API- Azacitidine

Packaging- Tablets

Strength- 200 mg and 300 mg

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Azacitidine is a nucleoside metabolic inhibitor used for continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and can not complete the intensive curative therapy.

Dosage and Side Effects

The recommended dosage of azacitidine tablet is 300 mg orally once daily with or without food on Days 1’st through 14’th of each 28-day cycle. Continue treatment until the disease is progressive or unacceptable toxicity occurs.

Do not crush, split, or chew the tablets of Azacitidine. Take a dose persistently each day. If a dose is missed, or not taken at the usual scheduled time, take the dose as promptly as possible on the same day, and resume the normal schedule the following day. Avoid taking a couple doses on the very same day. In case a dose is vomited, do not take another dose on the very same day. Resume the general schedule the following day.

Administer an antiemetic 30 minutes before each dose of Azacitidine for the first 2 cycles. Antiemetic prophylaxis may be omitted after 2 cycles in case there has been no vomiting and nausea.

Note: Do not substitute azacitidine tablets for intravenous or subcutaneous azacitidine. The indications and dosing regimen for this medicine differ from that of intravenous or subcutaneous azacitidine.

The most commonly reported side effects due to Azacitidine may include: decreased appetite, nausea, vomiting, diarrhea, fatigue/asthenia, febrile neutropenia, constipation, pneumonia, abdominal pain, arthralgia, dizziness, and pain in extremity.

Warning and Precautions

  • Because of substantial differences in the pharmacokinetic parameters, the standard dose and schedule for azacitidine are different from those for the intravenous or subcutaneous azacitidine products. Do not substitute azacitidine 200 mg or 300 mg pills for intravenous or subcutaneous azacitidine.
  • New or worsening Grade 3/4 thrombocytopenia and neutropenia occurred in those patients who received Azacitidine. Assess complete blood counts and modify the dosage as recommended. Standard supportive care needs to be provided, including hematopoietic growth factors, in case myelosuppression emerges.
  • The safety and effectiveness of azacitidine pills for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with azacitidine pills is not recommended.
  • Mechanism of action and findings suggest that, azacitidine 300 mg or 200 mg can cause fetal harm if administered to a pregnant woman. Females of reproductive age should use effective contraception during treatment and for at least 6 months after the final dose.


What is Azacitidine?

Azacitidine oral is authorized for the treatment of acute myeloid leukemia (AML) in thise who are in remission but cannot complete other treatments for this condition.

What dosage strengths Azacitidine Tablet is supplied?

This medicinal product is supplied in following dosage strengths, which are as follows:

  • Azacitidine 200 mg tablets
  • Azacitidine 300 mg tablets

How is Azacitidine administered?

Azacitidine comes as tablets and to be administered by (mouth) orally. It is typically taken with or without meals once daily. 

What are the different forms of Azacitidine?

It comes in two different forms:

Azacitidine Injection and Tablet

What type of medicine is Azacitidine?

Azacitidine specifically is a type of medicine known as demethylation agents.