Redtibin

Redtibin

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
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 groups. Adult patients ≥65 yr w/ newly diagnosed de novo or secondary acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy.
Dosage/Direction for Use
MDS Standard anti-emetic therapy may be used as premed. 1st regimen 15 mg/m2 by continuous IV infusion over 3 hr repeated every 8 hr for 3 days. Repeat cycle every 6 wk. Hematologic recovery from previous treatment cycle requiring >6 but <8 wk: Delay dose for up to 2 wk & temporarily reduce to 11 mg/m2 every 8 hr upon restarting therapy, >8 but <10 wk: Delay dose up to 2 more wk & reduce to 11 mg/m2 every 8 hr upon restarting therapy. 2nd regimen 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. Total daily dose: Not to exceed 20 mg/m2. Total dose/cycle: Not to exceed 100 mg/m2.
Contraindications
Special Precautions
Myelosuppression; interstitial lung disease; history of severe CHF or clinically unstable cardiac disease. Perform complete blood & platelet counts regularly & prior to each treatment cycle. Patients on controlled Na & K diet. May affect ability to drive & use machines. Hepatic & severe renal impairment (CrCl <30 mL/min). Women of childbearing potential must use effective contraception. Men should use effective contraception & not father a child during & for 3 mth after treatment. Not to be used during pregnancy & lactation. Ped patients.
Adverse Reactions
Neutropenia, thrombocytopenia; anemia; pyrexia. MDS: Fatigue; nausea; cough; petechiae; constipation; diarrhea; hyperglycaemia. AML: Pneumonia, UTI, other viral, bacterial & fungal infections; febrile neutropaenia, leukopaenia; headache; epistaxis; vomiting. Septic shock; hypersensitivity eg, anaphylactic reaction; stomatitis.
Drug Interactions
Other agents activated by sequential phosphorylation via intracellular phosphokinase activities &/or metabolized by enzymes implicated in decitabine inactivation (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
Redtibin powd for inj 50 mg
Packing/Price
1's
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