ANAVIP® Brochure

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ANAVIP® Brochure 11” NEW INDICATION ® EXPANDED ANAVIP [crotalidae immune F(ab')2 INDICATION (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric Choose ANAVIP® to treat patients with North American North American Pit Viper Pit Viper envenomation. envenomation IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Hypersensitivity IT’S 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 ABOUT urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute 8.5” appropriate treatment. TIME 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. 1 Please see full Important Safety Information Reconstitutes in seconds on page 5 and accompanying full Prescribing Ready for dosing in minutes1 Information for ANAVIP. Circulates for weeks1 1 ANTIVENOM WITH TIME ON ITS SIDE Reconstitutes in seconds1 Ready for dosing in minutes1 Most envenomations were controlled within 4 hours2,a,b Low incidence of late venom effects up to 8 days1,b Circulates for weeks1 Shelf-life of 3 years2 Free replacements for future expiryc NOW INDICATED FOR ALL NORTH AMERICAN PIT VIPERS1 WATCH A DOSE GET + + PREPARED IN MINUTES NOW INDICATED FOR ALL NORTH ON ANAVIP.COM Copperhead Rattlesnake Cottonmouth a AMERICAN PIT VIPERS^1 Most patients (n=70 of 79) achieved initial control in 1 or 2 infusions. b The efficacy analysis did not meet the prespecified statistically defined superiority criterion. However, the percentages of subjects (N=114) showing prespecified criteria for coagulopathic effect on either Day 5 and/or Day 8 were 10.3% and 5.3% in the Groups 1 and 2 when compared to 29.7% in Group 3 indicating efficacy of ANAVIP in management of coagulopathic effect in patients with North American Pit Viper envenomation. c Replacement policy available in accordance with state laws. Please see full Important Safety Information on page 5 and accompanying full Prescribing Information for ANAVIP. 2 GO FROM SHELF TO SOLUTION IN MINUTES1 Standardized dosing with no scheduled maintenance1 Before dosing, please read Dosage and Administration in the full Prescribing Information Reconstitute each Infuse for ~60 minutes1 Evaluate 3 components of initial control 1 vial in 11.8 seconds1,a 2 3 for 60 minutes1 Local Coagulation Systemic Initial 10-vial dose injury not parameters symptoms progressing 10 vials 10 mL each improving resolved 25 to 50 mL/hr If tolerated, All 3 venom effects controlled? for 10 minutes increase X incrementally NO YES to 250 mL/hr until completion Administer another 10-vial dose Observe for 18 hours 250 mL Repeat as needed starting from Step 1 Only if symptoms re-emerge, administer a 4-vial dose diluted There is no known in 250 mL of sterile normal saline maximum dose of ANAVIP Store at room Use within 6 hours 1,b 1 temperature 6 of reconstitution hours aRange of 8 to 26 seconds per vial when using continuous gentle swirling with sterile normal saline. bUp to 25°C (77°F). Brief temperature excursions are permitted up to 40°C (104°F). Please see full Important Safety Information on page 5 and accompanying full Prescribing Information for ANAVIP. 3 DESIGNED TO CIRCULATE FOR WEEKS1 Antivenoms are not built the same 3,4 5 1,4 Fab Antivenom Whole IgG F(ab')2 — ANAVIP Papain Pepsin cleavage cleavage 50 kDa molecular mass Non-binding ˜ region 100 kDa molecular mass 15-hour elimination half-life ˜ 133-hour elimination half-life Venom-binding region A difference in half-life has been attributed to molecular mass4,5 Please see full Important Safety Information on page 5 and accompanying full Prescribing Information for ANAVIP. 4 IMPORTANT SAFETY INFORMATION INDICATION Transmissible Infectious Agents ® ANAVIP [crotalidae immune F(ab')2 (equine)] is an ANAVIP is made from equine (horse) plasma and may therefore equine-derived antivenin indicated for the management carry a risk of transmitting infectious agents, e.g., viruses. of adult and pediatric patients with North American Pit Viper envenomation. Reactions to Cresol Trace amounts of cresol from the manufacturing process are IMPORTANT SAFETY INFORMATION contained in ANAVIP. Localized reactions and generalized CONTRAINDICATIONS myalgias have been reported with the use of cresol as an None. injectable excipient. WARNINGS AND PRECAUTIONS ADVERSE REACTIONS Hypersensitivity The most common adverse reactions observed in more than ANAVIP may cause allergic reactions. 2 percent (2%) of patients in the clinical trials for ANAVIP were: pruritus, nausea, rash, arthralgia, peripheral edema, erythema, Patients with known allergies to horse protein are headache, myalgia, pain in extremity, and vomiting. particularly at risk for an anaphylactic reaction. If signs or symptoms of anaphylaxis or hypersensitivity References: 1. ANAVIP [crotalidae immune F(ab')2 (equine)] Prescribing Information. Rare Disease Therapeutics, Inc.; Franklin, TN. April 2021. 2. Data on file, Rare Disease Therapeutics, Inc. reactions (including urticaria, rash, tightness of the 3. CroFab [crotalidae polyvalent immune fab (ovine)] Prescribing Information. BTG International, Inc.; West Conshohocken, PA. August 2018. 4. World Health Organization. (2018). WHO Expert Committee chest, wheezing, hypotension) occur, discontinue on Biological Standardization: WHO TRS No 1004. ANNEX 5: Guidelines for the production, control and regulation of snake antivenom immunoglobulins; 2017. https://www.who.int/bloodproducts/ immediately and institute appropriate treatment. AntivenomGLrevWHO_TRS_1004_web_Annex_5.pdf Accessed March 26, 2021. 5. Gutiérrez JM, Leon G, Lomonte B. Pharmacokinetic-pharmacodynamic relationships of immunoglobulin therapy for envenomation. Clin Pharmacokinet. 2003;42:721-741. Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, Poison Control Center: 1-800-222-1222 To order ANAVIP or report urticarial rash) and treat appropriately suspected adverse reactions, if necessary. call: 1-844-4RareTx (1-844-472-7389) © Rare Disease Therapeutics, Inc. | ANV-CSB-002-E | May 2021 | HCPCS: J0841 Please see accompanying full Prescribing Information for ANAVIP. 5 PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ANAVIP safely and effectively. See full prescribing Snake Species Used for Standardization Minimum Mouse LD50 Units per Vial information for ANAVIP. Bothrops asper 780 1 ANAVIP® (Terciopelo or fer-de-lance) crotalidae immune F(ab’)2 (equine) Crotalus simus (formerly Crotalus durissus) 790 1 Lyophilized Powder for Solution for Injection (Central American Rattlesnake) For Intravenous Use Only Crotalus adamanteus 244 (Eastern Diamondback Rattlesnake) Initial U.S. Approval: 2015 Crotalus atrox 147 ------------------------------------------RECENT MAJOR CHANGES------------------------------------------- (Western Diamondback Rattlesnake) Indications and Usage (1) April 2021 Crotalus scutulatus 185 Dosage and Administration (2) April 2021 (Mohave Rattlesnake)2 Animal Toxicology and/or Pharmacology (13.2) April 2021 Agkistrodon contortrix 28 -------------------------------------------INDICATIONS AND USAGE------------------------------------------- (Copperhead) ANAVIP [crotalidae immune F(ab’)2 (equine)] is an equine-derived antivenin indicated for the Agkistrodon piscivorus 61 management of adult and pediatric patients with North American Pit Viper envenomation. (1) (Cottonmouth or Water Moccasin) 1The venom of these species is used in the manufacture of ANAVIP. --------------------------------------DOSAGE AND ADMINISTRATION--------------------------------------- 2The Mohave phenotype A is used for standardization. Intravenous use only. -----------------------------------------CONTRAINDICATIONS--------------------------------------------------- Dose No. of Vials Infusion Rate None. (4) Initial dose 10 vials Infuse intravenously over 60 minutes. ---------------------------------------WARNINGS AND PRECAUTIONS--------------------------------------- Additional dose(s) to 10 vials Infuse intravenously over 60 minutes. • ANAVIP may cause allergic reactions. achieve initial control (as needed) o Patients with known allergies to horse protein are particularly at risk for an anaphylactic Observation and late 4 vials Infuse intravenously over 60 minutes. reaction. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including dosing urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment. • Initiate administration as soon as possible after North American Pit Viper bite in patients who o Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions develop signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash) and treat of envenomation). (2) appropriately if necessary. (5.1) • Monitor patients in a health care setting at least 18 hours following initial control of signs and • ANAVIP is made from equine plasma and may contain infectious agents, e.g., viruses. (5.2) symptoms.
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