ANKTIVA® is Co-Administered 
with BCG – for Familiar 
Storage and Dosing

Administration of ANKTIVA with BCG maintains the same favorable workflow 
and schedule as that of BCG alone in the urology practice environment

Preparation of BCG and ANKTIVA Admixture

Step 1
Preparing Anktiva - Step 1

BCG Diluted in 50 mL Saline

Prepare BCG suspension following the instructions provided in the Prescribing Information for BCG with saline as follows:

Draw 1 mL of sterile, preservative-free saline (0.9% Sodium Chloride Injection USP) from a 50 mL vial of sterile saline at 4-25°C into a small syringe (e.g., 3 mL) and add to 1 vial of BCG to resuspend. Ensure that the needle is inserted through the center of the rubber stopper of the vial. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

Dilute the cloudy BCG suspension in the same 50 mL sterile, preservative-free saline vial to a final volume of 50 mL. Mix the suspension gently prior to step 2.

Step 2
Preparing Anktiva - Step 2

Anktiva Admixed in 50 mL Saline with BCG

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution is clear to slightly opalescent and colorless to slightly yellow. Discard the vial if visible particles are observed. Draw 0.4 mL of ANKTIVA into a small syringe and using aseptic technique add to the 50 mL saline volume containing the BCG suspension from step 1 that has been prepared following the instructions provided in the Prescribing Information for BCG.

Mix the suspension gently.

Step 3
Preparing Anktiva - Step 3

50 mL Admixed Volume Transferred to 60 mL Syringe

Using a 60-mL syringe connected to an appropriate size needle, withdraw the ANKTIVA BCG mixture to a final volume of 50 mL.

If the admixture of ANKTIVA in combination with BCG is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 2 hours. Unused solution of admixture should be discarded after 2 hours.

Intravesical Administration

Step 1
Insert foley catheter under standard sterile conditions.
Step 2
Connect 60 mL syringe to foley catheter and infuse gently.
Step 3
The ANKTIVA plus BCG admixture to remain in the bladder for two-hours. 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.

Storage of ANKTIVA

ANKTIVA is stored at 2°C to 8°C (36°F to 46°F) and not frozen.

Do not shake.

Learn More About the Intravesical Instillation Schedule of ANKTIVA®

FIRST INDUCTION

MonthFirst Induction - Months 1 to 3
ANKTIVA 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course is not required if a complete response is achieved at month 3.

MAINTENANCE

Month
First Induction - Months 4 to 40
For Maintenance: After BCG and ANKTIVA induction therapy, ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later, maintenance instillations may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.

FIRST & SECOND INDUCTION

MonthFirst Induction - Months 1 to 4
ANKTIVA 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course is not required if a complete response is achieved at month 3.

MAINTENANCE

Month
First Induction - Months 5 to 40
For Maintenance: After BCG and ANKTIVA induction therapy, ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later, maintenance instillations may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.
1. Chamie K, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid. 2023 Jan;2(1): EVIDoa2200167. doi: 10.1056/EVIDoa2200167.

Preparation, Administration, and Storage

A summary of storage, preparation and administration, information for ANKTIVA

Patient Stories

Read about patients who participated in the clinical trials for ANKTIVA

Irv’s Journey

Irv’s Journey

He was first diagnosed with bladder cancer in 2016, when 
on Thanksgiving day, he had several concerning symptoms including blood in his urine. Several tumors on the interior surface of his bladder were removed by his local urologist, 
who treated him with BCG. Unfortunately, he failed to respond and the tumors came back. He was afraid he was going to lose his bladder.

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Wayne’s Journey

Wayne’s Journey

Wayne has lived a rich life with his wife, two daughters, and three grandchildren. He describes himself as someone who “just likes people”. When he was first told, “you might have a tumor in your bladder”, he became very concerned, especially when he learned his first treatment with BCG wasn’t working. Wayne feels lucky that a friend told him about a clinical trial for patients like himself who were not cured by BCG alone.

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ANKTIVA Resources

Information for ANKTIVA

DATASHEET

ANKTIVA: Efficacy & Safety

A clinical resource highlighting key efficacy and safety information about ANKTIVA (nogapendekin alfa inbakicept-pmln)

Download PDF

DATASHEET

ANKTIVA: Mechanism of Action

A description of how BCG and ANKTIVA work together in NMIBC CIS

Download PDF

DATASHEET

ANKTIVA: How to Order

A step-by-step guide on how to order ANKTIVA, including product codes

Download PDF

VIDEO

Physicians' Journey

Listen to the physicians' journey with their patients using ANKTIVA.

Watch Video

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatchor call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

ANKTIVA is a Novel Treatment for NMIBC CIS Patients Unresponsive to BCG

For more information, please call 1-877-ANKTIVA