Ipilimumab

Generic Name: ipilimumab (IP-i-LIM-ue-mab)
Brand Name: Yervoy

Ipilimumab may cause severe and sometimes fatal reactions. In instances when these reactions occur, they most commonly involve intestinal inflammation, liver problems, severe skin problems, nerve problems, or endocrine problems. Most of these reactions occurred during treatment with ipilimumab. However, some occurred weeks or months after treatment was stopped.

Medical assessments and lab tests, including liver and thyroid function, should be performed before you start to take ipilimumab and before each dose. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Tell your doctor right away if you develop any of the following:

  • Fever; stomach pain or tenderness; increased stool frequency; diarrhea; blood or mucus in the stool; black, tarry stools
  • Yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools
  • Red, swollen, blistered, or peeling skin; mouth sores or inflammation
  • Burning, tingling, or numbness; unusual muscle weakness
  • Feeling of being unusually cold or hot, inability to concentrate, mental or mood changes (eg, forgetfulness, irritability), dizziness, fainting, persistent or unusual headache, unusual fatigue, change in bowel habits, unexplained weight changes
  • Vision changes (eg, blurred vision, double vision), eye pain or redness

Ipilimumab is used for:

Treating certain types of melanoma (a kind of skin cancer). It may also be used for other conditions as determined by your doctor.

Ipilimumab is a monoclonal antibody. It works by helping the immune system to recognize and kill the cancer cells.

Do NOT use ipilimumab if:

  • you are allergic to any ingredient in ipilimumab

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using ipilimumab:

Some medical conditions may interact with ipilimumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an autoimmune disease (eg, ulcerative colitis, Crohn disease, rheumatoid arthritis, lupus, sarcoidosis)
  • if you have liver problems
  • if you have had an organ transplant

Some MEDICINES MAY INTERACT with ipilimumab. However, no specific interactions with ipilimumab are known at this time.

Ask your health care provider if ipilimumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ipilimumab:

Use ipilimumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ipilimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get ipilimumab refilled.
  • Ipilimumab is usually given as an injection at your doctor's office, hospital, or clinic.
  • Do not shake ipilimumab.
  • Do not use ipilimumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of ipilimumab, contact your doctor right away.

Ask your health care provider any questions you may have about how to use ipilimumab.

Important safety information:

  • Diarrhea may be a sign of a serious side effect that may be caused by ipilimumab. Contact your doctor if you develop diarrhea or increased stool frequency. Do not treat diarrhea without first checking with your doctor.
  • Tell your doctor or dentist that you take ipilimumab before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver and thyroid function, may be performed while you use ipilimumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ipilimumab should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Ipilimumab may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking ipilimumab while you are pregnant. It is not known if ipilimumab is found in breast milk. Do not breast-feed while you are taking ipilimumab.

Possible side effects of ipilimumab:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or mucus in the stool; burning, tingling, or numbness; chest pain; decreased sexual desire; decreased urination; diarrhea or increased stool frequency; dizziness; eye pain or redness; fainting; mental or mood changes (eg, forgetfulness, irritability); mouth sores or inflammation; muscle pain or weakness; persistent or unusual headache; red, swollen, blistered, or peeling skin; shortness of breath or trouble breathing; stiff neck; stomach pain or tenderness; symptoms of liver problems (eg, yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unusual fatigue, change in bowel habits, unexplained weight changes); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ipilimumab:

Ipilimumab is usually handled and stored by a health care provider. If you are using ipilimumab at home, store ipilimumab as directed by your pharmacist or health care provider. Keep ipilimumab out of the reach of children and away from pets.

General information:

  • If you have any questions about ipilimumab, please talk with your doctor, pharmacist, or other health care provider.
  • Ipilimumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ipilimumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ipilimumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ipilimumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ipilimumab.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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