Pronunciation:

nad-oh-FAR-a-jeen fye-ra-DEN-oh-vek - vncg

Brand Names:

• Adstiladrin

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Nadofaragene Firadenovec-vncg is used to treat patients with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with a tumor type called carcinoma in situ (CIS) with or without papillary tumors.

This medicine is to be used only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Adstiladrin® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Adstiladrin® in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune system problems—Use with caution. May increase risk for infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given through a tube (catheter) that is placed into your bladder once every 3 months.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you other medicine (eg, an anticholinergic) before you receive this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Using this medicine while you are pregnant can harm your unborn baby. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose If you think you have become pregnant while using this medicine, tell your doctor right away.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blood in the urine

burning while urinating

chills

difficult or painful urination

fever

trouble in holding or releasing urine

unusual tiredness or weakness

Less common

Anxiety

arm, back, or jaw pain

blurred vision

chest pain, discomfort, heaviness, or tightness

cold sweats

coma

confusion

cool, pale skin

decreased urination

depression

dizziness

dry mouth

fainting

fast or irregular heartbeat

headache

lightheadedness

nausea

nervousness

nightmares

rapid breathing

seizures

shakiness

slurred speech

sunken eyes

sweating

thirst

trouble breathing

wrinkled skin

Rare

Dilated neck veins

blue or pale skin

irregular breathing

problems with movement, walking, or speech

swelling of the face, fingers, feet, or lower legs

vomiting

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.