Dacogen

Dacogen

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Decitabine
Indications/Uses
Myelodysplastic syndromes (MDS) including previously treated & untreated, de novo & secondary MDS of all FAB subtypes & Int-1, Int-2 & high risk IPSS groups. Adults ≥65 yr w/ newly diagnosed de novo or secondary AML who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
MDS 1st treatment cycle: 15 mg/m2 by continuous IV infusion over 3 hr repeated every 8 hr for 3 days; repeat cycle every 6 wk. If hematologic recovery from previous treatment cycle requires 6-10 wk, reduce dose of next cycle to 11 mg/m2 every 8 hr & delay dosing by up to 2 wk. 2nd treatment cycle: 20 mg/m2 by continuous IV infusion over 1 hr repeated daily for 5 days; repeat cycle every 4 wk. AML 20 mg/m2 by IV infusion over 1 hr repeated daily for 5 consecutive days; repeat cycle every 4 wk depending on patient's response.
Contraindications
Special Precautions
Myelosuppression; history of severe CHF or clinically unstable cardiac disease. Perform complete blood & platelet count regularly & prior to each treatment cycle. May affect ability to drive & use machines. Hepatic & severe renal impairment (CrCl <30 mL/min). Men should not father a child during & up to 3 mth after treatment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Ped patients.
Adverse Reactions
Pneumonia, UTI, other viral, bacterial, fungal infections; febrile neutropenia, neutropenia, thrombocytopenia, anemia, leucopenia; headache; epistaxis; diarrhea, vomiting, stomatitis, nausea; pyrexia. Septic shock, sepsis, sinusitis; pancytopenia; hypersensitivity eg, anaphylactic reaction.
Drug Interactions
Other agents activated by sequential phosphorylation via intracellular phosphokinase activities &/or metabolized by enzymes implicated in decitabine inactivation.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC08 - decitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Dacogen infusion 50 mg
Packing/Price
1's
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