Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Yervoy

Descriptions


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.

This product is available in the following dosage forms:

  • Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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
  • Colitis (inflammation of the intestine) or
  • Eye or vision problems (eg, episcleritis, iritis, uveitis) or
  • Guillain-Barré syndrome or
  • Hemolytic anemia 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
  • 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

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.

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

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).

Side Effects

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

  1. Bloody, black, or tarry stools
  2. diarrhea
  3. fever
  4. heartburn
  5. indigestion
  6. itching skin
  7. nausea
  8. rash
  9. severe stomach pain, cramping, or burning
  10. unusual tiredness or weakness
  11. vomiting
  12. vomiting of material that looks like coffee grounds, severe and continuing
  13. watery or bloody diarrhea

Less common

  1. Abdominal or stomach tenderness
  2. blistering, crusting, irritation, itching, or reddening of the skin
  3. bloody or cloudy urine
  4. blurred vision or other changes in vision
  5. burning, dry, or itching eyes
  6. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  7. chest pain
  8. chills
  9. clay-colored stools
  10. cough
  11. cracked, dry, or scaly skin
  12. dark urine
  13. darkening of the skin
  14. decreased appetite
  15. decreased frequency or amount of urine
  16. difficulty with breathing, chewing, swallowing, or talking
  17. dizziness
  18. double vision
  19. drooping eyelids
  20. drowsiness
  21. eye discharge or excessive tearing
  22. eye pain or sensitivity to light
  23. fainting
  24. headache, possibly severe
  25. hives or welts
  26. loss of appetite
  27. mental depression
  28. muscle weakness
  29. pain, itching, burning, swelling, bleeding, or a lump under the skin where the needle was placed
  30. painful or difficult urination
  31. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  32. sensation of pins and needles
  33. severe tiredness
  34. sore throat
  35. sores, ulcers, or white spots on the lips or in the mouth
  36. stabbing pain
  37. swelling of the face, feet, or lower legs
  38. swollen glands
  39. unusual bleeding or bruising
  40. unusual weight gain
  41. yellow eyes or skin

Rare

  1. Anxiety
  2. bloating
  3. blue or pale skin
  4. chest pain, possibly moving to the left arm, neck, or shoulder
  5. confusion
  6. constipation
  7. difficulty with moving
  8. fast heartbeat
  9. general feeling of discomfort or illness
  10. increased thirst
  11. lower back or side pain
  12. muscle pain or stiffness
  13. muscle weakness
  14. pain or burning in the throat
  15. pain, swelling, or redness in the joints
  16. pains in the stomach or side, possibly radiating to the back
  17. skin irritation or rash, including rash that looks like psoriasis
  18. sores, welting, or blisters on the skin
  19. stiff neck or back

Incidence not known

  1. Back, leg, or stomach pains
  2. bleeding gums
  3. general body swelling
  4. inability to move the arms and legs
  5. nosebleeds
  6. 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

  1. Headache
  2. trouble sleeping
  3. 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.