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Xiaflex

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Xiaflex

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Medicine Name: Xiaflex
Generic Name (API): Collagenase Clostridium Histolyticum
Dosage Form & Strength: 0.9 mg
Route: Intralesional Injection
Drug Class:

Manufacturer / Innovator:

USA

Regulatory Approval:

N/A

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Understanding Xiaflex and Its Medical Uses

Xiaflex (collagenase clostridium histolyticum) is an enzyme therapy approved by the FDA for two indications: treatment of adult patients with Dupuytren's contracture who have a palpable cord, and treatment of adult men with Peyronie's disease who have a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

How Xiaflex Works

Xiaflex contains collagenase enzymes that break down excess collagen in the abnormal cords (Dupuytren's contracture) or plaques (Peyronie's disease) that form under the skin, helping to reduce contracture or curvature when combined with manual manipulation by the treating physician.

Approved Patient Population

Xiaflex is used in two distinct conditions: Dupuytren's contracture, where abnormal tissue cords limit finger extension, and Peyronie's disease, where a fibrous plaque causes penile curvature during erection.

Dosage and Administration

Xiaflex is administered as an injection of 0.58 mg directly into the palpable cord or plaque by a qualified healthcare provider, followed by a manipulation procedure to help break down the treated tissue, according to specific protocols for each indication.

Warnings and Precautions for Xiaflex

Boxed Warning — Xiaflex (Peyronie's Disease indication only): Corporal rupture (penile fracture) or other serious penile injury has occurred in patients treated with Xiaflex for Peyronie's disease. This risk is specific to the Peyronie's disease indication and does not apply to the Dupuytren's contracture indication.

Tendon and Ligament Injury (Dupuytren's Contracture)

Tendon rupture or other serious injury to the injected finger or hand, including ligament and pulley system damage, has occurred with treatment for Dupuytren's contracture.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported. Xiaflex should be used with caution in patients with a history of allergic reactions to collagenase.

Bleeding Risk

There is a risk of bleeding at the injection site, particularly in patients with coagulation disorders or those taking anticoagulant medicines.

REMS Program

Due to these risks, Xiaflex is available only through a restricted program called the Xiaflex REMS Program, which requires healthcare provider training and certification.

How to Access Xiaflex 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 and Availability of Xiaflex

Xiaflex is manufactured and marketed by Endo Pharmaceuticals. It is sourced through authorized distribution channels for patients seeking named-patient import into India.

Required Documentation

Patients typically need a valid prescription from a treating hand surgeon or urologist confirming diagnosis of Dupuytren's contracture or Peyronie's disease with a palpable cord or plaque. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.

Availability

As an FDA-approved therapy for Dupuytren's contracture and Peyronie's disease, Xiaflex is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.

Sourcing and Delivery of Xiaflex

NPP sources Xiaflex directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.

Cold Chain and Handling

Xiaflex vials should be stored refrigerated at 2°C to 8°C prior to reconstitution. NPP maintains a continuous, monitored cold chain throughout transit.

Delivery Timelines

Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile cold-chain logistics to the patient's city.

Availability of Xiaflex Across Major Cities in India

Patients across India can access Xiaflex through NPP's regulated import pathway, with hand surgery and urology specialists in major cities supporting the treatment process.

Mumbai

Leading hospitals in Mumbai support hand surgery and urology care coordination and documentation for Xiaflex access.

Delhi

Delhi's major hospitals assist patients with prescription support and documentation for Xiaflex.

Bangalore

Bangalore's specialist network offers access coordination for eligible patients seeking Xiaflex.

Chennai

Chennai-based specialists coordinate Xiaflex access alongside comprehensive Dupuytren's and Peyronie's care.

Hyderabad

Hyderabad's care institutions support patients pursuing Xiaflex therapy.

Kolkata

Kolkata's specialist centers help coordinate documentation and treatment access for Xiaflex.

Pune

Pune-based specialists assist with prescription support and Xiaflex treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Xiaflex.

Kochi

Kochi's specialist units assist patients with the documentation needed for Xiaflex access.

Chandigarh

Chandigarh's care centers support Xiaflex treatment coordination for patients from North India.

Jaipur

Jaipur's specialists help patients navigate the Xiaflex access process.

Lucknow

Lucknow-based centers assist patients pursuing Xiaflex therapy.

Bhubaneswar

Bhubaneswar's institutions support access to Xiaflex for eligible patients.

Guwahati

Guwahati's specialists help coordinate Xiaflex access for patients across the Northeast.

Patients in other cities across India can also access Xiaflex through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026

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