Decitabine

Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis. Decitabine inhibits DNA methylation in vitro, which is achieved at concentrations that do not cause major suppression of DNA synthesis. Decitabine-induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. In rapidly dividing cells, the cytotoxicity of decitabine may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA.

• Myelodysplastic Syndromes (MDS) - all FAB subtypes

Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis. Decitabine inhibits DNA methylation in vitro, which is achieved at concentrations that do not cause major suppression of DNA synthesis. In rapidly dividing cells, the cytotoxicity of decitabine may also be attributed to the formation of covalent adducts between DNA methyltransferase and decitabine incorporated into DNA.

Decitabine inhibits DNA methyltransferase, causing DNA hypomethylation, which reactivates tumor suppressor genes and induces cancer cell differentiation or apoptosis.

Three Day Regimen: 15 mg/m² IV infusion over 3 hours, repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery (minimum 4 cycles).

Five Day Regimen: 20 mg/m² IV infusion over 1 hour daily for 5 days. Repeat cycles every 4 weeks upon hematologic recovery (minimum 4 cycles).

This medicine is given as an intravenous infusion. Your doctor or nurse will give you this medicine. Kindly do not self administer.

Decitabine is an injection medicine given by healthcare professionals. You cannot miss a dose yourself. Do not miss your appointments with your doctor.

Common Side Effects (>50%): Neutropenia, thrombocytopenia, anemia, and pyrexia.

Other Side Effects: Fatigue, nausea, diarrhea, cough, headache, injection site reactions.

Neutropenia and thrombocytopenia: Perform complete blood counts and platelet counts. Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential to use effective contraception.

Hypersensitivity; Pregnancy; Lactation.

Drug interaction studies with decitabine have not been conducted. In vitro studies suggest that decitabine is unlikely to inhibit or induce cytochrome P450 enzymes. Plasma protein binding is negligible (<1%).

It is not known whether it is safe to consume alcohol with Decitabine. Please consult your doctor.

Pregnancy Category D. Decitabine is unsafe during pregnancy. Based on human data, animal studies, and mechanism of action, Decitabine can cause fetal harm.

Decitabine is unsafe during breastfeeding. There are no data on the presence of decitabine or its metabolites in human milk. Advise not to breastfeed.

Safety and effectiveness in pediatric populations have not been established.

No specific dosage adjustment is necessary for elderly patients.

No adequate information is available regarding dose adjustment in patients with kidney or liver problems. Please consult your doctor.

Overdose may lead to myelosuppression and other toxic effects. Seek medical attention.

Keep below 25°C temperature, away from light & moisture. Keep out of reach of children.

Decitabine