Ipilimumab can result in severe and fatal immune-mediated adverse reactions. Reactions may involve any organ system and manifest during treatment or weeks to months after discontinuation. The most common severe reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Assess patients for signs and symptoms of severe reactions and evaluate clinical chemistries (eg, liver function tests, adrenocorticotropic hormone levels, thyroid function tests) at baseline and before each dose. Permanently discontinue ipilimumab and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions .
Ipilimumab injection is used to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery. It is a monoclonal antibody that changes the immune system to help control the growth of cancer cells in the skin.
Ipilimumab injection is also used to help prevent melanoma from coming back after surgical removal.
This medicine is to be given only by or under the immediate supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ipilimumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ipilimumab injection in the elderly.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for at least 90 minutes.
This medicine is usually given every 3 weeks for a total of 4 doses. Your doctor may adjust how often you receive this medicine or how long the infusion may take.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 3 months after your last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are receiving this medicine.
Check with your doctor right away if you are having unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious nerve problem that can lead to paralysis.
Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.
Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.