PIXAR APIXABAN SPC 2.5/MG TAB 60/TAB

Indications

Approved Uses

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, Prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery, Treatment of DVT and pulmonary embolism (PE), To reduce the risk of recurrent DVT and PE after initial therapy.

Off-Label Uses

Common off-label uses include left ventricular thrombus and selected cancer-associated thrombosis scenarios (institution- and guideline-dependent).

Dosage & Administration

Dosing by Condition

Nonvalvular AF (stroke/systemic embolism prevention): 5 mg twice daily (reduce to 2.5 mg twice daily if ≥2 of age ≥80, weight ≤60 kg, SCr ≥1.5 mg/dL); DVT/PE treatment: 10 mg twice daily for 7 days then 5 mg twice daily; Prevention of recurrent DVT/PE: 2.5 mg twice daily after at least 6 months of treatment; VTE prophylaxis after hip replacement: 2.5 mg twice daily for 35 days starting 12-24 hours post-op; VTE prophylaxis after knee replacement: 2.5 mg twice daily for 12 days starting 12-24 hours post-op.

Initial Dose

2.5 mg twice daily (for VTE prophylaxis and dose-reduced AF patients); 10 mg twice daily for 7 days (for acute DVT/PE treatment)

Maintenance Dose

2.5 mg twice daily or 5 mg twice daily depending on indication and patient criteria

Maximum Dose

10 mg twice daily (20 mg/day, during initial DVT/PE treatment phase only)

Children's Dosage

Approved for treatment of VTE and reduction in risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment; see dosing in full prescribing information.

Dose Adjustment Notes

NVAF: reduce to 2.5 mg twice daily if patient has ≥2 of age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL; Drug interactions: with strong dual CYP3A4/P-gp inhibitors reduce apixaban dose by 50% (avoid combination if already on 2.5 mg twice daily); avoid/contraindicated with strong dual CYP3A4/P-gp inducers due to reduced exposure.

How to Take

Swallow tablet whole with or without food and water; for patients unable to swallow, tablet may be crushed and suspended in water, 5% dextrose in water, or apple juice, or mixed with applesauce and administered immediately

Side Effects

Common Side Effects

Bleeding (e.g., bruising, epistaxis, gingival bleeding, hematuria), anemia, nausea

Side Effect Frequency

Common (1-10%): bleeding-related adverse reactions overall (e.g., epistaxis, contusion/bruising, hematoma, hematuria, gastrointestinal/rectal bleeding), anemia, nausea. Uncommon (0.1-1%): hypersensitivity reactions (e.g., rash), thrombocytopenia. Rare (<0.1%): severe allergic reactions (e.g., anaphylaxis/angioedema).

Safety & Warnings

Contraindications

Contraindicated in: active pathological bleeding; severe hypersensitivity to apixaban (e.g., anaphylaxis).

Warnings & Precautions

Key warnings/precautions: increased risk of serious/fatal bleeding; avoid/use extreme caution with active bleeding or high bleeding-risk lesions/procedures; boxed warnings for premature discontinuation and neuraxial hematoma; caution in severe renal impairment; not recommended/avoid in severe hepatic impairment or hepatic disease with coagulopathy; not recommended in patients with prosthetic heart valves; consider availability of reversal (andexanet alfa) for life-threatening bleeding.

Age Restriction

Approved for pediatric use from birth and older for treatment of VTE and reduction in risk of recurrent VTE after at least 5 days of initial anticoagulant treatment.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major: strong dual CYP3A4 and P-gp inhibitors (e.g., ketoconazole, itraconazole, ritonavir) ↑ apixaban exposure/bleeding; strong dual CYP3A4 and P-gp inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) ↓ exposure/efficacy; additive bleeding risk with other anticoagulants, antiplatelets, and NSAIDs. Moderate: SSRIs/SNRIs may increase bleeding risk.

Interaction Severity

MAJOR: strong dual CYP3A4/P-gp inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) ↑ apixaban exposure/bleeding; strong dual CYP3A4/P-gp inducers (e.g., rifampicin, carbamazepine, phenytoin, St John’s wort) ↓ exposure/efficacy; other anticoagulants (additive bleeding). MODERATE: antiplatelets (aspirin, clopidogrel), NSAIDs, SSRIs/SNRIs (increased bleeding risk).

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Avoid breastfeeding; present in human milk at low levels.

Children

Approved for treatment of VTE and reduction in risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment; see dosing in full prescribing information.

Elderly

Dose reduction to 2.5mg twice daily for nonvalvular atrial fibrillation may be required if the patient is ≥80 years and has either a body weight ≤60 kg or a serum creatinine ≥1.5 mg/dL.

Kidney Impairment

NVAF: reduce to 2.5 mg twice daily only if patient has at least 2 of 3 criteria (age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL); severe renal impairment requires caution; ESRD/on dialysis: labeling varies-use is generally not recommended/insufficient data in many references, and if used it should follow local label/guideline.

Liver Impairment

Mild hepatic impairment (Child-Pugh A): no dose adjustment; Moderate (Child-Pugh B): use with caution (limited data); Severe (Child-Pugh C): not recommended/avoid.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Crushed tablets mixed with water, D5W, apple juice, or applesauce are stable for up to 4 hours.

Missed Dose

Take the missed dose as soon as remembered on the same day, then continue with the next dose at the usual time; do not take two doses at the same time to make up for a missed dose.

Stopping the Medicine

Do not discontinue abruptly without medical supervision; if stopping is necessary, ensure timely alternative anticoagulation to reduce thrombotic risk.

Overdose

Overdose increases bleeding risk; management is supportive (hold drug, monitor, local hemostasis/transfusion as needed); consider activated charcoal if recent ingestion; for life-threatening/uncontrolled bleeding use andexanet alfa (where available) or 4-factor PCC; dialysis is not effective.

Patient Counseling

Take twice daily consistently; do not stop without medical advice; watch for and seek care for signs of serious bleeding; inform all healthcare providers/dentists before procedures; avoid NSAIDs/other agents that increase bleeding unless directed; if a dose is missed take it the same day when remembered and do not double; store below 30°C.

Monitoring Requirements

No routine coagulation monitoring (e.g., INR) is required; monitor clinically for bleeding and periodically assess renal function (and CBC/hemoglobin/hematocrit as clinically indicated, especially if bleeding suspected or in high-risk patients).

Pharmacology

Mechanism of Action

Direct, selective, reversible Factor Xa inhibitor that inhibits free and clot-bound FXa and prothrombinase activity, reducing thrombin generation and thrombus formation without requiring antithrombin.

Onset of Action

Peak effect ~3-4 hours after a dose (Tmax).

Duration of Effect

Approximately 12 hours per dose (supports twice-daily dosing); clinically, anticoagulant effect diminishes substantially within ~24 hours after the last dose in many patients.

Half-Life

Approximately 12 hours.

Bioavailability

Approximately 50%.

Metabolism

Metabolized primarily by CYP3A4/5 with minor contributions from other CYPs (e.g., CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2J2); apixaban is also a P-gp and BCRP substrate.

Excretion

Elimination is via multiple pathways: renal excretion ~27% with the remainder via biliary/fecal and intestinal excretion and metabolism.

Protein Binding

Approximately 87-93%.

Product Information

Available Dosage Forms

Film-coated tablet (oral)

Composition per Dose

Each film-coated tablet: Apixaban 2.5 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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