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RECOTHROM thrombin topical recombinant Kit — NDC 00338-0330-01 package photo

RECOTHROM thrombin topical recombinant Kit

by Baxter Healthcare Corporation · 1 KIT in 1 KIT (0338-0330-01) * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 VIAL
NDC 00338-0330-01
🏷️ FDA NDC (as labeled) 0338-0330-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1082-2022

🆔 Identity & classification

FDA NDC (as labeled) 0338-0330-01
Product NDC 0338-0330
11-digit billing NDC 00338033001
NCPDP billing unit EA — each (per item)
RxCUI 1367418, 1367420
Application # BLA125248
SPL Set ID 54885644-e51e-4263-aadb-366abaeb56a3
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-06-09
Dosage form KIT
GPI-14 84200050102130
GPI class Recothrom Spray Kit
GCN Seq No 064054
GCN 99765
HICL code 035337
Ingredient (HICL) Thrombin (Recombinant)
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9A
Therapeutic class — specific (HIC3) Topical Hemostatics
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name RECOTHROM 20,000 UNIT SPRAY KT
FDB brand name Recothrom
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 0338-0330-01 — a 4-4-2 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 labeler segment → 00338-0330-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Blood Coagulation Factor class.

Pharmacologic class Blood Coagulation Factor, Human Blood Coagulation Factor
Drug family (ATC) Local hemostatics, Blood coagulation factors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBaxter Healthcare Corporation
FDA applicationBLA125248 (BLA)
Labeler code00338
First marketedJun 2008
Product typeHuman Prescription Drug
Portfolio282 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 RECOTHROM 20,000 UNIT SPRAY KT Ingredient Thrombin (Recombinant)

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Recothrom 00338-0322-01 Baxter 1 kit — — FDA listed —
Recothrom 00338-0326-01 Baxter 1 kit — — FDA listed —
Recothromthis 00338-0330-01 Baxter 1 kit — — 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

🏛️
2008
First FDA approval
Jan 2008
📍
2026
Currently FDA-listed
18 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for RECOTHROM (this brand).

Top reported reactions

Venous Occlusion8
Incorrect Route Of Product Administration6
Wrong Product Administered6
Incorrect Route Of Drug Administration5
Thrombosis4
Cardio-respiratory Arrest3
Epistaxis3

Reporter sex

0 reports
Male · 34%
Female · 51%
Unknown · 15%

Serious outcomes

Life-threatening7
Death6
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00338-0330-01 You're viewing this 1 KIT in 1 KIT (0338-0330-01) * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 VIAL 2008-06-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 0338-0330-01, 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: 00338-0330-01, written without dashes as 00338033001. 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 00338-0330-01, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (0330) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, 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 144 words ▾

1 INDICATIONS AND USAGE RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.

(1) RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For topical use only. DO NOT INJECT. For topical use only.

DO NOT INJECT. (2) • Reconstitute RECOTHROM Thrombin topical (Recombinant) powder with sterile 0.9% sodium chloride, USP, yielding a solution containing 1,000 units (international units of potency) per mL. (2.1) • Apply RECOTHROM solution with absorbable gelatin sponge or RECOTHROM Spray Applicator Kit directly to the bleeding site surface.

The amount required depends upon the area of tissue to be treated. (2.2) • 5,000-unit RECOTHROM may be used in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL ( 2.2 )

2.1Reconstitution of RECOTHROM Thrombin The volume of reconstituted RECOTHROM Thrombin topical (Recombinant) required will vary depending on the size and number of bleeding sites to be treated and the method of application. Inspect the integrity of the RECOTHROM package and contents. Do not use if the packaging or contents have been damaged or opened.

Reconstitute the lyophilized powder using the supplied diluent. Use aseptic technique when handling vials and syringes. 5,000-unit RECOTHROM Thrombin topical (Recombinant) Reconstitution Units used herein represent international units of potency determined using a reference standard that has been calibrated against the World Health Organization Second International Standard for Thrombin.

1. Remove flip-off cap from the top of the RECOTHROM vial. 2.

Attach the needle-free vial access device (VAD) and snap it into place on the vial by placing the vial on a flat surface and pushing the VAD straight down into the center of the vial stopper. 3. Attach the prefilled diluent syringe to the VAD.

4. Transfer the 5 mL of diluent from the syringe into the RECOTHROM vial. 5.

DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe. 6.

Gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature.

RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin. 7. Withdraw reconstituted RECOTHROM solution into transfer syringe labeled For topical use only, DO NOT INJECT.

Transfer RECOTHROM solution into a labeled sterile bowl or basin. 8. RECOTHROM is ready for application.

RECOTHROM is for topical use only – DO NOT INJECT. See Application techniques below (2.2). RECOTHROM is for single use only.

Discard unused contents. 20,000-unit RECOTHROM Thrombin topical (Recombinant) Reconstitution 1. Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.

2. There are two needle-free vial access devices (VADs) provided. Attach one VAD to the RECOTHROM vial and one VAD to the diluent vial.

To attach a VAD to a vial, place the vial on a flat surface and push straight down on the VAD into the center of the vial stopper. 3. Attach the empty 20-mL transfer syringe to the VAD on the diluent vial (injection of air into the diluent vial may facilitate withdrawal of the diluent).

This syringe will be used twice: 1. To draw up the diluent from the diluent vial to be transferred into the RECOTHROM vial for reconstitution and 2. To draw up the reconstituted RECOTHROM solution.

4. Draw up 20 mL of diluent from the vial into the syringe. 5.

Remove the diluent-filled syringe from the diluent vial and attach the syringe to the VAD on the RECOTHROM vial. 6. Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial.

7. Leave the syringe attached and gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation.

The powder should dissolve in less than one minute at room temperature. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin. 8.

Withdraw reconstituted RECOTHROM solution into the attached transfer syringe labeled For topical use only, DO NOT INJECT. Use the transfer syri…

💊 Dosage Forms and Strengths 77 words ▾

3 DOSAGE FORMS AND STRENGTHS RECOTHROM Thrombin topical (Recombinant) is available as a sterile lyophilized powder in 5,000- and 20,000-unit single-use vials. When reconstituted with the sterile 0.9% sodium chloride, USP provided, the powder yields a solution containing 1,000 units/mL of Thrombin topical (Recombinant). RECOTHROM Thrombin topical (Recombinant) is available as 5,000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution.

When reconstituted as directed, the final solution contains 1,000 units/mL of RECOTHROM. (3)

⛔ Contraindications 105 words ▾

4 CONTRAINDICATIONS • Do not inject directly into the circulatory system. • Do not use for the treatment of massive or brisk arterial bleeding. • Do not administer to patients with a history of hypersensitivity to RECOTHROM Thrombin topical (Recombinant) or any components of RECOTHROM. • Do not use in patients with known hypersensitivity to hamster proteins. • Do not inject directly into the circulatory system. (4) • Do not use for the treatment of massive or brisk arterial bleeding. (4) • Do not administer to patients with a history of hypersensitivity to RECOTHROM Thrombin topical (Recombinant), any components of RECOTHROM or hamster proteins.

(4)

⚠️ Warnings and Cautions 85 words ▾

5 WARNINGS AND PRECAUTIONS • RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. (5.1) • Hypersensitivity reactions, including anaphylaxis, may occur. (5.2)

5.1Thrombosis RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT.

5.2Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM Thrombin topical (Recombinant) is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins [see Contraindications (4) and Description (11) ] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM Thrombin topical (Recombinant) in all completed clinical trials (N=644) [see Warnings and Precautions (5.1) ] . Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin [see Adverse Reactions (6.2) ] . • The most common adverse reaction (incidence 6%) was thromboembolic events.

(5.1 , 6) • Antibody formation to RECOTHROM Thrombin topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials have been performed with RECOTHROM Thrombin topical (Recombinant) applied with absorbable gelatin sponge and applied with a spray applicator. A total of 644 patients were exposed to RECOTHROM in these studies.

RECOTHROM Thrombin topical (Recombinant) Used in Conjunction with Absorbable Gelatin Sponge Four hundred eleven (411) patients were treated in a randomized, double-blind, controlled trial that compared RECOTHROM to bovine thrombin. Both thrombins were applied with a gelatin sponge in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access. 1 The incidence of thromboembolic adverse reactions was similar between the RECOTHROM and bovine thrombin treatment groups (see Table 1 ).

Table 1: Incidence of Adverse Reactions with RECOTHROM Thrombin topical (Recombinant) and Bovine Thrombin Adverse Reaction Category RECOTHROM (N=205) n (%) Bovine Thrombin THROMBIN-JMI Thrombin, Topical (Bovine) (N=206) n (%) Thromboembolic events 11 (5%) 12 (6%) In an open-label, single-group trial (N=209), patients with documented or highly likely prior exposure to bovine thrombin within the previous three years were treated with RECOTHROM when undergoing surgeries (spinal, peripheral arterial bypass, or arteriovenous graft formation for hemodialysis access).

2 The incidence of thromboembolic adverse reactions in this study was 9%. In an open-label, single-group trial of re-exposure to RECOTHROM (N=31), patients with documented prior exposure to RECOTHROM were treated with RECOTHROM during surgery (spinal, peripheral arterial bypass, arteriovenous graft formation, or other procedures). 3 The incidence of thromboembolic adverse reactions in this study was 3%.

In other randomized, double-blind trials across a range of surgical settings (N=130; spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the safety of RECOTHROM (n=88 patients) was compared to placebo (RECOTHROM excipients reconstituted with sterile 0.9% sodium chloride, USP) (n=42 patients). The incidence of thromboembolic adverse reactions in this study was 5% for RECOTHROM and 12% for placebo. RECOTHROM Thrombin topical (Recombinant) Applied with Spray Applicator RECOTHROM was applied with a spray applicator in two open-label clinical trials: a single-group trial in adult and pediatric burn patients (N=72; ≤16 years of age, (n=4) and ≥17 years of age, (n=68)) treated with RECOTHROM applied to the wound excision site prior to autologous skin grafting 4 ; and in a single-group trial in pediatric patients (one month to 17 years of age) undergoing synchronous burn wound excision and autologous skin grafting (N=30; ≤16 years of age, (n=26); ≥17 years of age, (n=4)).

5 In the first study, the incidence of thromboembolic adverse reactions was 1%. I…

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data regarding RECOTHROM Thrombin topical (Recombinant) in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RECOTHROM. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of RECOTHROM Thrombin topical (Recombinant) in human milk, the effects on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RECOTHROM and any potential adverse effects on the breastfed child from RECOTHROM or from underlying maternal condition.

8.4Pediatric Use A total of 30 pediatric patients, ages 0 to 16 years (one month to 2 years, n=10; 2 to 12 years, n=12; 12 to 16 years, n=8), were treated in clinical trials with RECOTHROM Thrombin topical (Recombinant) using a spray applicator to burn wound excision sites prior to autologous skin grafting. No patient experienced a thromboembolic adverse reaction. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults.

Safety and efficacy have not been established in neonates [see Adverse Reactions (6) ] .

8.5Geriatric Use Of 644 patients in clinical studies of RECOTHROM Thrombin topical (Recombinant), 36% (n=232/644) were ≥65 years old and 15% (n=95/644) were ≥75 years old. No differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 53 words ▾

8.1Pregnancy Risk Summary There are no available data regarding RECOTHROM Thrombin topical (Recombinant) in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with RECOTHROM. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 111 words ▾

8.4Pediatric Use A total of 30 pediatric patients, ages 0 to 16 years (one month to 2 years, n=10; 2 to 12 years, n=12; 12 to 16 years, n=8), were treated in clinical trials with RECOTHROM Thrombin topical (Recombinant) using a spray applicator to burn wound excision sites prior to autologous skin grafting. No patient experienced a thromboembolic adverse reaction. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults.

Safety and efficacy have not been established in neonates [see Adverse Reactions (6) ] .

🧓 Geriatric Use 69 words ▾

8.5Geriatric Use Of 644 patients in clinical studies of RECOTHROM Thrombin topical (Recombinant), 36% (n=232/644) were ≥65 years old and 15% (n=95/644) were ≥75 years old. No differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 52 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action RECOTHROM Thrombin topical (Recombinant), is a specific human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding. RECOTHROM activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are steps that are essential for blood clot formation.

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action RECOTHROM Thrombin topical (Recombinant), is a specific human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding. RECOTHROM activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are steps that are essential for blood clot formation.

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages: NDC 0338-0322-01 A 5,000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free vial access device, and a 5-mL sterile empty transfer syringe. NDC 0338-0326-01 A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free vial access devices, and a 20-mL sterile empty transfer syringe.

NDC 0338-0330-01 The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM Spray Applicator Kit. No RECOTHROM kit components contain latex. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F).

Do not freeze. Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.

📋 Description 215 words ▾

11 DESCRIPTION RECOTHROM Thrombin topical (Recombinant), is a human coagulation protein produced via recombinant DNA technology from a genetically modified CHO cell line. RECOTHROM is identical in amino acid sequence and structurally similar to naturally occurring human thrombin. RECOTHROM precursor is secreted to culture medium as single chain form that is proteolytically converted to a two-chain active form (using a protein derived from snakes) and is purified by a chromatographic process that yields a product having hemostatic activities similar to native human thrombin.

The cell line used to manufacture RECOTHROM has been tested and shown to be free of known infectious agents. The cell culture process used in the manufacture of RECOTHROM employs no additives of human or animal origin. The purification process includes solvent-detergent treatment and nano-filtration steps dedicated to viral clearance.

RECOTHROM is provided as a sterile, white to off-white, preservative-free, lyophilized powder in vials for reconstitution with diluent (sterile 0.9% sodium chloride, USP). Reconstitution with the provided diluent, as described [see Dosage and Administration (2.1) ] , yields a solution with a pH of 6.0 containing 1,000 units/mL of recombinant thrombin for topical use. The formulated product is a clear, colorless solution upon reconstitution and contains the following excipients: histidine, mannitol, sucrose, polyethylene glycol 3350, sodium chloride, and calcium chloride dihydrate, USP.

💬 Information for Patients 85 words ▾

17 PATIENT COUNSELING INFORMATION Because topical thrombin may cause the formation of clots in blood vessels if absorbed systemically, advise patients to consult their physician if they experience leg tenderness or swelling, chest pain, shortness of breath, or difficulty speaking or swallowing [see Warnings and Precautions (5.1) ] . Baxter and Recothrom are registered trademarks of Baxter International Inc. Thrombin-JMI is a registered trademark of King Pharmaceuticals Research and Development, LLC.

Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA US License No. 0140 0719007359

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