Coagulation factor viia recombinant human Brand names: Sevenfact

What is coagulation factor viia recombinant human used for?

From the label: indications and usage

SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency. SEVENFACT is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors ( 1 ). Limitation s of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.

What does the patient leaflet for coagulation factor viia recombinant human say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about SEVENFACT?

The most serious possible side effect of SEVENFACT is abnormal blood clotting involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots. You should know the signs of abnormal clotting (thrombosis) described below and seek medical help immediately if they occur. New onset of swelling and pain in the limbs or abdomen, new onset of chest pain, shortness of breath, loss of sensation or motor power, and altered consciousness or speech can all be signs of clot formation in places other than your site of bleeding. Seek immediate medical attention if you experience one or more of these symptoms. SEVENFACT should be used as prescribed and directed by your healthcare provider.

From the patient leaflet: What should I avoid while using SEVENFACT?

Avoid activity that can create more bleeding once you have completed your SEVENFACT infusion Avoid mixing SEVENFACT with other medications Avoid infusing SEVENFACT and other factor-containing therapies [such as activated prothrombin complex concentrate (aPCC) or other recombinant Factor VIIa products] at the same time. This increases your risk of having a disabling blood clot.

From the patient leaflet: How should I store SEVENFACT?

SEVENFACT should be stored in its product packaging to protect from light. 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). 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. SEVENFACT should not be frozen.

Is there a generic for coagulation factor viia recombinant human (Sevenfact)?

No generic coagulation factor viia recombinant human is approved (Drugs@FDA, October 8, 2026).

What do FAERS reports show for coagulation factor viia recombinant human?

The FDA Adverse Event Reporting System holds 85 reports that list coagulation factor viia recombinant human among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 33 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)27
• Off Label Use (a use or a product term, not a reaction)19
• Haemorrhage8
• No Adverse Event (a use or a product term, not a reaction)7
• Anti Factor Viii Antibody Positive4
• Covid-194
• Fall4
• Haemarthrosis4

What next?

Coagulation factor viia recombinant human side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other