Vidaza

What is Vidaza?

• Vidaza (Azacitidine) is a nucleoside metabolic inhibitor used to treat myelodysplastic syndromes.

Azacitidine

Azacitidine2DACS

What are the uses of this medicine?

Vidaza (azacitidine) is used for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes:

• refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions)
• refractory anemia with excess blasts (RAEB)
• refractory anemia with excess blasts in transformation (RAEB-T)
• chronic myelomonocytic leukemia (CMMoL)

How does this medicine work?

• Azacitidine (ay" za sye' ti deen: also spelled azacytidine) is a pyrimidine analogue (5-azacytidine) which is converted intracellularly to a triphosphate which becomes incorporated into RNA and DNA.
• While azacitidine has anticancer effects, it proved to have limited usefulness in solid tumors and lymphomas.
• In low doses, azacitidine inhibits methylation of DNA and results in the expression of silenced genes, including tumor suppressor genes. Studies done in vitro and in vivo have shown that azacitidine induces differentiation of bone marrow cells and results in normalization of bone marrow in a proportion of patients with myelodysplasia.
• Vidaza stops cells from making DNA and may kill abnormal blood cells or cancer cells.
• It is a type of antimetabolite.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• advanced malignant hepatic tumors.
• a known hypersensitivity to azacitidine or mannitol.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Vidaza.

Is this medicine FDA approved?

• It was approved for medical use in the United States in 2004.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is Vidaza 75 mg/m2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion.
• Premedicate for nausea and vomiting.
• Repeat cycles every 4 weeks. After 2 cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred.
• Patients should be treated for a minimum of 4 to 6 cycles.
• Complete or partial response may require additional treatment cycles.
• Continue treatment as long as the patient continues to benefit.

Administration:

• Vidaza can be administered by subcutaneous injection or intravenous infusion.

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

This medicine is available in fallowing doasage form:

• As Lyophilized powder in 100 mg single-dose vials

This medicine is available in fallowing brand namesː

• Vidaza

What side effects can this medication cause?

The most common side effects of this medicine include:

• Most common adverse reactions by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis.
• Most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia.

What special precautions should I follow?

• Vidaza causes anemia, neutropenia and thrombocytopenia. Monitor complete blood counts (CBC) frequently.
• Because azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Safety and effectiveness of Vidaza in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials.
• Patients with renal impairment may be at increased risk for renal toxicity. Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys.
• Vidaza may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate.
• Vidaza can cause fetal harm. Advise females with reproductive potential of the potential risk to a fetus and to avoid pregnancy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• diarrhea
• nausea
• vomiting

Treatment of overdosage:

• In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary.
• There is no known specific antidote for Vidaza overdosage.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animals, Vidaza can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• AZACITIDINE

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• Celgene Corporation
• Summit, NJ

Manufactured by:

• Baxter Oncology GmbH
• 33790 Halle/Westfalen Germany

	Or

• BSP Pharmaceuticals S.p.A.
• Latina Scalo (Lt)
• Italy

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

Storage:

• Store unreconstituted vials at 25º C (77º F); excursions permitted to 15º-30º C (59º-86º F).

Handling and Disposal:

• Vidaza is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Vidaza
• FDA Vidaza

Vidaza Resources
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