Product image of Indifaxa (Rivaroxaban) supplied by GNH India

Indifaxa

Active Ingredient:
Rivaroxaban
Origin:
EU

Indifaxa (Rivaroxaban)

Rivaroxaban, the active ingredient in Indifaxa, is a Direct Factor Xa inhibitor presented as an oral tablet for oral use. It is used to reduce the risk of stroke and systemic embolism in patients with non‑valvular atrial fibrillation and to treat or prevent deep vein thrombosis and pulmonary embolism.
GNH India supplies Indifaxa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established distribution networks across Europe, Asia and the Americas.

Manufacturer / TM Owner

Errekappa Euroterapici Spa

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Indications & Clinical Uses

Rivaroxaban is a direct Factor Xa inhibitor used in several thromboembolic conditions.

  • Non‑valvular atrial fibrillation: reduces risk of stroke and systemic embolism.
  • Deep vein thrombosis and pulmonary embolism: provides treatment and secondary prevention.
  • Orthopedic surgery prophylaxis: prevents postoperative deep vein thrombosis.

How It Works

  • Rivaroxaban selectively and reversibly binds to the active site of coagulation Factor Xa, inhibiting both free and prothrombinase‑bound forms. This blocks the conversion of prothrombin to thrombin, decreasing thrombin generation and fibrin clot formation across the intrinsic and extrinsic pathways, resulting in anticoagulation without the need for antithrombin activation.

Side Effects

Rivaroxaban may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Bleeding gums: mild oral bleeding.
  • Nosebleeds: epistaxis.
  • Bruising: easy bruising of skin.
  • Gastrointestinal discomfort: nausea or dyspepsia.
  • Headache: mild to moderate.
  • Diarrhea: loose stools.

Serious or Rare Side Effects

  • Major hemorrhage: internal bleeding such as gastrointestinal or intracranial.
  • Hemorrhagic stroke: bleeding within the brain.
  • Spinal or epidural hematoma: bleeding in the spinal canal, especially after neuraxial procedures.
  • Liver injury: elevated transaminases or hepatitis.
  • Allergic reaction: severe rash, angioedema, or anaphylaxis.
  • Thrombocytopenia: low platelet count.

Precautions & Warnings

Before prescribing Indifaxa, clinicians should evaluate patient-specific risk factors.

  • Renal function: assess creatinine clearance prior to initiation.
  • Hepatic impairment: avoid in patients with severe liver disease.
  • Concomitant anticoagulants: avoid combining with other anticoagulants or antiplatelet agents unless clinically justified.
  • Surgery or invasive procedures: discontinue according to recommended interval before procedures.
  • Pregnancy and lactation: use only if potential benefit outweighs risk; limited data are available.
  • Store at below 25°C: keep in the original pack, protect from moisture and light.

Avoid Interactions

Rivaroxaban interacts with several drug classes that can alter its anticoagulant effect.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may increase exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Combined use with other anticoagulants (e.g., warfarin, heparin): heightened bleeding risk.
  • Antiplatelet agents at high doses (e.g., clopidogrel, aspirin): increased bleeding.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise levels.
  • NSAIDs (e.g., ibuprofen, naproxen): additive gastrointestinal bleeding risk.
  • SSRIs or SNRIs (e.g., sertraline, duloxetine): may increase bleeding tendency.

Frequently Asked Questions

Indifaxa contains rivaroxaban, a direct Factor Xa inhibitor indicated for preventing stroke and systemic embolism in non‑valvular atrial fibrillation, for treating and preventing recurrence of deep vein thrombosis and pulmonary embolism, and for reducing the risk of postoperative deep vein thrombosis after orthopedic surgery.

Rivaroxaban selectively blocks the activity of coagulation Factor Xa, an enzyme essential for converting prothrombin to thrombin. By inhibiting both free and complexed Factor Xa, it reduces thrombin generation, limits fibrin clot formation, and provides anticoagulation across the intrinsic and extrinsic pathways.

The appropriate dose of Indifaxa is determined by the prescribing clinician based on the specific indication, patient renal function, age, weight, and other clinical factors. Dosage regimens are not standardized in this description and should follow the prescriber’s order.

Data on rivaroxaban use during pregnancy and lactation are limited. It should only be used when the potential benefit justifies the potential risk to the fetus or infant. Clinicians must evaluate individual circumstances and discuss risks with the patient.

To order Indifaxa, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

The primary alternative to rivaroxaban is warfarin, a vitamin K antagonist that requires routine INR monitoring and has numerous food and drug interactions. Rivaroxaban offers fixed dosing without routine coagulation monitoring, fewer dietary restrictions, and a more predictable anticoagulant effect, though both carry bleeding risk.

Indifaxa should be stored at temperatures below 25 °C (77 °F). Keep the tablets in the original container, protect them from moisture and direct light, and avoid storing in bathrooms or other humid environments.

Indifaxa is administered orally as a tablet. It can be taken with or without food, according to the prescribing information. Patients should swallow the tablet whole with water and follow the dosing schedule provided by their healthcare professional.

The most serious risks include major bleeding events such as gastrointestinal hemorrhage, intracranial bleeding, and spinal or epidural hematoma. Patients should be alert for signs of unusual bruising, blood in urine or stool, severe headache, or any sudden weakness, and seek immediate medical attention if they occur.

Indifaxa is contraindicated in patients with active pathological bleeding, severe hepatic impairment, or a known hypersensitivity to rivaroxaban or any excipients. Caution is also advised for individuals with uncontrolled hypertension, recent major surgery, or those taking other strong anticoagulants unless specifically directed by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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