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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 bowel 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. Some of these reactions (eg, skin reactions, nerve problems) may lead to other health problems that may not go away.

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:

  • Symptoms of bowel problems (eg, fever; stomach pain or tenderness; increased stool frequency; diarrhea; blood or mucus in the stool; black, tarry stools)
  • 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 a skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (eg, red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes)
  • Symptoms of nerve problems (eg, burning, tingling, or numbness; unusual muscle weakness)
  • Symptoms of endocrine problems (eg, feeling of being unusually cold or hot; inability to concentrate; mental or mood changes, such as forgetfulness or irritability; dizziness; fainting; persistent or unusual headache; unusual fatigue; stomach pain; change in bowel habits; unexplained weight changes)

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: Melanoma And Other Skin Cancers - Why It's So Important To Be SunSmart

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 given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • 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:

  • Tell your doctor or dentist that you take ipilimumab before you receive any medical or dental care, emergency care, or surgery.
  • 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.
  • Lab tests 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.
  • 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 this medicine 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); chest pain; decreased sexual desire; shortness of breath or trouble breathing; stiff neck; symptoms of a skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (eg, red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes); symptoms of bowel problems (eg, fever; stomach pain or tenderness; increased stool frequency; diarrhea; blood or mucus in the stool; black, tarry stools); symptoms of eye or vision problems (eg, blurred vision, double vision, or other vision changes; eye pain or redness); symptoms of kidney problems (eg, not able to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain); symptoms of nerve problems (eg, burning, tinging, or numbness; muscle weakness); 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 endocrine problems (eg, feeling or being unusually cold or hot; inability to concentrate; mental or mood changes, such as forgetfulness or irritability; dizziness; fainting; persistent or unusual headache; unusual fatigue; stomach pain; change in bowel habits; unexplained weight changes); unusual tiredness or weakness.

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 handled and stored by a health care provider. You will not store it at home. 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 health care provider for complete information about the risks and benefits of using ipilimumab.

Issue Date: June 3, 2015
Database Edition 15.2.1.003
Copyright © 2015 Clinical Drug Information, LLC

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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