NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE)

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.

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 )

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 added to reservoir bottle, mix by gentle swirling – do not shake. • Administer the first 1 or 2 mL over a 3- to 5-minute period with careful observation of the patient for evidence of an allergic reaction. If no signs or symptoms of anaphylaxis appear, continue the injection or intravenous infusion. • Adjust the infusion rate by the severity of signs and symptoms of envenomation and tolerance of North American Coral Snake Antivenin (Equine). Administer at the maximum safe rate for intravenous fluids, based on body weight and general condition of the patient. o For adults, if given by intravenous infusion to a previously healthy adult, allow 250 or 500 mL to run in within 30 minutes; o For small children, allow the first 100 mL to run in rapidly but then decrease to a rate not to exceed 4 mL per minute. Response to treatment may be rapid and dramatic. • Observe the patient carefully and administer additional North American Coral Snake Antivenin (Equine) intravenously as required.

• 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 )

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.

Store vials between 2 and 8°C (36 and 46° F). Do not freeze. Use the reconstituted and diluted product within 4 hours.