Nogapendekin Alfa Inbakicept Dosage

Medically reviewed by Drugs.com. Last updated on Jun 18, 2024.

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 only

Use: 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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Report suspected adverse reactions to www.fda.gov/medwatch

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for Intravesical Use Only. Do NOT administer by subcutaneous, intravenous or intramuscular routes.
• Inspect visually for particulate matter and discoloration prior to administration. The solution is clear to slight opalescent and colorless to slightly yellow.
• Discard the vial if particles are observed.
• The admixture of this drug and BCG is instilled into the bladder via a catheter, retained for 2 hours and then voided. See this product and BCG prescribing information for detailed instructions on retention in the bladder and patient positioning during bladder instillation.

Storage requirements:

• Store vials under refrigeration at 2C to 8C (36F to 46F) in the original carton to protect from light.
• If the admixture with BCG is not used immediately, store refrigerated at 2C to 8C (36F to 46F).
• Unused admixture should be discarded after 2 hours.

Reconstitution/preparation techniques:

• Read the US FDA-approved prescribing information for further preparation and administration instructions.
• Read BCG US FDA-approved product information for further preparation, handling, and administration instructions.

Patient advice:

• Read the Patient Information and Instructions for Use.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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