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Ipilimumab

Precautions

Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: organ transplant, stem cell transplant with donor cells, immune system disorders (such as Guillain-Barre syndrome, lupus, sarcoidosis, Crohn's disease, ulcerative colitis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ipilimumab. Ipilimumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 months after the last dose. Consult your doctor before breastfeeding.

Side Effects

See also How To Use section.

Tiredness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication can cause serious (sometimes fatal) side effects in many parts of the body. These effects can occur during treatment with ipilimumab, but can also occur months after the last dose of this medication. Get medical help right away if you have any very serious side effects, including: headache that doesn't go away, signs of intestinal problems (such as diarrhea, mucus or blood in your stool, stomach pain), signs of liver disease (such as yellowing of skin/eyes, dark urine), unusual bleeding/bruising, unusual weakness, mouth sores, numbness/tingling in hands/feet, signs of thyroid problems (such as feeling cold all the time, heat intolerance, weight gain/loss, fast/pounding/irregular heartbeat), mental /mood changes, change in sex drive, signs of kidney problems (such as change in the amount of urine), increased thirst/urination, dizziness, fainting, eye pain/redness, vision changes (such as blurred vision, double vision, decreased vision, blindness), signs of lung problems (such as chest pain, shortness of breath, new/worsening cough), seizure, muscle pain, hearing loss, night sweats.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.