Tositumomab and Iodine I 131 Tositumomab

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Very bad dizziness or passing out.
• Very upset stomach or throwing up.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Black, tarry, or bloody stools.
• Chest pain or pressure.
• Flushing.
• Pale skin.
• Irritation where the shot is given.
• Shortness of breath.
• Swelling in the arms or legs.
• A big weight loss.
• A skin lump or growth.
• Sweating a lot.
• Throwing up blood or throw up that looks like coffee grounds.
• A wound that does not heal.

(toe si TYOO mo mab & EYE oh dyne eye one THUR tee one toe si TYOO mo mab)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Note: Not all components are shipped from the same facility. When ordering, ensure that all will arrive on the same day.

Kit [dosimetric package]: Tositumomab 225 mg/16.1 mL [2 vials], tositumomab 35 mg/2.5 mL [1 vial], and iodine I 131 tositumomab 0.1 mg/mL and 0.61mCi/mL (20 mL) [1 vial] [DSC]

Kit [therapeutic package]: Tositumomab 225 mg/16.1 mL [2 vials], tositumomab 35 mg/2.5 mL [1 vial], and iodine I 131 tositumomab 1.1 mg/mL and 5.6 mCi/mL (20 mL) [1 or 2 vials] [DSC]

• Antineoplastic Agent, Anti-CD20
• Antineoplastic Agent, Monoclonal Antibody
• Radiopharmaceutical

CD20-positive cell recovery begins at ~12 weeks

Half-Life Elimination

Tositumomab: 67 hours (range: 28-115 hours); decreased with high tumor burden, splenomegaly, or bone marrow involvement

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

The tositumomab and iodine I 131 tositumomab therapeutic regimen resulted in severe and prolonged thrombocytopenia and neutropenia in more than 70% of the patients in clinical studies. The tositumomab and iodine I 131 tositumomab therapeutic regimen should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm3 or neutrophil count less than 1,500 cells/mm3.

Serious, including fatal, allergic reactions have occurred during or following administration of the tositumomab and iodine I 131 tositumomab therapeutic regimen. Have medications for the treatment of allergic reactions available for immediate use. Permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions and administer appropriate medical treatment.

The tositumomab and iodine I 131 tositumomab therapeutic regimen may be administered only under the supervision of physicians who are certified under or participating in the tositumomab and iodine I 131 tositumomab therapeutic regimen certification program and who are authorized under the Radioactive Materials License at their clinical site. Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure during handling and after administration of the tositumomab and iodine I 131 tositumomab therapeutic regimen.

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:

• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.
• Feeling tired or weak.
• Headache.
• Cough.
• Muscle or joint pain.
• Back pain.
• Hard stools (constipation).
• Belly pain.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Not hungry.
• Dizziness.
• Feeling sleepy.
• Neck pain.

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.

Some side effects of iodine i 131 tositumomab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.