Product image of Kayfanda (Odevixibat) supplied by GNH India

Kayfanda

Active Ingredient:
Odevixibat
Origin:
EU

Kayfanda (Odevixibat)

Odevixibat, the active ingredient in Kayfanda, is an IBAT inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of cholestatic liver diseases such as progressive familial intrahepatic cholestasis type 2 and Alagille syndrome in pediatric patients.

GNH India supplies Kayfanda as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and specialty pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory support for global distribution, including customs clearance and cold‑chain logistics where required.

Manufacturer / TM Owner

Ipsen Pharma

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Indications & Clinical Uses

Odevixibat is employed in the management of cholestatic liver diseases, particularly in children, by inhibiting the ileal bile acid transporter and thereby reducing enterohepatic bile acid recirculation.

  • Progressive familial intrahepatic cholestasis type 2 (PFIC2): reduces serum bile acid concentrations and improves liver biochemistry, potentially delaying disease progression.
  • Alagille syndrome: decreases cholestasis, alleviates pruritus, and supports hepatic function in affected children.
  • Pediatric cholestasis associated with PFIC or Alagille syndrome: helps control itching and may improve growth parameters.
  • Bile acid–related pruritus in cholestatic conditions: may reduce itching severity and improve patient comfort.

How It Works

  • Odevixibat selectively inhibits the ileal bile acid transporter (IBAT), also known as the apical sodium‑dependent bile acid transporter (ASBT), located on the enterocytes of the distal ileum. By blocking this transporter, the drug prevents reabsorption of bile acids from the intestinal lumen, leading to increased fecal excretion and reduced enterohepatic circulation. The consequent lowering of systemic bile acid concentrations alleviates cholestatic injury in the liver.

Side Effects

Odevixibat may be associated with several adverse reactions, ranging from mild to serious.

Common Side Effects

  • Diarrhea: frequent loose stools that may affect hydration.
  • Abdominal pain: mild to moderate discomfort in the stomach area.
  • Fatigue: feeling unusually tired or low in energy.
  • Elevated liver enzymes: mild increases in ALT or AST observed in labs.
  • Nausea: occasional feeling of sickness or urge to vomit.

Serious or Rare Side Effects

  • Severe liver injury: marked elevation of bilirubin or hepatic failure.
  • Biliary obstruction: blockage of bile flow leading to jaundice.
  • Acute pancreatitis: sudden inflammation of the pancreas with abdominal pain.
  • Severe dehydration: significant fluid loss requiring medical attention.
  • Allergic reaction: rash, itching, or swelling that may require discontinuation.

Precautions & Warnings

When prescribing Odevixibat, several precautionary measures should be observed to ensure patient safety.

  • Liver function monitoring: regularly assess ALT, AST, and bilirubin levels.
  • Pruritus assessment: evaluate severity of itching and adjust therapy as needed.
  • Intestinal disease caution: use carefully in patients with inflammatory bowel disease or malabsorption.
  • Hepatic impairment adjustment: consider dose modification in moderate to severe liver dysfunction.
  • Allergy screening: avoid in individuals with known hypersensitivity to Odevixibat or excipients.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Odevixibat can interact with other medicines, affecting its absorption or efficacy.

Major Interactions (Avoid)

  • Bile acid sequestrants (e.g., cholestyramine): may bind Odevixibat and reduce its oral absorption.
  • Strong CYP3A4 inducers (e.g., rifampin): may lower plasma concentrations of Odevixibat.
  • Antacids containing aluminum or magnesium: may interfere with Odevixibat uptake in the gut.
  • Fatty meals: high‑fat food may delay absorption, consider dosing on empty stomach.

Moderate Interactions (Monitor Closely)

  • Oral antibiotics altering gut microbiota: may change bile acid pool and affect Odevixibat efficacy.
  • Concurrent use of other IBAT inhibitors: additive inhibition may increase risk of diarrhea.
  • Vitamin D supplements: may affect calcium metabolism when bile acid absorption is reduced; monitor levels.

Frequently Asked Questions

Kayfanda contains Odevixibat and is prescribed for children with cholestatic liver disorders, specifically progressive familial intrahepatic cholestasis type 2 (PFIC2) and Alagille syndrome. By lowering bile acid levels, it helps improve liver function and reduces symptoms such as severe itching.

Odevixibat blocks the ileal bile acid transporter (IBAT) in the distal small intestine. This inhibition prevents the re‑absorption of bile acids, increasing their elimination in the stool and lowering the total bile acid pool that circulates back to the liver, thereby reducing cholestatic injury.

The dosage of Kayfanda is individualized. A qualified prescriber determines the appropriate amount based on the patient’s age, weight, disease severity, and response to therapy. No standard dosing regimen is provided here.

Limited clinical data are available for Odevixibat use during pregnancy or lactation. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by the treating physician.

To request Kayfanda, 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 needs) and import documentation.

Kayfanda (Odevixibat) and other IBAT inhibitors such as maralixibat share the same mechanism of reducing bile acid reabsorption. Differences may lie in pharmacokinetic profiles, dosing flexibility, and specific regulatory approvals. Clinical choice depends on individual patient factors and physician judgment.

Kayfanda should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, and store it out of direct sunlight to maintain stability.

Kayfanda is administered orally, usually as a tablet or oral suspension. It can be taken with or without food, but consistent timing relative to meals helps maintain predictable absorption. Patients should follow the prescribing clinician’s instructions for administration.

Serious adverse events reported with Kayfanda include severe liver injury, biliary obstruction, acute pancreatitis, and significant dehydration. Patients should be monitored for signs such as jaundice, abdominal pain, persistent diarrhea, or rapid weight loss and seek medical attention promptly if these occur.

Kayfanda is contraindicated in individuals with known hypersensitivity to Odevixibat or any of its excipients. It should also be avoided in patients with severe hepatic impairment or those for whom the risk of reduced bile acid absorption outweighs the therapeutic benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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