Ibritumomab (Intravenous Route)

It is used together with another monoclonal antibody (rituximab) and two radioactive medications (In-111 and 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 .

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 ibritumomab 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 in the elderly.

Pregnancy

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:

• Acute myelogenous leukemia (AML) or


• Myelodysplastic syndrome (MDS) or


• Neutropenia (low white blood cells in the blood) or


• Thrombocytopenia (low platelets in the blood)a€”Use with caution. May make these conditions worse.

Proper Use

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

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 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.

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 with swallowing; dizziness; a fast heartbeat; wheezing; trouble with 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, and after you stop treatment with it, do not have any immunizations (live vaccinations) 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 .

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.

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

• 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 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:

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.