Apixaban Uses, Dosage, Side Effects & Warnings | DrugsAtlas
Authoritative Clinical Reference
Navigation
Therapeutic Class
Anticoagulant
Subclass
Direct Oral Anticoagulant (DOAC) ā Factor Xa inhibitor
Speciality
Haematology
Schedule (India)
Schedule H
Routes
Oral
Formulations
- Tablets: 2.5 mg, 5 mg
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Non-Valvular Atrial Fibrillation (NVAF) ā Prevention of Stroke and Systemic Embolism
Standard Dosing (Adults):
| Parameter | Recommendation |
|---|---|
| Starting dose | 5 mg orally twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 5 mg twice daily |
| Maximum dose | 10 mg/day (5 mg twice daily) |
Reduced Dose Criteria ā Use 2.5 mg twice daily if patient has ≥2 of the following:
- Age ≥80 years
- Body weight ≤60 kg
- Serum creatinine ≥1.5 mg/dL
| Parameter | Recommendation |
|---|---|
| Starting dose | 2.5 mg orally twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 2.5 mg twice daily |
| Maximum dose | 5 mg/day (2.5 mg twice daily) |
Clinical Notes:
- May be taken with or without food
- Contraindicated in valvular AF (mechanical prosthetic valves, moderate-to-severe mitral stenosis)
- If only one dose-reduction criterion present, use standard 5 mg twice daily dose
2. Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
Acute Treatment Phase (Days 1ā7):
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg orally twice daily |
| Titration | Not applicable during loading phase |
| Duration | 7 days |
| Maximum dose | 20 mg/day |
Maintenance Phase (Day 8 onwards):
| Parameter | Recommendation |
|---|---|
| Starting dose | 5 mg orally twice daily (from Day 8) |
| Titration | Not applicable |
| Usual maintenance dose | 5 mg twice daily |
| Maximum dose | 10 mg/day |
Clinical Notes:
- Minimum treatment duration: 3 months
- Provoked VTE with reversible risk factor: 3 months usually sufficient
- Unprovoked or recurrent VTE: consider extended therapy
- Reassess bleeding risk periodically during long-term treatment
3. Prevention of Recurrent DVT and PE (Extended Secondary Prevention)
Adults ā After Completion of Initial 6 Months of Anticoagulation:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2.5 mg orally twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 2.5 mg twice daily |
| Maximum dose | 5 mg/day |
Clinical Notes:
- Initiate after completing at least 6 months of standard therapeutic anticoagulation
- Periodically reassess need for continued therapy versus bleeding risk
- May be taken with or without food
4. Prophylaxis of Venous Thromboembolism (VTE) after Elective Hip or Knee Replacement Surgery
Adults:
| Parameter | Recommendation |
|---|---|
| Starting dose | 2.5 mg orally twice daily |
| Timing of first dose | 12ā24 hours post-surgery, after haemostasis established |
| Titration | Not applicable |
| Usual maintenance dose | 2.5 mg twice daily |
| Maximum dose | 5 mg/day |
Duration:
- Knee replacement: 10ā14 days
- Hip replacement: 32ā38 days
Clinical Notes:
- May be taken with or without food
- Delay initiation if surgical haemostasis concerns present
- Avoid if neuraxial catheter in situ; see Cautions for timing recommendations
Secondary Indications ā Adults Only (Off-label)
| Indication | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|
|
Cancer-Associated Thrombosis ā OFF-LABEL
|
10 mg BD × 7 days, then 5 mg BD | Minimum 6 months; continue while cancer active or on treatment | Specialist only (Oncology/Haematology) | CARAVAGGIO trial; non-inferior to dalteparin with lower major bleeding |
|
Left Ventricular Thrombus ā OFF-LABEL
|
5 mg twice daily (or 2.5 mg BD if dose-reduction criteria met) | Minimum 3 months; reassess with imaging | Specialist only (Cardiology) | Observational studies; emerging Indian cardiology practice |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Regulatory Status: NOT approved for paediatric use in India.
Age Restriction: Not recommended below 18 years of age.
Secondary Indications ā Paediatric (Off-label)
Treatment of VTE in Children ā OFF-LABEL
- NOT RECOMMENDED for routine paediatric use in India
- Paediatric dosing formulations NOT AVAILABLE in India
- International weight-band based dosing exists but not established in Indian protocols
- Use only in exceptional circumstances under specialist paediatric haematology supervision
- LMWH (enoxaparin) remains preferred anticoagulant for paediatric VTE in India
Minimum Age Statement:
Not recommended below 18 years of age except in highly specialised settings with paediatric haematology or cardiology supervision.
Not recommended below 18 years of age except in highly specialised settings with paediatric haematology or cardiology supervision.
Renal Adjustments
Apixaban has dual elimination (approximately 27% renal, 73% hepatic) ā less affected by renal impairment compared to other DOACs:
| Renal Function | NVAF Indication | VTE Treatment/Prophylaxis |
|---|---|---|
| eGFR ≥30 mL/min | Standard dosing (apply dose-reduction criteria for NVAF) | Standard dosing |
| eGFR 15ā29 mL/min | Use with caution; 2.5 mg BD if dose-reduction criteria apply | Use with caution; limited data |
| eGFR <15 mL/min (not on dialysis) | Avoid ā limited data | Avoid ā limited data |
| End-Stage Renal Disease on Haemodialysis | May be used with caution at 5 mg BD (or 2.5 mg BD if dose-reduction criteria met); limited data | Limited data; use with caution |
Notes:
- Serum creatinine ≥1.5 mg/dL is one of the three dose-reduction criteria for NVAF (when ≥2 criteria present)
- Monitor renal function every 6ā12 months in stable patients
- More frequent monitoring during acute illness or if receiving nephrotoxic drugs
Hepatic adjustment
Contraindications
- Active clinically significant bleeding (including GI, intracranial, or any site)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Known hypersensitivity to apixaban or any excipient
- Lesions at high risk of clinically significant bleeding (e.g., active peptic ulcer, recent brain/spinal surgery, intracranial neoplasm, arteriovenous malformation)
- Valvular atrial fibrillation:
-
- Mechanical prosthetic heart valves (any position)
- Moderate-to-severe mitral stenosis (usually rheumatic)
- Concomitant treatment with any other anticoagulant (except during transition periods)
- Concomitant use with strong dual CYP3A4 and P-glycoprotein inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- Concomitant use with strong dual CYP3A4 and P-glycoprotein inducers (e.g., rifampicin, phenytoin, carbamazepine)
Cautions
- Moderate renal impairment (eGFR 15ā29 mL/min) ā limited data; use with caution
- Elderly patients (≥75 years) ā increased bleeding risk
- Low body weight (<60 kg) ā potential for increased drug exposure; consider dose reduction in NVAF
- Concomitant use of antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor) ā additive bleeding risk
- Chronic NSAID use ā increased GI bleeding risk
- Recent major surgery or trauma
- History of GI bleeding, peptic ulcer disease, or GI malignancy
- Active malignancy with high bleeding risk
- Uncontrolled severe hypertension
- Neuraxial anaesthesia or spinal puncture ā risk of epidural/spinal haematoma:
-
- Delay apixaban for at least 20ā30 hours after catheter removal
- Remove catheter at least 20ā30 hours after last apixaban dose
- Moderate hepatic impairment (Child-Pugh B) ā increased exposure
- Patients with antiphospholipid syndrome (especially triple-positive) ā warfarin preferred
- Extremes of body weight (>120 kg) ā limited pharmacokinetic data
- Prosthetic heart valves (bioprosthetic) ā limited data; specialist decision
Pregnancy
| Parameter | Details |
|---|---|
| Risk category | Not recommended ā crosses placenta; potential for fetal bleeding; embryotoxicity in animal studies |
| Preferred alternatives | Low Molecular Weight Heparin (LMWH) ā enoxaparin is anticoagulant of choice during pregnancy in India |
| When may be used | Only in exceptional circumstances if LMWH absolutely contraindicated and no alternative exists; requires specialist decision (haematology/obstetrics) |
| Monitoring | If inadvertent exposure: maternal bleeding assessment; fetal ultrasound for anomalies; plan delivery with haematology input |
Lactation
| Parameter | Details |
|---|---|
| Compatibility | Not recommended ā insufficient human data on excretion in breast milk |
| Drug levels in milk | Unknown; expected to be low due to high protein binding (~87%) |
| Preferred alternatives | LMWH (enoxaparin) ā not excreted in breast milk; warfarin ā compatible with breastfeeding |
| Infant monitoring | If maternal exposure: monitor infant for bruising, bleeding, feeding difficulties |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | 5 mg twice daily (standard); use 2.5 mg twice daily if ≥2 dose-reduction criteria present (age ≥80 + weight ≤60 kg or creatinine ≥1.5 mg/dL) |
| Titration | Not applicable ā fixed dosing |
| Special risks | Increased bleeding risk (particularly GI and intracranial); higher prevalence of renal impairment; falls risk; polypharmacy with interacting drugs; cognitive impairment affecting adherence |
| Monitoring | Renal function at baseline and every 6 months; more frequently during acute illness; regular clinical assessment for bleeding |
Note: Age ≥80 years alone is not sufficient for dose reduction in NVAF; requires at least one additional criterion (weight ≤60 kg OR serum creatinine ≥1.5 mg/dL).
Major drug interactions
| Drug/Class | Mechanism/Effect | Recommendation |
|---|---|---|
| Strong CYP3A4 + P-gp inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, lopinavir) | Marked increase in apixaban exposure → high bleeding risk |
Contraindicated ā avoid concomitant use
|
| Strong CYP3A4 + P-gp inducers (rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) | Significant reduction (~50%) in apixaban levels → loss of efficacy |
Contraindicated ā avoid concomitant use
|
| Other anticoagulants (warfarin, LMWH, UFH, fondaparinux, rivaroxaban, dabigatran) | Additive anticoagulant effect → major bleeding risk |
Avoid ā exception: brief overlap during transition (specialist supervision)
|
| Thrombolytics (alteplase, tenecteplase, streptokinase) | Markedly increased bleeding risk |
Avoid concomitant use; hold apixaban during thrombolysis
|
| Dual antiplatelet therapy (DAPT ā aspirin + P2Y12 inhibitor) | Significantly increased bleeding risk | Use with extreme caution; triple therapy duration should be minimised; specialist decision |
Moderate drug interactions
| Drug/Class | Effect | Recommendation |
|---|---|---|
| Moderate CYP3A4 and/or P-gp inhibitors (erythromycin, clarithromycin, diltiazem, verapamil, amiodarone, dronedarone, fluconazole) | Modest increase in apixaban levels (~1.5ā2 fold) | Use with caution; no routine dose adjustment but monitor for bleeding; consider 2.5 mg BD in high-risk patients |
| Single antiplatelet (aspirin ≤100 mg, clopidogrel) | Increased bleeding risk | Use only when clinically indicated; monitor for bleeding |
| NSAIDs (diclofenac, ibuprofen, naproxen) | Increased GI and overall bleeding risk | Avoid chronic use; if short-term use required, consider gastroprotection |
| SSRIs/SNRIs (fluoxetine, sertraline, venlafaxine, duloxetine) | Increased bleeding tendency (platelet effect) | Monitor for bleeding; counsel patient |
| Naproxen | Increased GI bleeding risk; modest increase in apixaban exposure | Avoid if possible; use short courses only |
Common Adverse effects
- Bleeding ā minor (epistaxis, gingival bleeding, bruising, menorrhagia, haematuria)
- Anaemia (may indicate occult blood loss)
- Nausea
- Contusion / ecchymosis
- Elevated transaminases (usually mild and transient)
- Fatigue
Serious Adverse effects
| Adverse Effect | Clinical Action |
|---|---|
| Major bleeding (GI haemorrhage, intracranial haemorrhage, retroperitoneal bleeding) |
Immediate discontinuation; supportive care; consider reversal agent (andexanet alfa if available) or Prothrombin Complex Concentrate (PCC); hospitalisation
|
| Spinal/Epidural haematoma (with neuraxial procedures) |
Emergency ā can cause permanent paralysis; urgent neurosurgical consultation
|
| Severe hypersensitivity/Anaphylaxis | Discontinue immediately; emergency management |
| Hepatotoxicity (rare) | Discontinue if significant transaminase elevation (>3× ULN with symptoms) |
| Thrombocytopenia (rare) | Monitor; may need to discontinue |
Reversal in Major Bleeding:
- Andexanet alfa ā specific reversal agent (limited availability in India)
- Prothrombin Complex Concentrate (PCC) ā 4-factor PCC 25ā50 units/kg
- Tranexamic acid ā adjunctive
- Activated charcoal ā if ingestion within 2ā3 hours
- No role for FFP, vitamin K, or protamine
Monitoring requirements
Baseline:
- Complete blood count (haemoglobin, platelet count)
- Renal function (serum creatinine, calculated CrCl or eGFR)
- Liver function tests (transaminases, bilirubin)
- Coagulation screen (PT/INR, aPTT) ā for baseline documentation only, not for monitoring efficacy
- Weight and age assessment for dose-reduction criteria in NVAF
- Bleeding risk assessment (HAS-BLED score for AF patients)
After Initiation / Dose Change:
- Clinical assessment for bleeding at 1 month
- Haemoglobin if bleeding suspected
- Renal function at 1ā3 months (especially in elderly, CKD, acute illness)
Long-term Monitoring:
- Renal function: Every 6ā12 months in stable patients; more frequently if eGFR <60 or at-risk (elderly, diabetes, heart failure, dehydration, nephrotoxic drugs)
- Haemoglobin: Annually or if bleeding symptoms
- Liver function: Annually or if symptoms suggestive of hepatotoxicity
- Clinical bleeding assessment at every visit
- Reassess indication and bleeding risk annually
- Reassess dose-reduction criteria in NVAF if clinical status changes
Note: Routine coagulation monitoring (PT/INR, aPTT) not required and not reliable for assessing apixaban effect. Anti-Xa chromogenic assay (apixaban-calibrated) may be used in special situations (overdose, emergency surgery, extremes of body weight).
Brands in India
Originator:
- Eliquis (Pfizer/BMS)
Generic/Licensed Brands:
- Apigat (Lupin)
- Apiblitz (Glenmark)
- Apixaban (Cipla)
- Apixano (Dr. Reddy's)
- Apixamed (Medley)
- Apiban (Sun Pharma)
- Apixa (Torrent)
- Xareliq (Alkem)
Price range (INR)
| Formulation | Approximate Price per Tablet |
|---|---|
| Tablet 2.5 mg | ā¹20āā¹45 |
| Tablet 5 mg | ā¹30āā¹65 |
| Formulation | Approximate Price per Tablet |
|---|---|
| Tablet 2.5 mg | ā¹20āā¹45 |
| Tablet 5 mg | ā¹30āā¹65 |
- Not currently under NPPA price control
- Not included in NLEM 2022
- Significant price variation between originator and generic brands
- Generic options substantially more affordable
- Government supply mostly limited to tertiary care centres
Clinical pearls
- Lower GI bleeding risk than rivaroxaban ā apixaban often preferred in patients with GI bleeding history or elderly patients due to lower GI bleeding rates in clinical trials
- Preferred DOAC in renal impairment ā dual hepatic/renal elimination makes apixaban safest choice among DOACs when eGFR 15ā30 mL/min
- Dose reduction requires ≥2 criteria in NVAF ā common error is reducing dose with only one criterion present (e.g., age ≥80 alone); this leads to under-dosing and increased stroke risk
- No food requirement ā unlike rivaroxaban, apixaban bioavailability is unaffected by food; can be taken with or without meals
- Twice daily dosing ā remember BD dosing schedule; missed dose can be taken if remembered within 6 hours, otherwise skip and continue usual schedule
- Not for valvular AF ā contraindicated in mechanical prosthetic valves and moderate-to-severe rheumatic mitral stenosis; use warfarin for these patients
- Reversal agent limited in India ā andexanet alfa not widely available; PCC is the practical option for major bleeding requiring reversal
Version
RxIndia v1.0 ā 05 Jun 2025
Reference
-
- CDSCO approved product inserts
- Indian Pharmacopoeia
- National Formulary of India
- API Textbook of Medicine
- AIIMS Anticoagulation Protocols
- Cardiological Society of India ā AF and VTE management recommendations
- Harrison's Principles of Internal Medicine (supportive)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)
- ARISTOTLE, AMPLIFY, ADVANCE trials (for indication context)
- CARAVAGGIO trial (for cancer-associated VTE off-label context)
āļø
Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
Content Feedback
Is this information helpful?
Help us improve our clinical database for the medical community.