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Direct Oral Factor Xa Inhibitor — VTE / AF Stroke Prevention Pregnancy: There are no data from the use of apixaban in pregnant women; animal studies do not indicate reproductive toxicity, but as a precautionary measure it is preferable to avoid use during pregnancy. It is unknown whether apixaban or its metabolites are excreted in human milk and a risk to the suckling child cannot be excluded — a decision must be made whether to discontinue breast-feeding or apixaban therapy.

Apixaban

Brand names: Eliquis

Apixaban is an oral direct factor Xa inhibitor (a direct-acting oral anticoagulant) used to prevent and treat venous thromboembolism and to prevent stroke in non-valvular atrial fibrillation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF): 5 mg twice daily — reduced to 2.5 mg twice daily in patients with at least two of the following: age 80 years or over, body weight 60 kg or less, or serum creatinine 1.5 mg/dL (133 micromol/L) or above. Treatment of DVT and treatment of PE: 10 mg twice daily for the first 7 days, followed by 5 mg twice daily
Route: Oral, with or without food
Frequency: Twice daily
Max: Maximum daily dose 20 mg (10 mg twice daily) during the first 7 days of DVT/PE treatment; 10 mg daily thereafter; 5 mg daily for prevention of recurrent DVT and/or PE
OTHER REGIMENS IN THE SAME SPC — Prevention of recurrent DVT and/or PE: 2.5 mg twice daily, initiated following completion of 6 months of treatment with apixaban 5 mg twice daily or with another anticoagulant; short duration of DVT/PE treatment (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation), and the duration of overall therapy should be individualised after careful assessment of treatment benefit against bleeding risk. Prevention of VTE after elective hip or knee replacement surgery (VTEp): 2.5 mg twice daily, with the initial dose taken 12 to 24 hours after surgery; recommended duration 32 to 38 days after hip replacement and 10 to 14 days after knee replacement. NVAF therapy should be continued long-term. MISSED DOSE: take immediately and then continue with twice daily intake as before. SWITCHING: to/from parenteral anticoagulants at the next scheduled dose (not simultaneously); from a vitamin K antagonist, stop the VKA and start apixaban when INR is below 2; to a VKA, continue apixaban for at least 2 days after beginning VKA therapy, then check INR before the next apixaban dose and continue coadministration until INR is 2 or above. CARDIOVERSION (NVAF): apixaban can be initiated or continued; for patients initiating treatment, 5 mg twice daily for at least 2.5 days (5 single doses) before cardioversion (reduced to 2.5 mg twice daily if dose-reduction criteria are met); if cardioversion is required before 5 doses can be given, a 10 mg loading dose followed by 5 mg twice daily (or a 5 mg loading dose followed by 2.5 mg twice daily if dose-reduction criteria are met), with the loading dose given at least 2 hours before cardioversion. CATHETER ABLATION: patients can continue apixaban. Elderly and body weight: no dose adjustment required for VTEp/VTEt; for NVAF no adjustment unless dose-reduction criteria are met. Hepatic impairment: contraindicated in hepatic disease associated with coagulopathy and clinically relevant bleeding risk; not recommended in severe hepatic impairment; use with caution in mild or moderate impairment (no dose adjustment required); perform liver function testing before initiating. PAEDIATRIC: safety and efficacy in children and adolescents below age 18 have not been established and no recommendation on a posology can be made. SOURCE SCOPE: this entry is from the UK SPC for Apixaban 1 mg/1 mL Oral suspension, which expresses each dose as milligrams with the equivalent suspension volume (e.g. 5 mg = 5 mL); only the milligram doses are reproduced above. Confirm against the tablet SPC if this page is intended to describe apixaban tablets.

Dose adjustments

Renal

Mild or moderate renal impairment: no dose adjustment necessary for VTEp or VTEt; for NVAF, a dose reduction to 2.5 mg twice daily is required where serum creatinine is 1.5 mg/dL (133 micromol/L) or above in association with age 80 years or over or body weight 60 kg or less, otherwise no adjustment. Severe renal impairment (creatinine clearance 15-29 mL/min): use with caution for VTEp and VTEt; for NVAF, patients should receive the lower dose of 2.5 mg twice daily. Creatinine clearance below 15 mL/min or patients undergoing dialysis: there is no clinical experience, therefore apixaban is not recommended.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Active clinically significant bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
  • Lesion or condition considered a significant risk factor for major bleeding — including current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
  • Concomitant treatment with any other anticoagulant agent (e.g. unfractionated heparin, low molecular weight heparins, heparin derivatives, oral anticoagulants such as warfarin, rivaroxaban or dabigatran) except under specific circumstances of switching anticoagulant therapy, when UFH is given at doses necessary to maintain an open central venous or arterial catheter, or when UFH is given during catheter ablation for atrial fibrillation

Side effects

  • Haemorrhage and haematoma (common) — the overall incidence of bleeding-related adverse reactions was 24.3% in the NVAF apixaban vs warfarin study and 15.6% in the VTEt apixaban vs enoxaparin/warfarin study
  • Contusion and epistaxis (common)
  • Anaemia (common); thrombocytopenia (common in VTEt, uncommon in VTEp and NVAF)
  • Eye haemorrhage including conjunctival haemorrhage (common in NVAF); brain haemorrhage (uncommon in NVAF)
  • Hypotension including procedural hypotension (common in NVAF); haemoptysis (uncommon); hypersensitivity, allergic oedema, anaphylaxis and angioedema (uncommon to rare/not known)

Interactions

  • Any other anticoagulant — concomitant treatment is contraindicated due to increased bleeding risk (SPC §4.3)
  • Antiplatelet agents including acetylsalicylic acid — increase the risk of bleeding; following surgery, other platelet aggregation inhibitors are not recommended concomitantly (SPC §4.4)
  • SSRIs, SNRIs and NSAIDs including acetylsalicylic acid — care is to be taken due to bleeding risk (SPC §4.4)
  • Combined P-gp and strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) — increase apixaban exposure and bleeding risk; decrease the apixaban dose by 50% for patients on 5 mg or 10 mg twice daily, and avoid coadministration in patients on 2.5 mg twice daily (US labelling §7.1)
  • Combined P-gp and strong CYP3A4 inducers — reduce apixaban exposure and increase the risk of stroke and other thromboembolic events; avoid concomitant use (US labelling §7.2)
  • PROVENANCE: UK SPC §4.5 was not captured in the source bundle; the last two entries are taken from the US labelling in the same bundle and should be confirmed against the UK SPC

Clinical monograph

How it works

It directly and reversibly inhibits activated factor Xa, reducing thrombin generation and clot formation.

Prescribing in practice

  • The main risk is bleeding, so it is contraindicated with active clinically significant haemorrhage and used cautiously with other antithrombotic drugs and in high bleeding-risk states.
  • It is not suitable for patients with mechanical heart valves or moderate-to-severe mitral stenosis.
  • Dose and suitability depend on renal function, age and weight, and exposure is altered by combined strong CYP3A4 and P-glycoprotein inhibitors or inducers.

Monitoring

Assess renal and hepatic function and bleeding risk before starting and at least annually, with no routine coagulation monitoring required.

Counselling the patient

  • Take regularly as prescribed and do not stop without advice, as this raises clot risk.
  • Report unusual bruising, bleeding or black stools, and tell other clinicians you take an anticoagulant.

Evidence & guidelines

The ARISTOTLE and AMPLIFY trials established apixaban's efficacy and favourable bleeding profile in atrial fibrillation and venous thromboembolism.

Reference: AMPLIFY Trial; ARISTOTLE Trial; NICE TA341 (Apixaban for VTE); NICE TA275 (Apixaban for AF); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.