Zevalin In-111

Generic Name: ibritumomab tiuxetan (Intravenous route)

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

Commonly used brand name(s):

In the U.S.

• Zevalin In-111
• Zevalin Y-90

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Zevalin In-111

Ibritumomab tiuxetan is a protein called a monoclonal antibody. It is used along with another monoclonal antibody (rituximab) and two radioactive medications (In-111 and Y-90). Ibritumomab tiuxetan is used to treat a type of cancer called non-Hodgkin's lymphoma.

Ibritumomab tiuxetan is to be administered only by or under the immediate supervision of your doctor.

Before Using Zevalin In-111

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 tiuxetan in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibritumomab tiuxetan 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 ibritumomab tiuxetan. Make sure you tell your doctor if you have any other medical problems, or sensitivity or a previous severe allergic reaction to ibritumomab tiuxetan, rituximab, yttrium chloride, indium chloride or to mouse proteins.

Proper Use of ibritumomab tiuxetan

This section provides information on the proper use of a number of products that contain ibritumomab tiuxetan. It may not be specific to Zevalin In-111. 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 into one of your veins.

Precautions While Using Zevalin In-111

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. Tell your doctor right away if you think you have become pregnant while using the medicine.

If you experience a severe skin reaction, you should stop receiving this treatment and seek medical attention immediately. Symptoms may include blistering or loosening of skin; red, swollen, irritated, or scaly skin; fever, chills, headache, or diarrhea.

This medicine may cause a rare but serious type of allergic reaction. Tell your doctor right away if you start to have a cough; difficulty swallowing; dizziness; fast heartbeats; wheezing; trouble breathing; chest tightness; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; fever; chills; itching or hives; or lightheadedness or faintness while you are receiving this medicine.

While you are being treated with ibritumomab tiuxetan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Ibritumomab tiuxetan may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Ibritumomab tiuxetan 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 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 tiuxetan accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

Zevalin In-111 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 immediately if any of the following side effects occur:

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• cough or hoarseness
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• fever or chills
• headache
• increased menstrual flow or vaginal bleeding
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• lower back or side pain
• noisy breathing
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on skin
• prolonged bleeding from cuts
• red stools
• red or dark brown urine
• shortness of breath
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• swollen glands
• tightness in 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
• pain at site of tumor
• 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 skin
• unusual vaginal bleeding
• vomiting blood or material that looks like coffee grounds

• Agitation
• anxiety
• back pain
• blurred vision
• coma
• drowsiness
• fast, pounding, or irregular heartbeat or pulse
• hallucinations
• inability to speak
• irritability
• mood or mental changes
• nausea
• redness of skin
• seizures
• severe headache
• slurred speech
• stiff neck
• temporary blindness
• vomiting
• weakness in arm and/or leg on one side of the body, sudden and severe
• welts

• Blistering, peeling, loosening of skin
• cracks in the skin
• joint or muscle pain
• loss of heat from the body
• red irritated eyes
• red skin lesions, often with a purple center
• 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 pain or stomach pain
• bruising
• constipation
• difficult or labored breathing
• difficulty in 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
• pain in joints
• rash
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• sleeplessness
• sneezing
• stuffy nose
• sudden or increased sweating
• swelling of abdominal or stomach area
• swelling of hands, ankles, feet, or lower legs
• swollen joints
• throat irritation
• trouble sleeping
• unable to sleep
• weight loss

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• swelling or redness in 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
• blurred vision
• bone pain
• chills
• confusion
• cough
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• fainting
• fast heartbeat
• fever
• headache, sudden and severe
• inability to speak
• increased menstrual flow or vaginal bleeding
• lightheadedness
• lower back or side pain
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• prolonged bleeding from cuts
• rapid, shallow breathing
• red or black, tarry stools
• red or dark brown urine
• seizures
• shallow breathing
• shortness of breath
• slurred speech
• sore throat
• temporary blindness
• ulcers, sores, or white spots in mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in arm and/or leg on one side of body, sudden and severe

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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