Pronunciation:

ip-i-LIM-ue-mab

Brand Names:

• Yervoy

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

CTLA-4 Inhibitor

Uses of This Medicine:

Ipilimumab injection is used in combination with nivolumab 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.

Ipilimumab injection is used in combination with other medicines (eg, nivolumab) to treat patients with kidney cancer that has spread throughout the body.

Ipilimumab injection is used with nivolumab to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (cancer of the colon or rectum) that has spread. It is given to patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, irinotecan) but did not work well.

Ipilimumab injection is also used with nivolumab to treat liver cancer. It is given to patients who have previously received treatment with sorafenib.

Ipilimumab injection is also used with nivolumab as first-line treatment for metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and do not have an abnormal EGFR or ALK gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine.

Ipilimumab injection is also used with nivolumab and two cycles of cancer treatment that contains platinum and another cancer medicine as first-line treatment for metastatic (cancer that has already spread) or recurrent (cancer that has come back) non-small cell lung cancer (NSCLC) in patients whose tumors do not have an abnormal EGFR or ALK gene. Your doctor will perform a test before you receive this medicine.

Ipilimumab injection is also used with nivolumab as first-line treatment for malignant pleural mesothelioma (cancer that affects the lining of the lungs and chest wall) that cannot be removed by surgery.

Ipilimumab injection is also used with nivolumab as first-line treatment for squamous cell carcinoma of the esophagus that has spread or cannot be removed by surgery.

This medicine is to be given 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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ipilimumab injection to treat melanoma, to help prevent melanoma from coming back after surgical removal, and to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in children 12 years of age and older. Safety and efficacy have not been established in children younger than 12 years of age to treat other approved conditions.

Appropriate studies have not been performed on the relationship of age to the effects of ipilimumab injection to treat kidney cancer in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ipilimumab injection in the elderly.

Breast-feeding—

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.

Other medicines—

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.

Other interactions—

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
• Autoimmune disease (eg, Crohn disease, lupus, sarcoidosis, ulcerative colitis) or
• Colitis (inflammation of the bowel) or
• Diabetes or
• Eye or vision problems (eg, episcleritis, iritis, uveitis) or
• Guillain-Barré syndrome or
• Hemolytic anemia (blood disorder) or
• Hepatitis (inflammation of the liver) or
• Hyperthyroidism (overactive thyroid) or
• Hypopituitarism (low levels of pituitary hormone) or
• Hypothyroidism (underactive thyroid) 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
• Organ transplant, recent or history of or
• Pancreatitis (inflammation of the pancreas) or
• Pericarditis (inflammation of the heart) or
• Peripheral neuropathy (nerve problem in the arms and legs) or
• Pneumonitis (inflammation of the lungs)—Use with caution. May make these conditions worse.

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 to 90 minutes.

This medicine is usually given every 2, 3, or 6 weeks. Your doctor may adjust how often you will receive this medicine or how long the infusion will take.

Your doctor will give you other medicines (eg, steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

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.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while receiving 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, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness 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 your eyes be checked by an ophthalmologist (eye doctor).

This medicine may increase the risk for other problems caused by the immune system, including pneumonitis (inflammation of the lungs), nephritis (kidney problem), or encephalitis (inflammation of the brain). Check with your doctor if you have chest pain, thickening of bronchial secretions, trouble breathing, bloody or cloudy urine, unusual tiredness or weakness, nausea, vomiting, unusual weight gain, swelling of the face, feet, or lower legs, confusion, irritability, headache, seizures, or stiff neck.

This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Side Effects of This Medicine:

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:

More common

Bloody, black, or tarry stools

bone pain

chest pain or tightness

constipation

cough

depressed mood

diarrhea

dry skin and hair

feeling cold

fever

hair loss

heartburn

hoarseness or husky voice

indigestion

itching, skin rash

muscle cramps

nausea

pain in the arms or legs

severe stomach pain, cramping, or burning

slowed heartbeat

sneezing

sore throat

trouble breathing

unusual tiredness or weakness

vomiting

vomiting of material that looks like coffee grounds, severe and continuing

watery or bloody diarrhea

Less common

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

chills

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

dizziness

double vision

drooping eyelids

drowsiness

eye discharge or excessive tearing

eye pain or sensitivity to light

fainting

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

sores, ulcers, or white spots on the lips or in the mouth

stabbing pain

stomach tenderness

swelling of the face, feet, or lower legs

swollen glands

unusual bleeding or bruising

unusual weight gain

yellow eyes or skin

Rare

Anxiety

bloating

blue or pale skin

chest pain, possibly moving to the left arm, neck, or shoulder

confusion

difficulty with moving

fast heartbeat

general feeling of discomfort or illness

increased thirst

lower back or side pain

muscle pain, stiffness, or 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, welts, or blisters on the skin

stiff neck or back

Incidence not known

Back, leg, or stomach pains

blistering, peeling, or loosening of the skin

bleeding gums

general body swelling

inability to move the arms and legs

joint or muscle pain

nosebleeds

red irritated eyes

red skin lesions, often with a purple center

throbbing pain

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:

More common

Headache

swelling or inflammation of the mouth

trouble sleeping

weight loss

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.