Dacogen

Dacogen

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Decitabine
Indications/Uses
Myelodysplastic syndromes (MDS) including previously treated & untreated, de novo & secondary MDS of all French-American-British (FAB) subtypes & Intermediate-1, Intermediate-2 & High-Risk International Prognostic Scoring System (IPSS) groups. Adult patients (≥65 yr) newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
AML 20 mg/m2 IV infusion over 1 hr for 5 consecutive days. Repeat cycle every 4 wk. Max total daily dose: 100 mg/m2. MDS 3-Day Regimen: 15 mg/m2 IV infusion over a 3-hr period 8 hrly for 3 consecutive days. Repeat cycle approx every 6 wk. Max total daily dose: 45 mg/m2. Max total dose/treatment cycle: 135 mg/m2. If myelosuppression happens during treatment, modify the treatment depending on clinical conditions. If myelosuppression recovery is >6 wk but <8 wk, delay treatment up to 2 wk & reduce next cycle dose to 11 mg/m2 8 hrly upon restarting therapy; if >8 wk but <10 wk, delay dosing up to 2 more wk & reduce next cycle dose to 11 mg/m2 8 hrly upon restarting therapy &; if >10 wk, discontinue treatment. 5-Day Regimen: 20 mg/m2 IV infusion over 1 hr for 5 consecutive days. Repeat cycle every 4 wk. Max total daily dose: 20 mg/m2. Max total dose/treatment cycle: 100 mg/m2. If myelosuppression happens & it’s recovery is >8 wk, discontinue treatment.
Contraindications
Special Precautions
Perform regular CBC & platelet count as clinically indicated & prior to each treatment cycle. Patients w/ history of severe CHF or clinically unstable cardiac disease. May impair ability to drive & use machines. Hepatic or renal impairment. Men should be advised not to father a child while on treatment & for 3 mth following completion of treatment. May alter male fertility. Women of childbearing potential. Pregnancy. Childn.
Adverse Reactions
Pneumonia, UTI, other infections (viral, bacterial, fungal); febrile neutropenia, neutropenia, thrombocytopenia, anemia, leucopenia; headache; epistaxis; diarrhea, vomiting, stomatitis, nausea; pyrexia. Septic shock, sepsis, sinusitis; pancytopenia; hypersensitivity & anaphylactic reaction.
Drug Interactions
There is a potential reaction w/ agents that are activated by sequential phosphorylation &/or metabolized by enzymes implicated in the inactivation of decitabine eg, cytidine deaminase.
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
20 mL x 1's (Rp12,387,250/vial)
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