Drug Interaction:
Drugs activated by sequential phosphorylation (eg. clofarabine, NRTIs) and/or inactivated by the same enzymes as decitabine
Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DECITABINE FOR INJECTION safely and effectively. See full prescribing information for DECITABINE FOR INJECTION. DECITABINE for Injection
Initial U.S. Approval: 2006
Decitabine lyophilised powder for injection 50mg/20ml vial (additional indication)
Indication -
For the treatment of adult patients aged 65 years and above with newly diagnoised
de novo or secondary myeloid leukemia (AML) accorrding to (WHO) classification,
who are not candidates for standard induction chemotherapy
Approved by FDA on 09--04-2014 (Ref- FDA approved List- 2014)
Acute Myeloid Leukaemia
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Decitabine Lyophilized powder 25-04-2009
for Injection 50mg/20mg vial
For treatment of patients with Myelodysplastic syndromes (MDS)
including previously treated and untreated , De Novo and secondary
MDS of all French- American - British Subtypes (Refractory Anemia,
Refractory anemia with ringed sideroblasts , refractory anemia with
excess blasts, Refrractory anemia with excess blasts in transformation.
and chronic myelomonocytocytic leukemia) and intermediate
1.Intermediates 2. High-risk international Prognostic scoring system groups
2.Decitabine Lyophilised powder 09-04-2014
for Injection 50mg/20ml vial
For treament of adult patient aged 65 years and above with newly
diagnoed de novo or secondary acute leukemia (AML) ,according
to World HealthOrganization classification who are candidates for
Standard Induction Chemotherapy
Adverse Reaction:
Pneumonia, UTI, blood dyscrasias , thrombocytopenia , anemia, leucopenia,
Headache, fatigue, cough, epistaxis, petechiae,
GI upset, pyrexia, sepsis, sinusitis, hyperglycemia, hypersensitivity reactions
Contra-Indications:
Pregnancy -ensure effective contraception in women of childbearing potential,
and in men during treatment and for 3 months after stopping
Lactation
Special Precautions-
Perform complete blood and platelet counts before each treatment cycle and as clinically indicated
Consider delaying treatment if febrile neutropenia, infection, or haemorrhage occurs.
Hepatic and severe renal impairment ( CcrCl < 30ml/min)
Monitor hepatic and renal functions
Severe CHF , unstable cardiac disease
Risk of infertility , warn patient
Dosages/ Overdosage Etc:
Decitabine lyophilised powder for injection 50mg/20ml vial (additional indication)
Indication -
For the treatment of adult patients aged 65 years and above with newly diagnoised
de novo or secondary myeloid leukemia (AML) accorrding to (WHO) classification,
who are not candidates for standard induction chemotherapy
Dosage-
65 years and over - 20mg/m2 by i.v. infusion over 1 hour daily for 5 days
Repeat every 4 weeks for minumum 4 cycles until disease progression
Below 18 years - not recommended
Patient Information:
PATIENT COUNSELING INFORMATION
1.Instructions for Patients- Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Decitabine for Injection and for I month afterwards, and to use effective contraception during this time.
Men should be advised not to father a child while receiving treatment with Decitabine for Injection, and for 2 months afterwards. During these times, men with female partners of childbearing potential should use effective contraception
Patients should be advised to monitor and report any symptoms of neutropenia, thrombocytopenia, or fever to their physician as soon as possible.
Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202
Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. ISS. 12/2013 PJPI0428
Pregnancy and lactation:
Pregnancy and Lactation
Use contraindicated during pregnancy and lactation. Observe caution
Ensure effective contraception in women of childbearing potential,
and in men during treatment and for 3 months after stopping
