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Intravesical Immunotherapy with ANKTIVA®

Diagnosis:

Non-Muscle Invasive Bladder Cancer (includes Ta, T1, CIS tumors)

Treatment Category:

Intravesical therapy (in the bladder)

Treatment:

Intravesical therapy (in the bladder)

Suitable for:

This treatment is suitable for patients diagnosed with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

How it works:

ANKTIVA®  is the first U.S. FDA-approved immunotherapy that activates a type of cell called a natural killer (NK) cell, part of the body’s natural immune system, to attack and kill non-muscle invasive bladder cancer (NMIBC) cells.

How it is typically used:

ANKTIVA is used in combination with BCG and is administered directly into your bladder via a catheter.

How it is administered:

ANKTIVA is administered via a catheter directly into the bladder.

Recovery time:
The recovery time is similar to being given BCG alone.
Side effects:

Side effects include:

  • Fatigue
  • Nausea
  • Discomfort while urinating
  • Diarrhea
  • Blood in your urine

See patient brochure attached for details.

Is this given with other treatments?

ANKTIVA is used in combination with BCG.

Additional information:

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 nonmuscle 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)

 

Disclaimer: Information and services provided by the Bladder Cancer Advocacy Network (BCAN) are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. If you are ill, or suspect that you are ill, seek professional medical attention immediately! BCAN does not recommend or endorse any specific physicians, treatments, procedures or products even though they may be mentioned on this site.

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