VIDAZA *
Manufacturer Details
CELGENE CORP
Celgene Corp.
Compositions:
Azacitidine - 100mg lyophilized powder for injection in single use vials,
|
Strength
|
Rate
|
Packing Style
|
|
100mg inj
|
0.00
|
in single use vial
|
List of Related Indications:
- Myelodyplastic syndrome ( MDS )
List Of Drugs:
- Azacitadine - DNA Demethaltion Agents- @ - Antineoplastic Agents - (Apr 2014)
Indication Type Description:
Drug Interaction:
Concurrent chemo-therapy-
Renal abnormalites elevated serum creatinine to renal failure and death have been reported
Indication:
Azacitadine 100mg/vial
Indication-
For treatment of adult patients with all subtypes of Myelodysplastic syndrome
Approved by FDA on 29-04--2014 (Ref- FDA approved List- 2014)
Azacitadine
Indication-
For treatment of adult patients with all subtypes of Myelodysplastic syndrome
Approved by FDA on 23-07--2014 (Ref- FDA approved List- 2014)
Myelodyplastic syndrome ( MDS )
Adverse Reaction:
Most commonly occuring adverse reactions-
Discontinuation- leukopenia 4% neutropenia 3% febrile neutropenia 2%
Dose held - leukopenia 3% neutropenia 3% febrile neutropenia 2%
Dose reduced - leukopenia 3% neutropenia 3% thrombocytopenia 2%
Contra-Indications:
Azacitadine is contraindicated in patients with known hypersensitivites to azactidine or mannitol
Azacitadine is also contraindicated in patients with advanced hepatic tumors
Special precutions/Warnings-
Use in men - advice men not to father a child while receiving treatment with azactidine
MDS- safety and effectiveness of azactidine in patients with MDS have not been studied
Renal function impairment - safety and efficacy of azactidine in patients with renal impairment have not not been studied.
Hepatic function impairment - safety and efficacy has not been studied
Pregnancy - . Use only if required. If the patient becomes pregnant while taking this drug,
advice the patient of the potential hazard to the fetus.
Lactation- Excercise caution. Women treated with azactidine should not nurse.
Children- safety and efficacy in pediatric patients not established..
Elderly - elderly patients are more likely to have decreased renal function, .
Care should be taken on dose selection.
Monitoring- perform complete blood counts as need to monitor response and toxicity
Obtain liver chemistries and serun creatinine prior to initiation of therapy
Dosages/ Overdosage Etc:
Indication-
Myelodyplastic syndrome ( MDS )
Dosage -
Recommended starting dosefor the first treatment cycle is 75mg/m2 subcutaneously SC or intravenously daily for 7 days . Patients should be premedicated for nausea and vomiting.
Subsequent treatment cycles - should be repeated every 4 weeks . The dose may be increased to 100mg/m2 if no beneficial effect is seen after 2 weeks of treatment. It is recommended that patients be treated for a minimum of 4 to 6 cycles.
Maximum daily dose 100mg/m2 SC or IV daily for 7 days every 4 weeks
Patient Information:
1. Patients should inform their physician about any underlying liver or renal disease
2. Advice women of childbearing potential to avoid becoming pregnant while receiving
treatment with azactidine
3. Advice men not to father children while receiving treatment with azactidine
Pregnancy and lactation:
Pregnancy - .
Use only if required. If the patient becomes pregnant while taking this drug,
advice the patient of the potential hazard to the fetus.
Lactation-
Excercise caution. Women treated with azactidine should not nurse.
Children-
Safety and efficacy in pediatric patients not established..
Elderly -
Elderly patients are more likely to have decreased renal function, .
Care should be taken on dose selection.
