Patient leaflet - Anktiva 400 micrograms concentrate for intravesical solution
1. What ANKTIVA is and what it is used for
ANKTIVA contains the active ingredient nogapendekin alfa inbakicept; a modified version of a protein called interleukin-15 (IL-15). ANKTIVA acts as a receptor superagonist.
ANKTIVA is used to treat adult patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours, that have not responded to treatment with BCG (Bacillus Calmette-Guérin). When ANKTIVA is used with BCG it activates the immune system, including immune memory cells, to kill bladder cancer cells. This may help the patient to have a durable complete response.
How ANKTIVA works
Interleukin-15 (IL-15) is a protein that plays an important role in the immune system by affecting the development, maintenance, and function of immune cells. The active substance in ANKTIVA is an IL-15 superagonist complex that works by binding to IL-15 receptors on immune cells. It activates anti-tumour immune cells and limits the activation of immune-suppressing cells.
2. What you need to know before you are given ANKTIVA
You should not be given ANKTIVA
if you are allergic to nogapendekin alfa inbakicept or any of
the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving ANKTIVA.
Before you get ANKTIVA, tell your doctor:
if you have a tumour for which removal of the bladder or
another systemic therapy (e.g. chemotherapy) is indicated. if you have had a history of or evidence of muscle-
invasive, locally advanced metastatic bladder cancer.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and ANKTIVA
Tell your doctor or pharmacist if you are using, have recently used, or might take or use any other medicines.
Pregnancy, breast-feeding and fertility
Exposure to ANKTIVA during pregnancy may harm the foetus.
There is no information on the presence of ANKTIVA in breast milk or the effects on the breast-fed child, or on milk production.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Treatment with ANKTIVA and BCG could influence your ability to drive or use machines.
ANKTIVA contains potassium and sodium
This medicine contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per vial (0.4 mL), that is to say essentially “potassium- and sodium-free”.
3. How ANKTIVA is given
ANKTIVA will be given to you by a trained health care professional.
Dosage
The recommended dose is 400 micrograms. The content of one vial is required for one bladder instillation. This medicine is used together with BCG.
Administration
ANKTIVA must not be used for administration under the skin, into the muscle or vein.
ANKTIVA is prepared and administered by trained healthcare personnel only. ANKTIVA is given with BCG as an intravesical instillation, which is a liquid medicine delivered into the bladder through a tube (catheter) from the urethra.
You should wait 2 hours before you empty your bladder. If you are unable to hold the mixture for two hours, you may be allowed to empty it sooner, without having to repeat the dose.
Duration of the treatment
Induction therapy
You will receive one dose of ANKTIVA with
BCG once a week for 6 weeks.
If you do not completely respond to the treatment after 3
months, you may receive a second induction course.
Maintenance therapy
After induction therapy with ANKTIVA and BCG, you will receive
one dose of ANKTIVA with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). In case of an ongoing complete response at month 25
and later, you may receive maintenance instillations with BCG once a week for 3 weeks at months 25, 31 and 37 (for a maximum of 9 additional instillations).
Your doctor may recommend to stop maintenance
therapy with ANKTIVA and BCG if the disease remains after a second induction course, if the disease reappears or worsens, if you experience unacceptable toxicity or if you have been on the treatment for over 3 years.
If you stop receiving ANKTIVA
Do not stop treatment with ANKTIVA without talking to your doctor.
If you have any further questions about your treatment, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Irritable bladder symptoms may occur during instillation, and retention of ANKTIVA, and following voiding. For the first 24 hours following administration, red-tinged urine may occur. These symptoms are generally mild and temporary, occurring at a similar frequency as with BCG therapy alone. Tell your doctor or nurse immediately if you experience severe or prolonged symptoms.
The following side effects were seen in patients who received ANKTIVA together with BCG. Tell your doctor if you have any of the following:
Serious side effects
No serious side effects were reported as related to ANKTIVA in the 88 patients with BCG-resistant NMIBC CIS who had received ANKTIVA with BCG.
Other side effects
Very common side effects (may affect more than 1 in 10 people)
Painful or uncomfortable urination (dysuria)
Frequent, small amounts of urination (pollakiuria) Blood in the urine (haematuria)
A sudden strong need to urinate (micturition urgency) Fatigue
Common side effects (may affect up to 1 in 10 people)
Sudden squeeze of the bladder (bladder spasm)
Chills
Fever (pyrexia)
Urinary tract infection
Bladder inflammation not caused by infection (cystitis noninfective) Excessive urination at night (nocturia)
Nausea
Joint pain (arthralgia)
Night sweats
Urinary tract pain
Inability to control urination (urinary incontinence) Increase in creatinine in the blood
Abnormal presence of cells in the urine
Diarrhoea
Muscle pain (myalgia)
Inflammation of the prostate gland (prostatitis)
Incontinence
Difficulty in emptying the bladder (urinary retention) Urinary tract discomfort
Bladder irritation
Lower urinary tract symptoms, e.g. poor urinary stream, prolonged
urination, dribbling of urine, or incomplete bladder emptying Excessive or abnormally large production
or passage of urine (polyuria)
Urge incontinence
Urinary hesitation
Urine abnormality
Bladder inflammation (cystitis)
Headache
Pain in the lower abdomen
Decreased appetite
Difficulty breathing (dyspnoea)
Itchy skin (pruritus)
Rash
Muscular weakness
Flank pain (pain on the side between the lower ribs and the hip) Penile pain
Pain
Detection of bacteria in urine test
Excessive loss of body water (dehydration)
Vomiting
Influenza like illness
Inflammation of the joints (arthritis)
Pain in extremity
Decreased filtration activity of the kidneys (glomerular filtration rate
decreased)
Increased the levels of urea (a waste product that needs to be
removed from the body) in the blood
Enlargement of the prostate gland that is not cancerous (benign
prostatic hyperplasia)
Penile discharge
Vulvovaginal burning sensation
Pain above the pubic bone (suprapubic pain)
Urine test shows blood is present
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store ANKTIVA
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C to 8°C). Do not freeze.
Store in original carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What ANKTIVA contains
The active substance is nogapendekin alfa inbakicept.
One vial of 0.4 mL contains 400 micrograms nogapendekin alfa inbakicept.
The other ingredients are disodium phosphate, potasssium dihydrogen phosphate, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
What ANKTIVA looks like and contents of the pack
ANKTIVA is a clear to slightly opalescent and colourless to slightly yellow concentrate for intravesical solution.
ANKTIVA is available in a carton containing 1 single-dose clear type I glass vial of 400 micrograms concentrate for intravesical solution with a chlorobutyl elastomer stopper and an aluminum alloy seal containing a yellow plastic polypropylene flip-off cap.
Marketing Authorisation Holder
ImmunityBio Ireland Limited
15 Merrion Square North
Dublin 2
D02 YN15
Ireland
Manufacturer
Bilthoven Biologicals
Antonie van Leeuwenhoeklaan 9, 3721 MA
Bilthoven, Netherlands
This leaflet was last revised in 05/2026
The following information is intended for healthcare professionals only:
For information on posology, see section 4.2 of the Summary of Product Characteristics.
Administering the medicinal product
The admixture of ANKTIVA in combination with BCG is instilled into the bladder via a catheter. After instillation is complete, the catheter is removed. The ANKTIVA in combination with BCG admixture is retained in the bladder for 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary. Do not repeat the dose if the patient voids before 2 hours.
See BCG Summary of Product Characteristics for information on retention in the bladder and patient positioning during bladder instillation.
Special precautions for disposal and other handling
For single use only.
Do not shake.
Before administration, visually inspect the solution for particulate matter and discolouration prior to administration. Discard the vial if visible particles or discolouration are observed.
Draw 0.4 mL of ANKTIVA into a small syringe and using aseptic technique add to the saline containing the BCG suspension that has been prepared following the instructions provided in the Summary of Product Characteristics for BCG. Mix the suspension gently. Using a 60-mL syringe connected to an appropriate size needle, withdraw the ANKTIVA BCG mixture to a final volume of 50 mL.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
ANKTIVA®
(nogapendekin alfa
inbakicept-pmln)
solution, for intravesical use
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