Description
Zopapogene imadenovec-drba injection is used to treat recurrent respiratory papillomatosis.
This medicine is to be given only by or under the direct supervision of your 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 zopapogene imadenovec-drba injection in children. 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 zopapogene imadenovec-drba injection 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.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thighs or upper arms. This medicine is given 4 times over 12 weeks.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
This medicine may cause injection site reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site, facial swelling, skin rash, or trouble breathing 30 minutes after receiving this medicine.
Check with your doctor right away if you have pain in your chest, groin, or legs, especially in your calves, severe headache, sudden onset of slurred speech, sudden onset of trouble breathing, or sudden changes in vision. These may be symptoms of blood clot.
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
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- chills
- fast, pounding, or irregular heartbeat or pulse
- fever
Less common
- Chest tightness
- dizziness
- trouble breathing
Incidence not known
- Pain in the chest, groin, or legs, especially the calves
- sever, sudden headache
- slurred speech
- sudden, severe weakness or numbness in the arm or leg
- sudden loss of coordination
- vision changes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- headache
- increased sweating
- nausea
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- itching skin
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.
DRG-80008506
