Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine)

FDA Drug Information • Also known as: North American Coral Snake Antivenin (Equine)

Brand Names: North American Coral Snake Antivenin (Equine)
Route: INTRAVENOUS
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake ( Micrurus fulvius fulvius ) venom. Prior to lyophilization, the product contains 0.25% phenol.

What Is Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) Used For?

1 INDICATIONS AND USAGE North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties). 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

2 DOSAGE AND ADMINISTRATION For intravenous use only. 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) LD 50 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 ) 2.1 Dose

Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of Micrurus fulvius fulvius ( M. f. fulvius) venom.

In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment.

In small children, the dose may be decreased, depending on the response to treatment. 2.2 Preparation and Administration Preparation

Pry off the small metal disc in the cap over the diaphragms of the vials of North American Coral Snake Antivenin (Equine) and remove cap from diluent vials.

Swab the exposed surface of the rubber diaphragms of both vials with an appropriate germicide.

Withdraw 10 mL diluent (Sterile Water for Injection, USP) using a sterile syringe and needle, and insert the needle through the stopper of the vacuum-containing vial of North American Coral Snake Antivenin (Equine). o The vacuum in the North American Coral Snake Antivenin (Equine) vial will pull the diluent out of the syringe into the vial. Allow room air to be pulled into the North American Coral Snake Antivenin (Equine) vial until all vacuum is released. o Point the needle at the center of the lyophilized pellet of North American Coral Snake Antivenin (Equine) so that the diluent stream will wet the pellet.

Reconstitute by swirling, not by shaking, for 1 minute, at 5-minute intervals until you observe complete dissolution of the lyophilized North American Coral Snake Antivenin (Equine). Complete reconstitution usually requires at least 30 minutes. Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Start an intravenous infusion of 250 to 500 mL of Sodium Chloride Injection, USP.

Determine whether the patient has hypersensitivity to horse-serum in order to evaluate treatment decisions, and to prepare for treatment of anaphylaxis if it occurs [see Warnings and Precautions (5.1) ] .

After reconstitution of the lyophilized North American Coral Snake Antivenin (Equine) administer the contents of 3 to 5 vials (30 to 50 mL) intravenously by slow injection directly into the intravenous tubing or the reservoir bottle of the intravenous solution. If...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The most common adverse reactions observed after treatment with North American Coral Snake Antivenin (Equine) were anaphylaxis and serum sickness, vomiting, and abdominal pain. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. 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.

Contraindications

4 CONTRAINDICATIONS

Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. 1

Do not administer North American Coral Snake Antivenin (Equine) to 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.

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 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available human data that establish developmental toxicity related to the use of North American Coral Snake Antivenin (Equine). There are no available animal data informing the North American Coral Snake Antivenin (Equine)-associated risk. North American Coral Snake Antivenin (Equine) should be given to a pregnant woman only if clearly required. In the US general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING North American Coral Snake Antivenin (Equine) is supplied as a sterile lyophilized powder in single use vial (NDC 0008-0423-01) in a carton (NDC 0008-0423-03). Store vials between 2 and 8°C (36 and 46° F). Do not freeze. Use the reconstituted and diluted product within 4 hours.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.