EVOMELA- melphalan injection, powder, lyophilized, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

MELPHALAN HYDROCHLORIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9510P)

Dostupno od:

Acrotech Biopharma Inc

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. History of serious allergic reaction to melphalan. Risk Summary Based on its mechanism of action, Evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see Clinical Pharmacology (12.1)] . Melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see Nonclinical Toxicology (13.1)] . In animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see Data] . Advise a pregnant woman of the potential risk to a fetus.. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data   Animal Data Adequate ani

Proizvod sažetak:

How Supplied Evomela is supplied in a single carton containing one (1) vial. Each 50 mg vial contains a white to off- white lyophilized powder in single-dose vial for reconstitution (after reconstitution the solution is clear and coloress to light yellow). Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride. NDC 72893-001-01: Individual carton of Evomela single-dose vial containing 50 mg melphalan free base. Storage and Handling Store Evomela at room temperature 25°C (77°F). Temperature excursions are permitted between 15- 30°C (59-86°F). [see USP Controlled Room Temperature] Evomela is light sensitive. Retain in original carton until use. Melphalan is a hazardous drug. Follow applicable special handling and disposal procedures.1

Status autorizacije:

New Drug Application

Svojstava lijeka

EVOMELA - MELPHALAN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ACROTECH BIOPHARMA INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVOMELA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVOMELA.
EVOMELA (MELPHALAN) FOR INJECTION, FOR INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1964
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND
LEUKEMOGENICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE BONE MARROW SUPPRESSION WITH RESULTING INFECTION OR BLEEDING
MAY OCCUR.
CONTROLLED TRIALS COMPARING INTRAVENOUS (IV) MELPHALAN TO ORAL
MELPHALAN HAVE
SHOWN MORE MYELOSUPPRESSION WITH THE IV FORMULATION. MONITOR
HEMATOLOGIC
LABORATORY PARAMETERS. (5.1)
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS, HAVE OCCURRED IN
APPROXIMATELY
2% OF PATIENTS WHO RECEIVED THE IV FORMULATION OF MELPHALAN.
DISCONTINUE TREATMENT
WITH EVOMELA FOR SERIOUS HYPERSENSITIVITY REACTIONS. (5.4 )
MELPHALAN PRODUCES CHROMOSOMAL ABERRATIONS _IN VITRO_ AND _IN VIVO_.
EVOMELA SHOULD
BE CONSIDERED POTENTIALLY LEUKEMOGENIC IN HUMANS. (5.5)
RECENT MAJOR CHANGES
Indications and Usage, Palliative Treatment (1.2) Removed 8/2021
Dosage and Administration (2.2, 2.3, 2.4) 11/2021
Warnings and Precautions (5.1, 5.2) 8/2021
INDICATIONS AND USAGE
Evomela is an alkylating drug indicated for use as a high-dose
conditioning treatment prior to
hematopoietic progenitor (stem) cell transplantation in patients with
multiple myeloma. (1.1)
DOSAGE AND ADMINISTRATION
For CONDITIONING TREATMENT, the recommended dose of Evomela is 100
mg/m /day administered over
30 minutes by intravenous infusion for 2 consecutive days (Day -3 and
Day -2) prior to autologous stem
cell transplantation (ASCT, Day 0). (2.1)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 mg per vial, lyophilized powder in a single-dose
vial for reconstitution. (3)
CONTRAINDICATIONS
History of serious allergic reaction to melphalan (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal toxicity: Nausea, vomiti