GNH USA

Europe — EMA

Iqirvo

GNH USA supplies Iqirvo (Elafibranor), a PPAR α/δ agonist for primary biliary cholangitis treatment. Request a quote for global supply.

Elafibranor

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What is Elafibranor?

Elafibranor, the active ingredient in Iqirvo, is a PPAR α/δ agonist presented as an oral formulation for oral use. It is indicated for the treatment of primary biliary cholangitis in adults, targeting metabolic and inflammatory pathways to help manage liver disease progression. GNH USA supplies Iqirvo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Elafibranor used for?

Iqirvo (elafibranor) is indicated for the treatment of primary biliary cholangitis, a chronic autoimmune liver disease characterized by progressive destruction of intra‑hepatic bile ducts and associated inflammation and fibrosis. The drug targets metabolic and inflammatory pathways to modify disease progression. Primary biliary cholangitis: helps reduce liver inflammation and fibrosis, aiming to improve biochemical markers of disease activity.

What are the side effects of Elafibranor?

Common Side Effects: - Nausea: mild to moderate stomach upset. - Diarrhea: increased bowel movements. - Abdominal pain: discomfort in the upper abdomen. - Headache: transient head pain. - Pruritus: itching sensation. - Fatigue: feeling of tiredness.

Serious or Rare Side Effects: - Elevated liver enzymes: may indicate hepatic injury. - Severe allergic reaction: rash, swelling, or anaphylaxis. - Pancreatitis: inflammation of the pancreas. - Hepatic decompensation: worsening liver function. - Acute renal failure: sudden loss of kidney function. - Thromboembolic events: blood clot formation.

What precautions apply to Elafibranor?

Before initiating therapy, clinicians should consider several safety measures. - Monitor liver function: perform baseline and periodic liver enzyme tests. - Assess cardiovascular risk: evaluate for existing heart disease. - Evaluate renal function: adjust use in patients with severe impairment. - Review concomitant medications: check for potential interactions. - Avoid in patients with known hypersensitivity to elafibranor. - Store at ambient temperature: keep in the original pack, protect from moisture and light.

What does Elafibranor interact with?

Elafibranor may interact with other medicines, requiring careful management. Major Interactions (Avoid): - Strong CYP3A4 inhibitors: may increase elafibranor exposure. - Strong CYP3A4 inducers: may reduce therapeutic effect. - Bile acid sequestrants: can lower absorption of the drug. Moderate Interactions (Monitor Closely): - Statins: monitor for increased muscle toxicity. - Anticoagulants: watch for altered clotting parameters. - Oral contraceptives: may affect hormonal efficacy. - Antidiabetic agents: monitor blood glucose levels. - NSAIDs: assess for additive gastrointestinal risk.

Frequently asked questions

What is Iqirvo used for?+
Iqirvo (elafibranor) is prescribed for adults with primary biliary cholangitis, an autoimmune condition that causes progressive damage to the bile ducts in the liver. The medication aims to reduce inflammation and fibrosis, helping to stabilize liver function and improve disease‑related laboratory markers.
How does elafibranor work?+
Elafibranor activates the nuclear receptors PPARα and PPARδ, which regulate genes involved in lipid metabolism, inflammation, and fibrogenesis. By stimulating these receptors, the drug promotes fatty‑acid oxidation, lowers inflammatory cytokine production, and interferes with pathways that lead to liver scarring, thereby supporting healthier liver tissue.
What is the usual dose of Iqirvo?+
The dose of Iqirvo is determined by the prescribing clinician based on the individual patient's clinical status, liver function, and other relevant factors. Healthcare professionals tailor the regimen to achieve optimal therapeutic effect while monitoring safety, and patients should follow the prescriber’s specific instructions.
Is Iqirvo safe during pregnancy or breastfeeding?+
Safety of elafibranor in pregnancy and lactation has not been fully established. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives with their healthcare provider.
How do I order Iqirvo from GNH USA?+
To place an order, submit an enquiry on the Iqirvo product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. After verification, the team provides pricing, availability, shipping details (including any cold‑chain needs), and assists with import documentation.
How does Iqirvo compare with the main alternative treatment for primary biliary cholangitis?+
The primary approved therapy for primary biliary cholangitis is ursodeoxycholic acid (UDCA). While UDCA improves bile flow and liver enzymes, elafibranor targets metabolic and inflammatory pathways through PPAR activation, offering a complementary mechanism that may benefit patients with an inadequate response to UDCA. Clinical decisions depend on individual disease severity and response.
What are the storage and handling requirements for Iqirvo?+
Iqirvo should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging to protect it from moisture and light. Do not store in areas with high humidity or direct sunlight, and ensure the container remains tightly closed when not in use.
How is Iqirvo administered?+
Iqirvo is taken orally, usually as a tablet or capsule, with or without food as directed by the prescriber. Patients should swallow the dose whole with a full glass of water and follow any specific timing instructions provided by their healthcare professional.
What are the most serious risks associated with Iqirvo?+
Serious risks include significant elevations in liver enzymes indicating possible hepatic injury, severe allergic reactions such as anaphylaxis, and rare cases of hepatic decompensation or pancreatitis. Patients should be monitored regularly for signs of liver dysfunction, rash, swelling, or abdominal pain, and report any concerning symptoms promptly.
Who should not use Iqirvo?+
Iqirvo is contraindicated in individuals with known hypersensitivity to elafibranor or any of its excipients. It should also be avoided in patients with severe liver impairment, uncontrolled cardiovascular disease, or those taking medications that have a major interaction risk without appropriate monitoring. Clinicians must assess each patient’s medical history before prescribing.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Elafibranor
Route
Oral Use
Manufacturer
Ipsen Pharma
Origin
EU

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