Description
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.
This product is available in the following dosage forms:
- Suspension
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Adstiladrin® in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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 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
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.
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