Product image of Iqirvo (Elafibranor) supplied by GNH India

Iqirvo

Active Ingredient:
Elafibranor
Origin:
EU

Iqirvo (Elafibranor)

Elafibranor, the active ingredient in Iqirvo, is a PPARα/δ agonist presented as an oral tablet for oral use. It treats primary biliary cholangitis in adults who have an inadequate response to ursodeoxycholic acid. The medication is indicated for patients with persistent cholestasis despite standard therapy and aims to improve liver biochemistry and delay disease progression.

GNH India supplies Iqirvo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for global healthcare providers, ensuring product integrity throughout the supply chain.

Manufacturer / TM Owner

Ipsen Pharma

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Indications & Clinical Uses

  • Iqirvo acts on the cholestatic liver disease pathway, specifically primary biliary cholangitis.
  • Primary biliary cholangitis: improves liver enzyme levels and may slow disease progression in adults with inadequate response to ursodeoxycholic acid.

How It Works

  • Elafibranor binds to and activates both peroxisome proliferator‑activated receptor alpha (PPARα) and delta (PPARδ) nuclear receptors. Activation modulates gene expression involved in fatty acid oxidation, inflammation, and fibrogenesis, leading to improved lipid metabolism, reduced hepatic inflammation, and attenuation of fibrotic pathways in the liver. It also influences bile acid transporters and improves endothelial function, contributing to overall hepatic health.

Side Effects

Elafibranor may be associated with several adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial pain.
  • Diarrhea: loose stools.
  • Fatigue: feeling of tiredness.

Serious or Rare Side Effects

  • Elevated liver enzymes: significant increase in ALT/AST.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Pancreatitis: abdominal pain with elevated enzymes.

Precautions & Warnings

When prescribing Iqirvo, clinicians should consider several precautionary measures.

  • Liver monitoring: regularly assess ALT, AST, and bilirubin levels.
  • Drug interactions: review concomitant medications for potential PPAR agonist interactions.
  • Pregnancy and lactation: avoid use unless benefits outweigh risks; limited data available.
  • Gastrointestinal symptoms: counsel patients to report persistent nausea or diarrhea.
  • Discontinue if serious adverse events occur: stop therapy and seek medical evaluation.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Elafibranor can interact with other medicines; interactions are grouped by clinical significance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase Elafibranor plasma concentrations.
  • Concurrent use of other PPAR agonists: risk of additive effects on lipid metabolism.

Moderate Interactions (Monitor Closely)

  • Statins: monitor for increased risk of myopathy.
  • Anticoagulants (e.g., warfarin): observe INR for potential alterations.

Frequently Asked Questions

Iqirvo is prescribed for the treatment of primary biliary cholangitis in adult patients who have not achieved an adequate biochemical response to standard therapy with ursodeoxycholic acid. It aims to improve liver function tests and may help slow disease progression.

Elafibranor is a dual agonist of the nuclear receptors PPARα and PPARδ. By activating these receptors, it modulates genes that control fatty‑acid oxidation, inflammation, and fibrotic processes, thereby improving lipid metabolism and reducing hepatic inflammation and fibrosis.

The dosing regimen for Iqirvo is determined by the prescribing physician based on the individual patient's clinical condition, laboratory results, and response to therapy. No fixed dose is provided here; the prescriber will set the appropriate dose.

Safety data for Elafibranor during pregnancy and lactation are limited. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the Iqirvo product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

The primary alternative for primary biliary cholangitis is ursodeoxycholic acid, which works by improving bile flow. Iqirvo, as a PPARα/δ agonist, targets metabolic and inflammatory pathways rather than bile composition, offering a complementary mechanism for patients who do not respond sufficiently to ursodeoxycholic acid.

Iqirvo tablets should be stored at room temperature, below 25 °C, in the original blister pack. Keep the product away from excess moisture, heat and direct sunlight to maintain stability and potency.

Iqirvo is administered orally as a tablet. Patients should swallow the tablet whole with water, typically once daily, unless otherwise directed by their healthcare provider.

Serious risks include significant elevations in liver enzymes, which may indicate liver injury, severe allergic reactions such as anaphylaxis, and pancreatitis. Patients should promptly report symptoms like jaundice, rash, swelling, or persistent abdominal pain to their physician.

Iqirvo should be avoided in patients with known hypersensitivity to Elafibranor or any excipients, in those with severe hepatic impairment, and in individuals for whom the prescriber determines that the risk–benefit profile is unfavorable, such as certain pregnant or lactating women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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