BLOXIVERZ- neostigmine methylsulfate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOSTIGMINE METHYLSULFATE (UNII: 98IMH7M386) (NEOSTIGMINE - UNII:3982TWQ96G)

Available from:

Exela Pharma Sciences, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

BLOXIVERZ (Neostigmine Methylsulfate Injection, USP) is available in the following: NDC No. Strength Vial Size 51754-1240-3 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

Authorization status:

New Drug Application

Summary of Product characteristics

BLOXIVERZ- NEOSTIGMINE METHYLSULFATE INJECTION
EXELA PHARMA SCIENCES, LLC
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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
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DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL in 10 mL multiple-dose vials (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions during treatment: bradycardia, nausea
and vomiting. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EXELA PHARMA SCIENCES,
LLC AT 1-888-
451-4321 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)
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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
br