GNH USA

Europe — EMA

Kayfanda

GNH USA supplies Kayfanda (Odevixibat), a bile acid transport inhibitor for PFIC, Alagille syndrome and cholestatic pruritus.

Odevixibat

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What is Odevixibat?

Odevixibat, the active ingredient in Kayfanda, is an IBAT inhibitor presented as an oral formulation for oral use. It is used to treat cholestatic liver disorders such as progressive familial intrahepatic cholestasis, Alagille syndrome, and pruritus associated with cholestatic disease in pediatric and adult patients. GNH USA supplies Kayfanda as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and pharmacies worldwide.

What is Odevixibat used for?

Kayfanda acts on the bile acid transport pathway to manage cholestatic liver conditions. - Progressive familial intrahepatic cholestasis (PFIC): reduces bile acid accumulation and improves liver function. - Alagille syndrome: alleviates cholestasis and associated itching. - Pruritus associated with cholestatic liver disease: decreases bile‑acid‑induced itching and improves quality of life.

What are the side effects of Odevixibat?

Adverse reactions have been observed in clinical use of Odevixibat.

Common Side Effects: - Diarrhea: frequent loose stools. - Abdominal pain: mild to moderate discomfort. - Nausea: occasional feeling of sickness. - Fatigue: reduced energy levels. - Elevated liver enzymes: mild increases in ALT/AST. - Vitamin deficiencies: reduced absorption of fat‑soluble vitamins.

Serious or Rare Side Effects: - Severe dehydration: secondary to persistent diarrhea. - Acute liver injury: marked elevation of liver enzymes. - Severe abdominal pain requiring medical attention. - Allergic reactions: rash, urticaria, or anaphylaxis. - Electrolyte imbalance: especially low potassium due to gastrointestinal loss.

What precautions apply to Odevixibat?

When prescribing Kayfanda, clinicians should consider several safety measures. - Liver function monitoring: assess ALT, AST, bilirubin regularly. - Hydration status: ensure adequate fluid intake to prevent dehydration. - Vitamin supplementation: monitor and replace fat‑soluble vitamins as needed. - Pregnancy and lactation: use only if the potential benefit justifies the potential risk, as safety data are limited. - Renal function: evaluate kidney function in patients with pre‑existing impairment. - Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

What does Odevixibat interact with?

Odevixibat may alter the absorption of concomitant medications.

Major Interactions (Avoid): - Fat‑soluble vitamin supplements: may have reduced absorption, requiring dose adjustment. - Oral contraceptives: decreased efficacy due to altered bile‑acid mediated absorption. - Lipid‑soluble drugs (e.g., cyclosporine): potential reduction in systemic exposure.

Moderate Interactions (Monitor Closely): - Antacids containing aluminum or magnesium: may affect gastrointestinal pH and drug dissolution. - Antibiotics with enterohepatic recycling (e.g., rifampin): possible decreased effectiveness. - Statins: monitor lipid levels as absorption may be modestly reduced.

Frequently asked questions

What conditions is Kayfanda used to treat?+
Kayfanda is indicated for progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, and pruritus associated with cholestatic liver disease. It works by reducing bile‑acid accumulation, which helps improve liver function and relieve itching in affected patients.
How does Odevixibat work in the body?+
Odevixibat inhibits the ileal bile acid transporter (IBAT) in the distal ileum, blocking the re‑absorption of bile acids. This interruption reduces the enterohepatic circulation of bile acids, lowering their concentration in the liver and alleviating cholestasis‑related symptoms.
What is the usual dose of Kayfanda?+
The dosage of Kayfanda is individualized and set by the prescribing healthcare professional based on the patient’s age, weight, disease severity, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.
Is Kayfanda safe to use during pregnancy or breastfeeding?+
Safety data for Odevixibat in pregnancy and lactation are limited. It should be used only if the potential benefit outweighs any possible risk to the fetus or infant, and the decision should be made by the treating physician in consultation with the patient.
How do I order Kayfanda from GNH USA?+
To order Kayfanda, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Kayfanda compare with other treatments for cholestatic liver disease?+
Kayfanda’s mechanism—IBAT inhibition—differs from other therapies such as ursodeoxycholic acid or surgical biliary diversion. By directly reducing bile‑acid re‑absorption, it offers a targeted oral option that can be used when conventional treatments are insufficient or not tolerated.
What are the recommended storage conditions for Kayfanda?+
Kayfanda should be stored below 25 °C in its original packaging, protected from moisture and direct sunlight. Maintaining these conditions helps preserve the product’s stability and potency throughout its shelf life.
How is Kayfanda administered to patients?+
Kayfanda is taken orally, usually as a tablet or capsule, with or without food as directed by the prescriber. The exact administration schedule is determined by the healthcare professional based on individual patient needs.
What are the most serious risks associated with Kayfanda?+
Serious risks include severe dehydration from persistent diarrhea, acute liver injury marked by significant enzyme elevations, and rare allergic reactions such as rash or anaphylaxis. Patients should be monitored regularly for these events and seek medical attention if they occur.
Who should not use Kayfanda?+
Kayfanda is contraindicated in patients with known hypersensitivity to Odevixibat or any of its excipients. Caution is advised for individuals with severe hepatic impairment, uncontrolled electrolyte disturbances, or those who are pregnant or breastfeeding without a clear benefit.
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
Odevixibat
Route
Oral Use
Manufacturer
Ipsen Pharma
Origin
EU

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