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Ipilimumab (Intravenous route)

Pronunciation:

ip-i-LIM-ue-mab

Brand Names:

  • Yervoy

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

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:

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 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.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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
  • 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.

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.

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:

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
diarrhea
fever
heartburn
indigestion
itching skin
nausea
rash
severe stomach pain, cramping, or burning
unusual tiredness or weakness
vomiting
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
chills
clay-colored stools
cough
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
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
Rare
Anxiety
bloating
blue or pale skin
chest pain, possibly moving to the left arm, neck, or shoulder
confusion
constipation
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
nosebleeds
throbbing pain

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: 4/4/2014

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