Nadofaragene Firadenovec

Nadofaragene Firadenovec is a prescription medication used for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors.

• Nadofaragene Firadenovec is available under the following different brand names: Adstiladrin, nadofaragene Firadenovec-vncg.

Common side effects of Nadofaragene Firadenovec include:

• instillation site discharge
• fatigue
• bladder spasm
• urinary urgency
• blood in urine
• chills
• fever
• painful urination
• increased blood sugar
• increased triglycerides
• increased creatinine
• decreased phosphate

Serious side effects of Nadofaragene Firadenovec include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• urinary urgency
• urinary incontinency
• urinary frequency
• blood in your urine
• pain or discomfort when urinating
• abnormal lab results
• weakness
• shortness of breath
• fast heart rate

Rare side effects of Nadofaragene Firadenovec include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravesical solution

• 3 × 1011 viral particles (vp)/mL per vial
• Each vial contains an extractable volume of 20 mL.

Bladder cancer

Adult dosage

• Premedication with an anticholinergic is recommended before each installation.
• Instill 75 mL into the bladder at a concentration of 3 × 1011 viral particles (vp)/mL once every 3 months.
• Leave in the bladder for 1 hour following installation.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nadofaragene Firadenovec has severe interactions with no other drugs.
• Nadofaragene Firadenovec has serious interactions with no other drugs.
• Nadofaragene Firadenovec has moderate interactions with the following drug:
  • ublituximab
• Nadofaragene Firadenovec has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity reactions to interferon alfa or any component of the product.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nadofaragene Firadenovec?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nadofaragene Firadenovec?”

Cautions

• Risk of muscle-invasive or metastatic bladder cancer with delayed cystectomy
• Delaying cystectomy in patients with BCG-unresponsive CIS could lead to the development of muscle-invasive or metastatic bladder cancer
• Risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS
• The median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days
• If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy
• Risk of disseminated adenovirus infection.
• Owing to the possible presence of low levels of replication-competent adenovirus in drugs, immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection
• Avoid exposing immunosuppressed or immune-deficient individuals to Nadofaragene Firadenovec

Pregnancy and Lactation 

• No adequate and well-controlled studies have been conducted on pregnant women
• Advise pregnant women of the potential risk to a fetus
• Verify pregnancy status in women of reproductive potential before initiating
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 6 months following the last dose
  • Men with women partners of reproductive potential: Use effective contraception during treatment and for 3 months following the last dose
• Lactation
  • There is no information regarding drug presence in human milk, effects on breastfed infants, or effects on milk production