BORTEZOMIB injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

MAIA Pharmaceuticals, Inc.

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma. Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma. Bortezomib Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions [see Adverse Reactions (6.1)] . Bortezomib 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 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) . Advise pregnant women of the potential risk to the fetus. Adverse outcomes in

Přehled produktů:

Bortezomib Injection is a clear, colorless to slightly yellow ready-to-use, sterile solution supplied as individually cartoned 5 mL vials containing 3.5 mg/3.5 mL (1 mg/mL) or 2 mL vials containing 3.5 mg/1.4 mL (2.5 mg/mL) of Bortezomib Injection. 3.5 mg/3.5 mL (1mg/mL) in a single-dose 5 mL vial NDC 70511-161-05 3.5 mg/1.4 mL (2.5 mg/mL) in a single-dose 2 mL vial NDC 70511-162-02 Store Bortezomib Injection in a refrigerator at 2º to 8°C (36° to 46°F) in the original package to protect from light. Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact1 .

Stav Autorizace:

New Drug Application

Charakteristika produktu

BORTEZOMIB- BORTEZOMIB INJECTION
MAIA PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BORTEZOMIB INJECTION
SAFELY AND EFFECTIVELY.SEE FULL PRESCRIBING INFORMATION FOR BORTEZOMIB
INJECTION. BORTEZOMIB INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL:
2003
INDICATIONS AND USAGE
Bortezomib injection is a proteasome inhibitor indicated for: (1)
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma (1.2)
DOSAGE AND ADMINISTRATION
For intravenous use only. (2.1, 2.10)
The recommended starting dose of Bortezomib Injection is 1.3 mg/m
administered as a 3 to 5 second
bolus intravenous injection. (2.2, 2.4, 2.6)
Retreatment for multiple myeloma: May retreat starting at the last
tolerated dose. (2.6)
Hepatic Impairment: Use a lower starting dose for patients with
moderate or severe hepatic
impairment. (2.8)
Dose must be individualized to prevent overdose. (2.10)
DOSAGE FORMS AND STRENGTHS
Injection (3)
3.5 mg/3.5 mL (1 mg/mL) in a single-dose vial
3.5 mg/1.4 mL (2.5 mg/mL) in a single-dose vial
CONTRAINDICATIONS
Patients with hypersensitivity (not including local reactions) to
bortezomib, boron, or mannitol, including
anaphylactic reactions. (4)
Contraindicated for intrathecal administration. (4)
WARNINGS AND PRECAUTIONS
Peripheral Neuropathy: Manage with dose modification or
discontinuation. (2.7) Patients with
preexisting severe neuropathy should be treated with Bortezomib
Injection only after careful risk-benefit
assessment. (2.7, 5.1)
Hypotension: Use caution when treating patients taking
antihypertensives, with a history of syncope, or
with dehydration. (5.2)
Cardiac Toxicity: Worsening of and development of cardiac failure has
occurred. Closely monitor
patients with existing heart disease or risk factors for heart
disease. (5.3)
Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor
closely for new or worsening
symptoms and consider interrupting Bortezomib