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, weight gain, mental/mood changes, change in sex drive, unusual change in the amount of urine, dizziness, eye pain/redness, vision changes, fever, chest pain, shortness of breath, seizure, muscle pain, hearing loss, night sweats, fainting.
Ipilimumab is used to treat adults with melanoma (skin cancer) that has spread or cannot be removed by surgery. It works by changing the action of your own immune system, directing it to attack skin cancer cells. Unfortunately, other body parts may also be affected (see Warning section). Ipilimumab is a type of medication called a monoclonal antibody.
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 90 minutes. It is usually given every 3 weeks for up to 4 doses, or 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. The goal is to complete 4 doses of ipilimumab within 16 weeks.
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.
See also Warning section.
Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication have serious side effects.
A very serious allergic reaction to this drug is unlikely. 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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.
This medication may worsen certain types of immune system disorders (autoimmune type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders, among others: certain bowel diseases (Crohn's disease, ulcerative colitis), Guillain-Barre syndrome, lupus, sarcoidosis.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
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.
If overdose is suspected, contact a poison control center or emergency room 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.
Laboratory and/or medical tests (such as liver function tests, thyroid function test) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.
Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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