Sevenfact

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For i ntravenous u se after reconstitution only .
• Type of Bleeding Dosing Regimen Recommendation For Mild or Moderate bleeds 75 mcg/kg repeated every 3 hours until hemostasis is achieved or Initial dose of 225 mcg/kg.
• If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis For Severe bleeds 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT.
• The vial includes a rubber stopper under the plastic cap.
• The syringe plunger rod has a wide top end and threaded end.
• The pre-filled syringe with Water for Injection diluent has a plastic backstop, rubber stopper, syringe tip (luer lock top under syringe cap), and syringe cap.
• The SEVENFACT 1 mg and 2 mg vial adapter and SEVENFACT 5 mg vial adapter each contain a plastic cover, paper protective cover, and spike (under protective paper).
• 2.1 Dose For intravenous use after reconstitution only.
• Dose and duration of SEVENFACT depend on the location and severity of the bleeding, need for urgent hemostasis, frequency of administration, and known patient responsiveness to FVIIa-containing bypassing agents during prior bleeding events.
• Treatment with SEVENFACT should be initiated as soon as a bleeding event occurs.
• The dose, frequency, and duration of SEVENFACT therapy should be based on the patient’s clinical response and hemostasis evaluation.
• The use of laboratory assessment(s) of coagulation (PT/INR, aPTT, FVII:C) does not necessarily correlate with or predict the hemostatic effectiveness of SEVENFACT.
• Dose adjustment may be required if the patient has received other procoagulant therapies prior to treatment with SEVENFACT.
• Based on the clinical trial program for SEVENFACT, the recommended initial dose should be adjusted based on the criteria provided in Table 1.
• Table 1 Dosing for Treatment and Control of Bleeding Type of Bleeding Dosing Regimen Recommendation Duration of Therapy Mild and Moderate Joint, superficial muscle, soft tissue and mucous membranes. 75 mcg/kg repeated every 3 hours until hemostasis is achieved or Initial dose of 225 mcg/kg.
• If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis.
• Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT.
• Continue therapy to support healing and prevent recurrent hemorrhage after hemostasis to maintain the hemostatic plug.
• The site and severity of bleeding should determine therapy duration.
• Severe Life or limb threatening hemorrhage, iliopsoas and deep muscle with neurovascular injury, retroperitoneum, intracranial, or gastrointestinal.
• Patients should seek immediate medical care if signs or symptoms of severe bleeding occur in the home setting. 225 mcg/kg initially, followed if necessary 6 hours later with 75 mcg/kg every 2 hours until hemostasis is achieved.
• Subsequent Dosing:
• After achieving hemostasis, base the decision for dosing on clinical assessment and the type of bleeding.
• Consider the risk of thrombosis with subsequent dosing after achieving hemostatic efficacy.
• Continue therapy to support healing and prevent recurrent hemorrhage.
• The site and severity of bleeding and the use of other procoagulant therapies should determine therapy duration.
• 2.2 Reconstitution Follow the procedures below for reconstitution of SEVENFACT.
• Calculate the amount of SEVENFACT required and select the appropriate SEVENFACT packages containing the matching pre-filled syringe of sterile Water for Injection, and the vial adapters.
• Reconstitute each vial with the pre-filled syringe provided with each vial of SEVENFACT.
• Overview of SEVENFACT P ackage :
• Figure 1 Vial with SEVENFACT L yophilized P owder Lyophilized Powder Drug Vial Figure 2 Syringe P lunger R od and P re-filled S yringe with Water for Injection D iluent Syringe Plunger Rod Pre-filled S yringe with Diluent Figure 3 SEVENFACT 1 mg and 2 mg V ial A dapter and SEVENFACT 5 mg V ial A dapter Vial Adapters* and Packaging 1 mg and 2 mg V ial A dapter 5 mg V ial A dapter * N ote :
• Each SEVENFACT kit will contain only one vial adapter.
• The instructions below serve as a general guideline for reconstitution of SEVENFACT.
• Reconstitution :
• Based on the prescribed dose, take out the number of SEVENFACT kits (each kit containing one vial of SEVENFACT powder and one pre-filled Water for Injection diluent syringe with one vial adapter for needleless reconstitution), an infusion set (not supplied in the kit) and an alcohol swab (not supplied in the kit).
• Check the expiration date on the side of the box(es) for the SEVENFACT kit(s).
• Always use aseptic technique.
• Wash your hands with soap and water and dry them using a clean towel or air dry.
• Take out the contents of one kit and one alcohol swab.
• Place items on a clean surface.
• Inspect all contents of the kit.
• Make sure each vial has a matching colored syringe.
• Bring SEVENFACT (lyophilized powder) and the specified pre-filled syringe (diluent) to room temperature.
• The specified volume of diluent corresponding to the amount of SEVENFACT is as follows:
• 1 mg (1000 micrograms) vial + 1.1 mL Water for Injection diluent in pre-filled syringe 2 mg (2000 micrograms) vial + 2.2 mL Water for Injection diluent in pre-filled syringe 5 mg (5000 micrograms) vial + 5.2 mL Water for Injection diluent in pre-filled syringe Remove the plastic cap from the SEVENFACT vials to expose the central portion of the rubber stopper.
• Cleanse the rubber stoppers with an alcohol swab and allow to dry prior to use.
• Peel back the protective paper from the vial adapter.
• Do not remove the vial adapter from the package.
• Place the SEVENFACT vial on a flat surface.
• While holding the vial adapter package, place the vial adapter over the SEVENFACT vial and press down firmly on the package until the vial adapter spike breaks through the rubber stopper.
• Lightly squeeze the plastic cover and lift up to remove it from the vial adapter.
• Note:
• the 5 mg vial adapter may not sit flat against the vial, but it is fully functional.
• Remove the syringe cap from the pre-filled syringe by holding the syringe body with one hand to unscrew the syringe cap (turn to the left).
• While holding the edges of the vial adapter, screw on the pre-filled syringe (turn to the right) a few turns until it starts to tighten.
• Insert the plunger rod into the syringe, then screw a few turns (turn to the right) so that the plunger rod is attached to the gray rubber stopper in the syringe.
• Push the plunger rod to slowly inject all the diluent into the vial.
• Keep the plunger rod pressed down and swirl the vial gently until the powder is dissolved.
• The reconstituted solution is clear to slightly opaque.
• All powder must be mixed with no particles floating in the liquid.
• Without withdrawing any drug back into the syringe, unscrew the syringe from the vial adapter (turn to the left) until it is completely detached.
• Withdraw the liquid drug from the vial(s), using an infusion syringe provided by the pharmacy; the syringe should be large enough to hold the prescribed dose.
• The reconstituted solution should be stored in the vial at room temperature, but can be stored between 36 o F to 86 o F (2 o C to 30 o C) for up to 4 hours after reconstitution.
• After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg per mL SEVENFACT (1000 micrograms per mL).
• 2.3 Administration For Intravenous Use Only .
• Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.
• Do not use if particulate matter or discoloration is observed.
• Do not freeze reconstituted solution or store it in a syringe.
• SEVENFACT must be infused within 4 hours after reconstitution.
• SEVENFACT should be infused over 2 minutes or less as a bolus intravenous infusion.
• Do not mix with other infusion solutions.
• Any unused solution should be discarded 4 hours after reconstitution.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

• The safety and effectiveness of SEVENFACT have been established for pediatric patients ≥ 12 years of age for the treatment and control of bleeding episodes.
• Limited clinical data for SEVENFACT in adolescents (≥12 to <18 years) were collected in an adult and adolescent study (Study 1).
• A total of five patients were dosed with SEVENFACT.
• These five patients were treated for a total of 79 bleeding episodes (all mild or moderate) that occurred while patients were still under 18 years of age.
• Hemostatic efficacy in this subgroup (n=5) was comparable to efficacy observed in the overall population [ See Clinical Studies ( 14 ) ].
• The safety and effectiveness of SEVENFACT for the treatment and control of bleeding episodes have not been established in children < 12 years of age.
• Effectiveness was not demonstrated in a trial of 25 pediatric patients 6 months to < 12 years of age.
• The safety and effectiveness of SEVENFACT in infants less than 6 months of age have not been evaluated.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Safety and effectiveness of SEVENFACT in patients >65 years of age have not been evaluated in clinical trials (Study 1 and Study 2).
• The presence of age-related comorbidities and the attendant risks associated with thrombotic and thromboembolic events should be considered when administering SEVENFACT to patients older than 50 years of age.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most common adverse reactions (incidence ≥1%) were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever ( 6 ).
• To report SUSPECTED ADVERSE REACTIONS, contact HEMA Biologics at 855-718-HEMA (4362) or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• The safety database described in this section reflect exposure to SEVENFACT in two clinical studies, Study 1 and Study 2.
• A total of 42 patients with Hemophilia A or B with or without inhibitors received SEVENFACT:
• 27 patients in Study 1 at doses 75 mcg/kg and 225 mcg/kg and 15 patients in Study 2 at three escalating dose levels 25 mcg/kg, 75 mcg/kg and 225 mcg/kg [see Clinical Studies ( 14 )] .
• The most common adverse reactions (incidence ≥1%) reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.
• Adverse reactions reported in the two clinical studies are shown in Table 2.
• Table 2 Adverse Reactions Occurring in Clinical Studies Preferred Terms Number of Patient Adverse Reactions (% Incidence Rate) Study 2 (N=15) Number of A dverse R eactions * Study 2 Number of Patient Adverse Reactions (% Incidence Rate) Study 1 (N=27) Number of A dverse R eactions * Study 1 Infusion site discomfort - - 1 (4) 4 Infusion site hematoma - - 1 (4) 2 Dizziness 1 (7) 2 - - Headache 1 (7) 1 - - Body temperature increase - - 1 (4) 1 Infusion related reaction** 1 (7) 1 - - * Three patients experienced adverse reactions in Study 2 and two patients experienced adverse reactions in Study 1. ** Symptoms resolved without any intervention and did not recur with subsequent administration.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 1 7 PATIENT COUNSELING INFORMATION Advise patients:
• to read the FDA-approved patient labeling (Patient Product Information and Instructions for Use). about the early signs of hypersensitivity reactions and to seek medical help if the following occur:
• Hives, itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, low blood pressure, or other symptoms of anaphylaxis. about the signs of thrombosis and to seek medical help if the following occur:
• 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.
• Revised: November 13, 2025 U.S.
• License Number: 2061 “SEVENFACT” is a registered trademark of LFB S.A.
• PATENT Information:
• https://hemabiodup.wpengine.com/patents/ For I nformation C ontact :
• Call:
• 855.718.HEMA (4362) Email:
• medinfo@hemabio.com Manufacture d by :
• Laboratoire Français du Fractionnement et des Biotechnologies S.A.
• (LFB S.A.) Puteaux, 92800 France U.S.
• License Number: 2061 Distributed by: HEMA Biologics Louisville, KY 40241 U.S.
• License Number: 2061

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS SEVENFACT is a white to off-white lyophilized powder for reconstitution in a colorless solution for injection.
• It is supplied in single-dose vial sizes containing 1 mg, 2 mg or 5 mg of coagulation factor VIIa (recombinant)-jncw.
• The diluent for reconstitution of SEVENFACT is supplied in single-dose prefilled glass syringes containing 1.1 mL, 2.2 mL or 5.2 mL sterile Water for Injection.
• It is a clear colorless solution.
• After reconstitution with the appropriate volume of Water for Injection diluent, each mL of SEVENFACT contains 1 mg per mL of coagulation factor VIIa (recombinant)-jncw (1,000 micrograms per mL).
• SEVENFACT is available as a lyophilized powder in single-dose vials containing 1 mg, 2 mg or 5 mg of coagulation factor VIIa (recombinant)-jncw.
• After reconstitution with a specified volume of Sterile Water for Injection, each mL contains 1 mg (1000 mcg) of coagulation factor VIIa (recombinant)-jncw ( 3 ).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 1 6 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SEVENFACT [coagulation factor VIIa (recombinant)-jncw], is supplied as a room temperature stable, white to off-white, lyophilized powder in single-dose vials, one vial per carton.
• The diluent for reconstitution of SEVENFACT is Water for Injection supplied as a clear colorless solution in a pre-filled syringe.
• Single 1 mg, 2 mg or 5 mg vials of SEVENFACT are available in packages as indicated in Table 6.
• Table 6 SEVENFACT Presentations Presentation Cap Color Indication NDC Number Contents 1 mg per vial Yellow NDC 71127-1000-1 One 1 mg SEVENFACT single-dose vial [NDC 71127-1100-1] One pre-filled syringe containing 1.1 mL of Sterile Water for Injection [NDC 71127-1200-1] One 13 mm vial adapter with 5 micron filter 2 mg per vial Green NDC 71127-2000-1 One 2 mg SEVENFACT single-dose vial [NDC 71127-2100-1] One pre-filled syringe containing 2.2 mL of Sterile Water for Injection [NDC 71127-2200-1] One 13 mm vial adapter with 5 micron filter 5 mg per vial Purple NDC 71127-5000-1 One 5 mg SEVENFACT single-dose vial [NDC 71127-5100-1] One pre-filled syringe containing 5.2 mL of Sterile Water for Injection [NDC 71127-5200-1] One 20 mm vial adapter with 5 micron filter The SEVENFACT vials are made of glass, closed with a bromobutyl rubber stopper (not made with natural rubber latex), and sealed with an aluminum cap.
• The pre-filled diluent syringes are made of glass, with a siliconized bromobutyl rubber plunger (not made with natural rubber latex).
• Storage and Handling Prior to reconstitution, the SEVENFACT kit should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), protected from light in the product package.
• Do not freeze.
• After reconstitution, SEVENFACT should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), for up to 4 hours.
• Do not freeze or store in syringes.

Quoted from the official label, section “How Supplied”.

What is in it

• SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is a sterile, white to off-white lyophilized powder in a single-dose vial containing either 1 mg, 2 mg or 5 mg of coagulation factor VIIa (recombinant)-jncw as the active ingredient.
• SEVENFACT is to be reconstituted with Sterile Water for Injection in a pre-filled syringe supplied with the product.
• The reconstituted product is a clear to slightly opaque solution of coagulation factor VIIa (recombinant)-jncw at a concentration of 1 mg of protein per mL with a pH of approximately 6.0.
• SEVENFACT is formulated with arginine, isoleucine, citrate, glycine, lysine and polysorbate 80.
• It does not contain any antimicrobial preservatives nor human or bovine plasma-derived proteins.
• The active ingredient in SEVENFACT, activated coagulation Factor VII, is a glycoprotein of 406 amino acids with a molecular weight of approximately 50 kilodaltons.
• The amino acid sequence of activated coagulation Factor VII is identical to that of human plasma-derived Factor VIIa.
• It is >99% pure with a nominal specific activity of 45,000 IU/mg of protein when tested against the World Health Organization international standard for human Factor VIIa activity.
• SEVENFACT is produced by recombinant DNA technology using genetically engineered rabbits into which the DNA coding sequence for human Factor VII has been introduced.
• Human Factor VII is expressed in the rabbit mammary gland and secreted into the milk.
• During purification and processing, Factor VII is enzymatically converted to activated Factor VII.
• The manufacturing process of SEVENFACT includes specific steps to reduce impurities.
• SEVENFACT may contain trace amounts of rabbit proteins.
• The purification process also includes steps that are validated to inactivate or remove viruses, such as Xenotropic murine leukemia virus (X-MuLV), bovine viral diarrhea virus (BVDV), Pseudorabies virus (PRV), Feline Calicivirus (FCV), and Porcine Parvovirus (PPV).

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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