nogapendekin alfa inbakicept
Anktiva · ATC code L03AC03
Also known as: Nogapendekin alfa inbakisept
- Key facts
- Active substance
- nogapendekin alfa inbakicept
- Drug class
- Interleukins
- ATC code
- L03AC03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ANKTIVA 400 microgram concentrate for intravesical suspension
- Marketing authorisation holder
- Immunitybio Ireland Limited
- Information as of
- 2026-10-29
Key facts
Nogapendekin alfa inbakicept (Anktiva) is an interleukin-15 superagonist instilled into the bladder together with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer.
What it is used for
- In combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
Dosing
- Induction: 400 micrograms intravesically as a mixture with BCG once a week for 6 weeks; a second induction may be given for residual disease at week 12.
- Maintenance: 400 micrograms with BCG once a week for 3 consecutive weeks at months 4, 7, 10, 13 and 19 (15 doses in total); with an ongoing complete response, further instillations at months 25, 31 and 37.
- Maximum treatment duration 37 months; treatment ends with disease persistence, recurrence, progression or unacceptable toxicity.
- The mixture is retained in the bladder for 2 hours; the dose is not repeated if the patient voids earlier.
- No dose adjustment in the elderly or in hepatic or renal impairment.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- For intravesical use only; must not be given subcutaneously, intravenously or intramuscularly.
- Severe systemic BCG infections requiring anti-tuberculosis therapy are possible.
- Delaying cystectomy could lead to muscle invasive or metastatic bladder cancer.
Side effects
- Most common: dysuria (35%), haematuria (35%), pollakiuria (32%), urinary tract infection (24%), micturition urgency (22%), fatigue (20%), chills (13%), musculoskeletal pain (11%) and pyrexia (10%).
- Serious in more than one patient: urinary tract infection, bacteraemia and haematuria.
Interactions
- No interaction studies have been performed.
Pregnancy and breastfeeding
- Not recommended during pregnancy or in women not using contraception; contraception during treatment and for 1 week after the last dose.
- For breast-feeding, see the full text.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- AnktivaImmunitybio Ireland Limited · EMEA/H/C/006622
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Anktiva
- Liechtenstein
- Anktiva
- Norway
- Anktiva
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Anktiva – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/anktiva-epar-product-information_en.pdf
- Wikidata (CC0): ATC L03AC.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.