AZACITIDINE AZACITIDINE 100 mg/1
AZACITIDINE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Dr. Reddy's Laboratories Inc.
AZACITIDINE AZACITIDINE is a injection, powder, lyophilized, for solution containing azacitidine at 100 mg/1, taken intravenous. Manufactured by Dr. Reddy's Laboratories Inc..
Key Facts
- Brand Name
- AZACITIDINE AZACITIDINE
- Generic Name
- AZACITIDINE
- NDC Code (Product)
43598-678- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Strength
- 100 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA207518
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 12/13/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated 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), and chronic myelomonocytic leukemia (CMMoL).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for injection 75 mg/m 2 daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Premedicate for nausea and vomiting. ( 2.1 ) Repeat cycles every 4 weeks (2.2) . After 2 cycles, may increase dose to 100 mg/m 2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred ( 2.2 ). Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles ( 2.2 ). Continue treatment as long as the patient continues to benefit ( 2.2 ). Monitor patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.3 , 2.4 , 2.5 ). 2.1 First Treatment Cycle The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemistries and serum creatinine prior to the fir…
Contraindications
4 CONTRAINDICATIONS Advanced Malignant Hepatic Tumors ( 4.1 ). Hypersensitivity to Azacitidine or Mannitol ( 4.2 ). 4.1 Advanced Malignant Hepatic Tumors Azacitidine is contraindicated in patients with advanced malignant hepatic tumors [ see Warnings and Precautions (5.2) ]. 4.2 Hypersensitivity to Azacitidine or Mannitol Azacitidine is contraindicated in patients with a known hypersensitivity to Azacitidine or mannitol.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in other labeling sections: Anemia, Neutropenia and Thrombocytopenia [see Warnings and Precautions (5.1) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see Warnings and Precautions (5.2) ] Renal Toxicity [see Warnings and Precautions (5.3) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] Embryo-Fetal Risk [see Warnings and Precautions (5.5) ] Most Commonly Occurring Adverse Reactions (SC or IV Route) : nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis. The most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia. Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC or IV Route): Discontinuation: leukopenia, thrombocytopenia, neutropenia. Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia. Dose Reduced: leukopenia, neutropenia, thrombocytopenia. Most common adverse reactions (>30%) by SC route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection s…
Frequently Asked Questions
What is AZACITIDINE AZACITIDINE used for?
AZACITIDINE AZACITIDINE contains AZACITIDINE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is AZACITIDINE AZACITIDINE a controlled substance?
AZACITIDINE AZACITIDINE is not classified as a controlled substance by the DEA.
What is the generic name for AZACITIDINE AZACITIDINE?
The generic name for AZACITIDINE AZACITIDINE is AZACITIDINE. There are 11 other brand versions of AZACITIDINE.
What is the NDC code for AZACITIDINE AZACITIDINE 100 mg/1?
The NDC (National Drug Code) for AZACITIDINE AZACITIDINE 100 mg/1 is 43598-678, listed by Dr. Reddy's Laboratories Inc..