apixaban

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Related to Eliquis: Apixaban, Pradaxa, Xarelto

apixaban

(a-pix-a-ban) ,

Eliquis

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: factor xa inhibitors
Pregnancy Category: B

Indications

Decreases risk of stroke/systemic embolism associated with nonvalvular atrial fibrillation.

Action

Acts as a selective, reversible site inhibitor of factor Xa, inhibiting both free and bound factor. Does not affect platelet aggregation directly, but does inhibit thrombin-induced platelet aggregation. Decreases thrombin generation and thrombus development.

Therapeutic effects

Decreased thrombotic events associated with atrial fibrillation including stroke and systemic embolization.

Pharmacokinetics

Absorption: 50% absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: 25% metabolized (mostly by CYP3A4) and excreted in urine and feces. Biliary and direct intestinal excretion account for fecal elimination.
Half-life: 6 hr (12 hr after repeated dosing due to prolonged absorption).

Time/action profile (effect on hemostasis)

ROUTEONSETPEAKDURATION
POunknown3–4 hr†24 hr
†Blood levels.

Contraindications/Precautions

Contraindicated in: Previous severe hypersensitivity reactionsActive pathological bleedingSevere hepatic impairment;Not recommended for use in patients with prosthetic heart valves;Concurrent use of strong dual inducers of CYP3A4 and P-gp; Lactation: Should not be used.
Use Cautiously in: Discontinuation increases the risk of thromboses;Surgery;Renal impairment (dose reduction required for serum creatinine ≥1.5 mg/dL);Moderate hepatic impairment (↑ risk of bleeding);Concurrent use of strong dual inhibitors of CYP3A4 and P-gp systems (dose reduction required); Obstetric: Use during pregnancy only if potential benefit outweighs possible risks to mother and fetus; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Hematologic

  • bleeding

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

↑ risk of bleeding with other anticoagulants, fibrinolytics, heparins, NSAIDs, SNRIs, SSRIs, or thrombolytics.Concurrent use of strong inhibitors of both the CYP3A4 and P-gP enzyme systems (including clarithromycin, itraconazole, ketoconazole, and ritonavir ) ↑ levels and bleeding risk; dosage of apixaban should be ↓ to 2.5 mg twice daily. If other reasons for ↓ dose exist, apixaban should be avoided.Inducers of the CYP3A4 enzyme system and the P-gp system including carbamzepine, phenytoin, rifampin will ↓ levels and may ↑ risk of thromboses.Concurrent use St. John's wort, a strong dual inducer of the CYP3A4 and P-gp enzyme systems can ↓ levels and ↑risk of thromboses and should be avoided.

Route/Dosage

Oral (Adults) 5 mg twice daily; ≥80 yr or body weight ≤60 kg or concurrent use of strong inhibitors of both the CYP3A4 and P-gP enzyme systems—2.5 mg twice daily.

Renal Impairment

Oral (Adults) Serum creatinine ≥1.5mg/dL—2.5 mg twice daily.

Availability

Tablets: 2.5 mg, 5 mg

Nursing implications

Nursing assessment

  • Assess patient for symptoms of stroke or peripheral vascular disease periodically during therapy.

Potential Nursing Diagnoses

Activity intolerance

Implementation

  • When converting from warfarin, discontinue warfarin and start apixaban when INR is <2.0.
  • When converting from apixaban to warfarin, apixaban affects INR, so INR measurements may not be useful for determining appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue apixaban and begin both a parenteral anticoagulant and warfarin at time of next dose of apixaban, dicontinue parenteral anticoagulant when INR reaches acceptable range.
  • When switching between apixaban and anticoagulants other than warfarin, discontinue one being taken and begin the other at the next scheduled dose.
  • For surgery, discontinue apixaban at least 48 hrs before invasive or surgical procedures with a moderate or high risk of unacceptable or clinically significant bleeding or at least 24 hrs prior to procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
  • Oral: Administer twice daily without regard to food.

Patient/Family Teaching

  • Instruct patient to take apixaban as directed. Take missed doses as soon as remembered on the same day and resume twice daily administration; do not double doses. Do not discontinue without consulting health care professional; may increase risk of having a stroke. If temporarily discontinued, restart as soon as possible. Store apixaban at room temperature. Advise patient to read Medication Guide before beginning therapy and with each Rx refill in case of changes.
  • Inform patient that they may bruise and bleed more easily or longer than usual. Advise patient to notify health care professional immediately if signs of bleeding (unusual bruising, pink or brown urine, red or black, tarry stools, coughing up blood, vomiting blood, pain or swelling in a joint, headache, dizziness, weakness, recurring nose bleeds, unusual bleeding from gums, heavier than normal menstrual bleeding, dyspepsia, abdominal pain, epigastric pain) occurs or if injury occurs, especially head injury.
  • Caution patient to notify health care professional if skin rash or signs of severe allergic reaction (chest pain or tightness, swelling of face or tongue, trouble breathing or wheezing, feeling dizzy or faint) occur.
  • Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Risk of bleeding is increased with aspirin, NSAIDs, warfarin, heparin, SSRIs or SNRIs.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Reduction in the risk of stroke and systemic embolism.
References in periodicals archive ?
Strong operational performance from GIP was on the back of recent product launches, including Eliquis globally and Xeljanz in the US, coupled with impressive performance of Lyrica in the US and Japan and Viagra in the US.
Others who can afford it are able to take Eliquis, which is also prescribed by neurologists and cardiologists but doesn't need the same routine monitoring.
The company's slightly older immunotherapy drug, Yervoy, posted $325 million in sales, while sales of clot-preventer Eliquis more than tripled to $355 million and the new hepatitis C franchise posted a combined $264 million.
Pfizer and Bristol-Myers, both based in New York, said Friday advisers to the European Medicines Agency have issued a positive opinion on Eliquis for use in patients with the irregular rhythm called a trial fibrillation if it's not caused by a heart valve problem.
said, "The profile of ELIQUIS, combined with the strong legacy and complementary capabilities that Pfizer and Bristol-Myers Squibb have in the cardiovascular space, positions us well to deliver this important new treatment option to patients and health care professionals.
This approval in Japan is based on ARISTOTLE, the Phase 3 trial carried out in 18,201 NVAF patients, which examined the safety and efficiency of ELIQUIS against warfarin.
Bristol-Myers Squibb and Pfizer will provide additional information on the FDA approval of Eliquis in a separate press release, to be issued next week.
Dabigatran (Pradaxa) - Rivaroxaban (Xarelto) - Eliquis (Apixaban) - Edoxaban - Betrixaban - Antiplatelets - Clotting Assays - Cardiovascular Diseases - Cardiac Arrhythmia - Coronary Artery Disease - Myocardial Infarction - Heart Valve Replacement - Deep Vein Thrombosis (DVT)
ELIQUIS is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death.
para]]NEW YORK, June 16, 2015 /PRNewswire/ -- The New York City law firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP this week commenced a lawsuit involving the bleeding to death of a user of the new blood anticoagulant Eliquis.
Eliquis has recently received FDA approval and will soon capture a predominant share of the novel oral anticoagulant market.