Andexxa Side Effects
Generic name: coagulation factor Xa
Medically reviewed by Drugs.com. Last updated on Aug 9, 2024.
Note: This document provides detailed information about Andexxa Side Effects associated with coagulation factor Xa. Some dosage forms listed on this page may not apply specifically to the brand name Andexxa.
Applies to coagulation factor Xa: intravenous powder for solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (powder for solution)
Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden Deaths. Treatment 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.
Precautions
It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly. Blood tests will be needed to check for unwanted effects.
This medicine may increase your risk for blood clots, including stroke and heart attack, within 30 days of receiving the injection. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness.
Serious side effects of Andexxa
Along with its needed effects, coagulation factor Xa (the active ingredient contained in Andexxa) 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 side effects
- 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 side effects
- fast, pounding, or irregular heartbeat or pulse
- palpitations
Other side effects of Andexxa
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 side effects
- 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 adverse events
The most frequently reported side effects included urinary tract infections, infusion-related reactions, flushing, feeling hot, cough, dysgeusia, dyspnea, and pneumonia.[Ref]
Cardiovascular
- Very common (10% or more): Acute myocardial infarction (up to 16%), deep vein thrombosis (up to 25%)
- Common (1% to 10%): Cardiogenic shock, congestive heart failure, hypertension, hypotension, myocardial infarction
- Uncommon (0.1% to 1%): Cardiac arrest, cardiac thrombus, iliac artery occlusion, non-sustained ventricular tachycardia
- Frequency not reported: Flushing[Ref]
Dermatologic
- Frequency not reported: Mild hives[Ref]
Gastrointestinal
- Common (1% to 10%): Constipation, nausea
Genitourinary
- Very common (10% or more): Urinary tract infection (10%)[Ref]
Hematologic
- Very common (10% or more): Thromboembolic events (up to 18%)
Immunologic
- Very common (10% or more): Anti-drug antibodies (up to 17%)[Ref]
Nervous system
- Very common (10% or more): Cerebrovascular accident (up to 25%)
- Common (1% to 10%): Headache, ischemic stroke
- Uncommon (0.1% to 1%): Cerebral infarction, embolic stroke, transient ischemic attack
- Frequency not reported: Dysgeusia[Ref]
Other
- Very common (10% or more): Death (up to 15%), infusion-related reactions (up to 18%)
- Common (1% to 10%): Pyrexia, sudden death
- Frequency not reported: Chills, feeling hot, rigors[Ref]
Infusion-related reactions were characterized by a range of symptoms, which included flushing, feeling hot, cough, dysgeusia, dyspnea, rigors, chills, hypertension, oxygen desaturation, agitation, and confusion.
In clinical studies, death was reported in 15% of patients 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]
Psychiatric
- Common (1% to 10%): Delirium
- Frequency not reported: Agitation, confusion
Respiratory
- Very common (10% or more): Pulmonary embolism (up to 8%)
- Common (1% to 10%): Acute respiratory failure, pneumonia, pneumonia aspiration
- Frequency not reported: Cough, dyspnea, oxygen desaturation[Ref]
See also:
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Kcentra
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Mephyton
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Prothrombin complex
Prothrombin complex systemic is used for reversal of acquired coagulation factor deficiency
Phytonadione
Phytonadione systemic is used for hypoprothrombinemia, anticoagulant induced, hypoprothrombinemia ...
Idarucizumab
Idarucizumab systemic is used for reversal of dabigatran anticoagulation
References
1. (2022) "Product Information. Andexxa (coagulation factor Xa)." Portola Pharmaceuticals
2. (2023) "Product Information. Andexxa (andexanet alfa (factor Xa))." AstraZeneca Pty Ltd
3. (2023) "Product Information. Ondexxya (coagulation factor Xa)." AstraZeneca UK Ltd
Frequently asked questions
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Patient resources
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- Andexxa prescribing information
- Coagulation Factor Xa (recombinant), Inactivated-zhzo (AHFS Monograph)
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Further information
Andexxa 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.