INLEXZO - Use with Magnetic Resonance Imaging (MRI)

SUMMARY

• Johnson & Johnson cannot recommend any practices or procedures that deviate from product labeling and are not approved by the regulatory agencies.
• For information on using INLEXZO with MRI, please refer to the full Prescribing Information and Instructions for Use of INLEXZO.
• INLEXZO is a indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.¹
• INLEXZO is Magnetic Resonance (MR) Conditional. A patient with an indwelling INLEXZO may be safely scanned under specific conditions (see Warnings and Precautions [5.2]). Failure to follow these conditions may result in injury to the patient.¹
• The MRI Safety Information Card is available in the INLEXZO carton. After insertion of INLEXZO, the card should be completed and provided to the patient. The patient should be advised to carry the card and to show their current and future healthcare providers in case of need for MRI scans.¹
• An example image of the card is shown in: INLEXZO MRI Safety Information Card.

PRODUCT LABELING

• INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
• INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-instructions-for-use/INLEXZO-ifu.pdf.

INLEXZO Prescribing Information

Section 5 Warnings and Precautions

Section 5.3 Magnetic Resonance Imaging (MRI)

• INLEXZO may be used with MRI only under the specific pre-defined conditions provided below to avoid potential safety hazards or severe adverse reactions.
• Based on clinical experience in patients treated with INLEXZO indwelling in the bladder who underwent MRI scans and nonclinical testing, INLEXZO is MR Conditional. A patient with INLEXZO indwelling in the bladder can be scanned in an MR system under the following conditions:¹
  • Static magnetic field of 1.5-Tesla and 3-Tesla, only.
  • Maximum spatial gradient magnetic field of 5000 Gauss/cm or less.
  • Maximum magnetic resonance system reported, whole body averaged specific absorption rate of 2-W/kg for 60 minutes of continuous scanning (i.e., per pulse sequence or back-to-back sequences without breaks) in the Normal Operating Mode of operation for the MR system.
• Under the scan conditions defined, INLEXZO is expected to produce a maximum temperature rise of 2°C after 15 minutes of continuous scanning.¹
• In nonclinical testing, the image artifact caused by INLEXZO extends approximately 2 mm from INLEXZO using a gradient echo pulse sequence and a 3-Tesla MR system.¹

Section 17 Patient Counseling Information

MRI Safety Information

• Inform the patient that INLEXZO can only be safely scanned with MRI under specific conditions (see Warnings and Precautions [5.3]). Instruct patients who will have an MRI to tell their healthcare provider that they have INLEXZO.¹
• This information is included in the MRI Safety Information Card. Complete the MRI Safety Information Card and give it to the patient.¹

MRI Safety information Card

• An example image of the card is shown below: INLEXZO MRI Safety Information Card.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 29 April 2026.