INLEXZO (Gemcitabine Intravesical System)

INLEXZO, from Johnson & Johnson (Janssen), is a gemcitabine-releasing intravesical system indicated for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or have elected not to undergo radical cystectomy.

INLEXZO is a small, pretzel-shaped drug-releasing system placed directly into the bladder by a urologist through a catheter. It continuously releases gemcitabine into the bladder over approximately 3 weeks per placement, delivering sustained local chemotherapy while limiting systemic drug exposure.

• Device-related events such as urinary retention, device malposition, or difficulty removing the system have been reported and require specialist urological management.
• Urinary tract infections and bladder irritation (dysuria, urgency, hematuria) are common during treatment.
• Placement and removal must be performed by a trained urologist under appropriate imaging/cystoscopic guidance.
• Common side effects: urinary tract infection, hematuria, dysuria, urinary urgency, pollakiuria.

What documents are required to import INLEXZO to India?

INLEXZO may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered urologist/uro-oncologist
• Diagnostic/cystoscopy report confirming BCG-unresponsive NMIBC with CIS
• 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 and an import permit, if applicable.

Is INLEXZO available in India?

INLEXZO is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source INLEXZO from Johnson & Johnson’s (Janssen) authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For INLEXZO cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — 2024.

What is INLEXZO used for?

INLEXZO treats BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, in patients who are not candidates for or have declined bladder removal surgery.

Who manufactures INLEXZO?

INLEXZO is manufactured by Johnson & Johnson (Janssen).

How is INLEXZO administered?

It is a small device placed directly into the bladder by a urologist, which continuously releases gemcitabine locally over about 3 weeks per placement.

How much does INLEXZO cost in India?

Cost depends on sourcing logistics and quantity — share your prescription with IPN for a quote.