Coagulation Factor Viia Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 18, 2024.
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.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.
This medicine may increase your chance of having blood clotting problems. The risk is higher if you have a medical condition such as disseminated intravascular coagulation (DIC) or severe artery disease, or if you are taking certain blood clotting medicines. Tell your doctor right away if you have sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.
Serious side effects
Along with its needed effects, coagulation factor viia 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 side effects
- bleeding problems
- fever
- high blood pressure
- joint or muscle pain or stiffness
Less common or rare side effects
- 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
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 side effects
- 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 adverse events
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
Hepatic
- Rare (less than 0.1%): Alanine aminotransferase increased
- Frequency not reported: Abnormal hepatic function[Ref]
See also:
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References
1. (2022) "Product Information. NovoSeven (coagulation factor VIIa)." Apothecon Inc
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
More about coagulation factor viia
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: miscellaneous coagulation modifiers
- En español
Patient resources
- Coagulation factor VIIa injection drug information
- Coagulation factor viia (Advanced Reading)
- Coagulation factor viia-jncw (Advanced Reading)
Other brands
Professional resources
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Further information
Coagulation factor viia 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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.
