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, according to WHO classification, who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
Consider premed & baseline testing during treatment. MDS 3-day regimen: 15 mg/m2 by continuous IV infusion over 3 hr repeated every 8 hr for 3 days; repeat cycle every 6 wk for min of 4 cycles. Complete or partial response may take longer than 4 cycles. Delay & reduce dose for hematologic toxicity. 5-day regimen: 20 mg/m2 by continuous IV infusion over 1 hr daily for 5 days. Delay & reduce dose for hematologic toxicity. Repeat cycle every 4 wk upon hematologic recovery for min of 4 cycles. Complete or partial response may take longer than 4 cycles. AML 20 mg/m2 by IV infusion over 1 hr repeated daily for 5 consecutive days. Total daily dose: Not to exceed 20 mg/m2; total dose/treatment cycle: Not to exceed 100 mg/m2. Repeat cycle every 4 wk depending on patient's clinical response & observe toxicity.
Contraindications
Special Precautions
Myelosuppression, perform CBC & platelet count regularly. Treatment w/ high-dose IV corticosteroids & hemodynamic monitoring for differentiation syndrome, temporary discontinuation should be considered until resolution of symptoms. Cardiac disease (history of severe CHF or clinically unstable cardiac disease). Closely monitor patients w/ renal (CrCl < 30 mL/min) & hepatic impairment. May affect ability to drive & use machines. May affect fertility. Men should not father a child during & for 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 (including fatal); febrile neutropenia, neutropenia, thrombocytopenia, anemia, leucopenia; headache; epistaxis; diarrhea, vomiting, stomatitis, nausea; pyrexia. Septic shock, sepsis, sinusitis; pancytopenia; hypersensitivity including 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 powd for inj (vial) 50 mg
Packing/Price
1's
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