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

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 )

Each package contains one single use vial with lyophilized North American Coral Snake Antivenin (Equine) for dilution with 10 mL of diluent (Sterile Water for Injection, USP). Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of M. f. fulvius venom. Lyophilized powder in single use vial for reconstitution for injection. ( 3 )

• 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 )

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 )

5.1 Hypersensitivity Reactions 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. Consider the following precautions to manage hypersensitivity reactions:

• Emergency medical care (e.g., epinephrine, intravenous antihistamines and/or albuterol) should be readily available.
• Carefully monitor patients for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia).
• Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia). Patients who receive a course of treatment with a foreign protein such as North American Coral Snake Antivenin (Equine) may become sensitized to it. Therefore, use caution when administering a repeat course of treatment with North American Coral Snake Antivenin (Equine) for a subsequent envenomation episode.

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.

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.

8.2 Lactation Risk Summary Lactation studies have not been conducted with North American Coral Snake Antivenin (Equine). It is not known whether North American Coral Snake Antivenin (Equine) is excreted in human milk. North American Coral Snake Antivenin (Equine) should be administered to lactating women only if clearly indicated. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for North American Coral Snake Antivenin (Equine) and any potential adverse effects on the breastfed child from North American Coral Snake Antivenin (Equine) or from the underlying maternal condition.

8.4 Pediatric Use Controlled clinical studies of safety and effectiveness in pediatric patients have not been conducted. Potential cases of Coral Snake envenomation and subsequent treatment with North American Coral Snake Antivenin (Equine) have been reported in pediatric patients; 2 adverse reactions included anaphylaxis (wheezing) requiring treatment with epinephrine, vomiting, and abdominal pain.

8.5 Geriatric Use Specific studies in elderly patients have not been conducted.

North American Coral Snake Antivenin (Equine) specifically binds to and neutralizes coral snake venom.