JEMPERLI- dostarlimab injection
GlaxoSmithKline LLC
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MEDICATION GUIDE JEMPERLI (jem-PER-lee) (dostarlimab-gxly) injection |
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What is the most important information I should know about JEMPERLI? JEMPERLI is a medicine that may treat certain cancers by working with your immune system. JEMPERLI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. |
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Intestinal problems.
Liver problems. |
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Hormone gland problems. |
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Kidney problems. |
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Skin problems. |
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Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with JEMPERLI. Call or see your healthcare provider right away for any new or worse signs or symptoms. |
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Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: |
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Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. 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. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with JEMPERLI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with JEMPERLI, if you have severe side effects. |
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What is JEMPERLI? JEMPERLI is a prescription medicine used to treat adults with certain cancers that have been shown by a laboratory test to be mismatch repair deficient (dMMR), and your cancer has returned, or it has spread (advanced cancer). JEMPERLI may be used when:
It is not known if JEMPERLI is safe and effective in children. |
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Before receiving JEMPERLI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
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How will I receive JEMPERLI?
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What are the possible side effects of JEMPERLI? JEMPERLI can cause serious side effects.
The most common side effects of JEMPERLI in people with dMMR solid tumors include: |
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These are not all of the possible side effects of JEMPERLI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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General information about the safe and effective use of JEMPERLI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about JEMPERLI, talk with your healthcare provider. You can ask your healthcare provider for information about JEMPERLI that is written for healthcare professionals. |
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What are the ingredients in JEMPERLI? Active ingredient: dostarlimab-gxly Inactive ingredients: citric acid monohydrate, L-arginine hydrochloride, polysorbate 80, sodium chloride, trisodium citrate dihydrate, and Water for Injection. For more information, call 1-888-825-5249 or go to www.gsk.com. Trademarks are owned by or licensed to the GSK group of companies. Manufactured by: GlaxoSmithKline LLC, Philadelphia, PA 19104, U.S. License No. 1727 Distributed by: GlaxoSmithKline, Durham, NC 27701 ©2023 GSK group of companies or its licensor. JMP:3MG |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2023