Ipilimumab (Injection)

Introduction

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

Treats skin cancer (melanoma) that has spread or cannot be removed by surgery.

Brand Name(s)

Yervoy

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins. This medicine must be given slowly, so the needle will remain in place for at least 90 minutes.
• A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist 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

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have adrenal gland problems, an autoimmune disease (such as Crohn disease, lupus, or sarcoidosis), eye or vision problems, kidney disease, liver disease, lung disease (such as pneumonitis), myasthenia gravis, peripheral neuropathy (nerve problem), pituitary gland problems, stomach or bowel problems (such as colitis), or thyroid gland problems.
• Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.
• Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; a loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are receiving this medicine.
• Check with your doctor right away if you are having unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious muscle and nerve problem.
• Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches; changes in mood or behavior (eg, being irritable or forgetful); lightheadedness, dizziness, or fainting; unusual sluggishness; or an increase in weight.
• Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

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.
• Chest pain.
• Cold feeling, body weakness, tiredness, or weight changes.
• Dark-colored urine or pale stools.
• Diarrhea that may contain blood.
• Fever, chills, cough, sore throat, and body aches.
• Headache, severe or continuing.
• Lightheadedness, dizziness, or fainting.
• Muscle pain, tenderness, or weakness.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle was placed.
• Red or dark brown urine.
• Shortness of breath, tiredness, or uneven heartbeat.
• Sores, ulcers, or white spots in your mouth or on your lips.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Vomiting of blood or material that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

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

• Mild diarrhea.
• Mild skin rash.

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