AZACITIDINE AZACITIDINE- 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:

Dr. Reddy's Laboratories Inc.

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 is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions (5.2) ]. Azacitidine is contraindicated in patients with a known hypersensitivity to Azacitidine or mannitol. Risk Summary Based on its mechanism of action and findings in animals, Azacitidine 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 doses lower than the recommended

Product summary:

How Supplied Azacitidine for injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 43598-678-11). Storage Store unreconstituted vials at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP Controlled Room Temperature). 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- AZACITIDINE INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
DR. REDDY'S LABORATORIES INC.
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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 (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7) 8/2016
Warnings and Precautions (5.2, 5.3, 5.4, 5.5) 8/2016
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
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 (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 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).
DOSAGE FORMS AND STRENGTHS
Lyophilized powder in 100 mg single-dose vials (3).
CONTRAINDICATIONS
Advanced Malignant Hepatic Tumors (4.1).
Hyper