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DigiFab ovine digoxin immune fab 40 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 50633-0120-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DigiFab ovine digoxin immune fab 40 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 50633-120-11 (Billing 50633-0120-11)

by BTG International Inc. · 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

This is a package of 1 vial of DigiFab ovine digoxin immune fab 40 mg Injection, Powder, Lyophilized, For Solution from BTG International Inc., marketed since Aug 2001 and currently FDA-listed, this package's marketing is listed to end Feb 2028. It is this product's only package size.

NDC 50633-0120-11
🏷️ FDA NDC (as labeled) 50633-120-11 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 50633-120-11 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
50633 labeler · 120 product · 11 package
Package marketed since
Aug 31, 2001
Package marketing ended
Feb 29, 2028
Sample package
No — commercial package
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 5063312011 9
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50633-120-11
Product NDC 50633-120
11-digit billing NDC 50633012011
NCPDP billing unit EA — each (per item)
Application # BLA103910
SPL Set ID c05ee6a5-c98b-45f4-83fd-40781639d653
Established class (EPC) Cardiac Glycoside
Chemical class Cardiac Glycosides
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-08-31
Marketing end 2028-02-29
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance OVINE DIGOXIN IMMUNE FAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 049773
GCN 15446
HICL code 001118
Ingredient (HICL) Digoxin Immune Fab
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8E
Therapeutic class — specific (HIC3) Antidotes,Miscellaneous
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name DIGIFAB 40 MG VIAL
FDB brand name Digifab
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 049773
  • GCN: 15446
  • HICL (First Databank): 001118
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 50633-120-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50633-0120-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name DIGIFAB 40 MG VIAL Ingredient Digoxin Immune Fab

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1162 $5,383.321 / J1162 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)50633-120-11
11-digit billing NDC50633-0120-11
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1162
DescriptorInjection, digoxin immune fab (ovine), per vial
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is PER VIAL, so one package = 1 billing unit.
Medicare Part B spend (2025 (Q1-Q4))$192,651 · 16 claims · $12,040.69 per claim (all NDCs under J1162)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50633-0120-11 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 2001-08-31 Feb 29, 2028 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
DigiFab 40 mgthis 50633-0120-11 BTG 1 vial — — FDA listed —
DigiFab 40 mg 87131-0120-11 Salvagenix 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2001
First FDA approval
Aug 2001
📍
2026
Currently FDA-listed
25 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBTG International Inc.
FDA applicationBLA103910 (BLA)
Labeler code50633
First marketedAug 2001
Product typePlasma Derivative
Portfolio6 products on file

More NDCs from BTG International Inc. labeler code 50633

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 153 words ▾

1 INDICATIONS AND USAGE DigiFab ® is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including: Known suicidal or accidental consumption of fatal doses of digoxin: 10 mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 mg/kg) in healthy children, or ingestion of an amount that can cause steady state serum concentrations of ≥10 ng/mL; Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children; Manifestations of life-threatening toxicity of digoxin overdose such as severe ventricular arrhythmias, progressive bradycardia, and second or 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 progressive signs and symptoms of digoxin toxicity.

DigiFab ® is a digoxin immune fab (ovine) and is indicated for treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For Intravenous Use Only For intravenous use only Clinical Conditions Dosage Acute ingestion of unknown amounts of digoxin and toxicity in the absence of a serum digitalis concentration or estimated ingestion amount Administer 20 vials of DigiFab ® . Monitor for volume overload in small (< 20 Kg) children. Start with 10 vials followed by an additional 10 vials, if needed, to avoid a febrile reaction.

Chronic digoxin toxicity in the absence of a serum digitalis concentration Administer 6 vials of DigiFab ® in Adults and Children ≥ 20 Kg. Administer 1 vial of DigiFab ® in Infants and Children < 20 Kg. Acute ingestion of known amounts of digoxin Dose (in vials) = Amount of digoxin ingested (in mg) 0.5 mg/vial Chronic digoxin toxicity and known serum digitalis concentration Dose (in vials) = (Serum digoxin ng/mL)(weight in kg) 100

2.1Dosage General Guidelines: Adjust the dosage of DigiFab ® according to the amount of digoxin to be neutralized. Summary of Dosing Guidelines Clinical Conditions Dosage Acute ingestion of unknown amounts of digoxin and toxicity in the absence of a serum digitalis concentration or estimated ingestion amount Administer 20 vials of DigiFab ® . Monitor for volume overload in small (< 20 Kg) children.

Start with 10 vials followed by an additional 10 vials, if needed, to avoid a febrile reaction. Chronic digoxin toxicity in the absence of a serum digitalis concentration Administer 6 vials of DigiFab ® in Adults and Children ≥ 20 Kg. Administer 1 vial of DigiFab ® in Infants and Children < 20 Kg.

Acute ingestion of known amounts of digoxin Dose (in vials) = Amount of digoxin ingested (in mg) 0.5 mg/vial Chronic digoxin toxicity and known serum digitalis concentration Dose (in vials) = (Serum digoxin ng/mL)(weight in kg) 100 Failure of the patient to respond to DigiFab ® should alert the physician to the possibility that the clinical problem may not be caused by digitalis toxicity. DOSAGE CALCULATION General Methods for calculating a neutralizing dose of DigiFab ® , based on a known or estimated amount of digoxin or digitoxin in the body, are provided below.

When using the dose calculation methods provided, the following guidelines should be considered: Inaccurate estimates of the amount of digitalis ingested or absorbed may occur due to non-steady state serum concentrations or due to digitalis assay limitations. Most serum digoxin assay kits are designed to measure concentrations less than 5 ng/mL; therefore, sample dilution is required to accurately measure serum concentrations > 5 ng/mL. Dosage calculations are based on a steady state volume of distribution of approximately 5 L/kg for digoxin, which is used to convert serum digoxin concentrations to total body burden of digoxin in milligrams.

The volume of distribution is a population average and may vary among individuals. Many patients may require higher doses for complete neutralization and doses should usually be rounded up to the nearest whole vial. If toxicity has not adequately reversed after several hours, or appears to recur, re-administration of DigiFab ® , at a dose guided by clinical judgment, may be necessary.

If a patient is in need of re-administration of DigiFab ® due to recurrent toxicity, or to a new toxic episode that occurs soon after the first episode, measurement of free (unbound) serum digitalis concentrations should be considered since Fab may still be present in the body. 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 response to an adequate dose of DigiFab ® , the diagnosis of digitalis toxicity should be questioned.

Calculation for Ingestion of Known Amount: Each vial of DigiFab ® (40 mg of purified digoxin-specific Fab) binds approximately 0.5 mg of digoxin. The total number of vials required can be calculated by dividing the total body load of digoxin in milligrams (mg) by 0.5 mg per vial (see Formu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS DigiFab ® is supplied as a sterile, purified, lyophilized preparation containing 40 mg of digoxin immune Fab protein per vial. DigiFab ® is supplied as a sterile, lyophilized preparation. Each vial contains 40 mg of digoxin immune fab protein.

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS There are no known contraindications to the use of DigiFab ® . There are no known contraindications.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Rapid drop in serum potassium concentration after treatment with DigiFab ® . Monitor frequently, especially after the first several hours of DigiFab administration. ( 5.1 ) Anaphylaxis and hypersensitivity reactions are possible.

Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may be at risk for an allergic reaction to DigiFab ® . ( 5.2 ) Clinically misleading reading of standard serum digoxin concentration may occur after administration of DigiFab ® due to interference with digitalis immunoassay measurements. ( 5.4 )

5.1General Suicidal ingestion may result from 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 ® . Rapid drop in serum potassium concentration may occur after treatment with DigiFab ® . Monitor frequently, especially after the first several hours of DigiFab ® administration (see

5.4Laboratory Tests ). Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab ® . If needed, provide additional support by using other intravenous inotropes such as dopamine, dobutamine or vasodilators.

However, take additional care not to aggravate the digitalis induced rhythm disturbances. Postpone re-digitalization, 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.

5.2Hypersensitivity Reactions Anaphylaxis and hypersensitivity reactions are possible. Carefully monitor all patients treated with DigiFab ® 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 treat immediately with appropriate emergency medical care (e.g., oxygen, diphenhydramine, corticosteroids, volume expansion and airway management), if one occurs. If an anaphylactic reaction occurs during the infusion, terminate DigiFab ® administration at once and administer appropriate treatment.

Balance the need for epinephrine against its potential risk in the setting of digitalis toxicity. Patients with known allergies to sheep protein are particularly at risk for an anaphylactic reaction, as are individuals who have previously received intact ovine antibodies or ovine Fab. Do not administer DigiFab ® 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.Prior treatment with digoxin-specific ovine immune Fab carries a theoretical risk of sensitization to ovine serum protein and possible diminution of the efficacy of the drug due to the presence of human antibodies against ovine Fab.

To date, there have been no clinical reports of human anti-ovine immunoglobulin antibodies causing a reduction in binding of ovine digoxin immune Fab or neutralization response to ovine digoxin immune Fab.

5.3Use of DigiFab ® in Renal Failure The elimination half-life of DigiFab ® in renal failure has not been clearly defined. Monitor patients with severe renal failure who receive DigiFab ® for digitalis toxicity 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. 5

5.4Laboratory Tests DigiFab ® may interfere with digitalis immunoassay measurements. Thus, standard serum digoxin concentration measurements may be clinically misleading until the Fab fragments are eliminated from the body. This may take several days or a week or more in patients with markedly impaired renal function. Therefore, serum samples for digoxin concentration… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 219 words ▾

6 ADVERSE REACTIONS The most common adverse reactions (> 7%) related to DigiFab ® administration are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). The most common adverse reactions (>7%) are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG 1-877-377-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the clinical trials of DigiFab ® , 6 of 15 patients in the digoxin overdose study had a total of 17 adverse events. Three events occurred in one patient and consisted of the following: pulmonary edema, bilateral pleural effusion and renal failure.

The events were determined to be 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 ® , two experienced an adverse reaction that was considered to be related to DigiFab ® . The reactions were; one episode of phlebitis of the infusion-site vein and one episode of transient postural hypotension.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly needed. ( 8.1 )

8.1Pregnancy 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 clinically needed.

8.3Nursing 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. DigiFab ® should be given to nursing mothers only if clinically needed.

8.4Pediatric Use Safety data in pediatric population is limited. The pediatric dosing estimation is based on calculations for adult dosing.

8.5Geriatric 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

5.3Use of DigiFab ® in renal failure).

🤰 Pregnancy 52 words ▾

8.1Pregnancy 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 clinically needed.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use Safety data in pediatric population is limited. The pediatric dosing estimation is based on calculations for adult dosing.

🧓 Geriatric Use 109 words ▾

8.5Geriatric 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

5.3Use of DigiFab ® in renal failure).

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action DigiFab ® has an affinity for digoxin in the range of 10 9 to 10 10 M -1 , 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.

12.3Pharmacokinetics The pharmacokinetics and pharmacodynamics of DigiFab ® were assessed in a randomized and controlled study of DigiFab ® and Digibind ® (comparator Fab product for treatment of digoxin toxicity). Sixteen healthy subjects were given 1 mg of intravenous digoxin followed by an approximately equimolar neutralizing dose of either DigiFab ® (n=8) or Digibind (n=8). The objective of the pharmacokinetic and pharmacodynamic study was to compare parameters for DigiFab ® to those for Digibind.

7 The pharmacokinetics of both digoxin and Fab were determined and found to be similar for both products. The similar volumes of distribution (0.3 L/kg and

0.4L/kg for DigiFab ® and Digibind, respectively) indicate considerable penetration from the circulation into the extracellular space and are consistent with previous reports of ovine Fab distribution, as are the elimination half-life values (15 hours and 23 hours for DigiFab ® and Digibind, respectively). 8-12 The elimination half-life of 15-20 hours in patients with normal renal function appears to be increased up to 10 fold in patients with renal impairment, although volume of distribution remains unaffected. 12 The primary outcome measure for this study was the serum level of free (unbound) digoxin.

The results demonstrated that both products reduced the level of free digoxin in the serum to below the limit of assay quantitation for several hours after Fab administration. Cumulative urinary excretion of digoxin was comparable for both products and exceeded 40% of the administered dose by 24 hours. These results demonstrate that DigiFab ® and Digibind have equivalent pharmacodynamic effects on the digoxin parameters that are relevant to the treatment of digoxin toxicity.

🧬 Mechanism of Action 91 words ▾

12.1Mechanism of Action DigiFab ® has an affinity for digoxin in the range of 10 9 to 10 10 M -1 , 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.

📦 How Supplied / Storage and Handling 39 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING DigiFab is supplied as a carton that contains 1 vial of product (diluent not included). NDC 50633-120-11 Store at 2° to 8°C (36° to 46°F). Do not freeze. Use within 4 hours after reconstitution.

📋 Description 152 words ▾

11 DESCRIPTION DigiFab ® [Digoxin Immune Fab (Ovine)] is a sterile, 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.

💬 Information for Patients 74 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients to contact their physician immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, pruritus, urticaria) after hospital discharge. Manufactured for and distributed by: BTG International Inc. West Conshohocken, PA 19428 U.S.

License No. 1861 DigiFab ® is a registered trademark of BTG International Inc. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.

P12011D-1 August 2014

🍼 Nursing Mothers 49 words ▾

8.3Nursing 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. DigiFab ® should be given to nursing mothers only if clinically needed.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The pharmacokinetics and pharmacodynamics of DigiFab ® were assessed in a randomized and controlled study of DigiFab ® and Digibind ® (comparator Fab product for treatment of digoxin toxicity). Sixteen healthy subjects were given 1 mg of intravenous digoxin followed by an approximately equimolar neutralizing dose of either DigiFab ® (n=8) or Digibind (n=8). The objective of the pharmacokinetic and pharmacodynamic study was to compare parameters for DigiFab ® to those for Digibind.

7 The pharmacokinetics of both digoxin and Fab were determined and found to be similar for both products. The similar volumes of distribution (0.3 L/kg and

0.4L/kg for DigiFab ® and Digibind, respectively) indicate considerable penetration from the circulation into the extracellular space and are consistent with previous reports of ovine Fab distribution, as are the elimination half-life values (15 hours and 23 hours for DigiFab ® and Digibind, respectively). 8-12 The elimination half-life of 15-20 hours in patients with normal renal function appears to be increased up to 10 fold in patients with renal impairment, although volume of distribution remains unaffected. 12 The primary outcome measure for this study was the serum level of free (unbound) digoxin.

The results demonstrated that both products reduced the level of free digoxin in the serum to below the limit of assay quantitation for several hours after Fab administration. Cumulative urinary excretion of digoxin was comparable for both products and exceeded 40% of the administered dose by 24 hours. These results demonstrate that DigiFab ® and Digibind have equivalent pharmacodynamic effects on the digoxin parameters that are relevant to the treatment of digoxin toxicity.

🔬 Clinical Studies 202 words ▾

14 CLINICAL STUDIES One prospective multi-center safety, efficacy and pharmacokinetic study in patients presenting with life-threatening digoxin toxicity was conducted in U.S. and Finland. The objective of the study was to demonstrate safety, pharmacokinetics, and clinical response of DigiFab ® in patients. Results were compared to historical data on Digibind.

Fifteen patients received doses of DigiFab ® based on its theoretical binding capacity for digoxin, and based on the known amount of digoxin ingested or on blood concentrations of digoxin at the time of admission. Serum free digoxin concentrations fell to undetectable concentrations in all patients following DigiFab ® administration. Ten of the 15 patients studied who had baseline ECG abnormalities improved within 4 hours after the DigiFab ® infusion.

The remaining 5 patients who had baseline ECG abnormalities remained unchanged throughout the 24-hour assessment period, and in one case through the 30-day follow up period. Seven out of the 15 patients (47%) studied had complete resolution of digoxin toxicity within 4 hours of DigiFab ® administration, and 14 patients (93%) were classified as having resolved their digoxin toxicity by 20 hours. In this study, where 2/15 patients had serum available for human anti-ovine antibody determination, there was no measurable immune response.

🧪 Nonclinical Toxicology 109 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal carcinogenicity and reproduction studies have not been conducted with DigiFab.

13.2Animal Toxicology and/or Pharmacology No toxic effects were observed when DigiFab ® was administered to healthy male Sprague Dawley rats in equimolar doses sufficient to neutralize a 1 mg/kg dose of digoxin. In these studies, the physiologic changes produced by toxic serum concentrations of digoxin were ameliorated rapidly by the administration of DigiFab ® or comparator product Digibind. Statistically equivalent responses were observed with both DigiFab ® and Digibind to the following variables: PTQ index, heart rate, mean arterial pressure, ventilation, arterial blood gases, and serum potassium concentrations.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal carcinogenicity and reproduction studies have not been conducted with DigiFab.

📚 References ~1 min read ▾

15 REFERENCES Kojis FG. Serum sickness and anaphylaxis: analysis of cases of 6,211 patients treated with horse serum for various infections. Am J Dis Children 1942; 64:93-143, 313-350.

Quarre JP, Lecomte J, Lauwers D, Gilbert P, Thiriaux J. Allergy to latex and papain. J Allergy Clin Immunol 1995; 95(4):922.

Baur X, Chen Z, Rozynek P, Düser D, Raulf-Heimsoth M. Cross-reacting IgE antibodies recognizing latex allergens, including Hev b 1, as well as papain. Allergy 1995; 50(7):604-609.

Wenger TL. Experience with digoxin immune fab (ovine) in patients with renal impairment. Am J of Emer Med 1991; 9(supp.

1):21-23. Valdes R, Jortani SA. Monitoring of unbound digoxin in patients with antidigoxin antigen-binding fragments: a model for the future ?

Clin Chem 1998; 44(9):1883-1885. Kirkpatrick CHG, Digibind ® Study Advisory Panel. Allergic histories and reactions of patients treated with digoxin immune fab (ovine) antibody.

Am J of Emer Med 1991; 9(supp. 1):7-10. Ward, SB, Sjostrom L, and Ujhelyi MR.

Comparison of the pharmacokinetics and in vivo binding affinity of DigiTAb versus Digibind.Therapeutic Drug Monitoring 2000; 22:599-607. Hickey AR, Wenger TL, Carpenter VP, et al. Digoxin immune fab therapy in the management of digitalis intoxication: safety and efficacy results of an observational surveillance study.

J Am Coll Cardiol 1991; 17:590-598. Antman EM, Wenger TL, Butler VP, Haber E, and Smith TW. Treatment of 150 cases of life threatening digitalis intoxication with digoxin-specific fab antibody fragments.

Circulation 1990; 81:1744-1752. Wenger TL, Butler VP Jr, Haber E, Smith TW. Treatment of 63 severely digitalis-toxic patients with digoxin-specific antibody fragments.

J Am Coll Cardiol 1985; 5 (supp.):118A-123A. Schaumann W, Kaufmann B, Neubert P, Smolarz A. Kinetics of the fab fragments of digoxin antibodies and of bound digoxin in patients with severe digoxin intoxication.

Eur J Clin Pharmacol 1986; 30:527-533. Ujhelyi MR, Robert S. Pharmacokinetic aspects of digoxin-specific fab therapy in the management of digitalis toxicity.

Clin Pharmacokinet 1995; 28(6):483-493.

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 50633-120-11 - 40 mg Vial Label Vial Label

PRINCIPAL DISPLAY PANEL - NDC: 50633-120-11 - 40 mg Carton Label Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but BTG International Inc. has reported a marketing end date of 2028-02-29, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
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Yes — this NDC cross-references HCPCS code J1162 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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← 50633-0110-12 · BTG 50633-0210-11 · BTG →
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