Description
Eladocagene exuparvovec-tneq injection is used to treat aromatic L-amino acid decarboxylase (AADC) deficiency. Your doctor will perform a test before you receive this medicine.
This medicine is to be given only by or under the direct supervision of your doctor.
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 eladocagene exuparvovec-tneq injection in children younger than 16 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of eladocagene exuparvovec-tneq injection have not been performed 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:
- Skull maturity, not reached—Should not be used in patients with this condition.
Proper Use
A doctor will give you this medicine in a medical facility. It is injected into the putamen part of the brain using an infusion pump system through a tube placed inside your head.
Precautions
It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly. Blood 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 receiving this medicine.
This medicine may cause complications during procedure (eg, cardiac arrest, respiratory arrest, cerebrospinal fluid leak, intracranial bleeding, neuroinflammation, acute infarction, and infection). Check with your doctor right away if you have blurred vision, confusion, fever or chills, cough or hoarseness, headache, lower back or side pain, nausea and vomiting, numbness or tingling in the face, arms, or legs, no blood pressure or pulse, no breathing, painful or difficult urination, stopping of the heart, trouble speaking or walking, unconsciousness, or weakness.
This medicine may cause uncontrolled sudden movements (dyskinesia) or make such movements you already have worse or more frequent. Check with your doctor right away if you have twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs.
Do not donate blood, organs, tissues, or cells for transplant after treatment.
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
- Blurred vision
- bone pain
- confusion
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain, spasms, or cramps
- nausea or vomiting
- no blood pressure or pulse
- no breathing
- numbness or tingling in the hands, feet, or lips
- pale skin
- seizures
- stopping of the heart
- sweating
- trouble breathing
- trembling
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unconsciousness
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Cough or hoarseness
- fever or chills
- headache
- lower back or side pain
- painful or difficult urination
- trouble speaking or walking
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
- Increased watering of mouth
- trouble sleeping
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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