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Safety Information...

Important Safety Information

The most common adverse reactions observed in ≥ 2% of patients in the clinical studies for Anascorp® were: vomiting, pyrexia, rash, nausea, and pruritus.

Severe hypersensitivity reactions, including anaphylaxis, may occur with Anascorp®. Close patient monitoring for hypersensitivity reactions and readiness with intravenous therapy using epinephrine, corticosteroids, and diphenhydramine hydrochloride is recommended during the infusion of Anascorp®. If an anaphylactic reaction occurs during the infusion, terminate administration at once and administer appropriate emergency medical care.

Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. Patients who have had previous therapy with Anascorp® or another equine antivenom/antitoxin may have become sensitized to equine proteins and be at risk for a severe hypersensitivity reaction.

Monitor patients with follow-up visit(s) for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia), and treat appropriately if necessary. Eight out of 1,534 (0.5%) patients in the clinical trials exhibited symptoms suggestive of serum sickness.

Anascorp® is made from equine (horse) plasma, it may therefore carry a risk of transmitting infectious agents, e.g., viruses.

Trace amounts of cresol from the manufacturing process are contained in Anascorp®. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.

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