Dacogen

Dacogen

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Decitabine
Indications/Uses
Newly diagnosed de novo or secondary AML, according to the WHO classification, in adults who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
1 treatment cycle: 20 mg/m2 by IV infusion over 1 hr repeated daily for 5 consecutive days. Max total daily dose: 20 mg/m2. Max total dose per treatment cycle: 100 mg/m2. Repeat cycle every 4 wk. Recommended to treat patients for a min of 4 cycles.
Contraindications
Special Precautions
Myelosuppression & complications of myelosuppression, including infections & bleeding, may be exacerbated. Monitor for signs & symptoms of infection & treat promptly. Monitor for signs & symptoms of heart failure, especially in patients w/ cardiac disease history. Regularly perform complete blood & platelet counts as clinically indicated & prior to each treatment cycle. Perform liver &/or renal function tests prior to treatment initiation & each treatment cycle, & as clinically indicated. Reports of interstitial lung disease (including pulmonary infiltrates, organising pneumonia & pulmonary fibrosis) w/o signs of infectious aetiology; cardiomyopathy w/ cardiac decompensation; differentiation syndrome (retinoic acid syndrome). Moderate influence on the ability to drive & use machines. Patients w/ hepatic impairment; severe renal impairment (CrCl <30 mL/min); history of severe CHF or clinically unstable cardiac disease. Do not use during pregnancy & in women of childbearing potential not using effective contraception. Men should be advised not to father a child while on treatment, & for 3 mth following completion of treatment. Do not use in childn <18 yr.
Adverse Reactions
Pyrexia, anaemia, thrombocytopenia. Pneumonia, UTI, other infections (viral, bacterial, fungal); febrile neutropaenia, neutropaenia, leukopaenia; hyperglycaemia; headache; epistaxis; diarrhoea, vomiting, nausea; abnormal hepatic function. Septic shock, sepsis, sinusitis; hypersensitivity including anaphylactic reaction; stomatitis; hyperbilirubinaemia.
Drug Interactions
Potential for drug-drug interaction w/ other agents which are also activated by sequential phosphorylation (via intracellular phosphokinase activities) &/or metabolised by enzymes implicated in the inactivation of decitabine (eg, cytidine deaminase).
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 infusion 50 mg
Packing/Price
1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in