Ipilimumab Injection

Name: Ipilimumab Injection

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving ipilimumab injection,

  • tell your doctor and pharmacist if you are allergic to ipilimumab injection, any other medications, or any of the ingredients in ipilimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications that suppress your immune system, including oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have ever had an organ transplant and if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), lupus (a condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), or sarcoidosis (condition in which clumps of abnormal cells grow in various parts of the body including the lungs, skin, and eyes), or if your liver has been damaged by a medication or an illness.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ipilimumab injection, call your doctor. Ipilimumab injection may cause your baby to be born too early or to die before birth.

Brand names

  • Yervoy┬«

Warnings

Included as part of the "PRECAUTIONS" Section

Overdose

There is no information on overdosage with YERVOY.

Patient information

YERVOY®
(yur-voi)
(ipilimumab) injection

What is the most important information I should know about YERVOY?

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Call your healthcare provider right away if you develop any of these signs or symptoms or they get worse. Do not try to treat symptoms yourself.

Intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:

  • diarrhea (loose stools) or more bowel movements than usual
  • blood in your stools or dark, tarry, sticky stools
  • stomach pain (abdominal pain) or tenderness

Liver problems (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:

  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • nausea or vomiting
  • pain on the right side of your stomach
  • bleeding or bruise more easily than normal

Skin problems that can lead to severe skin reaction. Signs and symptoms of severe skin reactions may include:

  • skin rash with or without itching
  • sores in your mouth
  • your skin blisters or peels

Nerve problems that can lead to paralysis. Symptoms of nerve problems may include:

  • unusual weakness of legs, arms, or face
  • numbness or tingling in hands or feet

Hormone gland problems (especially the pituitary, adrenal, and thyroid glands). Signs and symptoms that your glands are not working properly may include:

  • persistent or unusual headaches
  • unusual sluggishness
  • feeling cold all the time
  • weight gain
  • changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
  • dizziness or fainting

Eye problems. Symptoms may include:

  • blurry vision, double vision, or other vision problems
  • eye pain or redness

Getting medical treatment right away may keep the problem from becoming more serious.

Your healthcare provider will check you for these problems during treatment with YERVOY. Your healthcare provider may treat you with corticosteroid medicines. Your healthcare provider may need to delay or completely stop treatment with YERVOY if you have severe side effects.

What is YERVOY?

YERVOY is a prescription medicine used to treat a kind of skin cancer called melanoma. YERVOY may be used:

  • in adults and children 12 years and older when melanoma has spread or cannot be removed by surgery
  • to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery

It is not known if YERVOY is safe and effective in children less than 12 years of age.

Before you receive YERVOY, tell your healthcare provider about all your medical conditions, including if you:

  • have immune system problems (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
  • have had an organ transplant
  • have liver problems
  • are pregnant or plan to become pregnant. YERVOY can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control during treatment with YERVOY and for 3 months after the last dose of YERVOY.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
    • Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll you in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
  • are breastfeeding or plan to breastfeed. It is not known if YERVOY passes into your breast milk.
    • Do not breastfeed during treatment with YERVOY and for 3 months after the last dose of YERVOY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive YERVOY?

  • YERVOY is given to you into your vein through an intravenous (IV) line over 90 minutes.
  • Your healthcare provider will decide how many treatments you will need.
  • Your healthcare provider will do blood tests before starting and during treatment with YERVOY.
  • It is important for you to keep all appointments with your healthcare provider. Call your healthcare provider if you miss an appointment. There may be special instructions for you.

What are the possible side effects of YERVOY?

YERVOY can cause serious side effects. See “What is the most important information I should know about YERVOY?”

The most common side effects of YERVOY include:

  • tiredness
  • diarrhea
  • itching
  • rash
  • nausea
  • vomiting
  • headache
  • weight loss
  • fever
  • decreased appetite
  • difficulty falling or staying asleep

These are not all of the possible side effects of YERVOY.

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

You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.

General information about the safe and effective use of YERVOY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider or pharmacist for information about YERVOY that is written for healthcare professionals.

What are the ingredients of YERVOY?

Active ingredient: ipilimumab

Inactive ingredients: diethylene triamine pentaacetic acid (DTPA), mannitol, polysorbate 80, sodium chloride, tris hydrochloride, and Water for Injection, USP

This Medication Guide has been approved by the U.S. Food and Drug Administration.

What should i discuss with my healthcare provider before receiving ipilimumab (yervoy)?

You should not receive ipilimumab if you are allergic to it.

To make sure you can safely receive ipilimumab, tell your doctor if you have any of these other conditions:

  • liver damage (caused by disease or by using certain medicines);
  • an autoimmune disorder such as systemic lupus erythematosus (SLE) or sarcoidosis;
  • Crohn's disease or ulcerative colitis; or
  • if you have received an organ transplant.

FDA pregnancy category C. It is not known whether ipilimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

In animal studies, ipilimumab caused stillbirth, premature delivery, low birth weight, miscarriage in the third trimester, and infant death. However, very high doses are used in animal studies. It is not known whether these effects would occur in people using doses recommended for human use. Ask your doctor about your individual risk.

It is not known whether ipilimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving ipilimumab.

What should i avoid while receiving ipilimumab (yervoy)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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