Yervoy

The recommended dose of Yervoy (Ipilimumab) for adults is based on weight. Dosing and how often treatments are given varies depending on the type of cancer being treated and whether Yervoy (Ipilimumab) is being used in combination with other medications.

Yervoy (Ipilimumab) is given by intravenous (into a vein) infusion. It is usually injected through a site on your skin specially prepared for this purpose.

Very careful handling of Yervoy (Ipilimumab) is required. Yervoy (Ipilimumab) should only be given by health care professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important Yervoy (Ipilimumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Yervoy (Ipilimumab), contact your doctor as soon as possible to reschedule your appointment.

Yervoy (Ipilimumab) will be stored at the hospital or clinic in the refrigerator and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each 1 mL of solution for infusion contains 5 mg of Yervoy (Ipilimumab). Nonmedicinal ingredients: tris hydrochloride, sodium chloride, mannitol, diethylene triamine pantaacetic acid (DTPS), polysorbate 80, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.

Do not take Yervoy (Ipilimumab) if you:

• are allergic to Yervoy (Ipilimumab) or any ingredients of the medication
• have a life-threatening autoimmune disease
• have had an organ transplant

There may be an interaction between Yervoy (Ipilimumab) and any of the following:

• medications that suppress the immune system (e.g., cancer medications, corticosteroids, mycophenolate, Tacrolimus, Cyclosporine)
• Vemurafenib

If you are taking any of these medications, speak with your doctor or pharmacist.

Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Yervoy (Ipilimumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Yervoy (Ipilimumab).

Autoimmune illnesses: If you have an autoimmune disease, such as Lupus or inflammatory bowel disease, using Yervoy (Ipilimumab) may make the condition worse by stimulating your immune system. Yervoy (Ipilimumab) is not intended for use by people with autoimmune disorders.

Drowsiness/reduced alertness: Yervoy (Ipilimumab) may cause tiredness or fatigue, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Yervoy (Ipilimumab) affects you.

Immune system reactions: Yervoy (Ipilimumab) can cause inflammation to many parts of the body, including the stomach, liver, skin, nerves, hormone glands (e.g. pituitary, adrenal, Thyroid), and eyes. This may occur during treatment and up to several months after your last infusion. It is important that you contact your doctor as soon as possible about any concerning side effects.

Immunosuppressant medications: Yervoy (Ipilimumab) works by stimulating the immune system. If you have had an organ transplant, Yervoy (Ipilimumab) may cause your body to reject the organ. Yervoy (Ipilimumab) is not intended for use by people who are taking immunosuppressants.

Infusion reactions: Yervoy (Ipilimumab) can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately.

Liver function: Yervoy (Ipilimumab) may cause liver damage or reduced liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medication-related diarrhea: Yervoy (Ipilimumab) can cause inflammation to many parts of the body, including the digestive system. This condition, known as enterocolitis, can become life threatening if it is not treated quickly. If you experience diarrhea with mucus or blood in the stool, contact your doctor as soon as possible.

Pregnancy: Yervoy (Ipilimumab) may cause harm to a developing baby if the mother uses Yervoy (Ipilimumab) during pregnancy. Yervoy (Ipilimumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Yervoy (Ipilimumab), contact your doctor immediately.

Women who may become pregnant should use effective birth control during treatment and for 3 months after the last dose.

Breast-feeding: It is not known if Yervoy (Ipilimumab) passes into breast milk. If you are breast-feeding and are taking Yervoy (Ipilimumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Yervoy (Ipilimumab) have not been established for children.