BORTEZOMIB- bortezomib injection, powder, lyophilized, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

BORTEZOMIB (UNII: 69G8BD63PP) (BORTEZOMIB - UNII:69G8BD63PP)

Dostupno od:

Fresenius Kabi USA, LLC

INN (International ime):

Bortezomib

Sastav:

Bortezomib 1 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy. Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric acid or glycine. Reactions have included anaphylactic reactions [see Adverse Reactions (6.1)] . Bortezomib for Injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib. Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)] and findings in animals, Bortezomib for Injection can cause fetal harm when administered to a pregnant woman. There are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. Bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose [see Data] . Advis

Proizvod sažetak:

Bortezomib for Injection is supplied in a 10 mL vial containing 3.5 mg of bortezomib as a white to off-white cake or powder in a single-dose vial for reconstitution (after reconstitution the solution is clear and colorless). Unopened vials may be stored at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. The vial stopper is not made with natural rubber latex. Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact1 .

Status autorizacije:

New Drug Application

Svojstava lijeka

BORTEZOMIB - BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BORTEZOMIB FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BORTEZOMIB FOR
INJECTION.
BORTEZOMIB FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.4, 2.5)
9/2021
Warnings and Precautions, Thrombotic Microangiopathy (5.10)
9/2021
INDICATIONS AND USAGE
Bortezomib for Injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma who have
received at least 1 prior therapy (1.2)
DOSAGE AND ADMINISTRATION
For intravenous use only. Exercise caution when calculating the volume
to be administered. (2.1, 2.8)
The recommended starting dose of Bortezomib for Injection is 1.3 mg/m
administered as a 3 to 5
second bolus intravenous injection. (2.2, 2.4)
Retreatment for multiple myeloma: May retreat starting at the last
tolerated dose. (2.4)
Hepatic Impairment: Use a lower starting dose for patients with
moderate or severe hepatic
impairment. (2.6)
Dose must be individualized to prevent overdose. (2.8)
DOSAGE FORMS AND STRENGTHS
For injection: Single-dose vial contains 3.5 mg of bortezomib as
lyophilized powder for reconstitution.
(3)
CONTRAINDICATIONS
Patients with hypersensitivity (not including local reactions) to
bortezomib, boron, boric acid or glycine,
including anaphylactic reactions. (4)
Contraindicated for intrathecal administration. (4)
WARNINGS AND PRECAUTIONS
Peripheral Neuropathy: Manage with dose modification or
discontinuation. (2.5) Patients with pre-
existing severe neuropathy should be treated with Bortezomib for
Injection only after careful risk-benefit
assessment. (2.5, 5.1)
Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor
closely for new or worsening
symptoms and consider interrupting Bortezom