ANASCORP Powder for solution for injection Ref.[10383] Active ingredients:

5.1 Hypers ensitivity 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.

5.2 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 (6.1).

5.3 Transmissible Infectious Agents

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

5.4 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.

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

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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.

Table 1 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.

Table 1. Advers e Reactions Reported in ≥1% of Patients:

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 both².

The following adverse reactions have been identified during post approval use of ANASCORP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Chest tightness, palpitations, rash and pruritus.

No drug interaction studies have been conducted with ANASCORP.

Risk Summary

Animal reproduction studies have not been conducted with ANASCORP. It is also not known whether ANASCORP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ANASCORP should be given to a pregnant woman only if clearly needed.

Risk Summary

It is not known whether ANASCORP is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when ANASCORP is administered to a nursing woman.

Seventy-eight percent of the patients enrolled in the clinical studies were pediatrics subjects (1204/1534), with ages ranging from less than one month to 18.7 years of age. Patient age groups were as follows: <2 years of age, 29%, 2 to 5 years, 37%, 5 to 18 years, 34%. The efficacy and safety of ANASCORP is comparable in pediatric and adult patients.

Specific studies in elderly patients have not been conducted, ANASCORP was administered to 77 patients over the age of 65 years with comparable efficacy and safety to the overall patient population.