Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - jemperli

Document Subject

Generated Narrative: MedicinalProductDefinition mpd03e5fa52b6e02a038d1625a63e785b4

identifier: http://ema.europa.eu/identifier/EU/1/21/1538/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: JEMPERLI 500 mg concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d03e5fa52b6e02a038d1625a63e785b4

identifier: http://ema.europa.eu/identifier/EU/1/21/1538/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - jemperli

Attesters

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

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.

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:

• 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 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) Conditions Possible symptoms 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
• rash, itching, dry skin, peeling or skin sores
• ulcers in the mouth, nose, throat or genital area 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-Barr 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 Conditions Possible symptoms
• confusion and sleepiness
• dizziness
• pricking or pins and needles sensations in the hands and feet
• 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;
• 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.

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
• decreased secretion of adrenal hormones (adrenal insufficiency)
• inflammation of the lung
• inflammation of the lining of the bowel (colon). 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

• 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 heart muscle

• inflammation of the pancreas

• 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.

  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 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.

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 (Ireland) Limited 12 Riverwalk Citywest Business Campus Dublin Ireland

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

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

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
T l/Tel: + 32 (0) 10 85 52 Lietuva GlaxoSmithKline (Ireland) Limited Tel: + 370 80000
GlaxoSmithKline (Ireland) Limited Te .: + 359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g GlaxoSmithKline (Ireland) Limited Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline (Ireland) Limited Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0) 33 2081Eesti GlaxoSmithKline (Ireland) Limited Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com
Hrvatska GlaxoSmithKline (Ireland) Limited Tel: +385 800787Rom nia GlaxoSmithKline (Ireland) Limited Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija GlaxoSmithKline (Ireland) Limited Tel: + 386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika GlaxoSmithKline (Ireland) Limited Tel: + 421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline (Ireland) Limited : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GlaxoSmithKline (Ireland) Limited Tel: + 371 80205United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: