Applies to coagulation factor viia: intravenous powder for solution.
Warning
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)
ThrombosisSerious 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
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
- 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
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
Antibody formation against this drug has only been reported in patients with factor VII deficiency.[Ref]
Common (1% to 10%): Antibody formation against this drug
Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[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]
