AZACITIDINE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZACITIDINE (UNII: M801H13NRU) (AZACITIDINE - UNII:M801H13NRU)

Available from:

Mylan Institutional LLC

INN (International Name):

AZACITIDINE

Composition:

AZACITIDINE 100 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). Azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions (5.2)] . Azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. Based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no data on the use of azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at dos

Product summary:

How Supplied: Azacitidine for Injection is supplied as a lyophilized powder in 100 mg single-dose vials. NDC 67457-254-30 carton containing one, 100 mg single-dose vial Storage: Store unreconstituted vials at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free. Handling and Disposal: Azacitidine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZACITIDINE- AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZACITIDINE FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZACITIDINE FOR
INJECTION.
AZACITIDINE FOR INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Dosage and Administration (2.7) 7/2018
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)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (> 30%) 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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline hematology
values, is azacitidine for injection 75 mg/m daily for 7 days to be
administered by subcutaneous injection or
intravenous infusion. Premedicate for nausea and vomiting. (2.1)
2
Repeat cycles every 4 weeks (2.2). After 2 cycles, may increase dose
to 100 mg/m if no beneficial effect is seen and
no toxicit