Inlexzo

Pronunciation: inn-lex-zo
Generic name: gemcitabine intravesical system
Brand name: Inlexzo
Dosage form: single-dose intravesical system (225 mg)
Drug class: Antimetabolites

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 10, 2025.

What is Inlexzo? Bladder Cancer Treatment

Inlexzo is used to treat non-muscle invasive bladder cancer (NMIBC) in adults that has not spread to other parts of the body and did not respond to BCG treatment (Bacillus Calmette-Guérin). This innovative intravesical drug delivery system provides targeted gemcitabine therapy directly to bladder cancer cells.

Key Treatment Details:

Generic name: Gemcitabine hydrochloride intravesical drug-releasing system
Brand name: Inlexzo
Treatment type: Intravesical bladder cancer therapy
Administration: Outpatient bladder insertion procedure
FDA approval date: September 9, 2025

How Does Inlexzo Bladder Cancer Treatment Work?

Inlexzo is a bladder drug delivery system that is inserted during an outpatient visit. The device stays in the bladder for three weeks and slowly releases gemcitabine chemotherapy directly into the bladder tissue. Patients can receive up to 14 treatment cycles, with each cycle lasting three weeks.

Mechanism of Action - Gemcitabine for Bladder Cancer:

Inlexzo slowly releases gemcitabine, which kills bladder cancer cells by disrupting DNA synthesis. It's converted to active forms that block enzymes needed for DNA building blocks and gets incorporated into DNA itself. This double action enhances gemcitabine's effectiveness (self-potentiation). Once in DNA, it stops further DNA construction, triggering the death of cancer cells.

Clinical Efficacy: BCG-Unresponsive Bladder Cancer Results

SunRISe-1 Clinical Trial Results:

Inlexzo's FDA approval is based on the SunRISe-1 Phase 2b trial (NCT04640623). 82% of patients with BCG-unresponsive NMIBC achieved complete response (no signs of cancer), with 51% maintaining response for at least one year.

Key Clinical Outcomes:

Complete response rate: 82%
Duration of response: 51% at 1 year
Study population: BCG-unresponsive non-muscle invasive bladder cancer
Trial phase: Phase 2b clinical study

Inlexzo Side Effects - What to Expect During Bladder Cancer Treatment

Most Common Side Effects (≥15% of patients):

Urinary frequency
Urinary tract infection (UTI)
Dysuria (pain or burning sensation when passing urine)
Urinary urgency
Decreased hemoglobin (anemia)
Increased lipase (pancreatic enzyme)
Urinary tract pain (felt in the lower stomach area or lower back)
Decreased lymphocytes (white blood cells)
Hematuria (blood in the urine)
Increased creatinine (kidney function marker)
Increased potassium
Elevated liver enzymes (AST, ALT)
Decreased sodium
Bladder irritation.

Serious Side Effects - Important Safety Information for Bladder Cancer Patients:

Critical Safety Warnings:

Bladder perforation risk: Cannot be used if the bladder is torn or damaged - your doctor will check this first
Delayed cystectomy risks: Putting off bladder removal surgery (if recommended) may allow bladder cancer to spread, which can be life-threatening
MRI safety concerns: Special precautions are needed for MRI scans while the device is in place
Pregnancy risks: Can harm unborn babies - use effective birth control during treatment.

For medical advice about side effects, call your healthcare provider or report to the FDA at 1-800-FDA-1088.

Male Fertility and Bladder Cancer Treatment:

Inlexzo may cause fertility problems in males, which may affect your ability to have children. It is unknown if these fertility side effects are reversible. Talk to your healthcare provider if this is a problem for you.

Before Receiving Inlexzo Bladder Cancer Treatment

Absolute Contraindications - Who Cannot Use Inlexzo:

Do not receive Inlexzo if you:

Have a tear or hole (perforation) in your bladder
Have had an allergic reaction to gemcitabine or any of the ingredients in Inlexzo

Caution Needed - Medical Conditions and Bladder Cancer Treatment:

Tell your healthcare provider about all of your medical conditions, including if you:

Are pregnant, or plan to become pregnant
Are breastfeeding, or plan to breastfeed
Have any kidney problems or liver disease

Note: It is not known if Inlexzo is safe and effective for use in children or pediatric bladder cancer.

Pregnancy and Breastfeeding with Bladder Cancer Treatment

Pregnancy Considerations:

Inlexzo can harm your unborn baby. You should not become pregnant during treatment with Inlexzo. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during bladder cancer treatment with Inlexzo.

For females who can become pregnant:

Your healthcare provider will check to see if you are pregnant before starting treatment
Use effective birth control during treatment and for 6 months after the final removal of Inlexzo

For males treated with Inlexzo:

If you have a female partner who can become pregnant, use effective birth control during treatment and for 3 months after the final removal of Inlexzo

Breastfeeding Considerations:

It is not known if Inlexzo passes into breastmilk. Do not breastfeed during treatment with Inlexzo and for 1 week after the final removal of Inlexzo.

How is Inlexzo Administered? Bladder Cancer Treatment Schedule

Treatment Protocol:

Inlexzo insertion and removal are performed by your healthcare provider
It is inserted into your bladder through a urinary catheter
Initial phase: 1 time every 3 weeks for up to 6 months (8 doses)
Maintenance phase: 1 time every 12 weeks for up to 18 months (6 doses)
Each device remains in the bladder for 3 weeks (3-week indwelling period)
Your healthcare provider will decide how many Inlexzo treatments you will receive.

Pre-Treatment Instructions:

Your healthcare provider may give you antibiotics before insertion or removal
Do not empty your bladder right before the insertion procedure
Keep all appointment schedules. Missing treatments can affect outcomes.

Post-Treatment Care Instructions:

Drink 6-7 cups (1500 mL) of fluids daily during treatment to ensure adequate urine production
You can urinate normally. No need to hold urine
Avoid skin contact with urine during the treatment period
Sit on the toilet to urinate (both males and females) and flush after each use
Wash your hands with soap and clean your genital area with water after urinating
Wash urine-soiled clothing immediately and separately from other clothing.

After Device Removal:

Avoid skin contact with urine for at least 24 hours after Inlexzo is removed

MRI Safety with Inlexzo Bladder Cancer Treatment

Important MRI Information: Tell your healthcare provider that you have Inlexzo before having an MRI scan. The device may be used under specific MRI conditions. Your healthcare provider will give you an MRI Safety Information Card. Keep this card safe and show it to all healthcare providers.

Drug Interactions with Bladder Cancer Treatment

Tell your healthcare provider about all medicines you take, including:

Prescription medications
Over-the-counter medicines
Vitamins and supplements
Herbal supplements.

Inlexzo Ingredients and Manufacturer Information

Active Ingredient:

Gemcitabine hydrochloride (chemotherapy drug)

Inactive Ingredients:

Gemcitabine component:

Polyethylene glycol 8000
Povidone K30
Urea

Osmotic components:

FD&C Blue No.1
Polyethylene oxide 600,000
Urea

Manufacturer:

Inlexzo is manufactured by Johnson & Johnson for Janssen Biotech Inc, Horsham, PA 19044, USA.

Frequently Asked Questions About Inlexzo Bladder Cancer Treatment

Is Inlexzo covered by insurance?

Contact your insurance provider to verify bladder cancer treatment coverage for Inlexzo.

How long does Inlexzo treatment last?

Treatment can last up to 2 years with up to 14 cycles total.

Can I drive after Inlexzo insertion?

Most patients can resume normal activities, but follow your healthcare provider's specific instructions.

What if I miss a treatment appointment?

Call your healthcare provider immediately to reschedule - consistent treatment timing is important for bladder cancer therapy effectiveness.

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