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Apixaban Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Anticoagulant

Subclass

Direct Oral Anticoagulant (DOAC) — Factor Xa inhibitor

Speciality

Haematology

Schedule (India)

Schedule H

Routes

Oral

Formulations

Tablets: 2.5 mg, 5 mg

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Non-Valvular Atrial Fibrillation (NVAF) — 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 — 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 1–7):

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 — 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	12–24 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: 10–14 days
Hip replacement: 32–38 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 – Adults Only (Off-label)

Indication	Dose	Duration	Supervision	Evidence Basis
Cancer-Associated Thrombosis — 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 — 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 – Paediatric (Off-label)

Treatment of VTE in Children — 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.

Renal Adjustments

Apixaban has dual elimination (approximately 27% renal, 73% hepatic) — 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 15–29 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 — limited data	Avoid — 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 6–12 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 15–29 mL/min) — limited data; use with caution
Elderly patients (≥75 years) — increased bleeding risk
Low body weight (<60 kg) — potential for increased drug exposure; consider dose reduction in NVAF
Concomitant use of antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor) — additive bleeding risk
Chronic NSAID use — 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 — risk of epidural/spinal haematoma:
- Delay apixaban for at least 20–30 hours after catheter removal
- Remove catheter at least 20–30 hours after last apixaban dose
Moderate hepatic impairment (Child-Pugh B) — increased exposure
Patients with antiphospholipid syndrome (especially triple-positive) — warfarin preferred
Extremes of body weight (>120 kg) — limited pharmacokinetic data
Prosthetic heart valves (bioprosthetic) — limited data; specialist decision

Pregnancy

Parameter	Details
Risk category	Not recommended — crosses placenta; potential for fetal bleeding; embryotoxicity in animal studies
Preferred alternatives	Low Molecular Weight Heparin (LMWH) — 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 — 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) — not excreted in breast milk; warfarin — 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 — 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 — 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 — avoid concomitant use
Other anticoagulants (warfarin, LMWH, UFH, fondaparinux, rivaroxaban, dabigatran)	Additive anticoagulant effect → major bleeding risk	Avoid — 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 — 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 (~1.5–2 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 — 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 — 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 — specific reversal agent (limited availability in India)
Prothrombin Complex Concentrate (PCC) — 4-factor PCC 25–50 units/kg
Tranexamic acid — adjunctive
Activated charcoal — if ingestion within 2–3 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) — 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 1–3 months (especially in elderly, CKD, acute illness)

Long-term Monitoring:

Renal function: Every 6–12 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	₹20–₹45
Tablet 5 mg	₹30–₹65

Formulation	Approximate Price per Tablet
Tablet 2.5 mg	₹20–₹45
Tablet 5 mg	₹30–₹65

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 — 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 — dual hepatic/renal elimination makes apixaban safest choice among DOACs when eGFR 15–30 mL/min
Dose reduction requires ≥2 criteria in NVAF — 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 — unlike rivaroxaban, apixaban bioavailability is unaffected by food; can be taken with or without meals
Twice daily dosing — remember BD dosing schedule; missed dose can be taken if remembered within 6 hours, otherwise skip and continue usual schedule
Not for valvular AF — contraindicated in mechanical prosthetic valves and moderate-to-severe rheumatic mitral stenosis; use warfarin for these patients
Reversal agent limited in India — andexanet alfa not widely available; PCC is the practical option for major bleeding requiring reversal

Version

RxIndia v1.0 — 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 — 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)

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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.

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