ANKTIVA – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine ANKTIVA, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What ANKTIVA is and what it is used for
ANKTIVA contains the active substance nogapendekin alfa inbakicept.
ANKTIVA is used in adults to treat a type of bladder cancer that has not spread outside the bladder . It is used in adults who have not responded to treatment with Bacillus Calmette -Guérin (BCG ).
ANKTIVA is used together with BCG and both are given through the urethra into the bladder . For more information on BCG, read the package leaflet for the BCG medicine you will be given.
How ANKTIVA works
The active substance in ANKTIVA, nogapendekin alfa inbakicept, works by binding to a protein in the immune system known as the interleukin -15 (IL -15) receptor . This activ ates cells in the immune system that target and destroy cancer ce lls.
⚠️ 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
Risk of your cancer getting worse if surgery to remove all or part of the bladder is delayed following treatment with this medicine
Children and adolescents
The safety and efficacy of ANKTIVA in children have not been established . You should not be given this medicine if you are under 18 years old .
Other medicines and ANKTIVA
22 Tell your doctor or pharmacist if you are using, have recently used, or might take or use any other medicines.
Pregnancy , breast -feeding and contraception
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Treatment with ANKTIVA is not recommended during pregnancy. This is because it is no t known if the medicine may harm the foetus.
Breast -feeding ANKTIVA can be used during breast -feeding.
Contraception If you are a woman who can become pregnant, you must use effective contraception (birth control) during treatment with ANKTIVA and for one week after you receive the last dose. Your doctor will give you advice on appropriate contraception methods.
Driving and using machines
Treatment with ANKTIVA has no or minimal impact on your ability to drive or use machines .
ANKTIVA contains potassium and sodium
This medicine contains potassium , less than 1 mmol (39 mg) per vial, i.e. essentially ‘potassium -free’.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium – free’.
💊 3. How ANKTIVA is given
ANKTIVA will be given to you by a trained health care professional.
The recommended dose of ANKTIVA is 400 micrograms. This medicine is given together with BCG .
Administration Before administration, do not drink any liquid the 4 hours before treatment is given to you. ANKTIVA is given with BCG as an intravesical instillation, which is a liquid medicine delivered directly into the bladder through a thin, flexible tube (catheter) inserted into the urethra (the tube through which urine leaves the body from the bladder) . After ANKTIVA and BCG are delivered to the bladder, the catheter is removed from your urethra.
You should wait 2 hours after you are given this medicine before you empty your bladder (i.e. urinate) . If you are unable to hold the mixture for two hours, you will be allowed to empty your bladder sooner, without having to repeat the dose.
Duration of treatment Induction therapy
- You will receive one dose of ANKTIVA with BCG once a week for 6 weeks. This is known as induction therapy.
If the first round of induction therapy does not fully work after 3 months, you may receive a second course (called re- induction) of ANKTIVA with BCG once a week for 6 more week s.
Maintenance therapy
- If induction therapy was successful, you will receive one dose of ANKTIVA with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19. This adds up to 15 maintenance doses.
23 – If there are no signs of cancer at month 25 or later, you may receive ANKTIVA with BCG once a week for 3 weeks at months 25, 31, and 37. A maximum of 9 additional doses may be given.
Your tumour’s response to treatment will be evaluated at least every 3 months for up to 24 months.
- Your doctor may recommend stopping ANKTIVA with BCG in these situations: o if the disease remains after re -induction therapy, o if the disease comes back or worsens, o if you experience serious side effects, or o if you have been on the treatment for 37 months .
If you stop receiving ANKTIVA Do not stop treatment with this medicine without talking to your doctor.
If you have any further questions on the use of this medicine , ask your doctor.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects were seen in patients who received ANKTIVA together with BCG.
Bladder irritation (such as burning or discomfort) may occur during treatment, while the medicine is in your bladder, or after you urinate. You may also notice blood in the urine for up to 24 hours after treatment. These symptoms are usually mild and temporary. Tell your doctor or nurse right away if your symptoms are severe or last a long time .
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) and bladder inflammation with bleeding (cystitis haemorrhagic )
- A sudden strong need to urinate (micturition urgency)
- Tiredness (f atigue )
- Urinary tract infection
- Chills
- Fever (pyrexia)
- Musculoskeletal pain , back pain, flank pain, and pain in arm or leg
Common side effects (may affect up to 1 in 10 people)
- Sudden squeeze of the bladder (bladder spasm), difficulty in emptying the bladder (urinary retention), urinary hesitation, excessive urination at night (nocturia) , lower urinary tract symptoms, urine flow decreased (poor urinary stream), inability to control urination (urinary incontinence), bladder inflammation ( cystitis), bladder inflammation not caused by infection (cystitis noninfective), urinary tract pain , urinary tract discomfort, bladder pain , bladder discomfort , bladder irritation , urgent and uncontrolled need to pee (urge incontinence), white blood cells in the urine ( leukocyt uria), cancer cells in urine
- Shortness of breath or difficulty breathing (dyspno ea), chest pain
- Swollen lymph nodes (lymphadenopathy)
- Nausea
- Night sweats
- Diarrhoea
- Headache
- Decreased appetite
- Itchy skin (pruritus)
- Rash
- Muscular weakness 24 – Penile pain, penile burning sensation, inflammation of the prostate gland (prostatitis), enlargement of the prostate gland that is not cancerous (benign prostatic hyperplasia), vulvovaginal burning sensation
- Dehydration
- Vomiting
- Influenza like illness
- Bacteria in urine with no symptoms (asymptomatic bacteriuria), and bacterial test positive in urine ( bacteriuria ),
- Low red blood cells (anaemia), low red blood cells caused by unusually large red blood cells (macrocytic anaemia ), increase in creatinine seen in blood test , increased white blood cells in the blood (l eukocytosis), bacteria in the blood (bacteraemia)
- Dizziness
- Constipation
- Muscle pain/ soreness and pain (myalgia), abdominal pain, lower abdominal pain, and pain just above the pubic bone (suprapubic pain)
- Joint pain (arthralgia)
- Body-wide infection ( Sepsis )
Uncommon side effects (may affect up to 1 in 100 people)
- Reduced kidney filtering (g lomerular filtration rate decreased)
- Urine abnormality
- Increase in blood waste levels (b lood urea increased )
- Frequent urination (polyuria)
- Unusual liquid from the penis (penile discharge)
- Joint pain (arthritis)
- Soreness at the treatment site (installation site pain)
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 via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store ANKTIVA
ANKTIVA will be stored at the hospital or clinic . Store in a refrigerator (2 °C-8 °C).
Do not freeze. Keep the vial in the outer carton in order to protect from light
📦 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 di sodium phosphate, potassium dihydrogen phosphate, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide. S ee section 2
“ANKTIVA contains potassium and sodium”.
What ANKTIVA looks like and contents of the pack This medicine is a clear to slightly opalescent and colourless to slightly yellow solution.
The medicine is available in a carton containing 1 single -dose vial.
Marketing Authorisation Holder
ImmunityBio Ireland Limited 25 6th Floor, 2 Grand Canal Square Dublin 2, Ireland, D02 A342
Manufacturer
Bilthoven Biologicals Antonie van Leeuwenhoeklaan 9 3721 MA Bilthoven The Netherlands
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . —————————————————————————————————————–
🩺 Information intended for healthcare professionals only
Administering the medicinal product ANKTIVA is recommended at a dose of 400 micrograms; administered intravesically as a mixture with BCG recommended at a dose of 50 m L 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.
In-use stability Chemical and physical in‑use stability of the admixture of ANKTIVA with:
- OncoTICE has been demonstrated for up to 2 hours at 2 °C to 8 °C, protected from light.
- BCG‑medac has been demonstrated for up to 24 hours at 2 °C to 8 °C, protected from light.
ANKTIVA has only been studied with OncoTICE and BCG -medac.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Special precautions for disposal and other handling Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if visible particles are observed.
Prepare a suspension of BCG according to the instructions provided in the manufacturer’s Summary of Product Characteristics for the specific BCG being used.
Only OncoTICE and BCG -medac should be used.
26 Obtain a vial of ANKTIVA (do not shake), remove the flip- off cap and disinfect the stopper.
Withdraw 0.4 mL of ANKTIVA using a sterile needle and syringe (1 -3 mL). Using clean technique, promptly add ANKTIVA to the sodium chloride solution containing the B CG suspension utilizing appropriate connectors and/or septum (as needed), depending on the saline container used for the BCG suspension. Mix the suspension gently.
Any spilled ANKTIVA BCG mixture should be cleaned by covering the area with paper towels soaked with tuberculocidal disinfectant for at least 10 minutes. Unused ANKTIVA with BCG and all equipment, supplies, and receptacles in contact with it should be handled and disposed of as biohazardous .
Accidental exposure to ANKTIVA BCG mixture could occur through self -inoculation, by dermal exposure through an open wound or by ingestion of ANKTIVA with BCG. Exposure should not produce significant adverse health outcomes in healthy individuals. However, in case of suspected, accidental self -inoculation, PPD skin testing is advised at the time of the accident and six weeks later to detect skin test conversion.
Precautions to be taken before handling or administering the medicinal product Standard precautions of personal protective equipment are the same as for BCG. No precautions are needed for ANKTIVA in addition to the BCG precautions.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information ANKTIVA (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/2002).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.