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Digifab Digoxin Immune Fab (Ovine)

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Digifab Digoxin Immune Fab (Ovine) ® DIGIFAB DIGOXIN IMMUNE FAB (OVINE) HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------DOSAGE FORMS AND STRENGTHS------------------- DIGIFAB is supplied as a sterile, lyophilized preparation. Each vial contains These highlights do not include all the information 40 mg of digoxin immune fab protein. (3) needed to use DIGIFAB safely and effectively. See full prescribing information for DIGIFAB. ------------------------------CONTRAINDICATIONS----------------------------- ® DigiFab , Digoxin Immune Fab (Ovine) ------------------WARNINGS AND PRECAUTIONS------------------- For Intravenous Injection Only – Lyophilized Powder for Solution • Rapid drop in serum potassium concentration after treatment with Initial U.S. Approval: 2001 DIGIFAB. Monitor frequently, especially after the first several hours of DigiFab administration. (5.1) ---------------------------INDICATIONS AND USAGE--------------------------- DIGIFAB is a digoxin immune fab (ovine) and is indicated for treatment of • Anaphylaxis and hypersensitivity reactions are possible. Patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. allergies to papain, chymopapain, other papaya extracts, or the pineapple (1) enzyme bromelain may be at risk for an allergic reaction to DIGIFAB. (5.2) ----------------------DOSAGE AND ADMINISTRATION---------------------- • Clinically misleading reading of standard serum digoxin concentration may occur after administration of DIGIFAB due to interference with For intravenous use only digitalis immunoassay measurements. (5.4) Clinical Conditions Dosage Acute ingestion of Administer 20 vials of DIGIFAB. -----------------------------ADVERSE REACTIONS------------------------------ unknown amounts of The most common adverse reactions (>7%) are worsening congestive heart Monitor for volume overload in small digoxin and toxicity in the failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). (6) (< 20 Kg) children. absence of a serum To report SUSPECTED ADVERSE REACTIONS, contact BTG 1- digitalis concentration or Start with 10 vials followed by an additional 877-377-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. estimated ingestion 10 vials, if needed, to avoid a febrile amount reaction. ----------------------USE IN SPECIFIC POPULATIONS---------------------- Administer 6 vials of DIGIFAB in Adults and • Pregnancy: No human or animal data. Use only if clearly needed. (8.1) Chronic digoxin toxicity in Children ≥ 20 Kg. the absence of a serum digitalis concentration Administer 1 vial of DIGIFAB in Infants and See 17 for PATIENT COUNSELING INFORMATION Children < 20 Kg. Revised: 06/2017 Dose (in vials) = Acute ingestion of known Amount of digoxin ingested (in mg) amounts of digoxin 0.5 mg/vial Chronic digoxin toxicity Dose (in vials) = and known serum digitalis (Serum digoxin ng/mL)(weight in kg) concentration 100 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 11 DESCRIPTION 2 DOSAGE AND ADMINISTRATION 12 CLINICAL PHARMACOLOGY 2.1 Dosage 12.1 Mechanism of Action 2.2 Preparation and Administration 12.3 Pharmacokinetics 3 DOSAGE FORMS AND STRENGTHS 13 NONCLINICAL TOXICOLOGY 4 CONTRAINDICATIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5 WARNINGS AND PRECAUTIONS 13.2 Animal Toxicology and/or Pharmacology 5.1 General 14 CLINICAL STUDIES 5.2 Hypersensitivity Reactions 15 REFERENCES 5.3 Use of DigiFab in Renal Failure 16 HOW SUPPLIED/STORAGE AND HANDLING 5.4 Laboratory Tests 17 PATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience * Sections or subsections omitted from the full prescribing information 8 USE IN SPECIFIC POPULATIONS are not listed 8.1 Pregnancy 8.2. Lactation 8.4 Pediatric Use 8.5 Geriatric Use Page 1 of 5 ® DIGIFAB DIGOXIN IMMUNE FAB (OVINE) digoxin concentrations to total body burden of digoxin in milligrams. The FULL PRESCRIBING INFORMATION volume of distribution is a population average and may vary among individuals. Many patients may require higher doses for complete 1 INDICATIONS AND USAGE neutralization and doses should usually be rounded up to the nearest whole vial. DIGIFAB is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including: • If toxicity has not adequately reversed after several hours, or appears to recur, re-administration of DIGIFAB, at a dose guided by clinical • Known suicidal or accidental consumption of fatal doses of digoxin: 10 judgment, may be necessary. If a patient is in need of re-administration of mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 DIGIFAB due to recurrent toxicity, or to a new toxic episode that occurs mg/kg) in healthy children, or ingestion of an amount that can cause soon after the first episode, measurement of free (unbound) serum steady state serum concentrations of ≥10 ng/mL; digitalis concentrations should be considered since Fab may still be present in the body. • Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children; • Failure of a patient to respond to DIGIFAB treatment may indicate that the clinical problem is not caused by digitalis intoxication. If there is no • Manifestations of life-threatening toxicity of digoxin overdose such as response to an adequate dose of DIGIFAB, the diagnosis of digitalis severe ventricular arrhythmias, progressive bradycardia, and second or toxicity should be questioned. third degree heart block not responsive to atropine, serum potassium levels exceeding 5.5 mEq/L in adults or 6 mEq/L in children with rapidly Calculation for Ingestion of Known Amount: progressive signs and symptoms of digoxin toxicity. • 2 DOSAGE AND ADMINISTRATION Each vial of DIGIFAB (40 mg of purified digoxin-specific Fab) binds approximately 0.5 mg of digoxin. For Intravenous Use Only • The total number of vials required can be calculated by dividing the total 2.1 Dosage body load of digoxin in milligrams (mg) by 0.5 mg per vial (see Formula 1). General Guidelines: • Following an acute ingestion, total body load will be approximately Adjust the dosage of DIGIFAB according to the amount of digoxin to be equal to the amount ingested in milligrams for either digoxin capsules or neutralized. digitoxin. Summary of Dosing Guidelines • In case of digoxin tablet ingestion , the total body load will be Clinical Conditions Dosage approximately equal to the amount ingested (in mg) multiplied by the Acute ingestion of Administer 20 vials of DIGIFAB. bioavailability of the tablet preparation, which is 0.8. unknown amounts of Monitor for volume overload in small Table 1 gives dosage estimates in number of vials for adults and children digoxin and toxicity in the (< 20 Kg) children. who have ingested a single large dose of digoxin and for whom the absence of a serum approximate number of tablets or capsules is known. The dose of DIGIFAB digitalis concentration or Start with 10 vials followed by an (in number of vials) represented in Table 1 can be approximated using the estimated ingestion additional 10 vials, if needed, to avoid following formula: amount a febrile reaction. Formula 1 Administer 6 vials of DIGIFAB in Chronic digoxin toxicity in Dose = total digitalis body load in mg Adults and Children ≥ 20 Kg. the absence of a serum (in # of vials) 0.5 mg of digitalis bound/vial digitalis concentration Administer 1 vial of DIGIFAB in Infants and Children < 20 Kg. Table 1 Approximate Dose of DIGIFAB for Reversal of a Single Dose (in vials) = Large Digoxin Overdose Acute ingestion of known Amount of digoxin ingested (in mg) amounts of digoxin Number of Digoxin Tablets Dose of DIGIFAB 0.5 mg/vial or Capsules Ingested* # of vials Chronic digoxin toxicity Dose (in vials) = 25 10 and known serum digitalis (Serum digoxin ng/mL)(weight in kg) 50 20 concentration 100 75 30 Failure of the patient to respond to DIGIFAB should alert the physician 100 40 to the possibility that the clinical problem may not be caused by digitalis 150 60 200 80 toxicity. * 0.25 mg tablets with 80% bioavailability or 0.2 mg capsules with DOSAGE CALCULATION 100% bioavailability General If, after several hours, toxicity is not adequately reversed, or appears to Methods for calculating a neutralizing dose of DIGIFAB, based on a known recur, additional administration of DIGIFAB at a dose guided by clinical or estimated amount of digoxin or digitoxin in the body, are provided judgment may be required. below. When using the dose calculation methods provided, the following Calculations Based on Steady-State Serum Digoxin Concentrations: guidelines should be considered: Adults • Inaccurate estimates of the amount of digitalis ingested or absorbed may occur due to non-steady state serum concentrations or due to digitalis Table 2 gives dosage estimates in number of vials for adult patients for assay limitations. Most serum digoxin assay kits are designed to measure whom a steady-state serum digoxin concentration is known. The dose of concentrations less than 5 ng/mL; therefore, sample dilution is required DIGIFAB (in number of vials) represented in Table 2 can be approximated to accurately measure serum concentrations > 5 ng/mL. using the following formula: • Dosage calculations are based on a steady state volume of distribution of approximately 5 L/kg for digoxin, which is used to convert serum Page 2 of 5 ® DIGIFAB DIGOXIN IMMUNE FAB (OVINE) Formula 2 (see Table 2) • Use the reconstituted product promptly. If not used immediately, store Dose = (Serum digoxin concentration
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