Apixaban

MSN Laboratories ,

Torrent Pharmaceuticals Ltd

Apiban 2.5mg Tablet ,

Apixator 2.5mg Tablet

Pulmonary Embolism ,

Venous Thrombosis

DRUG STATUS

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Approvals

US. FDA / uk mhra / ema / pdma

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Essential Medicine

WHO / India

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Use in Pregnancy

Not Advised / Caution

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Pharmaceutical Class

ama / pdma

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Summary

  • Apixaban is used to prevent and treat blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). It's also used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, a type of irregular heartbeat. Additionally, it's prescribed to prevent blood clots after hip or knee replacement surgery.

  • Apixaban works by inhibiting a substance in your body called Factor Xa, which is crucial for blood clot formation. By blocking this, it prevents the formation of blood clots, reducing the risk of conditions like stroke, DVT, and PE. However, it doesn't significantly affect existing clots.

  • Typically, for atrial fibrillation, the dose is 5 mg twice daily or 2.5 mg twice daily for patients with certain risk factors. For DVT or PE treatment, the initial dose is 10 mg twice daily for 7 days, followed by 5 mg twice daily. Apixaban can be taken with or without food, and doses should be taken at the same times daily for consistent effect.

  • Common side effects include bleeding, such as nosebleeds, gum bleeding, or easy bruising. Significant adverse effects can include severe bleeding, like gastrointestinal or intracranial hemorrhage, and anemia due to blood loss. Rarely, allergic reactions or liver enzyme abnormalities may occur.

  • Apixaban is not recommended for use while breastfeeding or for patients with active bleeding, severe liver disease, or known hypersensitivity to the drug. It should be used cautiously in those at high risk of bleeding, such as after recent surgery. Discontinuing Apixaban suddenly increases the risk of blood clots. It's not safe for use in patients with prosthetic heart valves.

Indications and Purpose

How does Apixaban work?

Apixaban works by selectively inhibiting Factor Xa, an enzyme essential for the blood clotting process. By blocking Factor Xa, it prevents the formation of thrombin, which is necessary to produce fibrin and stabilize blood clots. This action reduces the risk of abnormal clot formation while maintaining blood flow, helping to prevent conditions like stroke, DVT, and PE.

How does one know if Apixaban is working?

The benefit of Apixaban is evaluated by monitoring the prevention of blood clots, such as stroke, deep vein thrombosis (DVT), or pulmonary embolism (PE). Clinical success is assessed through regular follow-ups, reviewing symptoms, and, if necessary, performing imaging tests or blood tests. Patients are also monitored for side effects, like bleeding, to ensure the treatment is safe and effective.

 

 

Is Apixaban effective?

Clinical trials, such as ARISTOTLE and AMPLIFY, have shown Apixaban to be highly effective in reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It demonstrated superiority or non-inferiority compared to warfarin in preventing blood clots while causing fewer bleeding complications. These studies also confirmed its effectiveness in treating and preventing DVT and PE.

 

 

What is Apixaban used for?

Apixaban is indicated for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Additionally, it is prescribed for the prevention of blood clots after hip or knee replacement surgery.

 

 

Directions for Use

How do I take Apixaban?

Apixaban can be taken with or without food. Patients should take it at the same times each day to maintain consistent blood levels. There are no specific food restrictions, but alcohol should be limited as it may increase the risk of bleeding. Always follow the prescribed dose and consult a healthcare provider for personalized advice.

 

 

How long does it take for Apixaban to start working?

Apixaban starts working quickly, with peak plasma concentration reached within 3 4 hours after taking a dose. This means its blood thinning effects begin relatively soon after ingestion.

How should I dispose of Apixaban?

Keep unused medicines out of reach of children and pets. Don't flush them down the toilet, as this can harm the environment. Instead, check if there's a medicine take-back program in your area where you can safely dispose of them.

How should I store Apixaban?

Store apixaban tablets in a cool, dry place at room temperature between 68°F to 77°F (20°C to 25°C). Keep them out of reach of children.

What are the consequences to stopping Apixaban?

If you stop taking apixaban, your chances of getting blood clots go back to what they were before you started taking it. This can happen as quickly as within 1 or 2 days of your last apixaban dose. If this happens, it means you're more likely to have major health challenges such as stroke, heart attack, deep vein thrombosis or pulmonary embolism.

What is Apixaban’s dose and duration?

The usual dosage of Apixaban for adults depends on the condition being treated. For atrial fibrillation, the dose is typically 5 mg twice daily, or 2.5 mg twice daily in patients with certain risk factors like advanced age or kidney issues. For DVT or PE treatment, the initial dose is 10 mg twice daily for 7 days, followed by 5 mg twice daily. It can be taken with or without food, and doses should be taken at the same times daily for consistent effect.

What should I do if I miss a dose of Apixaban?

If you forget to take your medicine, take it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and take your next dose as scheduled. Do not take double the dose to make up for the missed one.

Warnings and Precautions

Can Apixaban be taken safely while breastfeeding?

Apixaban is a blood thinner that is not generally recommended for use while breastfeeding. This is because it can pass into breast milk and may cause harm to the baby. If you are taking apixaban and need to breastfeed, talk to your doctor about other medications that may be safer for use during breastfeeding.

Can Apixaban be taken safely while pregnant?

If you are pregnant or plan to become pregnant, talk to your doctor before taking apixaban. There is not enough information about the safety of apixaban during pregnancy.

Can Apixaban be taken safely while trying to conceive?

Apixaban is a medication used to prevent blood clots. There is no proof that taking apixaban affects fertility in men or women.

Can I take Apixaban with other prescription drugs?

  1. Anticoagulants (e.g., warfarin, heparin) – increases the risk of bleeding.
  2. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) – can increase Apixaban levels, raising bleeding risk.
  3. CYP3A4 inducers (e.g., rifampin, carbamazepine) – may decrease Apixaban’s effectiveness.
  4. Antiplatelet drugs (e.g., aspirin, clopidogrel) – increases bleeding risk when combined with Apixaban.

 

Can I take Apixaban with vitamins or supplements?

Apixaban may interact with supplements that affect blood clotting. Fish oil, garlic, ginkgo biloba, and vitamin E can increase the risk of bleeding when taken with Apixaban. High doses of calcium or iron may interfere with absorption if taken simultaneously. Always consult a healthcare provider before starting or stopping any vitamins or supplements while using Apixaban.

 

 

What are Apixaban possible harms and risks?

Common side effects of Apixaban include bleeding, such as nosebleeds, gum bleeding, or easy bruising. Significant adverse effects can include severe bleeding (e.g., gastrointestinal or intracranial hemorrhage) and anemia due to blood loss. Rarely, allergic reactions or liver enzyme abnormalities may occur. Immediate medical attention is needed for signs of excessive bleeding or severe side effects.

 

 

Who should avoid taking Apixaban?

Apixaban is contraindicated in patients with active bleeding, severe liver disease, or a known hypersensitivity to the drug. It should be used cautiously in those at high risk of bleeding, such as after recent surgery or trauma. Discontinuing Apixaban suddenly increases the risk of blood clots. Patients with prosthetic heart valves should not use it, as its safety in this group is not established.

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