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warnings and cautions
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, hypertension) 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 necessary.( 5.1 ) Anavip is made from equine plasma and may contain infectious agents, e.g. viruses.( 5.2 ) Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.( 5.3 )
The most common adverse reactions (>2%)in the clinical studies were: pruritus, nausea, rash, arthralgia, peripheral edema, myalgias, headache, pain in extremity, vomiting and erythema.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1 877-851-1902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions observed in more than 2 percent of patients in the clinical trials for Anavip were: pruritus, nausea, rash, arthralgia, peripheral edema, erythema, headache, myalgia, pain in extremity, and vomiting.