GNH USA

Europe — EMA

Kayfanda

GNH USA supplies Kayfanda (Odevixibat), a Ileal bile acid transporter (IBAT) inhibitor for progressive familial intrahepatic cholestasis type 2 and Alagille

Odevixibat

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What is Odevixibat?

Odevixibat, the active ingredient in Kayfanda, is an Ileal bile acid transporter (IBAT) inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of cholestatic liver disorders such as progressive familial intrahepatic cholestasis type 2 and Alagille syndrome, helping to lower bile acid accumulation in affected patients.

GNH USA supplies Kayfanda as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

What is Odevixibat used for?

Kayfanda acts on the bile acid transport pathway to manage cholestatic liver disease. - Progressive familial intrahepatic cholestasis type 2 (PFIC2): reduces serum bile acid levels and improves liver function. - Alagille syndrome: lowers bile acid accumulation and supports hepatic health. - Other cholestatic liver diseases: may decrease bile acid overload and alleviate related symptoms.

What are the side effects of Odevixibat?

Adverse reactions have been reported with odevixibat therapy.

Common Side Effects: - Diarrhea: loose stools occurring during treatment. - Abdominal pain: discomfort or cramping in the stomach region. - Nausea: feeling of queasiness that may lead to vomiting. - Fatigue: reduced energy levels or tiredness.

Serious or Rare Side Effects: - Severe liver injury: marked elevation of liver enzymes requiring medical attention. - Cholestatic hepatitis: inflammation of the liver associated with bile flow obstruction. - Allergic reactions: rash, itching, swelling, or difficulty breathing indicating hypersensitivity.

What precautions apply to Odevixibat?

Before initiating therapy, clinicians should consider several safety measures. - Dose adjustment: monitor liver function tests regularly to guide dosing. - Renal function: assess renal parameters before starting treatment. - Pediatric use: administer only under specialist supervision. - Pregnancy: evaluate risk‑benefit ratio; limited data are available. - Drug interactions: review concomitant bile‑acid sequestrants and other agents. - Store at ambient temperature: keep in the original pack, protect from moisture and heat.

What does Odevixibat interact with?

Odevixibat may interact with other medicines that affect bile acid metabolism or absorption.

Major Interactions (Avoid): - Bile acid sequestrants: can bind odevixibat and markedly reduce its absorption. - Strong CYP3A4 inhibitors: may increase systemic exposure and risk of adverse effects.

Moderate Interactions (Monitor Closely): - Antibiotics altering gut flora: may modify enterohepatic circulation and affect efficacy. - High‑fat meals: can decrease oral absorption of odevixibat. - Other IBAT inhibitors: additive reduction of bile acids may increase risk of liver‑related events.

Frequently asked questions

What conditions is Kayfanda used to treat?+
Kayfanda, containing odevixibat, is prescribed for progressive familial intrahepatic cholestasis type 2 (PFIC2) and Alagille syndrome. Both are rare genetic disorders that cause impaired bile flow and accumulation of bile acids, leading to liver dysfunction. By reducing bile acid reabsorption, Kayfanda helps manage these cholestatic conditions.
How does odevixibat work in the body?+
Odevixibat blocks the ileal bile acid transporter (ASBT) on the lining of the distal ileum. This inhibition prevents the normal recycling of bile acids from the intestine back to the liver, promoting their excretion in the stool. The resulting lower systemic bile acid levels alleviate the toxic buildup that characterises cholestatic liver diseases.
What is the usual dose of Kayfanda?+
The specific dose of Kayfanda is individualized by the prescribing clinician based on the patient’s age, weight, disease severity, and laboratory results. Healthcare professionals determine the appropriate amount and frequency to achieve optimal therapeutic effect while minimizing potential adverse reactions.
Is Kayfanda safe to use during pregnancy or breastfeeding?+
Safety data for odevixibat in pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the risks and alternatives with their healthcare provider.
How do I order Kayfanda from GNH USA?+
To request Kayfanda, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.
How does Kayfanda compare with other cholestasis treatments?+
Kayfanda’s mechanism—IBAT inhibition—differs from bile‑acid sequestrants or ursodeoxycholic acid, which aim to bind or replace bile acids. By directly reducing intestinal reabsorption, odevixibat offers a targeted approach that can achieve greater reductions in serum bile acids, particularly in genetic cholestasis such as PFIC2, where traditional therapies may be less effective.
What are the recommended storage conditions for Kayfanda?+
Kayfanda should be stored at ambient temperature, below 25 °C (77 °F). Keep the tablets in their original packaging, protect them from moisture, direct sunlight, and excessive heat to maintain stability and potency throughout the shelf life.
How is Kayfanda administered to patients?+
Kayfanda is taken orally, usually as a tablet swallowed whole with water. The exact timing relative to meals may be guided by the prescribing physician, but it is generally recommended to follow the dosing schedule provided on the prescription label.
What are the most serious risks associated with Kayfanda?+
Serious risks include severe liver injury, cholestatic hepatitis, and rare allergic reactions that may present as rash, swelling, or breathing difficulties. Patients should be monitored regularly for liver enzyme elevations and any signs of hypersensitivity, and they should seek immediate medical attention if serious symptoms develop.
Who should not use Kayfanda?+
Kayfanda is contraindicated in patients with known hypersensitivity to odevixibat or any component of the formulation. It should also be avoided in individuals taking strong bile‑acid sequestrants or potent CYP3A4 inhibitors without medical supervision, as these interactions can significantly alter drug exposure.
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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