IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
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 protein and be at risk for a severe hypersensitivity reaction.
Delayed Allergic Reactions (Serum Sickness)
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.
Transmissible Infectious Agents
ANASCORP is made from equine (horse) plasma, it may therefore carry a risk of transmitting infectious agents, e.g., viruses.
Reaction to Cresol
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.
ADVERSE REACTIONS
The most common adverse reactions observed in ≥ 2% of patients in the clinical studies for ANASCORP were: vomiting, pyrexia, rash, nausea and pruritus.
See Full Prescribing Information
To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
