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Note: This document contains side effect information about coagulation factor viia. Some of the dosage forms listed on this page may not apply to the brand name NovoSeven RT.
Applies to coagulation factor viia: intravenous powder for solution
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.
Along with its needed effects, coagulation factor viia (the active ingredient contained in NovoSeven RT) 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:
Less common or rare
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
Applies to coagulation factor viia: intravenous powder for injection
The most common adverse reactions were thrombotic events.
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
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.
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
Antibody formation against this drug has only been reported in patients with factor VII deficiency.
Common (1% to 10%): Antibody formation against this drug
Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction
Common (1% to 10%): Intracranial hypertension, headache
Uncommon (0.1% to 1%): Cerebrovascular accident
Frequency not reported: Cerebrovascular disorder
Common (1% to 10%): Localized phlebitis
Rare (less than 0.1%): Injection site reaction
Common (1% to 10%): Fever
Frequency not reported: Pain
Uncommon (0.1% to 1%): Rash, pruritus, urticaria
Postmarketing reports: Angioedema
Uncommon (0.1% to 1%): Nausea
Uncommon (0.1% to 1%): Dyspnea
Rare (less than 0.1%): Alanine aminotransferase increased
Frequency not reported: Abnormal hepatic function
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Novoseven Rt (www.drugs.com/mtm/novoseven-rt-with-mixpro-injection.html).
June 26, 2020
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