Anktiva Application Scope

Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class IL-15 receptor agonist immunotherapy approved by the U.S. FDA for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, in combination with Bacillus Calmette-Guérin (BCG) therapy.

anktiva

Characteristics

Ingredients: Nogapendekin alfa inbakicept-pmln

Properties: Interleukin-15 (IL-15) receptor agonist; stimulates immune response against bladder cancer cells
Packaging Specification: Single-dose vials containing 400 mcg/0.4 mL solution for intravesical instillation after dilution

Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); use within 2 hours after dilution
Expiry Date: Refer to the vial label for the specific expiration date
Executive Standard: FDA-approved prescribing information (U.S.)
Approval Number: J9028 (HCPCS code for billing)
Date of Revision: April 2024
Manufacturer: ImmunityBio, Inc.

Guidelines for the Use of Anktiva

Dosage and Administration:
- Induction: 400 mcg intravesically with BCG once weekly for 6 weeks. A second induction course may be administered if a complete response is not achieved at month 3.
- Maintenance: 400 mcg intravesically with BCG once weekly for 3 weeks at months 4, 7, 10, 13, and 19. For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once weekly for 3 weeks at months 25, 31, and 37.
- Administration: Instill intravesically only after dilution. The total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

Adverse Reactions:

Common (≥15%):
- Increased creatinine
- Dysuria
- Hematuria
- Urinary frequency
- Micturition urgency
- Urinary tract infection
- Increased potassium
- Musculoskeletal pain
- Chills
- Pyrexia
Contraindications: None identified
Precautions:
- Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
- May cause fetal harm; advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Interactions

Drug Interactions: No specific drug interactions have been identified. However, always inform your healthcare provider about all medications and supplements you are taking

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.