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DigiFab ovine digoxin immune fab 40 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 50633-0120-11 package photo

DigiFab ovine digoxin immune fab 40 mg Injection, Powder, Lyophilized, For Solution, 1 vial

by BTG International Inc. · 1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12)
NDC 50633-0120-11
🏷️ FDA NDC (as labeled) 50633-120-11 billing pads the product segment with a zero
Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

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
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance OVINE DIGOXIN IMMUNE FAB
GPI-14 93000025102120
GPI class DigiFab
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
Biologic (Purple Book) 351(a)
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.

🏭 Manufacturer & labeler

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

🩺 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.

🧪 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.

💲 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
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.

🔁 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50633-0120-11 You're viewing this 1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12) 2001-08-31 Active

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50633-120-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50633-0120-11, written without dashes as 50633012011. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50633-0120-11, the first segment (50633) is the labeler code FDA assigned to BTG International Inc.; the middle segment (0120) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BTG International Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BTG International Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. 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
🎯 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…

💊 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…

🤒 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50633-0110-12 · BTG 50633-0210-11 · BTG →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.