Gemcitabine Intravesical

Gemcitabine Intravesical is a prescription medication 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.

• Gemcitabine Intravesical is available under the following different brand names: Inlexzo

Common side effects of Gemcitabine Intravesical include:

• increased urinary frequency
• urinary tract infection 
• hematuria
• dysuria 
• micturition urgency
• pain in the urinary tract (felt in the lower abdomen or lower back)
• bladder irritation
• increased liver enzymes (alanine transaminase and aspartate aminotransferase)
• increased potassium
• increased lipase 
• increased creatinine
• decreased hemoglobin
• decreased sodium
• decreased lymphocytes

Serious side effects of Gemcitabine Intravesical include:

• urinary tract infection
• hematuria
• pneumonia
• urinary tract pain
• cognitive disorder

Rare side effects of Gemcitabine Intravesical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intravesical system includes:

• 225 mg single-dose tube
• sterile urinary catheter
• sterile stylet

Bladder Cancer

Adult dosage

• 225 mg intravesically once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Bladder perforation
• Prior hypersensitivity reactions to any product component

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gemcitabine Intravesical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gemcitabine Intravesical?”

Cautions

• Risks with perforated bladder
  • Systemic exposure and risk of severe adverse reactions may occur if administered to patients with a perforated bladder or compromised bladder mucosa integrity
  • Evaluate the bladder before Intravesical administration; do not administer until bladder integrity has been restored in patients perforated bladder or mucosal compromise
• Risk of metastatic bladder cancer with delayed cystectomy
  • Delaying cystectomy in patients with BCG-unresponsive CIS may increase the risk of muscle-invasive or metastatic bladder cancer
  • Progression to muscle-invasive bladder cancer was reported in 8% of patients in a clinical trial
  • Median time to detect persistent or recurrent CIS or T1 and progression to muscle invasive disease: 94 days
• Magnetic resonance imaging (MRI) safety
  • Can only be safely scanned with MRI under certain conditions (MR conditional)
  • Static magnetic field of 1.5-Tesla and 3-Tesla
  • Maximum spatial gradient magnetic field of less than 5000 Gauss/cm
  • Maximum magnetic resonance system reported, whole body averaged specific absorption rate of 2-W/kg for 60 min of continuous scanning (ie, per pulse sequence or back-to-back sequences without breaks) in normal operating mode of operation for the MR system
  • Expected to produce a maximum temperature rise of 2ºC after 15 min of continuous scanning
  • Using a gradient echo pulse sequence and a 3-Tesla MR system, the image artifact extends about 2 mm from the Gemcitabine Intravesical
• Embryo-fetal toxicity
  • May cause fetal harm if administered during pregnancy, if systemic exposure occurs
  • Systemic Gemcitabine administration is teratogenic, embryotoxic, and fetotoxic in animal studies
  • Advise pregnant patients and females of reproductive potential of fetal risk
  • Effective contraception is recommended during and after therapy in females of reproductive potential and males with partners of reproductive potential

Pregnancy and Lactation

• May cause fetal harm when administered during pregnancy if systemic exposure occurs, based on animal data and its mechanism of action
• There are no available data on use in pregnant patients to inform drug-associated risk
• Advise pregnant patients and females of reproductive potential of fetal risk
• Verify pregnancy status in females of reproductive potential before starting therapy
• Contraception requirements
  • Females of reproductive potential: Use effective contraception during therapy and for 6 months after final removal
  • Males with female partners of reproductive potential: Use effective contraception during therapy and for 3 months after final removal
• Infertility
  • May impair fertility in males, based on animal studies
  • Not known if the effects on fertility are reversible
• Lactation
  • No information regarding the presence of gemcitabine or its metabolites in human milk or its effects on breastfed infants or milk production
  • Due to the risk of serious adverse reactions in breastfed infants, avoid breastfeeding during therapy and for 1 week after final removal