Country: United States
Language: English
Source: NLM (National Library of Medicine)
NEOSTIGMINE METHYLSULFATE (UNII: 98IMH7M386) (NEOSTIGMINE - UNII:3982TWQ96G)
Exela Pharma Sciences, LLC
INTRAVENOUS
PRESCRIPTION DRUG
BLOXIVERZ is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. BLOXIVERZ is contraindicated in patients with: Risk Summary There are no adequate or well-controlled studies of BLOXIVERZ in pregnant women. It is not known whether BLOXIVERZ can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. All pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. No adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2 times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). Anticholinesterase drugs, including neostigmin
BLOXIVERZ (Neostigmine Methylsulfate Injection, USP) is available in the following: NDC No. Strength Vial Size 51754-1240-1 1 mg/mL 10 mL multiple-dose vials (supplied in packages of 10) The vial stopper is not made with natural rubber latex. BLOXIVERZ should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Protect from light. Store in carton until time of use. Manufactured for: Exela Pharma Sciences, LLC Rev. 07/20
New Drug Application
BLOXIVERZ- NEOSTIGMINE METHYLSULFATE INJECTION EXELA PHARMA SCIENCES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BLOXIVERZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BLOXIVERZ. BLOXIVERZ (NEOSTIGMINE METHYLSULFATE INJECTION), FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1939 INDICATIONS AND USAGE BLOXIVERZ, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery (1). DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Injection: 1 mg/mL in 10 mL multiple-dose vials (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS Most common adverse reactions during treatment: bradycardia, nausea and vomiting. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AVADEL AT 1-877-638-4579 OR FDA AT 1- 800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. USE IN SPECIFIC POPULATIONS • REVISED: 3/2021 ® Should be administered by trained healthcare providers (2.1) Peripheral nerve stimulator and monitoring for twitch responses should be used to determine when BLOXIVERZ should be initiated and if additional doses are needed (2.2) • • For reversal of NMBAs with shorter half-lives, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present: 0.03 MG/KG BY INTRAVENOUS ROUTE (2.2) For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline: 0.07 MG/KG BY INTRAVENOUS ROUTE (2.2) Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever is less) (2.2) An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with BLOXIVERZ (2.4) Hypersensitivity to neostigmine (4) Peritonitis or mechanical obstruction of the intestinal or urinary tract (4) Bradycardia: Atropine or glycopyrrolate should be administered prior to BLOXIVERZ to lessen risk of bradycardia. (5.1) Ser Read the complete document