Nogapendekin alfa inbakicept

Nogapendekin alfa inbakicept is given to adults along with BCG (Bacillus Calmette and Guérin) to treat bladder cancer that has not spread to other parts of the body.

Nogapendekin alfa inbakicept may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Follow your doctor's instructions about your specific dosing schedule.

Nogapendekin alfa inbakicept is injected directly into the bladder using a catheter inserted into the urethra (the tube for passing urine out of your bladder). You will receive this medicine in a clinic or hospital setting.

You will need to hold the medicine in your bladder for as long as possible, up to 2 hours. During that time, you may be encouraged to lie down or stay relaxed.

Your doctor may ask you to drink extra fluids for several hours after your nogapendekin alfa inbakicept treatment.

Sit on the toilet while urinating to prevent splashing of urine.

Use only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

Tell your doctor if you have ever had:

• a surgery for bladder cancer.

May harm an unborn baby. Use effective birth control while using nogapendekin alfa inbakicept and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Ask a doctor if it is safe to breastfeed while using nogapendekin alfa inbakicept.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Nogapendekin alfa inbakicept may cause serious side effects. Call your doctor right away if you have:

• high blood potassium--nausea, weakness, tingling feeling, chest pain, irregular heartbeats, loss of movement;
• irritable bladder symptoms--increased urination; or
• pain and burning when you urinate, red or pink urine.

Common side effects of nogapendekin alfa inbakicept may include:

• overactive bladder, incontinence or leakage, pain and burning when you urinate, red or pink urine;
• abnormal lab results;
• muscle pain; or
• fever, chills, body aches, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Bladder Cancer:

Induction dose: 400 mcg administered intravesically with Bacillus Calmette-Guérin (BCG) once a week for 6 weeks-A second induction course may be administered if complete response is not achieved at month 3.Maintenance dose: After induction, 400 mcg intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses) Maximum dose: For patients with complete response at month 25 and later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.Duration of therapy: Until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months.Comments:-For intravesical use onlyUse: In combination with BCG for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

In a medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect nogapendekin alfa inbakicept, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.