Yervoy

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

Yervoy 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 Yervoy. 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 Yervoy 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

Yervoy 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.

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

Do NOT use Yervoy if:

  • you are allergic to any ingredient in Yervoy

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Yervoy:

Some medical conditions may interact with Yervoy. 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 Yervoy. However, no specific interactions with Yervoy are known at this time.

Ask your health care provider if Yervoy 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 Yervoy:

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

  • Yervoy comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Yervoy refilled.
  • Yervoy is usually given as an injection at your doctor's office, hospital, or clinic.
  • Do not shake Yervoy.
  • Do not use Yervoy 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 Yervoy, contact your doctor right away.

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

Important safety information:

  • Diarrhea may be a sign of a serious side effect that may be caused by Yervoy. 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 Yervoy 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 Yervoy. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Yervoy should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Yervoy 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 Yervoy while you are pregnant. It is not known if Yervoy is found in breast milk. Do not breast-feed while you are taking Yervoy.

Possible side effects of Yervoy:

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 Yervoy:

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

General information:

  • If you have any questions about Yervoy, please talk with your doctor, pharmacist, or other health care provider.
  • Yervoy 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 Yervoy 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 Yervoy. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Yervoy. 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 Yervoy.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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