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Bylvay

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Bylvay

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Bylvay
Generic Name (API): Odevixibat
Dosage Form & Strength: 200 mcg, 400 mcg, 1200 mcg
Route: Oral
Drug Class: Ileal bile acid transport inhibitor (IBATi)

Manufacturer / Innovator:

USA

Regulatory Approval:

  • US FDA
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  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Bylvay Used For?

Bylvay (odevixibat) is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine. It is indicated for the treatment of:

  • Pruritus (itching) in patients 3 months and older with progressive familial intrahepatic cholestasis (PFIC)
  • Cholestatic pruritus in patients 12 months and older with Alagille syndrome (ALGS)

It is a prescription medicine and must be used under the supervision of a qualified pediatric hepatologist or gastroenterologist.

Recommended Dosage

  • Starting dose: 40 mcg/kg once daily
  • May be increased in 40 mcg/kg increments, up to a maximum of 120 mcg/kg once daily, if pruritus does not improve after 3 months
  • Maximum daily dose: 6 mg/day, regardless of body weight

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Bylvay Warnings and Precautions

  • Liver test abnormalities: Baseline liver tests should be obtained, with frequent monitoring during the first 6-8 months of treatment. Dose reduction or discontinuation may be needed if liver enzyme abnormalities or hepatitis symptoms occur.
  • Fat-soluble vitamin deficiency: Bylvay may reduce absorption of vitamins A, D, E, and K. Baseline and periodic monitoring is recommended, with supplementation if deficiency develops.
  • Gastrointestinal effects: Diarrhea and abdominal pain are common and should be monitored.

How to Access Bylvay in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Bylvay to India?

Bylvay (odevixibat) capsules may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:

  • A valid prescription from a qualified doctor
  • The patient's diagnostic reports confirming PFIC or Alagille syndrome
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Bylvay available in India?

Bylvay (odevixibat capsules) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Bylvay is not commercially marketed in India.

However, patients in India can legally access Bylvay through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of a specific patient for their personal treatment, under a valid prescription.

Bylvay received US FDA approval for PFIC in 2021, with the Alagille syndrome indication approved in 2023, ensuring full transparency throughout the process.

Bylvay can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) can source Bylvay from reliable global channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. Bylvay capsules should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and are handled under temperature-controlled shipping conditions throughout transit. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Bylvay cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability of Bylvay Across Major Cities in India

Patients across India can access Bylvay through regulated import pathways, with delivery arranged to the treating hospital based on a valid pediatric hepatologist's or gastroenterologist's prescription.

Mumbai

A major healthcare hub with leading pediatric hepatology centers, Mumbai coordinates access to advanced therapies like Bylvay for children with PFIC or Alagille syndrome.

Delhi

As part of the Delhi NCR region, the city has a strong concentration of pediatric liver disease specialists, making it a key location for accessing cholestatic pruritus treatments.

Bangalore

With a growing network of multispecialty hospitals, Bangalore supports access to Bylvay through structured import pathways guided by treating specialists.

Chennai

Home to several reputed pediatric hepatology practices, Chennai facilitates access to Bylvay for patients with PFIC.

Hyderabad

A growing hub for specialty pediatric care, Hyderabad supports coordinated access to Bylvay for eligible patients under specialist supervision.

Kolkata

Eastern India's leading medical centers in Kolkata coordinate Bylvay access for children with rare cholestatic liver conditions.

Pune

With an expanding base of pediatric gastroenterology clinics, Pune facilitates timely access to Bylvay under prescription.

Ahmedabad

Gujarat's leading hospitals support regulated access to Bylvay for eligible patients.

Kochi

Kerala's healthcare network, including major hospitals in Kochi, coordinates access to advanced pediatric liver disease therapies like Bylvay.

Chandigarh

Serving North India, Chandigarh's specialist centers facilitate access to Bylvay for patients from Punjab, Haryana, and Himachal Pradesh.

Jaipur

Rajasthan's leading hospitals support patient access to Bylvay through the Named Patient Program.

Lucknow

A key referral center for North India, Lucknow facilitates coordinated access to Bylvay under specialist care.

Bhubaneswar

Odisha's growing specialty healthcare sector supports patient access to Bylvay.

Guwahati

As a referral hub for the North-East, Guwahati facilitates access to Bylvay for patients across the region.

Access can also be coordinated for patients in other major Indian cities, subject to a valid prescription and regulatory requirements.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 08 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 08 September 2026

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