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NovoSeven RT Coagulation Factor VIIa (Recombinant) Kit — NDC 00169-7205-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NovoSeven RT Coagulation Factor VIIa (Recombinant) Kit — NDC 0169-7205-01 (Billing 00169-7205-01)

by Novo Nordisk · 1 KIT in 1 KIT * 5 mL in 1 VIAL, GLASS * 5 mL in 1 SYRINGE, GLASS

This is a package of NovoSeven RT Coagulation Factor VIIa (Recombinant) Kit from Novo Nordisk, marketed since Oct 2012 and currently FDA-listed. It is this product's only package size.

NDC 00169-7205-01
🏷️ FDA NDC (as labeled) 0169-7205-01 billing pads the labeler 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
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 0169-7205-01 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
0169 labeler · 7205 product · 01 package
Package marketed since
Oct 29, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0169720501 4
Medicaid fills, this package
418 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0169-7205-01
Product NDC 0169-7205
11-digit billing NDC 00169720501
NCPDP billing unit EA — each (per item)
Application # BLA103665
SPL Set ID ea65c32f-8518-4383-b621-17056c0eebc0
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-10-29
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85100026202145
GPI class NovoSeven RT
GCN Seq No 063987
GCN 99698
HICL code 011639
Ingredient (HICL) Coagulation Factor Viia,Recomb
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0E
Therapeutic class — specific (HIC3) Antihemophilic Factors
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name NOVOSEVEN RT 5 MG VIAL
FDB brand name Novoseven Rt
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063987
  • GCN: 99698
  • GPI-14 (Medi-Span): 85100026202145
  • HICL (First Databank): 011639
  • AHFS class code: 20:28.16.00
Why two NDCs? The FDA registers this code as 0169-7205-01 — 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 → 00169-7205-01. 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.

Clinical

Label name NOVOSEVEN RT 5 MG VIAL Ingredient Coagulation Factor Viia,Recomb

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $14,494.53 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7189 $2.772 / J7189 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)0169-7205-01
11-digit billing NDC00169-7205-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7189
DescriptorFactor viia (antihemophilic factor, recombinant), (novoseven rt), 1 microgram
Billing units / pkg5,000 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MCG, so one package = 5000 billing units.
Medicare Part B spend (2026 (Q1))$5,326,665 · 114 claims · $46,725.14 per claim (all NDCs under J7189)
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
00169-7205-01 You're viewing this Main listing 1 KIT in 1 KIT * 5 mL in 1 VIAL, GLASS * 5 mL in 1 SYRINGE, GLASS 2012-10-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
NovoSeven RT 00169-7010-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7020-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7040-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7050-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7201-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7202-01 Novo 1 kit — — FDA listed —
NovoSeven RTthis 00169-7205-01 Novo 1 kit — — FDA listed —
NovoSeven RT 00169-7208-01 Novo 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

🏛️
1999
First FDA approval
Mar 1999
📍
2026
Currently FDA-listed
27 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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant) Sevenfactcoagulation factor VIIa (recombinant)-jncw
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.

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.

Manufacturer & labeler

LabelerNovo Nordisk
FDA applicationBLA103665 (BLA)
Labeler code00169
First marketedOct 2012
Product typePlasma Derivative
Portfolio74 products on file

More NDCs from Novo Nordisk labeler code 00169

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~3 min read ▾

Warning: Serious thrombotic adverse events are associated with the use of NovoSeven RT outside labeled indications Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications. Fatal and non-fatal thrombotic events have been reported.

Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. See WARNINGS AND PRECAUTIONS section of prescribing information.

Safety and efficacy of NovoSeven RT has not been established outside the approved indications. Warning: Serious thrombotic adverse events are associated with the use of NovoSeven RT outside labeled indications Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications.

Fatal and non-fatal thrombotic events have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

See WARNINGS AND PRECAUTIONS section of prescribing information. Safety and efficacy of NovoSeven RT has not been established outside the approved indications.

Hemostatic Dosing 90 micrograms/kg given every two hours by bolus infusion until hemostasis is achieved, or until the treatment has been judged to be inadequate. Doses between 35 and 120 micrograms/kg have been used successfully in clinical trials for hemophilia A or B patients with inhibitors, and both the dose and administration interval may be adjusted based on the severity of the bleeding and degree of hemostasis achieved. 1 The minimum effective dose has not been established.

For patients treated for joint or muscle bleeds, a decision on outcome was reached for a majority of patients within eight doses although more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than twelve doses. Post-hemostatic Dosing The appropriate duration of post-hemostatic dosing has not been studied.

For severe bleeds, dosing should continue at 3-6 hour intervals after hemostasis is achieved, to maintain the hemostatic plug. The biological and clinical effects of prolonged elevated levels of Factor VIIa have not been studied; therefore, the duration of post-hemostatic dosing should be minimized. Patients should be appropriately monitored by a physician experienced in the treatment of hemophilia during this time period.

Minor Surgery An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery. For minor surgery, post-surgical dosing by bolus injection should occur at 2-hour intervals for the first 48 hours and then at 2- to 6-hour intervals until healing has occurred. Major Surgery An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery.

For major surgery, post-surgical dosing by bolus injection should occur at 2 hour intervals for 5 days, followed by 4 hour intervals until healing has occurred. Additional bolus doses should be administered if required.

🎯 Indications and Usage 158 words ▾

1 INDICATIONS AND USAGE NovoSeven RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable is indicated for: Treatment of bleeding episodes in hemophilia A or B with inhibitors and in acquired hemophilia (1.1) Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia (1.2) Treatment of bleeding episodes in congenital FVII deficiency (1.3) Prevention of bleeding in surgical interventions or invasive procedures in congenital FVII deficiency (1.4)

1.1Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX and in patients with acquired hemophilia

1.2Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX and in patients with acquired hemophilia

1.3 Treatment of bleeding episodes in patients with congenital FVII deficiency

1.4Prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous bolus injection only. After reconstitution, administer within 3 hours; do not freeze or store in syringes (2.6) NovoSeven RT should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders (2.1) Hemophilia A or B with Inhibitors - Bleeding Episodes (2.2) 90 micrograms/kg bolus injection every 2 hours until hemostasis is achieved Post-hemostatic dosing every 3-6 hours for severe bleeds Hemophilia A or B with Inhibitors - Surgery (2.2) 90 micrograms/kg immediately before surgery and every 2 hours during surgery Post-surgical dosing: Minor surgery - 90 micrograms/kg every 2 hours for 48 hours and then every 2-6 hours, until healing has occurred Major sugery - 90 micrograms/kg every 2 hours for the first 5 days and then every 4 hours, until healing has occurred Congenital FVII Deficiency - Bleeding Episodes or Surgery (2.3) 15-30 micrograms/kg every 4-6 hours until hemostasis is achieved Acquired Hemophilia - Bleeding Episodes or Surgery (2.4) 70-90 micrograms/kg every 2-3 hours until hemostasis is achieved

2.1General NovoSeven RT is intended for intravenous bolus administration only. Evaluation of hemostasis should be used to determine the effectiveness of NovoSeven RT and to provide a basis for modification of the NovoSeven RT treatment schedule. Coagulation parameters do not necessarily correlate with or predict the effectiveness of NovoSeven RT.

NovoSeven RT should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders.

2.2Hemophilia A or B with Inhibitors Treatment of Acute Bleeding Episodes Hemostatic Dosing 90 micrograms/kg given every two hours by bolus infusion until hemostasis is achieved, or until the treatment has been judged to be inadequate. Doses between 35 and 120 micrograms/kg have been used successfully in clinical trials for hemophilia A or B patients with inhibitors, and both the dose and administration interval may be adjusted based on the severity of the bleeding and degree of hemostasis achieved. 1 The minimum effective dose has not been established.

For patients treated for joint or muscle bleeds, a decision on outcome was reached for a majority of patients within eight doses although more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than twelve doses. Post-hemostatic Dosing The appropriate duration of post-hemostatic dosing has not been studied.

For severe bleeds, dosing should continue at 3-6 hour intervals after hemostasis is achieved, to maintain the hemostatic plug. The biological and clinical effects of prolonged elevated levels of Factor VIIa have not been studied; therefore, the duration of post-hemostatic dosing should be minimized. Patients should be appropriately monitored by a physician experienced in the treatment of hemophilia during this time period.

Dosing for Surgical Interventions Minor Surgery An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery. For minor surgery, post-surgical dosing by bolus injection should occur at 2-hour intervals for the first 48 hours and then at 2- to 6-hour intervals until healing has occurred. Major Surgery An initial dose of 90 micrograms per kg body weight should be given immediately before the intervention and repeated at 2-hour intervals for the duration of the surgery.

For major surgery, post-surgical dosing by bolus injection should occur at 2 hour intervals for 5 days, followed by 4 hour intervals until healing has occurred. Additional bolus doses should be administered if required.

2.3Congenital Factor VII deficiency The recommended dose range for treatment of bleeding episodes or for prevention of bleeding in surgical interventions or invasive procedures in congenital Factor VII deficient patients is 1… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 115 words ▾

3 DOSAGE FORMS AND STRENGTHS NovoSeven RT is supplied as a white lyophilized powder in single-use vials containing 1 mg (1000 micrograms), 2 mg (2000 micrograms), or 5 mg (5000 micrograms) rFVIIa per vial. The diluent for reconstitution of NovoSeven RT is a 10 mmol solution of L-histidine in water for injection and is supplied as a clear colorless solution and is referred to as the histidine diluent. After reconstitution with the histidine diluent, each vial contains approximately 1 mg/mL NovoSeven RT (1000 micrograms/mL).

Lyophilized powder in single-use vials: 1, 2, or 5 mg rFVIIa (3) After reconstitution with specified volume of histidine diluent, each vial contains 1 mg/mL (1000 micrograms/mL) of recombinant FVIIa (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thrombotic events of possible or probable relationship to NovoSeven occurred in 0.28% of bleeding episodes treated in clinical trials within the approved indications. ( 5.1 ) Increased risk of arterial thromboembolic adverse events with use of NovoSeven was demonstrated in 2 meta analyses of placebo-controlled clinical trials in populations outside the approved indications ( 5.2 ) Thrombosis has occurred in women treated with NovoSeven to control post-partum hemorrhage ( 5.2 ) Factor VII deficient patients should be monitored for prothrombin time (PT) and FVII coagulant activity, and for antibody formation to NovoSeven RT ( 5.4 ) Administer with caution in patients with known hypersensitivity ( 5.5 )

5.1Thrombotic Events within the Licensed Indications Clinical trials within the approved indications revealed that thrombotic events of possible or probable relationship to NovoSeven occurred in 0.28% of bleeding episodes treated, with the incidence within hemophilia patients with inhibitors to be 0.20%, and in acquired hemophilia an incidence of 4%. Thrombotic events have been identified through postmarketing surveillance following NovoSeven RT use for each of the approved indications 2 . The incidence of thrombotic events can not be determined from postmarketing data.

Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) have an increased risk of developing thrombotic events due to circulating tissue factor (TF) or predisposing coagulopathy [See Adverse Reactions (6.1) and Drug Interactions (7.1) ]. Caution should be exercised when administering NovoSeven RT to patients with an increased risk of thromboembolic complications.

These include, but are not limited to, patients with a history of coronary heart disease, liver disease, disseminated intravascular coagulation, post-operative immobilization, elderly patients and neonates. In each of these situations, the potential benefit of treatment with NovoSeven RT should be weighed against the risk of these complications . Patients who receive NovoSeven RT should be monitored for development of signs or symptoms of activation of the coagulation system or thrombosis.

When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, the NovoSeven RT dosage should be reduced or the treatment stopped, depending on the patient's symptoms.

5.2Thromboembolic Events outside the Licensed Indications NovoSeven has been studied in placebo controlled trials outside the approved indications to control bleeding in intracerebral hemorrhage, advanced liver disease, trauma, cardiac surgery, spinal surgery, and other therapeutic areas. Safety and effectiveness has not been established in these settings and the use is not approved by FDA. Two meta analyses of these pooled data indicate an increased risk of thrombotic events (10.0% in patients treated with NovoSeven versus 7.5% in placebo-treated patients).

Arterial thromboembolic adverse events including myocardial infarction, myocardial ischemia, cerebral infarction and cerebral ischemia were statistically significantly increased with the use of NovoSeven compared to placebo (5.3 to 5.6% in subjects treated with NovoSeven versus 2.8 to 3.0% in placebo-treated patients). Other arterial thromboembolic events (such as retinal artery embolism, renal artery thrombosis, arterial thrombosis of limb, bowel infarction and intestinal infarction) have also been reported. 3,4,5,6,7 While venous thromboembolic events such as deep venous thrombosis, portal vein thrombosis and pulmonary embolism have been reported in clinical trials, the meta analysis of these pooled data from placebo-controlled trials performed outside the currently approved indications did not suggest an increased risk of venous thromboembolic events in patients treate… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Because clinical studies 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 clinical trials of another drug, and may not reflect rates observed in practice. In clinical trials, the most common adverse reactions are pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-877-668-6777 or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.

6.1Clinical Trials Experience Thrombotic events following the administration of NovoSeven occurred in 0.28% of bleeding episodes treated, with the incidence in acquired hemophilia of 4% and in hemophilia patients of 0.20% in clinical trials within the approved indications. [ See Warnings and Precautions (5.1) ] . Adverse reactions observed in clinical trials for all labeled indications of NovoSeven included pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, rash (including allergic dermatitis and rash erythematous), pruritus, urticaria, hypersensitivity, cerebral artery occlusion, cerebrovascular accident, pulmonary embolism, deep vein thrombosis, angina pectoris, increased levels of fibrin degradation products, disseminated intravascular coagulation and related laboratory findings including elevated levels of D-dimer and AT-III, thrombosis at i.v. site, non-specified thrombosis, thrombophlebitis, superficial thrombophlebitis.

The following sections describe the adverse event profile observed during clinical studies for each of the labeled indications. Hemophilia A or B Patients with Inhibitors Two studies (Studies 1 and 2) are described for hemophilia A or B patients with inhibitors treated for bleeding episodes [ See Clinical Studies (14.1) ] . The table below lists adverse events that were reported in ≥2% of the 298 patients with hemophilia A or B with inhibitors that were treated with NovoSeven for 1,939 bleeding episodes.

The events listed are considered to be at least possibly related or of unknown relationship to NovoSeven administration. Body System Event # of episodes reported (n=1,939 treatments) # of unique patients (n=298 patients) Body as a whole Fever 16 13 Platelets, Bleeding, and Clotting Hemorrhage NOS Fibrinogen plasma decreased 15 10 8 5 Skin and Musculoskeletal Hemarthrosis 14 8 Cardiovascular Hypertension 9 6 Events which were reported in 1% of patients and were considered to be at least possibly or of unknown relationship to NovoSeven administration were: allergic reaction, arthrosis, bradycardia, coagulation disorder, DIC, edema, fibrinolysis increased, headache, hypotension, injection site reaction, pain, pneumonia, prothrombin decreased, pruritus, purpura, rash, renal function abnormal, therapeutic response decreased, and vomiting.

Serious adverse events that were probably or possibly related, or where the relationship to NovoSeven was not specified, occurred in 14 of the 298 patients (4.7%). Six of the 14 patients died of the following conditions: worsening of chronic renal failure, anesthesia complications during proctoscopy, renal failure complicating a retroperitoneal bleed, ruptured abscess leading to sepsis and DIC, pneumonia, and splenic hematoma and gastrointestinal bleeding. Thrombosis was reported in two of the 298 patients with hemophilia.

Surgery Studies Two clinical trials (Studies 3 and 4) were conducted to evaluate the safety and efficacy of NovoSeven administration during and after surgery in hemophilia A or B patients with inhibitors [See Clinical Studies (14.1) ]. In Study 3, six patients experienced serious adverse events: two of these patients had events which were considered probably or possibly related to study medication (acute post-operative hemarthrosis, internal jugular thrombosis). No deaths occ… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 75 words ▾

7 DRUG INTERACTIONS Avoid simultaneous use of NovoSeven RT and PCCs/aPCCs (7.1) NovoSeven RT should not be mixed with infusion solutions (7.2)

7.1Coagulation Factor Concentrates The risk of a potential interaction between NovoSeven RT and coagulation factor concentrates has not been adequately evaluated in preclinical or clinical studies. Simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates should be avoided.

7.2Infusion Solutions NovoSeven RT should not be mixed with infusion solutions.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. NovoSeven RT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Treatment of rats and rabbits with NovoSeven in reproduction studies has been associated with mortality at doses up to 6 mg/kg and 5 mg/kg. At 6 mg/kg in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg/kg, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg/kg of NovoSeven gave birth successfully, however, two of the 23 litters died during the early period of lactation.

No evidence of teratogenicity was observed after dosing with NovoSeven.

8.2Labor and Delivery NovoSeven was administered to a FVII deficient patient (25 years of age, 66 kg) during a vaginal delivery (36 micrograms/kg) and during a tubal ligation (90 micrograms/kg). No adverse reactions were reported during labor, vaginal delivery, or the tubal ligation. There are no adequate and well-controlled studies in labor, delivery, and postpartum periods.

In spontaneous reports of women without a prior diagnosis of bleeding disorders receiving NovoSeven for uncontrolled post-partum hemorrhage, thrombotic events were observed. During this period, patients are at increased risk for thrombotic complications. It is not known to what extent NovoSeven contributed to the occurrence of these events.

8.3Nursing Mothers It is not known whether NovoSeven RT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Clinical trials enrolling pediatric patients were conducted with dosing determined according to body weight and not according to age. The safety and effectiveness of NovoSeven RT has not been studied to determine if there are differences among various age groups, from infants to adolescents (0 to 16 years of age).

8.5Geriatric Use Clinical studies of NovoSeven in congenital factor deficiencies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 123 words ▾

8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. NovoSeven RT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Treatment of rats and rabbits with NovoSeven in reproduction studies has been associated with mortality at doses up to 6 mg/kg and 5 mg/kg. At 6 mg/kg in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg/kg, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg/kg of NovoSeven gave birth successfully, however, two of the 23 litters died during the early period of lactation.

No evidence of teratogenicity was observed after dosing with NovoSeven.

🧒 Pediatric Use 53 words ▾

8.4Pediatric Use Clinical trials enrolling pediatric patients were conducted with dosing determined according to body weight and not according to age. The safety and effectiveness of NovoSeven RT has not been studied to determine if there are differences among various age groups, from infants to adolescents (0 to 16 years of age).

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use Clinical studies of NovoSeven in congenital factor deficiencies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 172 words ▾

10 OVERDOSAGE There are no adequate and well controlled studies to support the safety or efficacy of using higher than labeled doses in the indicated populations. Dose limiting toxicities of NovoSeven RT have not been investigated in clinical trials. The following are examples of accidental overdose.

Congenital Factor VII Deficiency A newborn female with congenital factor VII deficiency was administered an overdose of NovoSeven (single dose: 800 micrograms/kg). Following additional administration of NovoSeven and various plasma products, antibodies against rFVIIa were detected, but no thrombotic complications were reported. A Factor VII deficient male (83 years of age, 111.1 kg) received two doses of 324 micrograms/kg (10-20 times the recommended dose) and experienced a thrombotic event (occipital stroke).

Hemophilia A or B with Inhibitors One hemophilia B patient (16 years of age, 68 kg) received a single dose of 352 micrograms/kg and one hemophilia A patient (2 years of age, 14.6 kg) received doses ranging from 246 micrograms/kg to 986 micrograms/kg on five consecutive days. There were no reported complications in either case.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action NovoSeven RT is recombinant Factor VIIa and, when complexed with tissue factor can activate coagulation Factor X to Factor Xa, as well as coagulation Factor IX to Factor IXa. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, which leads to the formation of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing local hemostasis. This process may also occur on the surface of activated platelets.

12.2Pharmacodynamics The effect of NovoSeven RT upon coagulation in patients with or without hemophilia has been assessed in different model systems. In an in vitro model of tissue-factor-initiated blood coagulation (Figure A) 10 , the addition of rFVIIa increased both the rate and level of thrombin generation in normal and hemophilia A blood, with an effect shown at rFVIIa concentrations as low as 10 nM. In this model, fresh human blood was treated with corn trypsin inhibitor (CTI) to block the contact pathway of blood coagulation.

Tissue factor (TF) was added to initiate clotting in the presence and absence of rFVIIa for both types of blood. In a separate model, and in line with previous reports 11 , escalating doses of rFVIIa in hemophilia plasma demonstrate a dose-dependent increase in thrombin generation (Figure B). In this model, platelet rich normal and hemophilia plasma was adjusted with autologous plasma to 200,000 platelets/microliter.

Coagulation was initiated by addition of tissue factor and CaCl 2 . Thrombin generation was measured in the presence of a thrombin substrate and various added concentrations of rFVIIa. Figure A Figure B

12.3Pharmacokinetics Healthy Subjects The pharmacokinetics of NovoSeven was investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study. Subjects were stratified according to gender and ethnic group and dosed with 40, 80 and 160 micrograms/kg NovoSeven 12 . The pharmacokinetics of rFVII were linear over the dose range of 40 to 180 micrograms/kg.

Pharmacokinetics were similar across gender and ethnic groups. Mean steady state volume of distribution ranged from 130 to 165 mL/kg, mean values of clearance ranged from 33 to 37 mL/h x kg, and mean terminal half-life ranged from 3.9 to 6.0 hours. Hemophilia A or B Single-dose pharmacokinetics of NovoSeven (17.5, 35, and 70 micrograms/kg) exhibited dose-proportional behavior in 15 subjects with hemophilia A or B.

13 Factor VII clotting activities were measured in plasma drawn prior to and during a 24-hour period after NovoSeven administration. The median apparent volume of distribution at steady state was 103 mL/kg (range 78-139). Median clearance was 33 mL/kg/hr (range 27-49).

The median residence time was 3.0 hours (range 2.4-3.3), and the t 1/2 was 2.3 hours (range 1.7-2.7). The median in vivo plasma recovery was 44% (30-71%). The products NovoSeven RT and NovoSeven are pharmacokinetically equivalent.

14 In a bolus single-dose pharmacokinetic study, 5 male adults (90 micrograms/kg) and 10 male pediatric (2-12 years) patients (crossover, 90 and 180 micrograms/kg) with severe hemophilia A (10 of 18 subjects had inhibitors) received NovoSeven 15 . The PK of rFVII following 90 and 180 micrograms/kg IV dose in children indicated dose linearity. Based on the FVII:C assay, the terminal half-life of NovoSeven was 2.6 hrs in pediatric patients and 3.1 hrs in adults.

Based on the 90 microgram/kg dose, the total clearance of NovoSeven in adults and children was 2767 ± 385 mL/hr (37.6 ± 13.1 mL/hr/kg) and 1375 ± 396 mL/hr (57.3 ± 9.5 mL/hr/kg), respectively. The volume of distribution at steady state (V ss ) in adults and children was 121 ± 30 and 153 ± 29 mL/kg, respectively. Congenital Factor VII deficiency Single dose pharmacokinetics of NovoSeven in congenital Factor VII deficiency, at doses of 15 and 30 micrograms per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameter… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action NovoSeven RT is recombinant Factor VIIa and, when complexed with tissue factor can activate coagulation Factor X to Factor Xa, as well as coagulation Factor IX to Factor IXa. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, which leads to the formation of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing local hemostasis. This process may also occur on the surface of activated platelets.

📦 How Supplied / Storage and Handling 216 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NovoSeven ® RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable is supplied as a white, lyophilized powder in single-use vials, one vial per carton. The vials are made of glass, closed with a latex-free, chlorobutyl rubber stopper, and sealed with an aluminum cap. The vials are equipped with a snap-off polypropylene cap.

The amount of rFVIIa in milligrams and in micrograms is stated on the label as follows: 1 mg per vial (1000 micrograms/vial) NDC 0169-7010-01 2 mg per vial (2000 micrograms/vial) NDC 0169-7020-01 5 mg per vial (5000 micrograms/vial) NDC 0169-7050-01 The diluent for reconstitution of NovoSeven RT is a 10 mmol solution of L-histidine in water for injection and is supplied as a clear colorless solution, and referred to as the histidine diluent. The vials are made of glass closed with a latex-free, chlorobutyl rubber disc, and covered with an aluminum cap.

The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene. Prior to reconstitution, keep refrigerated or store between 2-25°C/36-77°F. Do not freeze.

Store protected from light. Do not use past the expiration date. After reconstitution, NovoSeven RT may be stored either at room temperature or refrigerated for up to 3 hours.

Do not freeze reconstituted NovoSeven RT or store it in syringes.

📋 Description ~2 min read ▾

11 DESCRIPTION NovoSeven RT is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. 9 NovoSeven RT is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven RT is structurally similar to human plasma-derived Factor VIIa.

The gene for human Factor VII is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus).

No human serum or other proteins are used in the production or formulation of NovoSeven RT. NovoSeven RT is supplied as a sterile, white lyophilized powder of rFVIIa in single-use vials. Each vial of lyophilized drug contains the following: Contents 1 mg Vial 2 mg Vial 5 mg Vial rFVIIa 1000 micrograms 2000 micrograms 5000 micrograms sodium chloride* 2.34 mg 4.68 mg 11.7 mg calcium chloride dihydrate* 1.47 mg 2.94 mg 7.35 mg glycylglycine 1.32 mg 2.64 mg 6.60 mg polysorbate 80 0.07 mg 0.14 mg 0.35 mg mannitol 25 mg 50 mg 125 mg Sucrose 10 mg 20 mg 50 mg Methionine 0.5 mg 1.0 mg 2.5 mg * per mg of rFVIIa: 0.4 mEq sodium, 0.01 mEq calcium The diluent for reconstitution of NovoSeven RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution.

After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NovoSeven RT (corresponding to 1000 micrograms/mL). The reconstituted vials have a pH of approximately 6.0 in sodium chloride (2.3 mg/mL), calcium chloride dihydrate (1.5 mg/mL), glycylglycine (1.3 mg/mL), polysorbate 80 (0.1 mg/mL), mannitol (25 mg/mL), sucrose (10 mg/mL), methionine (0.5 mg/mL), and histidine (1.6 mg/mL). The reconstituted product is a clear colorless solution which contains no preservatives.

NovoSeven RT contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg).

💬 Information for Patients 164 words ▾

17 PATIENT COUNSELING INFORMATION Patients receiving NovoSeven RT should be informed of the benefits and risks associated with treatment. Patients should be warned about the early signs of hypersensitivity reactions, including hives, urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Patients should also be warned about the signs of thrombosis, including new onset swelling and pain in the limbs or abdomen, new onset chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech.

Patients should be told to immediately seek medical help if any of the above signs or symptoms occur. Date of issue: January 15, 2010 Version: 3 License Number: 1261 Novo Nordisk ® is a registered trademark of Novo Nordisk A/S. NovoSeven ® is a registered trademark of Novo Nordisk Health Care AG. ©1998-2010 Novo Nordisk A/S.

U.S. Patent No. 4,784,950 For information contact: Novo Nordisk Inc.

100 College Road West Princeton, NJ 08540, USA 1-877-NOVO-777 www.NovoSevenRT.com Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark

🍼 Nursing Mothers 60 words ▾

8.3Nursing Mothers It is not known whether NovoSeven RT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Healthy Subjects The pharmacokinetics of NovoSeven was investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study. Subjects were stratified according to gender and ethnic group and dosed with 40, 80 and 160 micrograms/kg NovoSeven 12 . The pharmacokinetics of rFVII were linear over the dose range of 40 to 180 micrograms/kg.

Pharmacokinetics were similar across gender and ethnic groups. Mean steady state volume of distribution ranged from 130 to 165 mL/kg, mean values of clearance ranged from 33 to 37 mL/h x kg, and mean terminal half-life ranged from 3.9 to 6.0 hours. Hemophilia A or B Single-dose pharmacokinetics of NovoSeven (17.5, 35, and 70 micrograms/kg) exhibited dose-proportional behavior in 15 subjects with hemophilia A or B.

13 Factor VII clotting activities were measured in plasma drawn prior to and during a 24-hour period after NovoSeven administration. The median apparent volume of distribution at steady state was 103 mL/kg (range 78-139). Median clearance was 33 mL/kg/hr (range 27-49).

The median residence time was 3.0 hours (range 2.4-3.3), and the t 1/2 was 2.3 hours (range 1.7-2.7). The median in vivo plasma recovery was 44% (30-71%). The products NovoSeven RT and NovoSeven are pharmacokinetically equivalent.

14 In a bolus single-dose pharmacokinetic study, 5 male adults (90 micrograms/kg) and 10 male pediatric (2-12 years) patients (crossover, 90 and 180 micrograms/kg) with severe hemophilia A (10 of 18 subjects had inhibitors) received NovoSeven 15 . The PK of rFVII following 90 and 180 micrograms/kg IV dose in children indicated dose linearity. Based on the FVII:C assay, the terminal half-life of NovoSeven was 2.6 hrs in pediatric patients and 3.1 hrs in adults.

Based on the 90 microgram/kg dose, the total clearance of NovoSeven in adults and children was 2767 ± 385 mL/hr (37.6 ± 13.1 mL/hr/kg) and 1375 ± 396 mL/hr (57.3 ± 9.5 mL/hr/kg), respectively. The volume of distribution at steady state (V ss ) in adults and children was 121 ± 30 and 153 ± 29 mL/kg, respectively. Congenital Factor VII deficiency Single dose pharmacokinetics of NovoSeven in congenital Factor VII deficiency, at doses of 15 and 30 micrograms per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8-79.1 mL/hr x kg), volume of distribution at steady state (280-290 mL/kg), mean residence time (3.75-3.80 hr), and half-life (2.82-3.11 hr).

The mean in vivo plasma recovery was approximately 20% (18.9%-22.2%). The normal Factor VII plasma concentration is 0.5 micrograms/mL. Factor VII levels of 15-25% (0.075 – 0.125 micrograms/mL) are generally sufficient to achieve normal hemostasis.

16 For example, a 70 kg individual with FVII deficiency (plasma volume of approximately 3000 mL) would thus require 3.2 - 5.4 micrograms/kg of NovoSeven RT to secure hemostasis, assuming 100% recovery but, since the mean plasma recovery for NovoSeven is 20% for FVII-deficient patients, a NovoSeven RT dose range of 16-27 micrograms/kg would be required to achieve sufficient FVII plasma levels for hemostasis, which is consistent with the recommended dose range.

🧬 Pharmacodynamics 185 words ▾

12.2Pharmacodynamics The effect of NovoSeven RT upon coagulation in patients with or without hemophilia has been assessed in different model systems. In an in vitro model of tissue-factor-initiated blood coagulation (Figure A) 10 , the addition of rFVIIa increased both the rate and level of thrombin generation in normal and hemophilia A blood, with an effect shown at rFVIIa concentrations as low as 10 nM. In this model, fresh human blood was treated with corn trypsin inhibitor (CTI) to block the contact pathway of blood coagulation.

Tissue factor (TF) was added to initiate clotting in the presence and absence of rFVIIa for both types of blood. In a separate model, and in line with previous reports 11 , escalating doses of rFVIIa in hemophilia plasma demonstrate a dose-dependent increase in thrombin generation (Figure B). In this model, platelet rich normal and hemophilia plasma was adjusted with autologous plasma to 200,000 platelets/microliter.

Coagulation was initiated by addition of tissue factor and CaCl 2 . Thrombin generation was measured in the presence of a thrombin substrate and various added concentrations of rFVIIa. Figure A Figure B

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES No direct comparisons to other coagulation products have been conducted, therefore no conclusions regarding the comparative safety or efficacy can be made.

14.1Hemophilia A or B with Inhibitors Open Protocol Use The largest number of patients who received NovoSeven during the investigational phase of product development were in an open protocol study (Study 1) 17,18,19 that began enrollment in 1988, shortly after the completion of the pharmacokinetic study. These patients included persons with hemophilia types A or B (with or without inhibitors), persons with acquired inhibitors to Factor VIII or Factor IX, and a few FVII deficient patients. The clinical situations were diverse and included muscle/joint bleeds, mucocutaneous bleeds, surgical prophylaxis, intracerebral bleeds, and other emergent situations.

Dose schedules were suggested by Novo Nordisk, but they were subject to the option of the investigator. Clinical outcomes were not reported in a standardized manner. Therefore, the clinical data from Study 1 are problematic for the evaluation of the safety and efficacy of the product by statistical methods.

Dosing Study Study 2 20 was a double-blind, randomized comparison trial of two dose levels of NovoSeven in the treatment of joint, muscle and mucocutaneous hemorrhages in hemophilia A and B patients with and without inhibitors. Patients received NovoSeven as soon as they could be evaluated in the treatment centers (4 to 18 hours after experiencing a bleed). Thirty-five patients were treated at the 35 micrograms/kg dose (59 joint, 15 muscle and 5 mucocutaneous bleeding episodes) and 43 patients were treated at the 70 micrograms/kg dose (85 joint and 14 muscle bleeding episodes).

Dosing was to be repeated at 2.5 hour intervals but ranged up to four hours for some patients. Efficacy was assessed at 12 ± 2 hours or at end of treatment, whichever occurred first. Based on a subjective evaluation by the investigator, the respective efficacy rates for the 35 and 70 micrograms/kg groups were: excellent 59% and 60%, effective 12% and 11%, and partially effective 17% and 20%.

The average number of injections required to achieve hemostasis was 2.8 and 3.2 for the 35 and 70 micrograms/kg groups, respectively. One patient in the 35 micrograms/kg group and three in the 70 micrograms/kg group experienced serious adverse events that were not considered related to NovoSeven. Two unrelated deaths occurred; one patient died of AIDS and the other of intracranial hemorrhage secondary to trauma.

Surgery Studies Two clinical trials (Studies 3 and 4) were conducted to evaluate the safety and efficacy of NovoSeven administration during and after surgery in hemophilia A or B patients with inhibitors. Study 3 was a randomized, double-blind, parallel group clinical trial (29 patients with hemophilia A or B and inhibitors or acquired inhibitors to FVIII/FIX, undergoing major or minor surgical procedures). 21 Patients received bolus intravenous NovoSeven (either 35 micrograms/kg, N=15; or 90 micrograms/kg, N=14) prior to surgery, intra-operatively as required, then every 2 hours for the following 48 hours beginning at closure of the wound.

Additional doses were administered every 2 to 6 hours up to an additional 3 days to maintain hemostasis. After a maximum of 5 days of double-blind treatment, therapy could be continued in an open-label manner if necessary (90 micrograms/kg NovoSeven every 2-6 hours). Efficacy was assessed during the intra-operative period, and post-operatively from the time of wound closure (Hour 0) through Day 5.

When efficacy assessments at each time point were tabulated by a last value carried forward approach (patients who completed the study early having achieved effective hemostasis were counted as “effective” and those who discontinued due to treatment failure or adverse events were counted as “ineffective” at each time point thereafter), the results at the end of the 5-day double-blind treatment period we… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 198 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two mutagenicity studies have given no indication of carcinogenic potential for NovoSeven. The clastogenic activity of NovoSeven was evaluated in both in vitro studies ( i.e. , cultured human lymphocytes) and in vivo studies ( i.e. , mouse micronucleus test). Neither of these studies indicated clastogenic activity of NovoSeven.

Other gene mutation studies have not been performed with NovoSeven RT ( e.g. , Ames test). No chronic carcinogenicity studies have been performed with NovoSeven RT. A reproductive study in male and female rats at dose levels up to 3.0 mg/kg/day had no effect on mating performance, fertility, or litter characteristics.

Treatment of rats and rabbits with NovoSeven in reproduction studies has been associated with mortality at doses up to 6 mg/kg and 5 mg/kg. At 6 mg/kg in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg/kg, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg/kg of NovoSeven gave birth successfully, however, two of the 23 litters died during the early period of lactation.

No evidence of teratogenicity was observed after dosing with NovoSeven.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 195 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two mutagenicity studies have given no indication of carcinogenic potential for NovoSeven. The clastogenic activity of NovoSeven was evaluated in both in vitro studies ( i.e. , cultured human lymphocytes) and in vivo studies ( i.e. , mouse micronucleus test). Neither of these studies indicated clastogenic activity of NovoSeven.

Other gene mutation studies have not been performed with NovoSeven RT ( e.g. , Ames test). No chronic carcinogenicity studies have been performed with NovoSeven RT. A reproductive study in male and female rats at dose levels up to 3.0 mg/kg/day had no effect on mating performance, fertility, or litter characteristics.

Treatment of rats and rabbits with NovoSeven in reproduction studies has been associated with mortality at doses up to 6 mg/kg and 5 mg/kg. At 6 mg/kg in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg/kg, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg/kg of NovoSeven gave birth successfully, however, two of the 23 litters died during the early period of lactation.

No evidence of teratogenicity was observed after dosing with NovoSeven.

📚 References ~2 min read ▾

15 REFERENCES 1. Hedner, U.: Dosing and Monitoring NovoSeven ® Treatment, Haemostasis 1996; 26 (suppl 1): 102-108. 2.

Girolami, B., et al.: Arterial and venous thrombosis in rare congenital bleeding disorders: a critical review, Haemophilia (2006); 12, 345-351. 3. Mayer, S.A., et al.: Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage, New England Journal of Medicine 2005; 352: 777-785.

4. Mayer, S.A., et al.: Efficacy and Safety of Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage, New England Journal of Medicine 2008; 358:2127-37. 5.

Thomas, R, et al: Thromboembolic complications associated with Factor VIIa administration, J Trauma 2007; 62:564-569. 6. Hsia, Cyrus C., et al., “Use of Recombinant Activated Factor VII in Patients Without Hemophilia, A Meta-Analysis of Randomized Control Trials,” Annals of Surgery, Vol 248, No.

1, July 2008. 7. Hardy, Jean-Francois, et al, “Efficacy and Safety of Recombinant Activated Factor VII to Control Bleeding in Nonhemophiliac Patients: A Review of 17 Randomized Controlled Trials,” Ann Thorac Surg 2008; 86: 1038-48.

8. Parameswaran, R., et al.: Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry, Haemophilia 2005; 11: 100-106. 9.

Roberts, H.R.: Thoughts on the mechanism of action of FVIIa, 2 nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen, Denmark, 1991, pgs. 153-156. 10.

Butenas, S., et al.: Mechanism of factor VIIa-dependent coagulation in hemophilia blood, Blood 2002; 99: 923-930. Figure A Copyright American Society of Hematology, used with permission. 11.

Allen, G.A., et al.: The effect of factor X level on thrombin generation and the procoagulant effect of activated factor VII in a cell-based model of coagulation, Blood Coagulation and Fibrinolysis 2000; 11 (suppl 1): 3-7. 12. Fridberg M.J., et al.: A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects, Blood Coagulation and Fibrinolysis 2005, 16 (4): 259-266.

13. Lindley, C.M., et al.: Pharmacokinetics and pharmacodynamics of recombinant Factor VIIa, Clinical Pharmacology & Therapeutics 1994; 55 (6): 638-648. 14.

Bysted B.V., et al.: A randomized double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25ºC stable formulation, Haemophilia 2007, 13, 527-532. 15. Villar, A., et al.: Pharmacokinetics of activated recombinant coagulation factor VIIa (NovoSeven ® ) in children vs. adults with haemophilia A, Haemophilia 2004; 10 (4):352-359.

16. Bauer, K.A.: Treatment of Factor VII deficiency with recombinant Factor VIIa, Haemostasis 1996; 26 (suppl 1): 155-158. 17.

Lusher, J., et al.: Clinical experience with recombinant Factor VIIa, Blood Coagulation and Fibrinolysis 1998; 9: 119-128. 18. Bech, M.R.: Recombinant Factor VIIa in Joint and Muscle Bleeding Episodes, Haemostasis 1996; 26 (suppl 1): 135-138.

19. Lusher, J.M.: Recombinant Factor VIIa (NovoSeven ® ) in the Treatment of Internal Bleeding in Patients with Factor VIII and IX Inhibitors, Haemostasis 1996; 26 (suppl 1): 124-130. 20.

Lusher, J.M., et al.: A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with hemophilia A and B, with and without inhibitor, Haemophilia 1998; 4: 790-798. 21. Shapiro A.D., et al: Prospective, Randomised Trial of Two Doses of rFVIIa (NovoSeven ® ) in Haemophilia Patients with Inhibitors Undergoing Surgery, Thrombosis and Haemostasis 1998; 80: 773-778.

📄 Recent Major Changes 7 words ▾

Boxed Warning Warnings and Precautions (5) 1/2010

📄 Package Label / Principal Display Panel 165 words ▾

PRINCIPAL DISPLAY PANEL 1 mg NDC 0169 7010 01 List: 701001 NovoSeven ® RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable 1 mg For IV administration only For human use only Single dose vial Administer within 3 hours of reconstitution Contains no preservative Rx only novo nordisk ® Image of NovoSeven RT 1 mg carton

PRINCIPAL DISPLAY PANEL 2 mg NDC 0169 7020 01 List: 702001 NovoSeven ® RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable 2 mg For IV administration only For human use only Single dose vial Administer within 3 hours of reconstitution Contains no preservative Rx only novo nordisk ® Image of NovoSeven RT 2 mg carton

PRINCIPAL DISPLAY PANEL 5 mg NDC 0169 7050 01 List: 705001 NovoSeven ® RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable 5 mg For IV administration only For human use only Single dose vial Administer within 3 hours of reconstitution Contains no preservative Rx only novo nordisk ® Image of NovoSeven RT 5 mg carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
418
Units reimbursed last 4 qtrs
2.4K
Gross reimbursed last 4 qtrs
$35.13M
Avg / prescription
$84,054.41
Avg / unit
$14,496.92
Latest quarter Q1 2026
94Rx
Fee-for-service vs managed care ⓘ
97% FFS
Fee-for-service · 404 Rx Managed care · 14 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 325 units · 28.7 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 216 units · 1.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 784 units · 24.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 140 units · 2.0 per 100k residents IN Ohio: no data reported OH Pennsylvania: 36 units · 0.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 723 units · 1.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 200 units · 3.2 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.328.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Montana 28.7 /100k
2 Nevada 24.5 /100k
3 Missouri 3.2 /100k
4 Indiana 2.0 /100k
5 California 1.9 /100k
6 New York 1.1 /100k
7 Pennsylvania 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Coagulation Factor VIIa (Recombinant) — the ingredient across all brands.

Top reported reactions

Haemorrhage8
Anti Factor Viii Antibody Positive4
Covid-194
Fall4
Haemarthrosis4
Haematoma4
Activated Partial Thromboplastin Time Prolonged3

Age at onset

Child6
Adolescent2
Adult13
Elderly15

Reporter sex

85 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization33
Death10
Life-threatening8
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 34 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.

About this NDC listing & data coverage

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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Novo Nordisk. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novo Nordisk 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 J7189 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.
← 00169-7202-01 · Novo 00169-7208-01 · Novo →
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.