Crotalidae Polyvalent Immune FAB (Ovine)

Crotalidae Polyvalent Immune FAB (Ovine) is an antivenom indicated for North American crotalid envenomation by Crotalinae rattlesnakes (eg, cottonmouths/water moccasins, copperheads, rattlesnakes)

• Crotalidae Polyvalent Immune FAB (Ovine) is available under the following different brand names: CroFab

Common side effects of Crotalidae Polyvalent Immune FAB (Ovine) include:

• itching,
• rash,
• nausea, and
• back pain

Serious side effects of Crotalidae Polyvalent Immune FAB (Ovine) include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• itching,
• redness,
• wheezing,
• trouble breathing,
• lightheadedness,
• fever,
• nausea,
• low back pain,
• easy bruising,
• unusual bleeding (nosebleeds, bleeding gums, bleeding from an injury),
• purple or red pinpoint spots under the skin,
• swollen glands,
• rash or itching,
• joint pain,
• general ill feeling,
• heavy menstrual bleeding, and
• rash

Rare side effects of Crotalidae Polyvalent Immune FAB (Ovine) include:

• blood clotting problems,
• back pain,
• chest pain,
• chills,
• low blood pressure,
• asthma,
• cough,
• loss of appetite,
• muscle pain,
• numbness and tingling, and
• nervousness.

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Powder for injection

• Up to 1 g/vial (ovine antiserum)

Envenomation

Adult and pediatric dosage

• Initial
  • Begin treatment as soon as possible (ideally within 6 hours 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 is not achieved with the initial dose
  • Repeat with 4-6 vials/dose until local tenderness/swelling not significantly progressing, coagulation tests and systemic signs trend toward normal
• Maintenance
  • Maintenance antivenom therapy may be indicated
  • Once control is achieved, may need to administer 2 vials IV every 6 hours  for up to 18 hours; optimal dosing past 18 hours is not established; however, treatment may be continued based on the patient's condition

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Crotalidae Polyvalent Immune FAB (Ovine) has no noted severe interactions with any other drugs.
• Crotalidae Polyvalent Immune FAB (Ovine) has no noted serious interactions with any other drugs.
• Crotalidae Polyvalent Immune FAB (Ovine) has no noted moderate interactions with any other drugs.
• Crotalidae Polyvalent Immune FAB (Ovine) has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Crotalidae Polyvalent Immune FAB (Ovine)?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Crotalidae Polyvalent Immune FAB (Ovine)?”

Cautions

• Contains up to 30 mcg of ethyl mercury from thimerosal or approximately 0.03 mg of mercury per vial or no more than 0.6 mg of mercuary per dose
• If the patient develops 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 hours of envenomation to prevent clinical deterioration and development of coagulation abnormalities

Pregnancy and Lactation

• Use with caution if benefits outweigh risks during pregnancy
• Lactation
  • Excretion in milk unknown; use with caution