Andexxa 200mg Inj, 1 Vial
WARNING: Very bad and sometimes life-threatening side effects have happened within several days to a month after getting this drug. This includes blood clots, heart attack, stroke, and sudden death. Follow what your doctor has told you about preventing these side effects after using this drug. If you have questions, talk with your doctor. @ COMMON USES: It is used to undo the effects of a certain blood thinner.
Drug Class
Anticoagulant reversal agent
Pharmacologic Class
Recombinant Factor Xa decoy protein
Pregnancy Category
Not available
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Andexxa is a medicine given by injection into a vein to quickly reverse the effects of certain blood thinners (apixaban or rivaroxaban) in people who are experiencing severe, uncontrolled bleeding. It works by binding to the blood thinner, allowing your blood to clot normally again. Because it reverses the blood thinner, there is an increased risk of blood clots forming after treatment.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered intravenously over a specified period.
Storing and Disposing of Your Medication
Since this injection is given in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the medication, and any disposal will be handled by the healthcare facility.
Missing a Dose
This medication is typically administered on an as-needed basis in a healthcare setting. If you have any concerns about your treatment schedule, consult with your healthcare provider.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered intravenously over a specified period.
Storing and Disposing of Your Medication
Since this injection is given in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the medication, and any disposal will be handled by the healthcare facility.
Missing a Dose
This medication is typically administered on an as-needed basis in a healthcare setting. If you have any concerns about your treatment schedule, consult with your healthcare provider.
Lifestyle & Tips
- This medication is for acute, emergency use. No specific lifestyle modifications are typically associated with its administration.
- Patients should be aware of the increased risk of blood clots after treatment and should discuss with their doctor when it is safe to restart their blood thinner or other antithrombotic therapy.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Dosing is based on the specific Factor Xa inhibitor (apixaban or rivaroxaban), the dose of the Factor Xa inhibitor, and the time since the last dose. There are two regimens: Low Dose and High Dose.
Condition-Specific Dosing:
Low Dose Regimen:
For patients receiving apixaban (≤5 mg) or rivaroxaban (≤10 mg) and last dose was ≤8 hours ago, OR for patients receiving apixaban (>5 mg) or rivaroxaban (>10 mg) and last dose was >8 hours ago or unknown time. Administer 400 mg IV bolus at 30 mg/min, followed by 4 mg/min continuous infusion for 120 minutes.
High Dose Regimen:
For patients receiving apixaban (>5 mg) or rivaroxaban (>10 mg) and last dose was ≤8 hours ago. Administer 800 mg IV bolus at 30 mg/min, followed by 8 mg/min continuous infusion for 120 minutes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific recommendations; not expected to be dialyzable due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Pharmacology
Mechanism of Action
Andexanet alfa is a recombinant, modified human Factor Xa (FXa) protein. It acts as a decoy protein for direct FXa inhibitors (apixaban, rivaroxaban) by binding to them with high affinity. This binding sequesters the FXa inhibitor, making it unavailable to inhibit endogenous FXa, thereby restoring FXa activity and promoting hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable for IV bolus/infusion; peak concentration achieved rapidly after bolus.
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 5 L (similar to plasma volume)
ProteinBinding:
Not applicable (it is a protein that binds to other proteins)
CnssPenetration:
Limited (large molecule)
Elimination:
HalfLife:
Terminal half-life: 5-7 hours; however, the effect on anti-FXa activity is transient, returning towards baseline within 2-4 hours after infusion discontinuation.
Clearance:
Approximately 4.3 L/hr
ExcretionRoute:
Not directly excreted; products of proteolysis are eliminated.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 2 minutes (reduction in anti-FXa activity)
PeakEffect:
Within 5-10 minutes (maximum reduction in anti-FXa activity)
DurationOfAction:
Transient; anti-FXa activity begins to increase within 2-4 hours after the end of the infusion, returning towards baseline levels by 4-6 hours post-infusion.
Safety & Warnings
BLACK BOX WARNING
THROMBOEMBOLIC RISK, ISCHEMIC RISK, AND DEATH: Patients treated with Andexxa have an increased risk of thromboembolic events, ischemic stroke, and death. Monitor patients for signs and symptoms of thromboembolic events and promptly treat as medically appropriate. To mitigate the risk of thrombosis, resume anticoagulant therapy as soon as medically appropriate.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Persistent cough
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Flushing
Feeling hot
Change in taste
* Cough
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Persistent cough
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Flushing
Feeling hot
Change in taste
* Cough
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of new or worsening bleeding (e.g., unusual bruising, nosebleeds, blood in urine or stool, severe headache, weakness)
- Signs of a blood clot (e.g., chest pain, shortness of breath, sudden numbness or weakness on one side of the body, difficulty speaking, sudden vision changes, swelling or pain in a leg)
- Signs of an allergic reaction (e.g., rash, itching, hives, swelling of the face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you plan to use heparin after receiving this medication.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you plan to use heparin after receiving this medication.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. If you experience any bleeding after receiving this drug, contact your doctor immediately. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely in a clinical setting as it is administered by healthcare professionals for a specific indication. Potential effects of excessive dosing are not well characterized but could theoretically include prothrombotic effects.
What to Do:
Management would be supportive. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Baseline anti-Factor Xa activity
Rationale: To confirm presence and level of Factor Xa inhibitor, though not required for treatment initiation.
Timing: Prior to administration, if available and feasible.
Hemoglobin/Hematocrit
Rationale: To assess baseline bleeding severity and monitor for ongoing blood loss.
Timing: Prior to administration.
Vital Signs (BP, HR, RR, Temp)
Rationale: To assess patient stability and monitor for infusion reactions or changes in clinical status.
Timing: Prior to administration and frequently during/after infusion.
Coagulation parameters (PT/INR, aPTT)
Rationale: To assess baseline coagulation status, though these may not directly reflect the effect of direct Factor Xa inhibitors.
Timing: Prior to administration.
Routine Monitoring
Clinical signs of hemostasis/bleeding cessation
Frequency: Continuously during and after infusion
Target: Cessation of active bleeding
Action Threshold: Persistent or worsening bleeding requires further intervention.
Signs and symptoms of thromboembolic events
Frequency: Regularly for several days post-treatment
Target: Absence of new thrombotic events
Action Threshold: New or worsening symptoms (e.g., chest pain, dyspnea, limb swelling, neurological deficits) require immediate evaluation.
Infusion site reactions
Frequency: During and immediately after infusion
Target: Absence of pain, swelling, redness
Action Threshold: Significant reactions may require slowing or stopping infusion.
Hemoglobin/Hematocrit
Frequency: As clinically indicated (e.g., every 6-12 hours)
Target: Stable or improving
Action Threshold: Significant drop may indicate re-bleeding.
Symptom Monitoring
- Signs of re-bleeding (e.g., hematoma expansion, melena, hematemesis, hematuria, epistaxis, petechiae)
- Signs of new thrombosis (e.g., chest pain, shortness of breath, sudden weakness or numbness on one side of the body, slurred speech, vision changes, swelling or pain in a leg)
- Signs of infusion reactions (e.g., flushing, rash, urticaria, dyspnea, fever, chills)
Special Patient Groups
Pregnancy
There are no available data on Andexxa use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown; no human data.
Second Trimester:
Risk unknown; no human data.
Third Trimester:
Risk unknown; no human data.
Lactation
There are no data on the presence of Andexxa in human milk, the effects on the breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Andexxa and any potential adverse effects on the breastfed infant from Andexxa or from the underlying maternal condition.
Infant Risk:
Risk unknown.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between older (≥65 years) and younger patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Andexxa is specifically indicated for the reversal of apixaban and rivaroxaban in patients with life-threatening or uncontrolled bleeding. It is not indicated for other Factor Xa inhibitors (e.g., edoxaban, fondaparinux) or other anticoagulants.
- The reversal effect on anti-FXa activity is transient. Patients remain at risk for thromboembolic events after treatment with Andexxa.
- Resumption of anticoagulant therapy should be considered as soon as medically appropriate to mitigate the risk of thrombosis.
- Monitor patients closely for signs of re-bleeding and new thromboembolic events following treatment.
- Andexxa is a high-cost medication and its use should be reserved for appropriate indications as per guidelines.
Alternative Therapies
- Prothrombin Complex Concentrates (PCCs) (e.g., Kcentra, Octaplex): These are non-specific reversal agents that contain Factors II, VII, IX, and X. They are often used off-label for FXa inhibitor reversal but do not directly bind the inhibitor.
- Activated Prothrombin Complex Concentrates (aPCCs) (e.g., FEIBA): Contains activated clotting factors and is used for hemophilia with inhibitors, sometimes off-label for FXa inhibitor reversal.
- Fresh Frozen Plasma (FFP): Provides clotting factors but requires large volumes and is less effective than specific reversal agents or PCCs for FXa inhibitors.
- Tranexamic Acid (TXA) or Aminocaproic Acid: Antifibrinolytic agents that can help stabilize clots but do not reverse the anticoagulant effect.
Cost & Coverage
Average Cost:
Extremely high per vial
Insurance Coverage:
Specialty drug, typically covered under medical benefit for specific indications (life-threatening or uncontrolled bleeding). Prior authorization is almost always required.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.