Sevenfact Side Effects

Generic name: coagulation factor viia

Medically reviewed by Drugs.com. Last updated on Jun 16, 2024.

Note: This document provides detailed information about Sevenfact Side Effects associated with coagulation factor viia. Some dosage forms listed on this page may not apply specifically to the brand name Sevenfact.

Applies to coagulation factor viia: intravenous powder for solution.

Important Warnings This medicine can cause some serious health issues

Intravenous route (Powder for Solution)

Serious arterial and venous thrombotic events are associated with the use of coagulation factor VIIa.

Patients should be advised of the risks and know the signs and symptoms of thrombotic and thromboembolic events.

Monitor for signs/symptoms of thrombosis and of activation of the coagulation cascade.

Intravenous route (Powder for Solution)

Thrombosis Serious arterial and venous thrombotic events may occur following administration of coagulation factor VIIa recombinant-jncw.Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive coagulation factor VIIa (recombinant)-jncw.Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Serious side effects of Sevenfact

Along with its needed effects, coagulation factor viia (the active ingredient contained in Sevenfact) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking coagulation factor viia:

More common

• bleeding problems
• fever
• high blood pressure
• joint or muscle pain or stiffness

Less common or rare

• bloating or swelling of the face, hands, lower legs, or feet
• bluish color of the hands or feet
• blurred vision
• changes in facial color
• chest pain
• chills
• cold sweats
• confusion
• continuing thirst
• cough
• dizziness
• excessive sweating
• faintness
• fast heartbeat
• hives, itching, or skin rash
• large flat blue or purplish patches on the skin
• lightheadedness when getting up suddenly from a lying or sitting position
• persistent bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder)
• puffiness or swelling of the eyelids or around the eyes
• shakiness
• slow or irregular heartbeat (less than 50 beats per minute)
• slurred speech
• sneezing
• sore throat
• sudden decrease in the amount of urine
• swelling of the face, fingers, feet, or lower legs
• troubled breathing, tightness in the chest
• unusual tiredness or weakness
• unusual weight gain

Other side effects of Sevenfact

Some side effects of coagulation factor viia may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• burning or stinging at the injection site
• drowsiness
• feeling of warmth
• headache
• nausea or vomiting
• pinpoint red or purple spots on the skin
• redness of the face, neck, arms and occasionally, upper chest

For Healthcare Professionals

Applies to coagulation factor viia: intravenous injection, intravenous powder for injection.

General

The most common adverse reactions were thrombotic events.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, thromboembolic events
• Uncommon (0.1% to 1%): Shock
• Rare (less than 0.1%): Angina pectoris
• Postmarketing reports: Intracardiac thrombus, flushing^[Ref]

Specific arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), specific venous thromboembolic events (pulmonary embolism, deep vein thrombosis), and angina pectoris were reported with a frequency of common (1% to 10%) in clinical trials of 61 patients with acquired hemophilia.^[Ref]

Hematologic

• Common (1% to 10%): Plasma fibrinogen decreased, acute post-operative hemarthrosis
• Rare (less than 0.1%): Disseminated intravascular coagulation, D dimer increased, antithrombin decreased, coagulopathy, fibrin degradation products increased, alkaline phosphatase increased, lactate dehydrogenase increased, prothrombin increased^[Ref]

Immunologic

• Common (1% to 10%): Antibody formation against this drug
• Rare (less than 0.1%): Hypersensitivity
• Postmarketing reports: Anaphylactic reaction^[Ref]

Antibody formation against this drug has only been reported in patients with factor VII deficiency.^[Ref]

Nervous system

• Common (1% to 10%): Intracranial hypertension, headache
• Uncommon (0.1% to 1%): Cerebrovascular accident
• Frequency not reported: Cerebrovascular disorder^[Ref]

Local

• Common (1% to 10%): Localized phlebitis
• Rare (less than 0.1%): Injection site reaction^[Ref]

Other

• Common (1% to 10%): Fever
• Frequency not reported: Pain^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Rash, pruritus, urticaria
• Postmarketing reports: Angioedema^[Ref]

Gastrointestinal

• Uncommon (0.1% to 1%): Nausea^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Dyspnea^[Ref]

Hepatic

• Rare (less than 0.1%): Alanine aminotransferase increased
• Frequency not reported: Abnormal hepatic function^[Ref]

Further information

Sevenfact side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer