Decitex

Decitex

Manufacturer:

Sun Pharma

Distributor:

DKLL

Marketer:

Ranbaxy
Concise Prescribing Info
Contents
Decitabine
Indications/Uses
Adults w/ myelodysplastic syndromes (MDS) including previously treated & untreated, de novo & secondary MDS of all French-American-British subtypes & intermediate-1 & 2, & High-risk International Prognostic Scoring System groups; newly diagnosed de novo or secondary AML, according to WHO classification who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
AML 20 mg/m2 BSA IV infusion over 1 hr repeated daily for 5 consecutive days (total: 5 doses per treatment cycle). Total daily dose: Not to exceed 20 mg/m2; total dose per treatment cycle: Not to exceed 100 mg/m2. Repeat cycle every 4 wk depending on patient's clinical response & observed toxicity. MDS 3-day dosing treatment regimen: 15 mg/m2 over 3-hr period every 8 hr for 3 consecutive days (total: 9 doses per treatment cycle). May be repeated approx every 6 wk. Total daily dose: Not to exceed 45 mg/m2; total dose per treatment cycle: Not to exceed 135 mg/m2. 5-day dosing treatment regimen: 20 mg/m2 over 1 hr repeated daily for 5 consecutive days (total: 5 doses per treatment cycle). Total daily dose: Not to exceed 20 mg/m2; total dose per treatment cycle: 100 mg/m2. Repeat cycle every 4 wk depending on patient's clinical response & observed toxicity.
Contraindications
Special Precautions
Interrupt treatment & reduce dose in the presence of myelosuppression or its complications. Patients w/ history of severe CHF or clinically unstable cardiac disease. Regularly perform CBC & platelet counts prior to each treatment cycle. May affect ability to drive or use machines. Severe renal impairment (CrCl <30 mL/min). Hepatic impairment or patients developing signs or symptoms of hepatic impairment. Men should not father a child during treament, & for 3 mth following treatment completion. Women of childbearing potential should seek consultation for oocyte cryopreservation prior to initiation of treatment. Women of childbearing potential should use effective contraceptive measures & avoid becoming pregnant during treatment. Not to be used during pregnancy. Discontinue lactation during treament. Not recommended in ped patients w/ AML.
Adverse Reactions
Pneumonia, UTI, viral, bacterial & fungal infections; febrile neutropenia, neutropenia, thrombocytopenia, anemia, leucopenia; headache; epistaxis; diarrhea, vomiting, stomatitis, nausea; pyrexia. Septic shock, sepsis, sinusitis; pancytopenia; hypersensitivity including anaphylactic reaction & shock, anaphylactoid reaction & shock.
Drug Interactions
Concomitant use w/ cytidine deaminase.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01BC08 - decitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Decitex powd for soln for inj 50 mg
Packing/Price
((+ 10 mL diluent)) 1's
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