MYLOTARG- gemtuzumab ozogamicin injection, powder, lyophilized, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

GEMTUZUMAB OZOGAMICIN (UNII: 8GZG754X6M) (GEMTUZUMAB OZOGAMICIN - UNII:8GZG754X6M)

Dostupné z:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (Medzinárodný Name):

GEMTUZUMAB OZOGAMICIN

Zloženie:

GEMTUZUMAB OZOGAMICIN 5 mg in 5 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions (5.2), Adverse Reactions (6)] . Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1), Nonclinical Toxicology (13.1)] , MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on MYLOTARG use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

Prehľad produktov:

MYLOTARG (gemtuzumab ozogamicin) for injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial [see Dosage and Administration (2)] . Refrigerate (2°C to 8°C; 36°F to 46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE. MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

MYLOTARG- GEMTUZUMAB OZOGAMICIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYLOTARG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYLOTARG.
MYLOTARG™ (GEMTUZUMAB OZOGAMICIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATOTOXICITY, INCLUDING SEVERE OR FATAL HEPATIC VENO-OCCLUSIVE
DISEASE (VOD), ALSO
KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), HAS BEEN REPORTED IN
ASSOCIATION
WITH THE USE OF MYLOTARG. (5.1, 6.1)
RECENT MAJOR CHANGES
Dosage and Adminstration, Instructions for Reconstitution, Dilution,
and
Administration (2.4)
08/2021
INDICATIONS AND USAGE
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate
indicated for:
treatment of newly-diagnosed CD33-positive acute myeloid leukemia
(AML) in adults and pediatric
patients 1 month and older (1.1).
treatment of relapsed or refractory CD33-positive AML in adults and
pediatric patients 2 years and
older (1.2).
DOSAGE AND ADMINISTRATION
Newly-diagnosed, de novo AML (combination regimen)
Adults:
–
–
Pediatric patients 1 month and older:
–
–
–
Newly-diagnosed AML (single-agent regimen):
Adults:
–
–
Relapsed or refractory AML (single-agent regimen):
–
_Induction:_ 3 mg/m (up to one 4.5 mg vial) on Days 1, 4, and 7 in
combination with daunorubicin
and cytarabine (2.2).
2
_Consolidation:_ 3 mg/m on Day 1 (up to one 4.5 mg vial) in
combination with daunorubicin and
cytarabine (2.2).
2
3 mg/m for patients with body surface area (BSA) 0.6 m or greater
(2.2).
2
2
0.1 mg/kg for patients with BSA less than 0.6 m (2.2).
2
See Full Prescribing Information for complete dosing information
(2.2).
_Induction:_ 6 mg/m (not limited to one 4.5 mg vial) on Day 1 and 3
mg/m (not limited to one 4.5
mg vial) on Day 8 (2.2).
2
2
_Continuation:_ For patients without ev