IPILIMUMAB - INJECTION

PHONETIC PRONUNCIATION: (IP-i-LIM-ue-mab)

COMMON BRAND NAME(S): Yervoy

GENERIC NAME(S): ipilimumab

Uses

USES: Ipilimumab is used to treat melanoma (skin cancer) and kidney cancer. It works by changing the action of your own immune system, directing it to attack cancer cells. Unfortunately, other body parts may also be affected (see Warning section). Ipilimumab is a type of medication called a monoclonal antibody.

How to use IPILIMUMAB - INJECTION

HOW TO USE: Read the Medication Guide and Patient Wallet Card provided by your pharmacist before you start using ipilimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with ipilimumab. This medication is given by injection into a vein by a health care professional. It should be injected slowly over 30 or 90 minutes as directed by your doctor. The dosage is based on your medical condition, weight and response to treatment. Your doctor may prescribe other medications to help with serious side effects if they occur, or your doctor may delay your dose. If the side effects lessen, then treatment with ipilimumab may continue. Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of organ transplant, immune system disorders (such as Guillain-Barre syndrome, lupus, sarcoidosis, Crohn's disease, ulcerative colitis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ipilimumab. Ipilimumab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 3 months after stopping treatment. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug include: vemurafenib.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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YERVOY 50 MG/10 ML VIAL

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YERVOY 200 MG/40 ML VIAL

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Warning

WARNING: This medication can cause serious (sometimes fatal) side effects in many parts of the body. These effects can occur during treatment with ipilimumab, but can also occur months after the last dose of this medication. Get medical help right away if you experience any of the following serious side effects: diarrhea, mucus or blood in your stool, stomach pain, yellowing of skin/eyes, dark urine, unusual bleeding/bruising, unusual weakness, mouth sores, numbness/tingling in hands/feet, persistent headache, feeling cold all the time, heat intolerance, weight gain/loss, fast/pounding/irregular heartbeat, mental/mood changes, change in sex drive, signs of kidney problems (such as change in the amount of urine), increased thirst/urination, dizziness, eye pain/redness, vision changes (such as blurred vision, double vision, decreased vision, blindness), fever, chest pain, shortness of breath, new/worsening cough, seizure, muscle pain, hearing loss, night sweats, fainting.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.