Bexxar(tositumomab)DARYA OSMAN HUSSEIN

GENERAL INFORMATIONTherapeutic class:

Antineoplastic agent

Pharmacologic class:Monoclonal antibody

APPLICATIONUsed alone or in combination with iodine I 131

Used to treat CD20-positive, relapsed or refractory non-Hodgkin's lymphoma

Not used for initial treatment of patients with CD20-positive NHL

Used only as a single course of treatment

Non-Hodgkin’s Lymphoma

MECHANISM OF ACTIONBinds to the CD20 (human B-lymphocyte restricted differentiation antigen) antigen

This antigen is found on >90% of B-cell NHL

Bexxar acts through:Addition of ionizing radiationInduction of apoptosisComplement dependent cytotoxicityAntibody-dependent cellular toxicity

DOSE AND CLEARANCEGiven as IV solution

Dose for non-Hodgkin's lymphoma is tositumomab 450mg IV infusion over 60 minutes

Follow by I-131 tositumomab dose (calculated to deliver 75cGy total body irradiation for patients with normal platelet count) for 7 to 14 days

For those with decreased platelet count therapeutic dose adjusted to 65cGy total body irradiation

Clearance of the drug is 68.2 mg/hr.

Storage requirementsStore at 36F to 46F (2oC – 8oC) and protect from strong light

Thaw directly prior to administration and Do not shake

When diluted tositumomab stable for 24 hours refrigerated and 8 hours at room temperature

Thawed I131 tositumomab stable for up to 8 hours at room temperature

Dose preparation and disposalMust be prepared directly before administration

Unused portion and infusion set components must be discarded according to laws regarding radioactive and biohazardous waste

MONITORINGMonitor for infusion reactions

decreased rate by 50% for mild – moderate reactionsInterrupt infusion for serious reactions and resume at 50% of original if reaction resolves

Monitor for grade 3 or 4 cytopenias up to 3 months after treatment (primarily thrombocytopenia and neutropenia

Life-long monitoring for hypothyroidism

PREGNANCY AND BREASTFEEDINGPregnancy

High risk to fetus in all trimestersMales and females should used contraception to prevent

pregnancy during and for 12 months after stopping drug

Breastfeeding:Harmful to infant

PRECAUTIONSSerious allergic reactions (i.e. anaphylaxis – rash, itching, fever, chills, light-headedness or dizziness, nausea, trouble breathing or swelling of hands, face, mouth or throat)

Causes susceptibility to infection (because of temporary decreased number of WBCs)

Bleeding (due to decreased number of platelets)

May increase chance of certain cancer types or thyroid problems

SIDE EFFECTS(require immediate medical attention)

Bleeding gums

Bloating or swelling

Blurred vision

Bone pain

Chest pain

Chills

Confusion

Constipation

Coughing up blood

Depression

Difficulty breathing

Difficulty swallowing

Dizziness

Dry skin and hair

Shortness of breath

Skin rash

Slowed heartbeat

Sore throat

Sores or ulcers on mouth

Sweating

Swollen glands

Tightness of hands or feet

Unusual bleeding or bruising

Fast heartbeat

Feeling cold

Hair loss

Headache

Hives

Hoarseness or husky voice

Increased menstrual flow

Itching

Lower back or side pain

Muscle cramps and stiffness

Noisy breathing

Painful or difficult urination

Pale skin

Paralysis

Pinpoint red spots on the skin

Prolonged bleeding from cuts

Puffiness or swelling of eyelids

Rapid weight gain

Red or black tarry stools

Red or dark brown urine

Unusual weight gain or loss

wheezing

Trouble breathing with exertion

Acid or sour stomach

Back pain

Belching

Body aches and pain

Congestion

Difficulty with moving

Heartburn

Indigestion

Itching skin

Joint pain

Lack or loss of strength

Loss of appetite

Loose or liquid stools

Muscle aches or pains

Nausea

Neck pain

Runny nose

Stomach pain

Sudden sweating

Swollen joints

Trouble with swallowing

Voice changes

Vomiting

Weight loss

Sleepiness or drowsiness

Dryness or soreness of throat

Diarrhea or increased bowel movement

Difficult or labored breathing

Tender, swollen glands in neck

SIDE EFFECTS(do not require immediate medical attention)