ANAVIP Powder for solution for injection Ref.[10413] Active ingredients:

5.1 Hypersensitivity

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 necessary⁴.

5.2 Transmissible Infectious Agents

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

5.3 Reactions to Cresol

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

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.

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 86 patients were treated with ANAVIP, ranging from 2 to 80 years old. The patient population was comprised of 60 males and 26 females. Patients were monitored for signs and symptoms of adverse reactions including acute hypersensitivity reactions and serum sickness. Follow-up interviews were conducted at 5, 8, 15 and 22 days after treatment to assess symptoms 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 ANAVIP. Seventy-six percent (65/86) of patients receiving ANAVIP reported at least one adverse reaction.

Table 1. Incidence of Advers e Events in Clinical Studies of ANAVIP by Body System:

Risk Summary

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

Risk Summary

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

Twenty-four percent (21/86) of patients studied in clinical trials were 16 years of age or younger (6 patients were 2 years of age to 5 years of age, 15 patients ranged from at least 5 years of age to 16 years of age). None of the pediatric patients in the phase 3 study experienced a recurrent coagulopathic effect. All adverse reactions in the pediatric patients were non-serious. The most frequent adverse reactions among pediatric patients were nausea and vomiting, itching and fever. Thus, the safety and efficacy in the pediatric population was not different from adults.

Over nine percent (9%; 8/86) of patients studied in clinical trials were over 65 years of age. The efficacy of ANAVIP in the geriatric population appears comparable to the overall population.