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ANTIVENIN® (micrurus fulvius) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use North American Coral Snake Antivenin (Equine) safely and effectively. See full prescribing information for North American Coral Snake Antivenin (Equine).

North American Coral Snake Antivenin (Equine)
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 1967

INDICATIONS AND USAGE

North American Coral Snake Antivenin (Equine) is a horse-derived antivenin indicated for the treatment of envenomation caused by North American coral snakes - Micrurus. (1)

DOSAGE AND ADMINISTRATION

For intravenous use only.

  • In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment. (2.1)
  • In small children, the dose may be decreased, depending on the response to treatment. (2.1)
  • Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD50 or approximately 2 mg of M. fulvius venom. (2.1)
  • Infuse the first 1 or 2 mL over a 3- to 5-minute period, observing for allergic reaction. If tolerated, administer the rest of the dose at the rate that is comfortable for the patient based on body weight and general condition. Do not exceed 4 mL per minute for children. (2.2)

DOSAGE FORMS AND STRENGTHS

Lyophilized powder in single use vial for reconstitution for injection. (3)

CONTRAINDICATIONS

  • Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. (4)
  • Do not use in patients with a known history of hypersensitivity to horse serum unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. (4)

WARNINGS AND PRECAUTIONS

Patients sensitive to North American Coral Snake Antivenin (Equine) or horse serum may develop anaphylaxis. Prior to intravenous North American Coral Snake Antivenin (Equine) administration consider performing a proper skin test and modify therapy if indicated. (5.1)

ADVERSE REACTIONS

Adverse reactions may include anaphylaxis and serum sickness, vomiting, and abdominal pain. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2019

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