Version November 2024
Dosage guidance:
Safety: For intravesical use only; do not administer IV, IM, or SUBQ. Patients should maintain adequate hydration following nogapendekin alfa inbakicept treatment.
Bladder cancer, BCG unresponsive, non–muscle invasive:
Induction: Intravesical: 400 mcg once a week (in combination with Bacillus Calmette-Guérin [BCG]) for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3 (Ref).
Maintenance: Intravesical: 400 mcg once a week (in combination with BCG) for 3 weeks at months 4, 7, 10, 13, and 19 (for a total of 15 maintenance doses); for patients with an ongoing complete response at month 25 and beyond, maintenance dosing may be administered once weekly for 3 weeks at months 25, 31, and 37 (for a total of 9 additional maintenance doses). The recommended duration of treatment is until disease persistence after second induction, until disease recurrence or progression or unacceptable toxicity, or for a maximum of 37 months (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Increased serum potassium (18%)
Gastrointestinal: Nausea (14%)
Genitourinary: Bladder mucosa irritation (11%), dysuria (32%), hematuria (32%; serious: 3%), urinary frequency (27%), urinary tract infection (24%), urinary urgency (25%)
Nervous system: Chills (15%), fatigue (14%)
Neuromuscular & skeletal: Musculoskeletal pain (17%)
Renal: Increased serum creatinine (76%)
Miscellaneous: Fever (15%)
1% to 10%:
Gastrointestinal: Diarrhea (9%)
Genitourinary: Nocturia (7%)
There are no contraindications listed in the manufacturer's labeling.
Disease-related concerns:
• Risk of muscle-invasive or metastatic bladder cancer: Delaying cystectomy in patients with Bacillus Calmette-Guérin (BCG)–unresponsive carcinoma in situ (CIS) may lead to development of muscle-invasive or metastatic bladder cancer, which can be lethal. The risk increases the longer cystectomy is delayed. Of the patients with BCG-unresponsive CIS treated with nogapendekin alfa inbakicept with BCG (intravesical), some progressed to muscle invasive (≥T2) bladder cancer, most occurring during the treatment period; most of these patients were determined to have progression at the time of cystectomy. The median time between determination of persistent or recurrent CIS and progression to muscle-invasive disease was 107 days (range: 0 to 210 days). Reconsider cystectomy if patients with CIS do not have a complete response to treatment after a second induction course of nogapendekin alfa inbakicept (with BCG).
Other warnings/precautions:
• Universal precautions: Follow universal precautions and facility biosafety guidelines for handling and disposal due to the BCG component.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravesical [preservative free]:
Anktiva: Nogapendekin alfa inbakicept-pmln 400 mcg/0.4 mL (0.4 mL)
No
Solution (Anktiva Intravesical)
400 mcg/0.4 mL (per 0.4 mL): $42,960.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Intravesical instillation: Instill nogapendekin alfa inbakicept in Bacillus Calmette-Guérin (BCG) (intravesical) suspension into the urinary bladder via a catheter. Remove catheter after instillation is complete. Patients should retain nogapendekin alfa inbakicept in BCG (intravesical) suspension in the bladder for 2 hours and then void. If unable to retain suspension for 2 hours, allow patient to void sooner (if needed); do not repeat doses that are voided prior to dwelling for 2 hours. Follow BCG (intravesical) manufacturer instructions for bladder retention and patient positioning during bladder installation and dwell time. Instill within 2 hours of preparation (vial puncture); the total time from start of preparation to the completion of the intravesical instillation should not exceed 2 hours.
Patients should maintain adequate hydration following nogapendekin alfa inbakicept treatment. Inform patients to void while seated to avoid splashing of urine.
For intravesical use only; do not administer IV, IM, or SUBQ.
Follow universal precautions and facility biosafety guidelines for handling and disposal for BCG component.
Bladder cancer, BCG unresponsive, non–muscle invasive: Treatment of Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer, in combination with BCG (intravesical), in adults with carcinoma in situ (CIS) with or without papillary tumors.
None known.
There are no known significant interactions.
Verify pregnancy status prior to treatment initiation. Patients who could become pregnant should use effective contraception during therapy and for 1 week after the last dose of nogapendekin alfa inbakicept.
Animal reproduction studies have not been conducted.
Based on the mechanism of action, in utero exposure to nogapendekin alfa inbakicept may cause fetal harm. Advise patients of the potential risk to a fetus. Systemic exposure is below the limit of quantification following intravesical administration at the approved dose.
It is not known if nogapendekin alfa inbakicept is present in breast milk.
Systemic exposure is below the limit of quantification following intravesical administration at the approved dose. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Purified protein derivative (PPD) test PRIOR to nogapendekin alfa inbakicept with Bacillus Calmette-Guérin (BCG) (intravesical) treatment initiation. Verify pregnancy status prior to treatment initiation (in patients who could become pregnant).
Nogapendekin alfa-inbakicept (NAI) is a fusion protein complex composed of an interleukin (IL)-15 variant bound to a dimeric IL-15 receptor alpha Fc fusion protein. This IL-15-based immunostimulatory protein complex works as an activation and proliferation factor for natural killer cells as well as effector and memory T cells. Binding of nogapendekin alfa inbakicept to its receptor results in proliferation and activation of NK, CD8+, and memory T cells without proliferation of immuno-suppressive Treg cells. In a carcinogen-induced animal bladder cancer model, intravesical nogapendekin alfa inbakicept alone or in combination with Bacillus Calmette-Guérin (BCG) showed anti-tumor activity (compared to BCG alone). When administered in combination with BCG (intravesical), BCG establishes an immunotherapeutic effect in bladder cancer when enhanced with a second unrelated IL-15 protein complex stimulus such as NAI (Ref).
Absorption: Systemic exposure of nogapendekin alfa-inbakicept is below the limit of quantification following intravesical administration at the approved dose.
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