Zevalin Y-90

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.

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 ibritumomab injection in children. 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 ibritumomab injection in the elderly.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain ibritumomab. It may not be specific to Zevalin Y-90. Please read with care.

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.

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:

• 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

• 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

• 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

• 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:

• 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

• 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.

• It is used to treat lymphoma.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling tired or weak.
• Nose and throat irritation.
• Loose stools (diarrhea).
• Upset stomach.
• Belly pain.
• Muscle pain.
• Not hungry.
• Night sweats.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.