Crotalidae Polyvalent Immune Fab (Ovine)

Dosage Forms And Strengths

CROFAB is supplied as a sterile, nonpyrogenic, purified, lyophilized powder. Each vial contains up to 1 gram of total protein, a maximum of 0.03 mg of mercury, and not less than the indicated number of mouse LD50 neutralizing units* :

Storage And Handling

CROFAB is supplied as a carton that contains 2 vials of product (diluent not included). Each vial of CROFAB contains up to 1 gram of lyophilized total protein and not less than the indicated number of mouse LD50 neutralizing units:

NDC 50633-110-12

• Store at 2° to 8°C (36° to 46°F).
• Do not freeze.
• Use within 4 hours after reconstitution.

REFERENCES

3. Lavonas EJ, Ruha AM, Banner W, Bebarta V, Bernstein JN, Bush SP, Kerns WP, Richardson WH, Seifert SA, Tanen DA, Curry SC, Dart RC. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med February 3 2011;11:2 (http://www.biomedcentral.com/1471-227X/11/2).

12. Kirkpatrick CH, The Digibind Study Advisory Panel. Allergic histories and reactions of patients treated with digoxin immune Fab (ovine) antibody. Am J Emerg Med 1991; 9(2 Suppl 1):7 10.

Distributed by: BTG International Inc. West Conshohocken, PA 19428. Revised: July 2016

Included as part of the "PRECAUTIONS" Section

Antivenom; ovine IgG Fab fragments capable of binding and neutralizing venom toxins of Crotalinae (pit vipers, crotalines; formerly known as Crotalidae or crotalids) native to North America.1

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Wheezing or coughing.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Fever.
• Muscle or joint pain.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

CroFab: (1 ea) [contains thimerosal]

Refer to adult dosing.

Reconstitute each vial with 18 mL NS and mix by continuous manual inversion until no solid material is visible. Do not shake. The contents of all of the reconstituted vials should be further diluted to a total volume of 250 mL NS; swirl gently to mix. Due to fluid overload concerns in children who weigh <10 kg, it has been proposed that approximately half of the normal fluid volume for dilution (ie, 125 mL NS) should be used in this patient population (Johnson 2008).

Note: Reconstitution with 25 mL SWFI and hand rolling/inverting may result in shorter dissolution times and allow for more rapid administration (Quan 2010).

Administer IV over 60 minutes at a rate of 25 to 50 mL/hour for the first 10 minutes. If no allergic reaction is observed, increase rate to 250 mL/hour. Monitor closely. Immediate treatment for anaphylactoid and/or hypersensitivity reactions should be available during the infusion. Decreasing the rate of infusion may help control some infusion-related adverse effects (eg, fever, low back pain, wheezing and nausea).

Frequency not always defined.

Cardiovascular: Hypotension

Central nervous system: Chills

Dermatologic: Pruritus, skin rash, urticaria

Gastrointestinal: Anorexia, nausea

Hypersensitivity: Hypersensitivity reaction (5% to 19%), serum sickness (5%), anaphylactoid reaction, anaphylaxis

Respiratory: Asthma, cough, dyspnea, wheezing

Miscellaneous: Fever

<1% (Limited to important or life-threatening): Angioedema, blood coagulation disorder (delayed, recurrent), chest discomfort, delayed hypersensitivity, dizziness, erythema, headache, hemorrhage, hyperhidrosis, laryngeal edema, musculoskeletal chest pain, swelling of lips, swelling (recurrent and refractory to treatment), swollen tongue, tachycardia, tachypnea, thrombocytopenia (refractory to treatment), tremor