Indication:
Non- Hodgkins lymphoma - NHL
Adverse Reaction:
Most serious adverse reactions reported-
Allergic reactions, (bronchospasm, and angioedema,)
hemorrhage while thrombocytopenic resulting in death
infections predominently bacterial in origin and
prolonged cytopenia
Most common adverse reactions-
Anemia, anorexia, anxiety, arthalgia, dizziness, GI symptoms,including
abdominal pain, diarrhea, nausea, and vomiting, increased cough,
neutropenia, and thrombocytopenia
Cardiovasular 16% hypotension 5%
CNS 25% - dizziness 8% headache 10% insomnia 4%
Dermatologic 25% - pruritus 8% rash 7%
GI - 45% - abdominal pain 14% anorexia 7% constipation 4% diarrhea 7%
nausea 28% throar irritation 8% vomiting 10%
GU- 5%
Hematologic /lymphatic 90% - anemia 58% ecchymosis 6% neutropenia 73%
thrombocytopenia 90%
Metabolic - 20% - angioedema 4% periheral edema 7%
Musculoskeletal 15% - arthalgia 5%
Respiratoy - 33% - bronchospasm 4% dyspnea 12% increased cough 8% rhinitis 5%
Special senses - 5%
Miscellaneous - 75% - asthenia 40% back pain 7% chills 22% fever 15%
flushing 5% infection 26% pain 11%
Contra-Indications:
Anaphylactic reactions to murine proteins or any other components
Special reactions/Warnings-
Hematologic toxicity -
Do not administer ibrutumomab tiuxetan therapeutic regimen to patients with at least
25% lymphoma marrow involement and or impaired bone marrow reserve ,
platelet count less than 100000cells/mm3, neutrophil count less than 1500 cells.mm3
Severe infusion reactions- ibritumomab tiuxetan therapeutic regimen may cause severe
and potentially fatal infusion reactions. These reactions occur during the rituximab infusion
with time to onset of 30 to 120 minutes.
Immuniazation- sdafety of imunization with live vaccines following ibritumomab tiuxetan
therapeutic regimen has not been studied.
Pregnancy- Advice women of child bearing to avoid becoming pregnant during treatment.
Use effective contraceptive methods during treatmentand for 12 months following
ibritimomab therapeutic regimen.
Lactation- Advice women to discontinue breast feeding and to substitute formula feeding
Children- safety and efficacy of ibritumomab tiuxetan therapeutic regimen in children have
not been established
Elderly- No overall differences in safety and efficacy were observed between elderly and younger subjects. but greater sensitivity to older individuals can not be ruled out.
Monitoring- obtain complete blood cell counts CBC and platelet counts weekly following
ibritumomab tiuetan and continue until levels recover.
regimen and continue
Dosages/ Overdosage Etc:
Indication-
Non- Hodgkins lymphoma - NHL
Dosage-
Rituximab administration - note the dose of rituximab is lower when used as apart of
ibritumomab tiuxetan therapeutic regimen as compared with the dose of rituximab
when used as a single agent. Do not administer rituximab as an intravenous IV push
or bolus-
Dosage modification-
The Y-90 inbritumomab tiuxetan dose should be reduced to 0.3mCi/kg 11.1 MBq/kg
for patients with a baseline platelet count between 100.000 and 149.000 cells/mm2
Premedication- hypersensitivity reactions may occur. Premedication consisting of
acetoaminophen and diphenhydramine should be considered before each infusion
of rituximab.
Patient Information:
1. Advice women of child bearing potential to avoid becoming pregnant and to use contraceptive methods during treatment and for upto 12 months following tiuxetan therapeutic regimen
Pregnancy and lactation:
Pregnancy-
Advice women of child bearing to avoid becoming pregnant during treatment.
Use effective contraceptive methods during treatmentand for 12 months following
ibritimomab therapeutic regimen.
Lactation-
Advice women to discontinue breast feeding and to substitute formula feeding
Children-
Safety and efficacy of ibritumomab tiuxetan therapeutic regimen in children have
not been established
Elderly-
No overall differences in safety and efficacy were observed between elderly and younger
subjects. but greater sensitivity to older individuals can not be ruled out.
Manufacturer Details