Dostarlimab

Dostarlimab is used to treat adults with specific cancers when other treatments have not worked, have stopped working, or when the cancer has come back, spread, or cannot be removed by surgery.

Your doctor will confirm that your tumor type is suitable for treatment with dostarlimab.

Dostarlimab may also be used for reasons not mentioned in this medication guide.

Dostarlimab is given as an injection into a vein by a healthcare provider. This injection is done slowly over 30 minutes.

Dostarlimab is typically administered every 3 weeks at the beginning, and then every 6 weeks afterward.

You may need medical tests to help decide how long you should continue using dostarlimab.

Call your doctor right away if you have new or worsening symptoms like: cough, chest pain, trouble breathing, severe stomach pain, diarrhea, bloody or dark stools, headaches, confusion, severe weakness, vision problems, less urination, bruising or bleeding, blood in your urine, dark urine, or yellowing of your skin or eyes.

Tell your doctor if you have ever had:

• breathing problems; or
• immune system problems.

This medicine may harm an unborn baby. You may need a pregnancy test to confirm that you are not pregnant. Use birth control while using dostarlimab and for at least 4 months after your last dose. Inform your doctor if you become pregnant.

Do not breastfeed while using dostarlimab, and for at least 4 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may happen during the injection. Tell your caregiver if you feel light-headed, chilled or feverish, itchy, or short of breath.

Dostarlimab boosts your immune system to help it fight cancer cells, but it may also attack healthy cells, leading to serious or life-threatening side effects.

Dostarlimab may cause serious side effects. Call your doctor right away if you have:

• new or worsening cough, shortness of breath;
• chest pain, irregular heartbeats;
• feeling light-headed, like you might faint;
• a seizure;
• confusion, hallucinations, eye pain or redness, vision problems;
• severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;
• low red blood cells (anemia)--pale skin, tiredness, cold hands and feet;
• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough;
• kidney problems--swelling in your ankles, blood in your urine, little or no urination;
• liver problems--pain in the upper right side of your stomach, loss of appetite, bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a hormonal disorder--frequent or unusual headaches, dizziness, feeling very weak, changes in mood or behavior, a hoarse or deeper voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain or loss.

Your cancer treatments may be delayed or stopped permanently if you experience certain side effects.

Common side effects of dostarlimab may include:

• abnormal liver function tests;
• nausea, diarrhea, constipation;
• low white blood cell counts, anemia; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Endometrial Carcinoma:

Initial dose: -Dose 1 through Dose 4: 500 mg IV over 30 minutes every 3 weeks Maintenance dose:-Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1000 mg IV over 30 minutes every 6 weeks Duration of therapy:-Until disease progression or unacceptable toxicityUse: For the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an approved test, that has progressed on or following prior treatment with a platinum-containing regimen and are not candidates for curative surgery or radiation

Usual Adult Dose for Solid Tumors:

Initial dose: -Dose 1 through Dose 4: 500 mg IV over 30 minutes every 3 weeks Maintenance dose:-Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1000 mg IV over 30 minutes every 6 weeks Duration of therapy:-Until disease progression or unacceptable toxicityComment:-This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).Use: For the treatment of solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options

Call your doctor for instructions if you miss an appointment for your dostarlimab injection.

Since dostarlimab is given in a medical setting, it is unlikely that you will receive too much.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect dostarlimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.