Nogapendekin alfa inbakicept-pmln Intravesical

WHY is this medicine prescribed?

Nogapendekin alfa inbakicept-pmln is used in combination with Bacillus Calmette-Guerin (BCG) to treat a type of bladder cancer (carcinoma in situ; CIS) that was not effectively treated with BCG therapy alone. Nogapendekin alfa inbakicept-pmln is in a class of medications called interleukin-15 (IL-15) receptor agonists. It works by causing the body's immune system to fight the cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nogapendekin alfa inbakicept-pmln comes as a solution (liquid) to be infused (injected slowly) through a catheter (small flexible plastic tube) with BCG into your bladder while you are lying down. Nogapendekin alfa inbakicept-pmln solution is given by a doctor or a health care provider in a medical office, hospital, or clinic. Your doctor will tell you how often you will receive nogapendekin alfa inbakicept-pmln. The length of treatment depends on how well your body responds to the medication.

You should keep the medication in your bladder for 2 hours or as long as possible. During the first hour after the medication is infused, you will lie on your stomach, back, and sides for 15 minutes each. If you cannot keep the medication in your bladder for the entire 2 hours, tell your health care provider. At the end of 2 hours you will empty your bladder in a seated manner for safety reasons.

Your urine should be disinfected for 6 hours after the medication is administered. Pour a similar amount of undiluted bleach in the toilet after you urinate. Let it stand for 15 minutes before flushing.

You may have symptoms of an irritable bladder during or shortly after treatment with nogapendekin alfa inbakicept-pmln such as a sudden need to urinate or leaking of urine. Your urine may turn a red color for the first 24 hours after your treatment. Call your doctor immediately if you have continue to have symptoms of an irritable bladder or red colored urine more than 24 hours after your treatment with nogapendekin alfa inbakicept-pmln.

Drink plenty of fluids after receiving your treatment with nogapendekin alfa inbakicept-pmln.

Your doctor will watch you carefully to see how well treatment with nogapendekin alfa inbakicept-pmln works for you. If you do not respond fully to treatment or if your cancer returns, your doctor will probably recommend treatment with surgery.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving nogapendekin alfa inbakicept-pmln,

• tell your doctor and pharmacist if you are allergic to nogapendekin alfa inbakicept-pmln, any other medications, or any of the ingredients in nogapendekin alfa inbakicept-pmln solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney problems or any other medical problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving nogapendekin alfa inbakicept-pmln. If you are a female that can become pregnant, you will need to have a pregnancy test before you begin treatment, and you should use effective birth control during your treatment and for 1 week after your final dose. If you become pregnant while receiving nogapendekin alfa inbakicept-pmln, call your doctor. Nogapendekin alfa inbakicept-pmln may harm the fetus.

• you should know that delaying surgery to treat your bladder cancer while you are receiving treatment with nogapendekin alfa inbakicept-pmln may increase the risk that your bladder cancer could spread to nearby tissues or other parts of the body. Talk to your doctor about the risks of receiving this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of nogapendekin alfa inbakicept-pmln, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Nogapendekin alfa inbakicept-pmln may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• leakage of urine
• bladder spasms
• frequent, urgent, or painful urination
• difficulty urinating
• fatigue
• fever
• chills
• nausea
• diarrhea
• muscle or bone pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• blood in urine

Nogapendekin alfa inbakicept-pmln may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor will order certain tests to check your body's response to nogapendekin alfa inbakicept-pmln.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.