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Summary Brochure
Learn more about ANAVIP.
Dosing Algorithm
North American Pit Viper Envenomation Treatment Algorithm.
ANAVIP Package Insert
Read the ANAVIP full Prescribing Information.
Vial Replacement Policy
Review the terms of the generous replacement goods policy.
Understanding Purification
Read more on the ANAVIP purification process.
ANAVIP Dosing Card
Learn more about dosing and administering ANAVIP.
ANAVIP Ordering Information
Basic information for ordering, storing, and replacing ANAVIP.
ANAVIP Reconstitution Video
Discover how to reconstitute ANAVIP®.
ANAVIP 'Trailer' Video
See why it’s time for ANAVIP.
IMPORTANT SAFETY INFORMATION
INDICATION
ANAVIP® [crotalidae immune F(ab′)2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
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 necessary.
Transmissible Infectious Agents
ANAVIP is made from equine (horse) plasma and may therefore carry a risk of transmitting infectious agents, e.g., viruses.
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.
ADVERSE REACTIONS
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.
USE IN SPECIFIC POPULATIONS
- Pediatric Use: 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 the adults.
Please see complete Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or by email at safety@raretx.com , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
INDICATION
ANAVIP® [crotalidae immune F(ab′)2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
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 necessary.
Transmissible Infectious Agents
ANAVIP is made from equine (horse) plasma and may therefore carry a risk of transmitting infectious agents, e.g., viruses.
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.
ADVERSE REACTIONS
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.
USE IN SPECIFIC POPULATIONS
- Pediatric Use: 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 the adults.
Please see complete Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or by email at safety@raretx.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.