Nogapendekin Alfa Inbakicept-pmln

Nogapendekin Alfa Inbakicept is a prescription medication indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

• Nogapendekin Alfa Inbakicept is available under the following different brand names: Anktiva, Nogapendekin Alfa Inbakicept-pmln.

Common side effects of Nogapendekin Alfa Inbakicept include:

• increased creatinine
• dysuria
• hematuria 
• urinary frequency 
• micturition urgency 
• urinary tract infection 
• increased potassium 
• musculoskeletal pain 
• chills, and pyrexia
• fatigue
• nausea
• bladder irritation
• diarrhea
• nocturia

Serious side effects of Nogapendekin Alfa Inbakicept include:

• not available

Rare side effects of Nogapendekin Alfa Inbakicept 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 solution

• 400 mcg/0.4mL single-dose vial

Bladder cancer

Adult dosage

• Induction
  • 400 mcg intravesically with BCG every week for 6 weeks
  • May administer a second induction course if the complete response is not achieved at 3 months
• Maintenance
  • 400 mcg intravesically with BCG every week for 3 weeks at months 4, 7, 10, and 19 (for up to 15 doses)
  • Ongoing complete response at month 25 and later: Administer maintenance instillations with BCG every week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional installations
• Duration of treatment
  • Continue until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nogapendekin Alfa Inbakicept has no noted severe interactions with any other drugs
• Nogapendekin Alfa Inbakicept has no noted serious interactions with any other drugs
• Nogapendekin Alfa Inbakicept has no noted moderate interactions with any other drugs
• Nogapendekin Alfa Inbakicept has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, 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. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nogapendekin Alfa Inbakicept?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nogapendekin Alfa Inbakicept?”

Cautions

• Risk of metastatic bladder cancer with delayed cystectomy H4
• Delaying cystectomy in patients with BCG-unresponsive CIS could lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal
• Risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS
• If patients with CIS do not have a complete response to treatment after the second induction course, reconsider cystectomy

Pregnancy and Lactation

• There are no available data regarding use in pregnant women to inform of a drug-associated risk. Advise pregnant women and women of reproductive potential of potential risk to the fetus. Based on its mechanism of action, it may cause fetal harm when administered to pregnant women if systemic exposure occurs. Verify pregnancy status in women of reproductive potential before initiating treatment
• Contraception
  • Advise women of reproductive potential to use effective contraception during treatment and for 1 week after the last dose
• Lactation
  • There are no data on the presence of Nogapendekin Alfa Inbakicept in human milk, its effects on breastfed children, or milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or underlying maternal condition