Ipilimumab (Intravenous route)
Ipilimumab can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation that 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/symptoms of severe reactions and evaluate clinical chemistries (eg, liver function tests, thyroid function tests) at baseline and before each dose. Permanently discontinue ipilimumab and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions .
Uses of This Medicine:
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.
This medicine is to be administered only by or under the immediate supervision of your doctor.
Before Using This Medicine:
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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:
- Adrenal gland problem or
- Allergic skin reactions (eg, dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), severe or
- Colitis (inflammation of the intestine) or
- Eye or vision problems (eg, episcleritis, iritis, uveitis) or
- Guillain-Barre syndrome or
- Hemolytic anemia or
- Hepatitis (inflammation of the liver) or
- Hyperthyroidism (high levels of thyroid hormone) or
- Hypopituitarism (low levels of pituitary hormone) or
- Hypothyroidism (low levels of thyroid hormone) or
- Intestinal or bowel perforation (a hole in the bowel) or
- Meningitis (inflammation of the brain) or
- Myasthenia gravis (severe muscle weakness) or
- Nephritis (inflammation of the kidney) or
- Pancreatitis (inflammation of the pancreas) or
- Pericarditis (inflammation of the heart) or
- Peripheral neuropathy (nerve problem in arms and legs) or
- Pneumonitis (inflammation of the lung)—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
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.
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 muscle and nerve problem.
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).
Side Effects of This Medicine:
- More common
- Bloody, black, or tarry stools
- itching skin
- severe stomach pain, cramping, or burning
- unusual tiredness or weakness
- vomiting of material that looks like coffee grounds, severe and continuing
- watery or bloody diarrhea
- Less common
- Abdominal or stomach tenderness
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- blurred vision or other changes in vision
- burning, dry, or itching eyes
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- chest pain
- clay-colored stools
- cracked, dry, or scaly skin
- dark urine
- darkening of the skin
- decreased appetite
- decreased frequency or amount of urine
- difficulty with breathing, chewing, swallowing, or talking
- double vision
- drooping eyelids
- eye discharge or excessive tearing
- eye pain or sensitivity to light
- headache, possibly severe
- hives or welts
- loss of appetite
- mental depression
- muscle weakness
- pain, itching, burning, swelling, bleeding, or a lump under the skin where the needle was placed
- painful or difficult urination
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- sensation of pins and needles
- severe tiredness
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stabbing pain
- swelling of the face, feet, or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual weight gain
- yellow eyes or skin
- blue or pale skin
- chest pain, possibly moving to the left arm, neck, or shoulder
- difficulty with moving
- fast heartbeat
- general feeling of discomfort or illness
- increased blood pressure
- increased thirst
- lower back or side pain
- muscle pain or stiffness
- muscle weakness
- pain or burning in the throat
- pain, swelling, or redness in the joints
- pains in the stomach or side, possibly radiating to the back
- skin irritation or rash, including rash that looks like psoriasis
- sores, welting, or blisters on the skin
- stiff neck or back
- Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- general body swelling
- inability to move the arms and legs
- throbbing pain
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:
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.
Last Updated: 11/4/2014