Anavip

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Anavip

Classes

Snake Antivenoms and Immunoglobulins

Adverse Reactions
Moderate

peripheral edema / Delayed / 8.0-8.0
erythema / Early / 4.0-4.0
dehydration / Delayed / 2.0-2.0
thrombocytopenia / Delayed / 1.0-1.0
dyspnea / Early / 1.0-1.0
wheezing / Rapid / Incidence not known
hypertension / Early / Incidence not known

Mild

pruritus / Rapid / 43.0-43.0
nausea / Early / 23.0-23.0
rash / Early / 12.0-12.0
arthralgia / Delayed / 11.0-11.0
myalgia / Early / 7.0-7.0
vomiting / Early / 6.0-6.0
headache / Early / 6.0-6.0
fever / Early / 5.0-5.0
chills / Rapid / 4.0-4.0
insomnia / Early / 2.0-2.0
anxiety / Delayed / 2.0-2.0
urticaria / Rapid / Incidence not known

Common Brand Names

Anavip

Dea Class

Rx

Description

Parenteral antivenin from horses immunized against venoms of Bothrops asper (fer-de-lance) and Crotalus durissus (tropical rattlesnake)
For management of North American rattlesnake bites
Initial dose consists of 10 vials, but total dose is highly variable

Dosage And Indications
For the management of crotalid snake bite (North American rattlesnake envenomation).
NOTE: The total dose of antivenin required is highly variable and depends on: venom burden; potency of the venom; and time to health care presentation.
NOTE: Prior to administration and at regular intervals during therapy, perform laboratory tests (i.e., complete blood count, platelet count, PT, PTT, serum fibrinogen concentration, serum chemistry) to assess response to therapy and need for additional doses.
Intravenous dosage Adults, Adolescents, Children, and Infants

Initially, 10 vials via IV infusion. The initial infusion must proceed slowly during the first 10 minutes at a rate of 25—50 mL/hr with careful observation for any allergic reaction. The infusion rate may be increased to 250 mL/hr until completion if no reaction occurs. Observe patient for at least 1 hour following completion of the first dose. If initial control is not achieved by the first dose, an additional dose of 10 vials should be administered every hour until initial control of the envenomation syndrome has been achieved; there is no maximum dose. After initial control has been achieved, monitor patient in a health care setting for at least 18 hours. Additional 4-vial doses may be administered during the 18 hour monitoring period to suppress any re-emerging symptoms that may develop.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Crotaline Antivenin, Crotalidae products.

How Supplied

Anavip Intravenous Inj Pwd F/Sol

Maximum Dosage

Not applicable; dosage must be individualized to the envenomation.

Mechanism Of Action

Crotalidae immune F(ab')2 binds and neutralizes venom toxins, facilitating their redistribution away from target tissues and their elimination from the body. Its administration following envenomation has been shown to prevent or reverse the progression of local tissue damage and coagulopathy.

Pharmacokinetics

Crotalidae immune F(ab')2 is administered by intravenous infusion. To evaluate the pharmacokinetics of this drug, 13 healthy volunteers were administered a single one-vial dose of antivenin. After the infusion, blood samples were collected from each volunteer at 15 specific time points. Data from these blood samples showed the drug to have a mean steady-state volume of distribution of 3.3 L and a systemic exposure of 4144 mcg x hour/mL. Mean total clearance was 22 mL/h, resulting in an elimination half-life of 133 hours.

Pregnancy And Lactation
Pregnancy

Crotalidae immune F(ab')2 is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women, and the ability of the drug to cause fetal harm or to affect reproduction capacity is unknown. According to the manufacturer, the drug should only be administered to pregnant women if clearly needed.

Data are limited regarding use of crotalidae immune F(ab')2 during breast-feeding and the excretion in breast milk is unknown. The manufacturer recommends caution when administering to lactating women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.