Applies to coagulation factor Xa: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden DeathsTreatment with coagulation factor Xa (recombinant) IV injection has been associated with serious and life-threatening adverse events, including:Arterial and venous thrombolic eventsIschemic events, including myocardial infarction and ischemic strokeCardiac arrestSudden deathsMonitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
Serious side effects
Along with its needed effects, coagulation factor Xa 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 Xa:
More common
- Anxiety
- blue lips, fingernails, or skin
- chest pain or discomfort
- confusion
- cool, sweaty skin
- cough
- decreased urine output
- difficulty in speaking
- dilated neck veins
- dizziness
- double vision
- extreme tiredness or weakness
- fainting
- fast heartbeat
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular heartbeat
- irregular, fast or slow, or shallow breathing
- lightheadedness
- nausea
- pain or discomfort in the arms, jaw, back, or neck pain
- redness, or swelling in the arm or leg
- slow speech
- sweating
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- troubled breathing
- vomiting
- weakness
- weight gain
Less common
- Fast, pounding, or irregular heartbeat or pulse
- palpitations
Other side effects
Some side effects of coagulation factor Xa 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:
More common
- Bladder pain
- bloody or cloudy urine
- change in taste
- chills
- cough
- difficult, burning, or painful urination
- feeling of warmth
- fever
- frequent urge to urinate
- loss of taste
- lower back or side pain
- redness of the face, neck, arms, and occasionally, upper chest
- sneezing
- sore throat
For Healthcare Professionals
Applies to coagulation factor Xa: intravenous powder for injection.
General
The most common adverse reactions (5% or greater) were urinary tract infections and pneumonia.[Ref]
Other
Very common (10% or more): Infusion-related reactions (18%), death prior to day 30 follow-up (14%)
Common (1% to 10%): Sudden death
Frequency not reported: Feeling hot[Ref]
In the ongoing ANNEXA-4 study, there were 25 deaths (14%) prior to the day 30 follow-up visit. The percentage of patients, by bleeding type, who died prior to the day 30 follow-up was: 14% for intracranial bleeding, 10% for gastrointestinal bleeding, and 19% for other bleeding types.[Ref]
Immunologic
Very common (10% or more): Antibodies against this drug (up to 17%)[Ref]
Cardiovascular
Common (1% to 10%): Deep vein thrombosis, acute myocardial infarction, cardiogenic shock, congestive heart failure
Uncommon (0.1% to 1%): Cardiac arrest, cardiac thrombus, iliac artery thrombosis, non-sustained ventricular tachycardia
Frequency not reported: Flushing[Ref]
Respiratory
Common (1% to 10%): Pulmonary embolism, acute respiratory failure
Frequency not reported: Cough, dyspnea, pneumonia[Ref]
Genitourinary
Frequency not reported: Urinary tract infection[Ref]
Dermatologic
Frequency not reported: Mild hives[Ref]
Nervous system
Common (1% to 10%): Ischemic stroke
Uncommon (0.1% to 1%): Embolic stroke
Frequency not reported: Dysgeusia[Ref]
