Digoxin immune fab: Difference between revisions
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* 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). | |||
* Patients should be closely monitored, including temperature, blood pressure, electrocardiogram, and potassium concentration, during and after administration of DigiFab. | |||
* | * Patients with severe renal failure who receive DigiFab for digitalis toxicity should be monitored for a prolonged period for possible recurrence of toxicity. Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate in order to establish recrudescent toxicity in renal failure patients. | ||
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Revision as of 23:56, 4 July 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi
Disclaimer
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Overview
Digoxin immune fab is a Immunoglobulin G antidote that is FDA approved for the {{{indicationType}}} of potentially life-threatening digoxin toxicity or overdose. Common adverse reactions include hypokalemia, exacerbation of low cardiac output, and rapid ventricular response in patients with atrial fibrillation.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- Dosing Information
- Dosage
Condition2
- Dosing Information
- Dosage
Condition3
- Dosing Information
- Dosage
Condition4
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Digoxin immune fab in adult patients.
Non–Guideline-Supported Use
Toxic Ingestions of Lanatoside C
- Dosing Information
- Fab fragments (500 mg) were added to 500 mL dextrose 5% in water and infused continuously at 32 drops per minute over a total period of 5.5 hours (total dose, 460 mg).[1]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Digoxin immune fab in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Digoxin immune fab in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Digoxin immune fab in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Digoxin immune fab in the drug label.
Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Digoxin immune fab in the drug label.
Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Digoxin immune fab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Digoxin immune fab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Digoxin immune fab with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Digoxin immune fab with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Digoxin immune fab with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Digoxin immune fab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Digoxin immune fab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Digoxin immune fab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Digoxin immune fab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Digoxin immune fab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Digoxin immune fab in patients who are immunocompromised.
Administration and Monitoring
Administration
- Intravenous
Monitoring
- 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).
- Patients should be closely monitored, including temperature, blood pressure, electrocardiogram, and potassium concentration, during and after administration of DigiFab.
- Patients with severe renal failure who receive DigiFab for digitalis toxicity should be monitored for a prolonged period for possible recurrence of toxicity. Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate in order to establish recrudescent toxicity in renal failure patients.
IV Compatibility
There is limited information regarding IV Compatibility of Digoxin immune fab in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Digoxin immune fab in the drug label.
Pharmacology
Digoxin immune fab
| |
Systematic (IUPAC) name | |
Anti-digoxin antibody fragment | |
Identifiers | |
CAS number | ? |
ATC code | V03 |
PubChem | ? |
DrugBank | |
Chemical data | |
Formula | Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox |
Mol. mass | 144602.257 g/mol |
Pharmacokinetic data | |
Bioavailability | ? |
Metabolism | ? |
Half life | 15 hours for DigiFab, 23 hours for Digibind |
Excretion | Renal |
Therapeutic considerations | |
Pregnancy cat. |
C(US) |
Legal status | |
Routes | IV infusion, injection |
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Digoxin immune fab in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Digoxin immune fab in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Digoxin immune fab in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Digoxin immune fab in the drug label.
Condition1
- Description
How Supplied
Storage
There is limited information regarding Digoxin immune fab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Digoxin immune fab in the drug label.
Precautions with Alcohol
- Alcohol-Digoxin immune fab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Digibind®[2]
- Digifab®[3]
Look-Alike Drug Names
- A® — B®[4]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Hess, T. (1979-12). "Treatment of a case of lanatoside C intoxication with digoxin-specific F(ab')2 antibody fragments". American Heart Journal. 98 (6): 767–771. ISSN 0002-8703. PMID 495429. Unknown parameter
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