Decitabine

What is Decitabine?

• Decitabine (Dacogen) is a nucleoside metabolic inhibitor used in the therapy of myelodysplastic syndromes.

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Decitabine

Decitabine2

What are the uses of this medicine?

Decitabine (Dacogen) is used for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

How does this medicine work?

• Decitabine (dee sye' ta been) is a pyrimidine analogue (5-aza-deoxy-cytidine) which is the deoxyribose form of 5-azacitidine.
• Decitabine is converted intracellularly to a triphosphate which becomes incorporated into DNA and appears to inhibit DNA methylation, resulting in increased expression of silenced genes including tumor suppressor genes.
• Studies done in vitro and in vivo have shown that decitabine induces differentiation of bone marrow cells and results in normalization of bone marrow in a proportion of patients with myelodysplasia.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Drug interaction studies with decitabine have not been conducted.

Is this medicine FDA approved?

• Decitabine was approved for use in the United States in 2006 and the current single indication is for therapy of myelodysplasic syndromes.

How should this medicine be used?

• Consider pre-medicating for nausea with antiemetics.
• Conduct baseline laboratory testing complete blood count (CBC) with platelets, serum hepatic panel, and serum creatinine.

Recommended dosage: Three Day Regimen:

• Administer Dacogen at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days.
• Repeat cycle every 6 weeks.

Five Day Regimen:

• Administer Dacogen at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days.
• Repeat cycle every 4 weeks.

Administration:

• Decitabine comes as a powder to be to be added to fluid and injected slowly over 3 hours intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic.
• It is usually injected every 8 hours for 3 days.
• This treatment period is called a cycle, and the cycle may be repeated every 6 weeks for as long as your doctor recommends.
• Decitabine should usually be given for at least four cycles but may be continued if your doctor decides that you will benefit from additional treatment.
• Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of decitabine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mg of decitabine as a lyophilized powder in a single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

• Dacogen

What side effects can this medication cause?

The most common side effects of this medicine include:

• neutropenia
• thrombocytopenia
• anemia
• pyrexia

What special precautions should I follow?

• Fatal and serious myelosuppression occurs in Dacogen-treated patients. Perform complete blood counts and platelet counts.
• Based on findings from human data, animal studies and its mechanism of action, Dacogen can cause fetal harm when administered to a pregnant woman. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Advise women to avoid breastfeeding while receiving Dacogen and for at least 2 weeks after the last dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• myelosuppression including prolonged neutropenia and thrombocytopenia

Management of overdosage:

• There is no known antidote for overdosage with Dacogen.
• Standard supportive measures should be taken in the event of an overdose.

Can this medicine be used in pregnancy?

• Based on findings from human data, animal studies, and the mechanism of action, Dacogen can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Dacogen in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DECITABINE

Inactive ingredients:

• MONOBASIC POTASSIUM PHOSPHATE
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Manufactured by Pharmachemie B.V. Haarlem, The Netherlands
• Manufactured for Otsuka America Pharmaceutical, Inc., Rockville, MD USA

• Dacogen is a registered trademark of Astex Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

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