Pronunciation:

eye-bri-TOOM-oh-mab tye-UX-e-tan

Brand Names:

• Zevalin In-111
• Zevalin Y-90

Dosage Forms:

• Solution

Warnings:

Serious infusion reactions, including fatalities, have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. Most fatal infusion reactions (80%) occurred with the first rituximab infusion. Administration also results in severe and prolonged cytopenias in most patients. The ibritumomab tiuxetan therapeutic regimen should not be administered to patients with 25% or greater lymphoma marrow involvement and/or impaired bone marrow reserve. Severe cutaneous and mucocutaneous reactions, some with fatal outcome, can occur with therapy. The dose of Y-90 ibritumomab tiuxetan should not exceed the absolute maximum allowable dose of 32 millicurie (1184 megabecquerels) .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Ibritumomab injection is a monoclonal antibody. It is used together with another monoclonal antibody (rituximab) and one radioactive medication (Y-90). Ibritumomab is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL) in patients who have never received any treatment and for those who have received other cancer medicines.

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 ibritumomab injection in children. 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 ibritumomab 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:

• Acute myelogenous leukemia (AML) or
• Myelodysplastic syndrome (MDS) or
• Neutropenia (low white blood cells in the blood) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

You will receive this medicine while you are in a hospital or cancer treatment center. 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.

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you think you have become pregnant while using the medicine.

This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, chest tightness, swelling in your face or hands, lightheadedness, or if you feel like fainting within a few hours after you receive it.

If you have a severe skin reaction with this medicine, you should seek medical attention right away. Symptoms may include blistering or loosening of the skin; red, swollen, irritated, or scaly skin; fever; chills; headache; or diarrhea.

While you are being treated with ibritumomab, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Ibritumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Ibritumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid sports or other situations where bruising or injury could occur.

If ibritumomab accidentally seeps out of the vein where it is injected, it may damage the tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

This medicine contains albumin, which is derived from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Black, tarry stools

bleeding gums

blood in the urine or stools

cough or hoarseness

coughing up blood

difficulty with breathing or swallowing

dizziness

fever or chills

headache

increased menstrual flow or vaginal bleeding

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lower back or side pain

noisy breathing

nosebleeds

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

red or dark brown urine

red stools

shortness of breath

sore throat

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

swollen glands

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

Less common

Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes

bluish lips or skin

chest pain or discomfort

confusion

diarrhea

fainting

fast heartbeat

hives

itching

lightheadedness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

skin rash

small red or purple spots on the skin

unusual vaginal bleeding

vomiting blood or material that looks like coffee grounds

Rare

Agitation

anxiety

back pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site

blurred vision

coma

drowsiness

fast, pounding, or irregular heartbeat or pulse

hallucinations

inability to speak

irritability

mood or mental changes

nausea

redness of the skin

seizures

severe headache

slurred speech

stiff neck

temporary blindness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

welts

Incidence not known

Blistering, peeling, or loosening of the skin

cracks in the skin

joint or muscle pain

loss of heat from the body

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

skin blisters

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

Abdominal or stomach pain

bruising

constipation

difficult or labored breathing

difficulty with moving

faintness or lightheadedness when getting up from a lying or sitting position

fear

feeling of warmth

full or bloated feeling or pressure in the stomach

joint pain

lack or loss of strength

large, flat, blue or purplish patches in the skin

loss of appetite

muscle aching or cramping

muscle pain or stiffness

nervousness

pain

rash

redness of the face, neck, arms and occasionally, upper chest

runny nose

sleeplessness

sneezing

stuffy nose

sudden or increased sweating

swelling of the abdominal or stomach area

swelling of the hands, ankles, feet, or lower legs

swollen joints

throat irritation

trouble with sleeping

unable to sleep

weight loss

Less common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort, upset, or pain

swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

Bleeding gums

bone pain

headache, sudden and severe

inability to speak

increased menstrual flow or vaginal bleeding

red or black, tarry stools

red or dark brown urine

temporary blindness

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.