AZACITIDINE injection, powder, lyophilized, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Meitheal Pharmaceuticals Inc.

Podání:

SUBCUTANEOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions (5.3)]. 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

Přehled produktů:

How Supplied Azacitidine for Injection is a white to off-white lyophilized powder or lyophilized cake and is supplied as follows: Storage Store unreconstituted vials at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Handling and Disposal Azacitidine for Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AZACITIDINE- AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MEITHEAL PHARMACEUTICALS 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)
5/2022
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6)
5/2022
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)
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 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
White to off-white lyophilized powder or lyophilized cake in 100 mg
single-dose vials (3).
CONTRAINDICATIONS
Advanced Malignant Hepatic Tumors (4.1).
Hypersensitivity to Azacitidine or Mannitol (4.2).
WARNING