Digoxin Immune Fab use in specific populations
| Digoxin Immune Fab |
|---|
| DIGIFAB® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings |
| Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| How Supplied/Storage and Handling |
| Patient Counseling Information |
| Labels and Packages |
| Clinical Trials on Digoxin Immune Fab |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
For patient information about Digoxin immune fab, click here.
USE IN SPECIFIC POPULATIONS
Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been conducted with DigiFab. It is also not known whether DigiFab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DigiFab should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether DigiFab is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when DigiFab is administered to a nursing woman.
Geriatric Use:
Specific studies in elderly patients have not been conducted. Of the 15 patients given DigiFab for digoxin toxicity in one clinical trial, the average age of all patients was 64 years and over half of the patients (8 of the 15) were 65 years of age or older. The oldest patient studied was 86 years old. There is no evidence that the efficacy of DigiFab would be altered due to advanced age alone, however elderly patients have a higher chance of having impaired renal function and therefore should be monitored more closely for recurrent toxicity (see PRECAUTIONS).
Pediatric Use:
Specific studies in pediatric patients have not been conducted and no pediatric patients were enrolled in the clinical studies of DigiFab. A similar digoxin ovine Fab product, Digibind, has been used successfully to treat infants.2 As with all drugs, the use of DigiFab in infants and children should be based on careful consideration of the benefits compared with the potential risks.
References
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6832767f-db6b-4eea-b88b-bdfc905749e1