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About ANASCORP®...

Adverse Reactions

A total of 1534 patients were treated with ANASCORP®, ranging from less than one month to 90 years old. The patient population was comprised of 802 males and 732 females. Patients were monitored for signs and symptoms of adverse reactions, including acute hypersensitivity reactions and serum sickness. Follow-up telephone interviews were conducted at 24 hours, 7 days, and 14 days after treatment to assess symptoms suggestive of ongoing venom effect, serum sickness, and any other adverse reactions.

The table below shows the adverse reactions occurring in patients across all clinical trials for ANASCORP®. Twenty-seven percent (421/1534) of patients receiving ANASCORP® reported at least one adverse reaction.

No patients died or discontinued study participation for severe adverse reactions.
Eight patients were considered to have serum sickness (Type III hypersensitivity); no patient manifested the full serum sickness syndrome. Three patients were treated with systemic corticosteroids and five others received either no treatment or symptomatic therapy.

34 patients experienced a total of 39 severe adverse reactions such as respiratory distress, aspiration, hypoxia, ataxia, pneumonia, and eye swelling. It is not clear whether these adverse reactions were related to ANASCORP®, envenomation, or a combination of both.

Anascorp®
Brochure

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Anascorp®
Package Insert

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Anascorp®
Video 

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Anascorp®
Replacement Policy

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INDICATION

ANASCORP® [centruroides (scorpion) immune F(ab')2 (equine) injection] is an equine-derived antivenom indicated for treatment of patients with clinical signs of scorpion envenomation.

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.