Crotalidae polyvalent immune FAB (ovine) (Rx)

Brand and Other Names:CroFab

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • Up to 1g/vial (ovine antiserum)

Envenomation

Indicated for North American crotalid envenomation by Crotalinae rattlesnakes (eg, cottonmouths/water moccasins, copperheads, rattlesnakes)

Initial

  • Begin treatment as soon as possible (ideally within 6 hr of snakebite) in patients who develop signs of progressive envenomation including worsening local injury, coagulation abnormality, or systemic signs of envenomation
  • Start with 4-6 vials/dose IV infused over 1 hr; monitor for 1 hr following infusions for allergic reaction; repeat with additional 4-6 vials if control not achieved with initial dose
  • Repeat with 4-6 vials/dose until local tenderness/swelling not significantly progressing, coagulation tests and systemic signs trend toward normal
  • Supportive measures for manifestations of envenomation, such as pain, swelling, hypotension, and wound infection

Maintenance

  • Maintenance antivenom therapy may be indicated
  • Once control achieved, may need to administer 2 vials IV q6hr for up to 18 hr; optimal dosing past 18 hr not established; however, treatment may be continued based on patient contition

Dosage Forms & Strengths

powder for injection

  • Up to 1g/vial (ovine antiserum)

Envenomation

Indicated for North American crotalid envenomation by Crotalinae rattlesnakes (eg, cottonmouths/water moccasins, copperheads, rattlesnakes)

The absolute venom dose following snakebite is expected to be the same in children and adults, and therefore, no dosage adjustment for age should be made

Initial

  • Begin treatment as soon as possible (ideally within 6 hr of snakebite) in patients who develop signs of progressive envenomation including worsening local injury, coagulation abnormality, or systemic signs of envenomation
  • Start with 4-6 vials/dose IV infused over 1 hr; monitor following infusions for allergic reaction; repeat with additional 4-6 vials if control not achieved with initial dose
  • Repeat with 4-6 vials/dose IV until local local tenderness/swelling not significantly progressing, coagulation tests and systemic signs trend toward normal
  • Supportive measures for manifestations of envenomation, such as pain, swelling, hypotension, and wound infection

Maintenance

  • Maintenance antivenom therapy may be indicated
  • Once control achieved, may need to administer 2 vials IV q6hr for up to 18 hr; optimal dosing past 18 hr not established; however, treatment may be continued is determined to be necessary based on patient condition
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Adverse Effects

Frequency Not Defined

Pruritus

Rash

Urticaria

Hypotension

Chills

Fever

Anorexia

Nausea

Asthma

Cough

Dyspnea

Wheezing

Anaphylaxis

Anaphylactoid reaction

>10%

Hypersensitivity reactions (5-19%)

1-10%

Serum sickness (5%)

<1%

Angioedema

Chest discomfort

Dizziness

Erythema

Headache

Hyperhydrosis

Lip swelling

Musculoskeletal chest pain

Tachycardia

Tachypnea

Tongue swelling

Tracheal edema

Postmarketing reports

Delayed allergic reaction manifested by fever, pruritus and/or rash

Delayed or recurrent coagulopathy or thrombocytopenia

Failure to achieve intial control

Recurrent swelling refractory to treatment

Thrombocytopenia refractory to treatment

Prolonged hospitalization

Bleeding

Nausea

Tremor

Worsening eye sight

Treatment failure resulting in death

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Warnings

Contraindications

(Relative) History of hypersensitivity to papaya or papain unless benefits outweigh risks and appropriate anaphylaxis treatment is readily available

Cautions

Contains up to 30 mcg of ethyl mercury from thimerosal or approximately 0.03 mg of mercuary per vial or no more than 0.6 mg of mercuary per dose

If patient develop coagulopathy, due to snakebite, monitor for recurrent coagulopathy for up to 1 week or longer

Monitor for anaphylaxis and hypersensitivity reactions; patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may be at risk for hypersensitivity reaction

Use treatment within 4-6 hr of envenomation to prevent clinical deterioration and development of coagulation abnormalities

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Venom-specific Fab fragment of immunoglobulin G (IgG) that works by binding and neutralizing the venom toxins and facilitate their redistribution away from the target tissue and their elimination from the body

Absorption

Onset: Within 1 hr of administration

Distribution

Vd (total Fab): 300 mL/kg

Elimination

Systemic clearance: 32 mL/min (approximately 0.4 mL/min/kg)

Half-life: 12-23 hr

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Administration

IV Preparation

Inspect visually for particulate matter and discoloration prior to administration

Reconstitute each vial in 18 mL of 0.9% saline and mix; do not shake

Further dilute content of reconstituted vials in 250 mL of 0.9% NaCl; mix gently

Use within 4 hr of reconstitution

IV Administration

IV infusion over 60 min

Infuse slowly over first 10 min at 25-50 mL/hr rate with careful observation for allergic reaction

If no allergic reaction, increase infusion rate to 250 mL/hr

Administer within 6 hr of snakebite advised

Storage

Refrigerate virgin vials, don't freeze

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Images

Pricing & Images are not currently available for this monograph.
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Patient Handout

Patient Education
crotalidae polyval immune fab injection

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.