AZACITIDINE injection, powder, lyophilized, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Azacitidine (UNII: M801H13NRU) (Azacitidine - UNII:M801H13NRU)

Disponibil de la:

Dr. Reddy's Laboratories Inc.

INN (nume internaţional):

Azacitidine

Compoziție:

Azacitidine 100 mg

Calea de administrare:

SUBCUTANEOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 not labeled with that information. Azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions (5.3)]. Azacitidine for injection 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 for injec

Rezumat produs:

How Supplied Azacitidine for injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 43598-305-62). Storage Store unreconstituted vials at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Handling and Disposal Azacitidine for injection is a hazardous drug. Follow applicable special handling and disposal procedures.1

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

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
USEAZACITIDINE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FORAZACITIDINE FOR
INJECTION.
AZACITIDINE FOR INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 5/2022
Warnings and Precautions (5.1, 5.6) 5/2022
INDICATIONS AND USAGE
Azacitidine for injection is a nucleoside metabolic inhibitor
indicated for the treatmentof:
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)
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 injection75 mg/m 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).
DOSAGE FORMS AND STRENGTHS
Lyophilized powder in 100 mg single-dose vials (3).
CONTRAINDICATIONS
Advanced Malignant Hepatic Tumors (4.1).
Hypersensitivity to Azacitidine or Mannitol (4.2).
WARNINGS AND PRECAUTIONS
Risks of Substitution with Other Azacitid