How ANKTIVA is Administered

Similar to how BCG is given, a combination of ANKTIVA and BCG are administered to the bladder through a urinary catheter. The procedure can be done at your physician’s office or medical clinic.

ANKTIVA is administered by your urologist in their office.

The process is similar to treatment with BCG alone:

The urologist will insert a catheter that goes directly to the bladder.
ANKTIVA and BCG will be introduced into the bladder through the catheter.
The medicine will stay in your bladder for about two hours.
Initially, this treatment will take place once a week for six weeks.

After that, you’ll receive additional doses every few months.

Your urologist will run regular tests to monitor your progress.

For more information on how ANKTIVA is administered, please consult with your physician.

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (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/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

When BCG Alone Isn’t Enough,

Bring On the Tri-Offense With Anktiva.

For more information, please call 1-877-ANKTIVA.