מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BORTEZOMIB (UNII: 69G8BD63PP) (BORTEZOMIB - UNII:69G8BD63PP)
Fresenius Kabi USA, LLC
Bortezomib
Bortezomib 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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 .
New Drug Application
BORTEZOMIB - BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- 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 קרא את המסמך השלם