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ovine digoxin immune fab
Overview
What is DigiFab?
DigiFab [Digoxin Immune Fab (Ovine)] is a sterile, purified, lyophilized preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments. These fragments are obtained from the blood of healthy sheep immunized with a digoxin derivative, digoxin-dicarboxymethoxylamine (DDMA), a digoxin analogue which contains the functionally essential cyclopentaperhydrophenanthrene:lactone ring moiety coupled to keyhole limpet hemocyanin (KLH).
The final product is prepared by isolating the immunoglobulin fraction of the ovine serum, digesting it with papain and isolating the digoxin-specific Fab fragments by affinity chromatography. These antibody fragments have a molecular weight of approximately 46,000 Da.
Each vial of DigiFab, which will bind approximately 0.5 mg digoxin, contains 40 mg of digoxin immune Fab, 75 mg (approx) of mannitol USP, and 2 mg (approx) sodium acetate USP as a buffering agent.
The product contains no preservatives and is intended for intravenous administration after reconstitution with 4 mL of Sterile Water for Injection USP.
What does DigiFab look like?
What are the available doses of DigiFab?
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What should I talk to my health care provider before I take DigiFab?
Sorry No records found
How should I use DigiFab?
DigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Although designed specifically to treat digoxin overdose, a product very similar to DigiFab (Digibind) has been used successfully to treat life-threatening digitoxin overdose. Since human experience is limited, and the consequences of repeated exposure are unknown, DigiFab is not indicated for milder cases of digitalis toxicity.
Clinical conditions requiring administration of DigiFab include:
The dosage of DigiFab will vary according to the amount of digoxin or digitoxin to be neutralized.
What interacts with DigiFab?
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What are the warnings of DigiFab?
Sorry No Records found
What are the precautions of DigiFab?
Sorry No Records found
What are the side effects of DigiFab?
Sorry No records found
What should I look out for while using DigiFab?
There are no known contraindications to the use of DigiFab.
Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked, especially in cases where signs and symptoms of digitalis toxicity are not relieved by administration of DigiFab.
The possible risks and side-effects that attend the administration of heterologous animal proteins in humans include anaphylactic and anaphylactoid reactions, delayed allergic reactions and a possible febrile response to immune complexes formed by animal antibodies. Since the Fab fragment of the antibody lacks the antigenic determinants of the Fc fragment, it should pose a reduced immunogenic threat to patients compared with intact immunoglobulin molecules. Being monovalent, the product is also unlikely to form extended immune complexes with the antigen. Although no patient in the clinical studies of DigiFab has experienced a severe anaphylactic reaction, the possibility of an anaphylactic reaction should be considered. All patients should be informed of the possibility of an anaphylactic reaction and when receiving DigiFab should be carefully monitored for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) and treated immediately with appropriate emergency medical care (e.g., oxygen, diphenhydramine, corticosteroids, volume expansion and airway management). If an anaphylactic reaction occurs during the infusion, DigiFab administration should be terminated at once and appropriate treatment administered. The need for epinephrine should be balanced against its potential risk in the setting of digitalis toxicity. Patients with known allergies to sheep protein would be particularly at risk for an anaphylactic reaction, as would individuals who have previously received intact ovine antibodies or ovine Fab.
Papain is used to cleave the whole antibody into Fab and Fc fragments, and trace amounts of papain or inactivated papain residues may be present in DigiFab. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to DigiFab. In addition, it has been noted in the literature that some dust mite allergens and some latex allergens share antigenic structures with papain and patients with these allergies may be allergic to papain. DigiFab should not be administered to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.
Skin testing has not proved useful in predicting allergic response to Digibind. Because of this, and because it may delay urgently needed therapy, skin testing was not performed during the clinical studies of DigiFab and is not suggested prior to dosing with this product.
What might happen if I take too much DigiFab?
The maximum amount of DigiFab that can safely be administered in single or multiple doses has not been determined.
How should I store and handle DigiFab?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .DigiFab is supplied as a sterile, purified, lyophilized preparation. Each vial contains 40 mg of digoxin immune Fab protein, contains no preservatives and is intended for one time use. Each box contains 1 vial of DigiFab. NDC 0281-0365-10 DigiFab is supplied as a sterile, purified, lyophilized preparation. Each vial contains 40 mg of digoxin immune Fab protein, contains no preservatives and is intended for one time use. Each box contains 1 vial of DigiFab. NDC 0281-0365-10 DigiFab is supplied as a sterile, purified, lyophilized preparation. Each vial contains 40 mg of digoxin immune Fab protein, contains no preservatives and is intended for one time use. Each box contains 1 vial of DigiFab. NDC 0281-0365-10
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
DigiFab has an affinity for digoxin in the range of 10 to 10 M, which is greater than the affinity of digoxin for its sodium pump receptor, the presumed receptor for its therapeutic and toxic effects. When administered to the intoxicated patient, DigiFab binds to molecules of digoxin reducing free digoxin levels, which results in a shift in the equilibrium away from binding to the receptors, thereby reducing cardio-toxic effects. Fab-digoxin complexes are then cleared by the kidney and reticuloendothelial system.
Non-Clinical Toxicology
There are no known contraindications to the use of DigiFab.Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked, especially in cases where signs and symptoms of digitalis toxicity are not relieved by administration of DigiFab.
The possible risks and side-effects that attend the administration of heterologous animal proteins in humans include anaphylactic and anaphylactoid reactions, delayed allergic reactions and a possible febrile response to immune complexes formed by animal antibodies. Since the Fab fragment of the antibody lacks the antigenic determinants of the Fc fragment, it should pose a reduced immunogenic threat to patients compared with intact immunoglobulin molecules. Being monovalent, the product is also unlikely to form extended immune complexes with the antigen. Although no patient in the clinical studies of DigiFab has experienced a severe anaphylactic reaction, the possibility of an anaphylactic reaction should be considered. All patients should be informed of the possibility of an anaphylactic reaction and when receiving DigiFab should be carefully monitored for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) and treated immediately with appropriate emergency medical care (e.g., oxygen, diphenhydramine, corticosteroids, volume expansion and airway management). If an anaphylactic reaction occurs during the infusion, DigiFab administration should be terminated at once and appropriate treatment administered. The need for epinephrine should be balanced against its potential risk in the setting of digitalis toxicity. Patients with known allergies to sheep protein would be particularly at risk for an anaphylactic reaction, as would individuals who have previously received intact ovine antibodies or ovine Fab.
Papain is used to cleave the whole antibody into Fab and Fc fragments, and trace amounts of papain or inactivated papain residues may be present in DigiFab. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to DigiFab. In addition, it has been noted in the literature that some dust mite allergens and some latex allergens share antigenic structures with papain and patients with these allergies may be allergic to papain. DigiFab should not be administered to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.
Skin testing has not proved useful in predicting allergic response to Digibind. Because of this, and because it may delay urgently needed therapy, skin testing was not performed during the clinical studies of DigiFab and is not suggested prior to dosing with this product.
Studies of drug interactions have not been conducted with DigiFab.
Standard management of digitalis intoxication includes withdrawal of the intoxicating agent, correction of electrolyte disturbances (especially hyperkalemia), acid-base imbalances, hypoxia and treatment of cardiac arrhythmias.
Massive digitalis intoxication can cause hyperkalemia; administration of potassium supplements in the setting of digitalis intoxication may be hazardous. After treatment with DigiFab, the serum potassium concentration may drop rapidly and must be monitored frequently, especially after the first several hours after DigiFab is given (see ).
Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab. If needed, additional support can be provided by using other intravenous inotropes such as dopamine, dobutamine or vasodilators. However, care must be taken not to aggravate the digitalis induced rhythm disturbances. Re-digitalization should be postponed, if possible, until the Fab fragments have been eliminated from the body, which may require several days, and patients with impaired renal function may require a week or longer.
Based on experience with Digibind, the following adverse reactions could occur with the use of DigiFab:
In the clinical trials of DigiFab, 6 of 15 patients in the digoxin overdose study had a total of 17 adverse experiences, most were mild to moderate in nature and all were deemed "remotely associated" with DigiFab. Three events were deemed "severe", all occurred in one patient and consisted of the following: pulmonary edema, bilateral pleural effusion and renal failure. After reviewing the case, it was determined that these events were likely due to the loss of digoxin inotropic support in combination with the patient's underlying medical condition. Of 8 healthy volunteers who received DigiFab, only 2 experienced an adverse reaction that was considered to be associated with DigiFab. The reactions were 1 episode of phlebitis of the infusion vein and 1 episode of moderate postural hypotension, which became mild prior to resolving.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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