Ipilimumab (ip-i-LIM-ue-mab)

Treats cancer, including colon, rectum, skin, kidney, liver, lung, and esophagus cancer. Also helps prevent melanoma from coming back after surgical removal.

Brand Name(s):

Yervoy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to remain in place for at least 30 to 90 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will give you other medicines (including steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for at least 3 months after your last dose.
• Do not breastfeed during treatment and for at least 3 months after your last dose.
• Tell your doctor if you have kidney disease, liver disease, an autoimmune disease (including Crohn disease, lupus, sarcoidosis, ulcerative colitis), muscle or nerve problems (including Guillain-Barré syndrome, myasthenia gravis), or if you have had a transplant.
• This medicine may cause the following problems:
  • Enterocolitis (swelling inside the bowels)
  • Liver problems
  • Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis)
  • Nerve problems, which may lead to paralysis
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Other problems caused by the immune system, including pneumonitis (swelling of the lungs), nephritis (kidney problem), encephalitis (swelling of the brain), or eye or vision problems
  • Infusion reaction
  • Increased risk of possible organ transplant rejection
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blurred vision, trouble seeing, eye pain, or other vision changes
• Chest pain, trouble breathing, swelling in your hands, ankles, or feet
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea that may contain blood
• Fever, chills, cough, sore throat, body aches while receiving the infusion
• Increased hunger or thirst, dry mouth, sweating, changes in how much or how often you urinate
• Lightheadedness, dizziness, or fainting
• Muscle pain, tenderness, or weakness
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Sores, ulcers, or white spots in your mouth or on your lips
• Vomiting blood or material that looks like coffee grounds
• Weakness, headache, tiredness, weight changes, or feeling unusually cold or hot

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Skin rash, itching
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088