ANKTIVA

Generic Name/API: nogapendekin alfa inbakicept-pmln

Manufacturer: AGC Biologics

Dosage Forms & Strength & Pack Size:
400 mcg/0.4 mL, clear to slightly opalescent and colorless to slightly yellow solution in single-dose vials for intravesical instillation after dilution. Carton containing 400 mcg/0.4 mL, single-dose vial.

Storage:
Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE:
ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (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.

WARNINGS AND PRECAUTIONS:
Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
CONTRAINDICATIONS: None
DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

Scroll to Top