Azacitidine 100 mg/1
azacitidine · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Apotex Corp
Azacitidine is a injection, powder, lyophilized, for solution containing azacitidine at 100 mg/1, taken intravenous. Manufactured by Apotex Corp.
Key Facts
- Brand Name
- Azacitidine
- Generic Name
- azacitidine
- NDC Code (Product)
60505-6271- Manufacturer
- Apotex Corp
- Strength
- 100 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA215905
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 01/23/2024
Recall History
Teva Pharmaceuticals USA Inc
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Shilpa Medicare Limited
CGMP Deviations
Shilpa Medicare Limited
CGMP Deviations
Dr. Reddy's Laboratories, Inc.
Failed stability specifications
Dr. Reddy's Laboratories, Inc.
Failed stability specifications
CIPLA
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Amerisource Health Services LLC
Subpotent Drug
Infusion Options, Inc.
Lack of Assurance of Sterility
Side 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: Adult 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 ) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of adult 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). Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection). However, due to Celgene Corporation's marketing exclusivity rights, this drug product is no…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not substitute Azacitidine for injection for oral azacitidine. The indications and dosing regimen for Azacitidine for injection differ from that of oral azacitidine ( 2.1 , 5.1 ). MDS: The recommended starting dosage 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 injection or intravenous infusion. See full prescribing information for schedule for subsequent cycles. Premedicate for nausea and vomiting ( 2.2 ). Continue treatment as long as the patient continues to benefit ( 2.3 ). Monitor all patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.3 , 2.6 , 2.7 ). 2.1 Important Administration Information Do not substitute Azacitidine for injection for oral azacitidine. The indications and dosing regimen for Azacitidine for injection differ from that of oral azacitidine [see Warnings and Precautions (5.1) ] 2.2 First Treatment Cycle for Adults The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 …
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 (5.3) ]. 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 Most common adverse reactions (>30%) in adult patients with MDS 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Shilpa Medicare Limited 1-888-557-1212 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are described in other labeling sections: Anemia, Neutropenia and Thrombocytopenia [ see Warnings and Precautions (5.2) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [ see Warnings and Precautions (5.3) ] Renal Toxicity [ see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [ see Warnings and Precautions (5.5) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. MDS The data describ…
Frequently Asked Questions
What is Azacitidine used for?
Azacitidine contains azacitidine. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Azacitidine a controlled substance?
Azacitidine is not classified as a controlled substance by the DEA.
What is the generic name for Azacitidine?
The generic name for Azacitidine is azacitidine. There are 4 other brand versions of azacitidine.
What is the NDC code for Azacitidine 100 mg/1?
The NDC (National Drug Code) for Azacitidine 100 mg/1 is 60505-6271, listed by Apotex Corp.