ROMIDEPSIN injection, solution, concentrate

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ROMIDEPSIN (UNII: CX3T89XQBK) (ROMIDEPSIN - UNII:CX3T89XQBK)

Tersedia dari:

Teva Parenteral Medicines, Inc.

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Romidepsin Injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. None. Risk Summary Based on its mechanism of action and findings from animal studies, Romidepsin Injection can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see Data) . Advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a backgrou

Ringkasan produk:

How Supplied Romidepsin Injection is supplied as a sterile, clear, colorless to pale yellow solution available in single-dose vials in the following carton packaged strengths. Romidepsin Injection, 10 mg/2 mL (5 mg/mL)         NDC 0703-3071-01 Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL)   NDC 0703-4004-01 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59° to 86°F) in the carton [see USP Controlled Room Temperature].  Protect from light. Romidepsin Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1

Status otorisasi:

New Drug Application

Karakteristik produk

ROMIDEPSIN- ROMIDEPSIN INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROMIDEPSIN INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROMIDEPSIN INJECTION.
ROMIDEPSIN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Indications and Usage, Peripheral T-cell Lymphoma (1.2) Removed
12/2021
INDICATIONS AND USAGE
Romidepsin Injection is a histone deacetylase (HDAC) inhibitor
indicated for the treatment of cutaneous T-
cell lymphoma (CTCL) in adult patients who have received at least one
prior systemic therapy (1).
DOSAGE AND ADMINISTRATION
14 mg/m administered intravenously over a 4-hour period on days 1, 8,
and 15 of a 28-day cycle.
Repeat cycles every 28 days provided that the patient continues to
benefit from and tolerates the drug
(2.1).
Discontinue or interrupt treatment (with or without dose reduction to
10 mg/m ) to manage drug
toxicity (2.2).
Reduce starting dose in patients with moderate and severe hepatic
impairment (2.3).
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/2 mL (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL) in
single-dose vials (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Myelosuppression: Romidepsin can cause thrombocytopenia, leukopenia
(neutropenia and
lymphopenia), and anemia; monitor blood counts during treatment with
Romidepsin Injection; interrupt
and/or modify the dose as necessary (5.1).
Infections: Fatal and serious infections. Reactivation of DNA viruses
(Epstein Barr and hepatitis B).
Consider monitoring and prophylaxis in patients with evidence of prior
hepatitis B (5.2).
Electrocardiographic (ECG) changes: Consider cardiovascular monitoring
in patients with congenital
long QT syndrome, a history of significant cardiovascular disease, and
patients taking medicinal
products that lead to significant QT prolongation. Ensure that
potassium and magnesium are within the
normal range before administration of