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Bexxar
(tositumomab)
DARYA OSMAN HUSSEIN
GENERAL INFORMATION
Therapeutic class:
Antineoplastic agent
Pharmacologic class:
Monoclonal antibody
APPLICATION
Used 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 ACTION
Binds 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 radiation
Induction of apoptosis
Complement dependent cytotoxicity
Antibody-dependent cellular toxicity
DOSE AND CLEARANCE
Given 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 requirements
Store 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 disposal
Must be prepared directly before administration
Unused portion and infusion set components must be
discarded according to laws regarding radioactive and
biohazardous waste
MONITORING
Monitor for infusion reactions
decreased rate by 50% for mild – moderate reactions
Interrupt 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 BREASTFEEDING
Pregnancy
High risk to fetus in all trimesters
Males and females should used contraception to prevent
pregnancy during and for 12 months after stopping drug
Breastfeeding:
Harmful to infant
PRECAUTIONS
Serious 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)
Bexxar

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Bexxar

  • 2. GENERAL INFORMATION Therapeutic class: Antineoplastic agent Pharmacologic class: Monoclonal antibody
  • 3. APPLICATION Used 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
  • 5. MECHANISM OF ACTION Binds 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 radiation Induction of apoptosis Complement dependent cytotoxicity Antibody-dependent cellular toxicity
  • 6. DOSE AND CLEARANCE Given 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.
  • 7. Storage requirements Store 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
  • 8. Dose preparation and disposal Must be prepared directly before administration Unused portion and infusion set components must be discarded according to laws regarding radioactive and biohazardous waste
  • 9. MONITORING Monitor for infusion reactions decreased rate by 50% for mild – moderate reactions Interrupt 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
  • 10. PREGNANCY AND BREASTFEEDING Pregnancy High risk to fetus in all trimesters Males and females should used contraception to prevent pregnancy during and for 12 months after stopping drug Breastfeeding: Harmful to infant
  • 11. PRECAUTIONS Serious 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
  • 12.
  • 13. 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
  • 14. 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)