Product image of Andexxa - 5s (Andexanet Alfa) 200 mg/20mL Vials supplied by GNH India

Andexxa - 5s

Active Ingredient:
Andexanet Alfa
Form:
Vials
Brand:
ANDEXXA
Origin:
USA

Andexxa - 5s (Andexanet Alfa Vials) 200 mg/20mL

Andexanet alfa, the active ingredient in Andexxa - 5s, is a factor Xa inhibitor reversal agent presented as a 200 mg/20mL vial for intravenous use. It is indicated for patients treated with apixaban or rivaroxaban when rapid reversal is required due to uncontrolled bleeding. GNH India supplies Andexxa - 5s as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Andexxa - 5s is a recombinant modified human factor Xa decoy protein designed to reverse the anticoagulant effects of factor Xa inhibitors. It is used in emergency situations where rapid reversal of anticoagulation is necessary to manage life-threatening or uncontrolled bleeding.

Strength

200 mg/20mL

Pack Size

5s

Storage

2-8°

Manufacturer / TM Owner

AstraZeneca Pharmaceuticals LP

1
Pack/s
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Indications & Clinical Uses

Andexxa - 5s is a factor Xa inhibitor reversal agent used to manage anticoagulation in patients treated with apixaban or rivaroxaban.

  • Uncontrolled bleeding: Reverses the anticoagulant effects of apixaban or rivaroxaban in patients experiencing life-threatening or uncontrolled bleeding.
  • Emergency surgery: Facilitates rapid reversal of anticoagulation in patients requiring urgent or emergency surgery who are on factor Xa inhibitors.
  • Invasive procedures: Provides a means to manage anticoagulation in patients undergoing invasive procedures while on factor Xa inhibitors.

How It Works

  • Andexanet alfa is a recombinant modified human factor Xa decoy protein that binds factor Xa inhibitors (e.g., apixaban, rivaroxaban, edoxaban) with high affinity. By sequestering these inhibitors, it restores normal hemostasis by allowing native factor Xa to function properly, thereby reversing the anticoagulant effects.

Side Effects

Andexxa - 5s, like all medications, can cause side effects.

Common Side Effects

  • Nausea: Feeling sick to the stomach.
  • Vomiting: Expelling stomach contents through the mouth.
  • Fever: Elevated body temperature.
  • Headache: Pain or discomfort in the head or neck.
  • Flushing: Redness or warmth in the skin.
  • Chest pain: Discomfort or pain in the chest area.

Serious or Rare Side Effects

  • Thromboembolic events: Blood clots that can lead to serious conditions such as stroke or heart attack.
  • Allergic reactions: Severe allergic responses that may include difficulty breathing, swelling, or rash.
  • Anaphylaxis: A severe, life-threatening allergic reaction requiring immediate medical attention.
  • Ischemic events: Reduced blood flow to organs or tissues, which can cause damage or dysfunction.

Precautions & Warnings

Andexxa - 5s should be used with caution and under the supervision of a healthcare professional.

  • Monitor for thromboembolic events: Regularly check for signs of blood clots.
  • Allergic reactions: Be aware of potential allergic responses and seek immediate medical attention if they occur.
  • Pregnancy: Use with caution in pregnant women, as the safety has not been established.
  • Breastfeeding: Avoid use in breastfeeding women unless necessary, as the safety has not been established.
  • Pre-existing conditions: Use with caution in patients with pre-existing conditions that may be exacerbated by the medication.
  • Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Andexxa - 5s may interact with other medications, which can affect its efficacy or increase the risk of side effects.

Major Interactions (Avoid)

  • Anticoagulants: Avoid concurrent use with other anticoagulants, as it may increase the risk of bleeding.
  • Antiplatelet agents: Avoid concurrent use with antiplatelet agents, as it may increase the risk of bleeding.
  • Thrombolytics: Avoid concurrent use with thrombolytics, as it may increase the risk of bleeding.

Moderate Interactions (Monitor Closely)

  • NSAIDs: Monitor closely when used with non-steroidal anti-inflammatory drugs, as it may increase the risk of bleeding.
  • SSRIs: Monitor closely when used with selective serotonin reuptake inhibitors, as it may increase the risk of bleeding.
  • Other medications that affect coagulation: Monitor closely when used with other medications that affect coagulation, as it may increase the risk of bleeding.

Frequently Asked Questions

Andexxa - 5s is used to reverse the anticoagulant effects of factor Xa inhibitors such as apixaban and rivaroxaban in patients experiencing life-threatening or uncontrolled bleeding. It is also used in emergency situations where rapid reversal of anticoagulation is necessary, such as during urgent or emergency surgery or invasive procedures.

Andexanet alfa is a recombinant modified human factor Xa decoy protein that binds factor Xa inhibitors with high affinity. By sequestering these inhibitors, it restores normal hemostasis by allowing native factor Xa to function properly, thereby reversing the anticoagulant effects.

The dose of Andexxa - 5s is determined by a healthcare professional based on the patient's condition, the specific factor Xa inhibitor being used, and other individual factors. It is important to follow the prescribed dosage and administration instructions provided by the healthcare professional.

The safety of Andexxa - 5s during pregnancy or breastfeeding has not been established. It should be used with caution in pregnant women and avoided in breastfeeding women unless necessary. Always consult a healthcare professional for personalized advice.

To order Andexxa - 5s from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then provide pricing, availability, shipping (including cold-chain where relevant), and the necessary import paperwork.

Andexxa - 5s is specifically designed to reverse the anticoagulant effects of factor Xa inhibitors such as apixaban and rivaroxaban. It works by binding to these inhibitors and sequestering them, allowing normal hemostasis to be restored. Other anticoagulant reversal agents may have different mechanisms of action and be used for different types of anticoagulants.

Andexxa - 5s should be stored at 2-8°C, kept refrigerated, protected from light, and not frozen or shaken. Proper storage and handling are essential to maintain the efficacy and safety of the medication. Always follow the storage instructions provided by the manufacturer and healthcare professional.

Andexxa - 5s is administered intravenously. The specific administration instructions, including the dosage and infusion rate, are determined by a healthcare professional based on the patient's condition and the specific factor Xa inhibitor being used. It is important to follow the administration instructions provided by the healthcare professional.

The most serious risks to watch for with Andexxa - 5s include thromboembolic events, such as blood clots that can lead to serious conditions like stroke or heart attack, and severe allergic reactions, including anaphylaxis. Regular monitoring and immediate medical attention are necessary if any of these serious risks occur.

Andexxa - 5s should not be used in patients with known hypersensitivity to andexanet alfa or any of its components. It should also be used with caution in patients with pre-existing conditions that may be exacerbated by the medication. Always consult a healthcare professional for personalized advice.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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