Medicine Information

Apixa

Name: Apixa
Brand: Apixa
Rating: 4.5 (117 reviews)

Tablet2.5 mgAnticoagulants (Direct Factor Xa Inhibitors)ATC: B01AF02

Generic Name

Apixaban

Manufacturer

Meditopix Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
apixa 25 mg tablet	৳ 15.00	৳ 150.00

Description

Overview of the medicine

Apixaban is an oral anticoagulant that selectively and reversibly inhibits Factor Xa, preventing thrombin generation and blood clot formation. It is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF), for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prophylaxis of DVT following hip or knee replacement surgery.

Uses & Indications

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery.

Dosage

Adults

For NVAF: 5 mg orally twice daily. Dose reduction to 2.5 mg twice daily may be considered in patients with at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL. For DVT/PE treatment: 10 mg orally twice daily for 7 days, followed by 5 mg orally twice daily. For DVT prophylaxis after hip/knee replacement: 2.5 mg orally twice daily.

Elderly

Dose reduction may be needed for NVAF if also meeting other criteria (weight, creatinine). No general reduction for DVT/PE treatment or prophylaxis.

Renal_impairment

For NVAF, reduce dose to 2.5 mg twice daily if serum creatinine ≥ 1.5 mg/dL AND age ≥ 80 years or body weight ≤ 60 kg. Avoid in severe renal impairment (CrCl < 15 mL/min) or on dialysis.

How to Take

Apixaban tablets can be taken with or without food. For patients unable to swallow whole tablets, Apixaban tablets may be crushed and suspended in water, 5% dextrose in water (D5W), or apple juice, or mixed with apple sauce, and administered immediately.

Mechanism of Action

Apixaban is a selective, reversible, direct inhibitor of Factor Xa. By inhibiting Factor Xa, apixaban prevents the conversion of prothrombin to thrombin and subsequently thrombus formation. It does not require antithrombin III for antithrombotic activity.

Pharmacokinetics

Onset

Within a few hours.

Excretion

Approximately 27% of the dose is recovered as unchanged drug in urine, and approximately 25% is recovered in feces.

Half life

Approximately 12 hours.

Absorption

Absolute bioavailability is approximately 50% for doses up to 10 mg. Peak concentrations occur 3-4 hours after oral administration.

Metabolism

Primarily metabolized via CYP3A4/5, with minor contributions from CYP1A2, 2C8, 2C9, 2C19, and 2J2.

Side Effects

Contraindications

Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
Hypersensitivity to apixaban or any component of the formulation.
Severe hepatic impairment.

Drug Interactions

Other Anticoagulants/Antiplatelet Agents (e.g., heparin, warfarin, aspirin, NSAIDs)

Increased risk of bleeding.

Strong Dual Inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)

Decreased apixaban exposure; avoid concomitant use.

Strong Dual Inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir)

Increased apixaban exposure; dose reduction to 2.5 mg twice daily may be necessary in some NVAF patients.

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.

Overdose

Overdose of apixaban increases the risk of bleeding. Activated charcoal may be considered to reduce absorption if administered soon after overdose. A specific antidote, andexanet alfa, is available for reversal of Factor Xa inhibitors.

Pregnancy & Lactation

Pregnancy Category B. Use only if potential benefit outweighs potential risk to the fetus. Bleeding risk during pregnancy and delivery. Excretion in human milk is unknown; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

Blister pack of 10 tabletsBox of 30 tablets

Shelf Life

Typically 24 to 36 months from the date of manufacture, specific to manufacturer.

Availability

Pharmacies, Hospitals

Approval Status

FDA Approved

Patent Status

Patented by Bristol-Myers Squibb and Pfizer

Clinical Trials

Apixaban was extensively studied in key clinical trials: ARISTOTLE (comparing apixaban to warfarin in NVAF), AVERROES (apixaban vs. aspirin in NVAF patients unsuitable for VKAs), AMPLIFY (apixaban vs. enoxaparin/warfarin for DVT/PE treatment), and AMPLIFY-EXT (extended apixaban vs. placebo for DVT/PE prevention).

Lab Monitoring

Routine coagulation monitoring (e.g., PT, aPTT, INR) is not required for assessing the anticoagulant effect. Periodic assessment of renal function, liver function, and complete blood counts (CBC) may be appropriate.

Doctor Notes

Thoroughly assess bleeding risk factors (e.g., age, renal function, concomitant medications) before initiating and periodically during apixaban treatment.
Consider dose adjustments for NVAF based on age, body weight, and serum creatinine. No dose adjustment is recommended for DVT/PE treatment or prophylaxis based on these factors alone.
Educate patients on the critical importance of medication adherence and recognition of bleeding signs/symptoms. Provide clear instructions for missed doses.
Avoid concomitant use with other anticoagulants or strong dual inhibitors/inducers of CYP3A4 and P-gp unless benefits outweigh risks and careful monitoring is ensured.

Patient Guidelines

Take exactly as prescribed by your doctor. Do not stop taking Apixaban without consulting your doctor, as this may increase your risk of stroke or blood clots.
Be aware of signs of bleeding (unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools, severe headaches) and report them immediately to your doctor.
Inform your doctor or dentist that you are taking apixaban before any surgery or dental procedure.
Avoid missing doses. If a dose is missed, take it as soon as you remember, then continue with your regular schedule. Do not take two doses at once to make up for a missed dose.

Missed Dose Advice

If a dose is missed, the patient should take Apixaban as soon as possible and then continue with two doses per day as recommended. Do not double the dose to make up for a missed dose.

Driving Precautions

Apixaban is not known to directly impair the ability to drive or use machines. However, if side effects like dizziness or vision disturbances occur, patients should avoid driving or operating machinery.

Lifestyle Advice

Avoid activities with a high risk of injury or falls, which could lead to bleeding.
Maintain good oral hygiene to reduce the risk of gum bleeding.
Limit alcohol intake, as excessive alcohol can increase the risk of bleeding.