supervision of an experienced oncologist.

When JEMPERLI is administered as monotherapy, the recommended dose of JEMPERLI is 500mg every 3weeks for 4doses, followed by

1000mg every 6weeks for subsequent doses.

When JEMPERLI is administered in combination with carboplatin and paclitaxel, the recommended dose ofJEMPERLI is500mg every 3weeks for 6doses, followed by 1000mg every 6weeks for subsequent doses.

Your doctor will administer JEMPERLI through a vein by infusion (intravenous infusion) for about 30minutes.

Your doctor will decide how many treatment cycles you need.

If you missed an appointment to receive JEMPERLI

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

It is very importantthat you do not miss any doses of this medication.

If you interrupt treatment with JEMPERLI

Interrupting your treatment may stop the medication's effect. Do not interrupt treatment with JEMPERLI unless you have discussed it with your doctor.

Patient Information Leaflet

The important information in this leaflet can be found in the Patient Information Leaflet that your doctor gave you. It is essential that you keep this Patient Information Leaflet and show it to your partner or caregivers.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be severe, and you need to know what symptoms to pay attention to.

Severe side effect symptoms

JEMPERLI can cause severe side effects. If you experience symptoms, you should inform your doctor or nurse as soon as possible.They 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 treatment altogether.

Reactions related to infusion

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

The symptoms include:

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

Transplant rejection 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 (allogenic).These complications can be severe and life-threatening. These complications can occur if you have had a transplant before or after receiving JEMPERLI treatment. Your doctor will monitor you for these complications.

??Seek medical attention immediatelyif you think you are having a reaction.

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

Very common side effects– (can affect more than 1 in 10 people):

• decreased red blood cell count (anemia);
• reduced thyroid gland activity;
• diarrhea; nausea and vomiting;
• skin redness or eruption; blisters on the skin or mucous membranes; itching on the skin;
• joint pain;
• elevated body temperature, fever;
• increased liver enzyme levels in the blood.

??See the previous table for possible severe side effect symptoms.

Common side effects– (can affect up to 1 in 10 people):

• overactive thyroid gland;
• adrenal insufficiency;
• lung inflammation;
• inflammation of the colon;
• pancreatitis;
• stomach inflammation;
• liver inflammation;
• muscle pain;
• chills;
• infusion reaction;
• hypersensitivity reaction to infusion.

??See the previous table for possible severe side effect symptoms.

Rare side effects– (can affect up to 1 in 100 people):

• brain inflammation;
• autoimmune hemolytic anemia;
• inflammation of the pituitary gland, located at the base of the brain;
• thyroid gland inflammation;
• type 1 diabetes or diabetic complications (diabetic ketoacidosis);
• esophageal inflammation;
• myasthenia gravis;
• joint inflammation;
• muscle inflammation;
• generalized inflammation of the body.

?See the previous table for possible severe side effect symptoms.

Other side effects reported(unknown frequency):

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

JEMPERLI will be administered in a hospital or clinic and healthcare professionals will be responsible for its storage.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in 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 to the end of administration.

Do not use this medication if you observe visible particles.

Do not store unused medication for reutilization. All unused medication or residual material must be disposed of in accordance with local requirements. These measures will help protect the environment.

Composition of JEMPERLI

• The active ingredient is dostarlimab.

• One vial of 10 ml of 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 components are trisodium citrate dihydrate; citric acid monohydrate; L-arginine hydrochloride; sodium chloride; polisorbate 80; and water for injection preparations (see section 2).

Appearance of the product and contents of the package

JEMPERLI is a transparent to slightly opalescent, colorless to yellow, essentially particle-free solution.

It is available in containers that contain a glass vial.

Marketing Authorization Holder

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible for manufacturing

GlaxoSmithKline Trading Services Ltd.

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

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

Last review date of this leaflet:

Other sources of information

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