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Jemperli 500mg/10ml Injection
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Indications & Clinical Uses
- Jemperli 500 mg/10 mL concentrate contains dostarlimab (dostarlimab-gxly in the United States), a programmed death receptor-1 blocking monoclonal antibody, a type of immunotherapy.
- It is approved for adults with primary advanced or recurrent endometrial cancer, given with carboplatin and paclitaxel and then continued alone, and as a single agent for mismatch repair deficient recurrent or advanced endometrial cancer that has progressed after a platinum-based regimen.
- The United States label adds an accelerated-approval indication for adults with mismatch repair deficient recurrent or advanced solid tumours of any type that have progressed on prior treatment and have no satisfactory alternative; that tissue-agnostic use is not part of the European authorisation, which covers endometrial cancer only.
- Jemperli is authorised in the European Union since 21 April 2021 and is given only in hospital or a specialist cancer clinic by a healthcare professional as an intravenous infusion.
Side Effects
- With carboplatin and paclitaxel, reactions affecting more than 1 in 5 people include reduced haemoglobin in 79 percent, raised creatinine in 75 percent, nerve tingling or numbness in 64 percent, tiredness in 56 percent, nausea in 54 percent, hair loss in 54 percent, rash in 37 percent and joint pain in 37 percent.
- Used alone, tiredness or weakness affects 42 percent, anaemia 30 percent, diarrhoea 25 percent and nausea 22 percent.
- Jemperli carries NO boxed warning.
- Because it switches on the immune system it can cause severe or fatal immune-mediated inflammation of the lungs in 2.3 percent, bowel in 1.3 percent, liver in 0.5 percent, and of hormone glands, kidneys and skin.
- Severe infusion reactions can occur.
- Report new breathlessness or cough, persistent diarrhoea, severe abdominal pain, yellowing of the skin, or extreme tiredness at once.
Precautions & Warnings
- Jemperli must be diluted before use and given as an intravenous infusion over 30 minutes; it must never be given as an intravenous push or bolus.
- Your healthcare team will check blood counts, kidney, liver and thyroid function and blood glucose before and during treatment and will watch for immune-related inflammation, which can appear weeks or months after a dose and may need corticosteroids or permanent stopping of treatment.
- Tell your team about any autoimmune condition, a previous organ or stem cell transplant, or ongoing steroid or immunosuppressant use.
- Dostarlimab can harm an unborn baby, so women able to become pregnant must use effective contraception during treatment and for four months after the last dose, and breastfeeding must be avoided.
- Vials are kept refrigerated at 2 to 8 degrees Celsius in the original carton and must not be frozen or shaken.
Avoid Interactions
- The Jemperli label does not list a formal drug interaction section, but several combinations matter in practice.
- Medicines that can worsen toxicity or mask it include systemic corticosteroids and other immunosuppressants started before treatment, which may blunt how well dostarlimab works; your team will normally treat immune-related side effects with steroids only once they appear.
- When given with carboplatin and paclitaxel, the chemotherapy adds bone marrow suppression, nerve damage and hair loss, so blood counts are monitored closely.
- Live and live-attenuated vaccines are generally avoided during immunotherapy; inactivated vaccines should be discussed with your team first.
- At pharmacy level, Jemperli must be diluted only in 0.9 percent sodium chloride or 5 percent dextrose to 2 to 10 mg per mL and must not be mixed with other medicines in the same line.
- Tell your prescriber about all medicines, herbal products and supplements.
References
Frequently Asked Questions
Jemperli (dostarlimab) treats adults with primary advanced or recurrent endometrial cancer, given with carboplatin and paclitaxel then continued alone. The US label also covers mismatch repair deficient endometrial cancer after platinum therapy and, under accelerated approval, mismatch repair deficient advanced solid tumours of any type.
Jemperli (dostarlimab) is given by a healthcare professional as a drip into a vein over 30 minutes. The usual schedule is 500 mg every 3 weeks for the first four to six cycles, then 1,000 mg every 6 weeks. It must never be given as a rapid injection.
Common Jemperli (dostarlimab) side effects include anaemia, tiredness, nausea, diarrhoea, rash, joint pain and raised creatinine. Because it activates the immune system, it can inflame the lungs, bowel, liver, thyroid or kidneys. Report new cough, breathlessness, persistent diarrhoea, severe stomach pain or yellow skin straight away.
Avoid live vaccines and pregnancy while receiving Jemperli (dostarlimab). Tell your team before starting any steroid or immunosuppressant, or if you have an autoimmune disease or past transplant, because these change how immunotherapy works. Jemperli must not be mixed with other medicines in the same infusion line.
Jemperli (dostarlimab) is diluted in saline or dextrose and infused into a vein over about 30 minutes in a hospital or cancer clinic. Staff watch for infusion reactions such as fever, chills, flushing or breathlessness and can slow or stop the drip. Blood tests are taken before each cycle.
No. Jemperli (dostarlimab) can harm an unborn baby, so pregnancy must be avoided. Women able to become pregnant need effective contraception during treatment and for four months after the last dose. Breastfeeding is not recommended during treatment or for four months afterwards.
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