Pit viper (crotalinae) immune globulin antivenin (equine)

ANAVIP [crotalidae immune F(ab') 2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation.

ANAVIP contains venom-specific F(ab') 2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. 1,2

Intravenous use only. Dose No. of Vials Infusion Rate Initial Dose 10 vials Infuse intravenously over 60 minutes. Additional dose(s) to achieve initial control 10 vials (as needed) Infuse intravenously over 60 minutes. Observation and late dosing 4 vials Infuse intravenously over 60 minutes. Initiate administration as soon as possible after North American Pit Viper bite in patients who develop signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs of envenomation). Monitor patients in a health care setting at least 18 hours following initial control of signs and symptoms. Re-emerging symptoms including coagulapathies may be suppressed with an additional 4 vial doses of ANAVIP as needed. Reconstitute each vial with 10 milliliters (mL) of sterile normal saline (0.9% NaCl). Combine and further dilute to a total of 250 mL with sterile normal saline (0.9% NaCl).

None. 4 CONTRAINDICATIONS None.

ANAVIP may cause allergic reactions. Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment. Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash) and treat appropriately if necessary. ANAVIP is made from equine plasma and may contain infectious agents, e.g., viruses. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient. 5 WARNINGS AND PRECAUTIONS

The most common adverse reactions (>2%) in the clinical trials were: pruritus, nausea, rash, arthralgia, peripheral edema, myalgia, headache, pain in extremity, vomiting and erythema. 6 ADVERSE REACTIONS The most common adverse reactions observed in more than 2 percent (2%) of patients in the clinical trials for ANAVIP were: pruritus, nausea, rash, arthralgia, peripheral edema, erythema, headache, myalgia, pain in extremity, and vomiting.

Store at room temperature (up to 25 ºC (77 ºF)). Brief temperature excursions are permitted up to 40 ºC (104ºF). DO NOT FREEZE.