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 rattlesnake envenomation.
ANAVIP® [crotalidae immune F(ab’)2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.
None.
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.
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.
REFERENCES:
1. Bush SP, Ruha A-M, Seifert SA, et al. Comparison of F(ab’)2 versus Fab antivenom for pit viper envenomation: a prospective, blinded, multicenter, randomized clinical trial. Clin Tox. 2015;53(1):37-45.
2. Lavonas EJ, Ruha A-M, Banner W, et al. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med. 2011;11(2):1-15.
3. Seifert SA, Boyer LV. Recurrence phenomena after immunoglobulin therapy for snake envenomations: part 1. Pharmacokinetics and pharmacodynamics of immunoglobulin antivenoms and related antibodies. Ann Emerg Med. February 2001;37:189-195.
4. World Health Organization. WHO guidelines for the production, control, and regulation of snake antivenom immunoglobulins; 2016. http://www.who.int/biologicals/expert_committee/Antivenom_WHO_Guidelines_DJW_DEB_mn_cp.pdf. Accessed January 7, 2019.
5. ANAVIP [crotalidae immune F(ab’)2 (equine)] Prescribing Information. Rare Disease Therapeutics, Inc.; Franklin, TN. June 2020.
6. CroFab [crotalidae polyvalent immune fab (ovine)] Prescribing Information. BTG International Inc.; West Conshohocken, PA. August 2018.
7. Gutierrez JM, Leon G, Lomonte B. Pharmacokinetic-pharmacodynamic relationships of immunoglobulin therapy for envenomation. Clin Pharmacokinet. 2003;42(8):721-741.
8. Data on file, Rare Disease Therapeutics, Inc.
ANAVIP® [crotalidae immune F(ab’)2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.
None.
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.
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.