ANAVIP (crotalidae immune f(ab)2- equine injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (UNII: 92VV7G83ED) (PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) - UNII:92VV7G83ED)

Available from:

Rare Disease Therapeutics, Inc

INN (International Name):

PIT VIPER IMMUNE GLOBULIN ANTIVENIN IMMUNE GLOBULIN ANTIVENIN - UNII:92VV7G83ED)

Composition:

PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 24 mg in 1 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

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.

Product summary:

ANAVIP is supplied as a sterile, lyophilized preparation in a single-dose vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom and 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay. Each carton NDC 66621-0790-2 contains 1 vial of ANAVIP NDC 66621-0790-1.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ANAVIP- CROTALIDAE IMMUNE F(AB)2(EQUINE) INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
RARE DISEASE THERAPEUTICS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANAVIP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANAVIP.
ANAVIP
CROTALIDAE IMMUNE F(AB') (EQUINE)
LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
FOR INTRAVENOUS USE ONLY
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indication and Use (1) April 2021
Dosage and Administration (2) April 2021
Animal Toxicology and/or Pharmacology (13.2) April 2021
INDICATIONS AND USAGE
ANAVIP [crotalidae immune F(ab') (equine)] is an equine-derived
antivenin indicated for the management
of adult and pediatric patients with North American Pit Viper
envenomation. (1)
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY.
DOSE
NO. OF VIALS
INFUSION RATE
Initial Dose
10 vials
Infuse intravenously over 60 minutes.
Additional dose(s) to achieve initial control
10 vials
(as needed)
Infuse intravenously over 60 minutes.
Observation and late dosing
4 vials
Infuse intravenously over 60 minutes.
Initiate administration as soon as possible after North American Pit
Viper bite in patients who develop
signs of envenomation (e.g., local injury, coagulation abnormality, or
systemic signs of envenomation).
(2)
Monitor patients in a health care setting at least 18 hours following
initial control of signs and
symptoms. Re-emerging symptoms including coagulapathies may be
suppressed with an additional 4
vial doses of ANAVIP as needed. (2)
Reconstitute each vial with 10 milliliters (mL) of sterile normal
saline (0.9% NaCl). (2)
Combine and further dilute to a total of 250 mL with sterile normal
saline (0.9% NaCl). (2)
DOSAGE FORMS AND STRENGTHS
Each vial contains a sterile, lyophilized preparation containing not
more than 120 milligrams total protein
and not less than the indicated number of mouse LD neutralizing units
(3):
SNAKE SPECIES USED FOR STANDARDIZATION
MINIMUM MOUSE
LD UNITS PER VIAL
_Bothrops asper_
(T