Decitabine

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What is Decitabine?[edit | edit source]


Decitabine
Decitabine2



What are the uses of this medicine?[edit | edit source]

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?[edit | edit source]

  • 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 ?[edit | edit source]

  • This medicine have no usage limitations.


What drug interactions can this medicine cause?[edit | edit source]

  • Drug interaction studies with decitabine have not been conducted.


Is this medicine FDA approved?[edit | edit source]

  • 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?[edit | edit source]

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?[edit | edit source]

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

  • Dacogen


What side effects can this medication cause?[edit | edit source]

The most common side effects of this medicine include:


What special precautions should I follow?[edit | edit source]

  • 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?[edit | edit source]

Symptoms of overdosage may include:

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?[edit | edit source]

  • 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?[edit | edit source]

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


What are the active and inactive ingredients in this medicine?[edit | edit source]

Active ingredient:

  • DECITABINE

Inactive ingredients:

  • MONOBASIC POTASSIUM PHOSPHATE
  • SODIUM HYDROXIDE


Who manufactures and distributes this medicine?[edit | edit source]

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


What should I know about storage and disposal of this medication?[edit | edit source]

  • 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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