Pronunciation:

tos-IT-too-moe-mab

Brand Names:

• Bexxar

Dosage Forms:

• Solution

Warnings:

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions. Prolonged and severe cytopenias occur in most patients. Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3). The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals. Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff .

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions. Prolonged and severe cytopenias occur in most patients. Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3). The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals. Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Tositumomab and iodine I 131 tositumomab combination regimen is used to treat patients with CD20-positive, relapsed or refractory non-Hodgkin's lymphoma. It is also given to patients with non-Hodgkin's lymphoma who already have received rituximab.

This medicine is to be given only by or under the immediate supervision of your doctor.

The tositumomab and iodine I 131 tositumomab combination regimen will be withdrawn from the United States market on February 20, 2014.

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 the Bexxar® regimen in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of the Bexxar® regimen have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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:

• Anemia (low number of red blood cells) or
• Hypothyroidism (underactive thyroid) or
• Leukemia or
• Myelodysplastic syndrome (MDS) or
• Neutropenia (low number of white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Kidney disease or
• Urinary tract blockage—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

Bexxar® therapeutic regimen consists of 2 separate components (tositumomab and iodine I 131 tositumomab) which are given in 2 separate steps 7 to 14 days apart. You may also receive medicines (e.g., acetaminophen, diphenhydramine) to help prevent possible allergic reactions to the injection.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This is 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. Male patients should also use effective contraception to prevent pregnancy while receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you become pregnant while using the medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, lightheadedness or dizziness, nausea, trouble breathing, or any swelling of your hands, face, mouth, or throat during treatment or within 48 hours receiving this medicine.

Tositumomab and iodine I 131 tositumomab regimen 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.

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

This medicine may increase your risk for certain types of cancer or thyroid problems. Talk with your doctor about these risks.

While you are being treated with tositumomab and iodine I 131 tositumomab regimen, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Tositumomab and iodine I 131 tositumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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

Bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

bone pain

chest pain

chills

confusion

constipation

cough

coughing up blood

depressed mood

difficulty with breathing

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry skin and hair

fast heartbeat

feeling cold

fever or chills

hair loss

headache

hives

hoarseness or husky voice

increased menstrual flow or vaginal bleeding

itching

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

lower back or side pain

muscle cramps and stiffness

noisy breathing

nosebleeds

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

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

rapid weight gain

red or black, tarry stools

red or dark brown urine

shortness of breath

skin rash

slowed heartbeat

sore throat

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

sweating

swollen glands

tightness in the chest

tingling of the hands or feet

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

wheezing

Less common

Feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

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

Acid or sour stomach

back pain

belching

body aches or pain

congestion

diarrhea or increased bowel movements

difficult or labored breathing

difficulty with moving

dryness or soreness of the throat

heartburn

indigestion

itching skin

joint pain

lack or loss of strength

loose or liquid stools

loss of appetite

muscle aches or pains

nausea or feeling of upset stomach or feeling like you may vomit

neck pain

runny nose

stomach discomfort, upset, or pain

sudden sweating

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

swollen joints

tender, swollen glands in the neck

trouble with swallowing

voice changes

vomiting

weight loss

Less common

Sleepiness or unusual drowsiness

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.