500 mg concentrate for infusion solution
dostarlimab
What JEMPERLI is and what it is used for
JEMPERLI contains the active substance dostarlimab, which is a monoclonal antibody, ie. a type of protein that is designed to recognize and bind to a specific target substance in the body.
JEMPERLI works by helping the immune system fight cancer.
JEMPERLI is used in adults to treat a type of cancer called uterine cancer (cancer of the uterine lining). It is given when cancer has spread or cannot be operated on and has continued to grow during or after previous treatment.
What you need to know before using JEMPERLI
You should not receive JEMPERLI:
- if you are allergic to dostarlimab or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or nurse before receiving JEMPERLI if you have:
- problems with the immune system
- lung or breathing problems
- liver or kidney problems
- severe skin rash
- other medical problems.
Symptoms that you need to be aware of
JEMPERLI can cause serious side effects that can sometimes be life-threatening and lead to death. These side effects can occur at any time during treatment and even after treatment has ended. You can get more than one side effect at a time.
You need to be aware of any symptoms so that your doctor can give you treatment for side effects if needed.
→ Read the information under “Symptoms of serious side effects” in section 4. Talk to your doctor or nurse if you have any questions or concerns.
Children and young people
JEMPERLI should not be used in children and adolescents under 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 affect the effect of JEMPERLI:
- drugs that weaken the immune system, for example corticosteroid s that prednisone.
→ Tell your doctor if you are taking such medicine.
However, when you are being treated with JEMPERLI, your doctor may give you corticosteroids to reduce any side effects.
Pregnancy and breastfeeding
Pregnancy
- You must not be given JEMPERLI if you are pregnant unless your doctor explicitly recommends it.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- JEMPERLI can cause birth defects or fetal death.
- If you are a woman of childbearing potential , you must use an effective method of 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, talk to your doctor before taking this medicine.
- You must not breast-feed during treatment and for at least 4 months after your last dose of JEMPERLI.
- It is unknown whether 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 experience side effects that affect your ability to concentrate and react, you should be careful when driving or using machines.
JEMPERLI contains polysorbate and sodium
JEMPERLI contains polysorbate 80
This medicine contains 2 mg of polysorbate 80 in each vial. In rare cases, polysorbate can cause severe allergic reactions. If you have difficulty breathing or swelling or feel dizzy, see a doctor immediately.
JEMPERLI contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free. Before receiving JEMPERLI, however, it is mixed with a solution that may contain sodium. Talk to your doctor if you are on a low-salt diet.
How to use JEMPERLI
You will receive JEMPERLI in a hospital or clinic under the supervision of a doctor who has experience in treating cancer.
The recommended dose of JEMPERLI is 500 mg every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks for all subsequent cycles.
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 miss a visit then you would have received JEMPERLI
→ Contact a doctor or hospital immediately to book a new visit.
You mustn’t miss a dose of this medicine.
If you stop taking JEMPERLI
If you stop treatment, the effect of the medicine may stop. Do not stop treatment with JEMPERLI unless you have discussed it with your doctor.
Patient card
Important information in this leaflet can be found on the patient care provided by your doctor. You must save the patient card and show it to your partner or caregiver.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious, and you need to know what symptoms to look out for.
Symptoms of a serious side effect s
JEMPERLI can cause serious side effects due to inflammation. If you get symptoms of inflammation, you must tell your doctor or nurse as soon as possible. Your doctor may prescribe you other medicines to prevent more serious complications and reduce your symptoms. Your doctor may decide to skip a dose of JEMPERLI or stop your treatment completely.
| Inflammation in | Possible symptoms |
|---|---|
| Lungs | shortness of breath chest pain new or worsening cough ( pneumonitis ) |
| Intestines ( colitis ) | diarrhea or more frequent bowel movements than normal black, tarry, sticky stools; blood or mucus in the stools every abdominal pain or tenderness nausea, vomiting |
| Liver ( hepatitis ) | nausea, vomiting decreased / no appetite pain on the right side of the abdomen (stomach)yellowing of the skin or whites of the eye dark urine greater tendency to bleed or bruise than normal |
| Hormone glands (especially the thyroid gland, pituitary gland, adrenal glands, and pancreas) | palpitation weight loss or weight gain increased sweating hair loss freezing unitconstipationabdominal pain deeper voice muscle aches dizziness or fainting headache that does not go away or unusual headache |
| Kidneys (nephritis) | altered amount and color of urineswollen ankles decreased / no appetite blood in the urine |
| Skin | skin rash, itching, scaly skin or skin ulcer sores in the mouth, nose, throat, or around the genitals |
| Eyes | visual changes |
| Other organs | severe or persistent muscle or joint pain severe muscle weakness swollen or cold hands or feet fatigue |
Infusion-related reactions
Some people may get allergic reactions when they receive an infusion. These usually occur within a few minutes or hours but can develop up to 24 hours after treatment.
The symptoms can be:
- shortness of breath or wheezing
- itching or rash
- redness
- dizziness
- chills or tremors
- fever
- drop in blood pressure (feeling faint).
Rejection of transplanted organs and other complications, including graft vs Host Disease (GvHD), in people who have had a bone marrow transplant ( stem cells ) with donor stem cells (allogeneic). These complications can be serious and lead to death. These complications can occur if you undergo a transplant either before or after treatment with JEMPERLI. Your doctor will monitor you for these complications.
→ Seek medical attention immediately if you think you may have reacted.
The following side effects have been reported with dostarlimab treatment alone.
Very common side effects are (can occur in more than 1 in 10 people)
- decreased number of red blood cells ( anemia )
- decreased thyroid activity
- diarrhea, nausea, vomiting
- redness or rash, blisters on the skin or mucous membranes, itching
- high temperature, fever
- elevated levels of liver enzymes in the blood.
→ See the table above for symptoms of possible serious side effects.
Common side effects are (may affect up to 1 in 10 people)
- overactive thyroid gland
- decreased secretion of hormones from the adrenal glands (adrenal insufficiency)
- pneumonia
- inflammation of the lining of the colon ( colon )
- inflammation of the pancreas
- muscle or joint pain
- overindulge
- infusion reaction
- hypersensitivity reaction to infusion one.
→ See the table above for symptoms of possible serious side effects.
Less common side effects are (may affect up to 1 in 100 people)
- inflammation of the pituitary gland , located on the underside of the brain
- inflammation of the thyroid gland
- type 1 diabetes or diabetic complications (diabetic ketoacidosis )
- inflammation of the iris (the colored part of the eye) and of the ciliary body (the area around the iris)
- inflammation of the kidneys.
→ See the table above for symptoms of possible serious side effects.
→ Tell your doctor or nurse as soon as possible if you get any of these symptoms.
How to store JEMPERLI
Dostarlimab will be given to you at a hospital or reception and the healthcare staff will be responsible for storing the medicine.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label on the carton and vial after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2-8 ° C). Do not freeze. Store in the original package. Sensitive to light.
If the reconstituted infusion solution is not used immediately, it can be stored for up to 24 hours at 2-8 ° C or up to 6 hours at room temperature (up to 25 ° C) from the time of reconstitution/dilution until the end of an administration.
Do not use this medicine if it contains visible particles.
Do not store unused medicine for reuse. Any unused product or waste material should be disposed of by local requirements. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is dostarlimab.
One vial of 10 ml concentrate for solution for infusion (sterile concentrate) contains 500 mg dostarlimab.
Each ml of concentrate for solution for infusion contains 50 mg dostarlimab.
The other ingredients are trisodium citrate dihydrate, citric acid monohydrate, L-arginine hydrochloride, sodium chloride, polysorbate 80, water for injections (see section 2).
What the medicine looks like and contents of the pack
JEMPERLI is a clear to slightly mother-of-pearl colorless to the yellow solution, essentially free of visible particles.
The medicine is supplied in cartons containing a glass vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation 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
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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