What is Elivaldogene Autotemcel?
Elivaldogene autotemcel can be used to prevent damage to nerves in boys aged 4–17 who have active, early cerebral adrenoleukodystrophy (CALD), which is a genetic disorder that can damage the brain.Elivaldogene autotemcel could be used for other purposes that are not mentioned in this medication guide.
Side effects of Elivaldogene Autotemcel
Take immediate medical attention. If your child shows symptoms warning of an allergic reaction, such as symptoms of hives, difficulty breathing, and swelling of the lips, face, tongue, throat, or face,Contact your pediatrician immediately if your child experiences:
- Symptoms of signs of cancer—bruising or bleeding or blood in stool or urine symptoms of blood cancer: an intense headache in the stomach, the back glands swelling, and nausea or the coughing up of blood;
- Symptoms of signs of infection symptoms of infection include fever, chills, a sore throat or body aches, unusual fatigue, loss of appetite, bleeding or bruising,
- Low blood cell counts, mouth sores, skin scabs, bleeding that is not normal, pale skin, cold feet and hands, and feeling lightheaded or breathless
Common adverse effects of elivaldogene autotemcel can include:
- Fever, chills, and sore throats body aches, unusual hunger, fatigue, bleeding, or bruising
- Skin sores, easily bruises, pale skin, cold feet, hands, and feet, feeling lightheaded or short of breath.
- Leg cramps or irregular heartbeats heart flutter, more frequent urination or thirst sensation of tingling or numbness, muscles feeling weak or sluggish;
- White patches or sores in or on the lips; difficulty speaking or swallowing; dry mouth; bad breath; a change in taste sensation;
- Nausea vomiting nausea, vomiting, and lack of appetite nausea, stomachache, constipation, diarrhea;
- Hair loss;
- Headaches,
This isn't an exhaustive list of all the side effects. Other side effects could occur. Consult your child's physician to seek medical advice on adverse effects. Contact the FDA with any adverse reactions by dialing their toll-free number 1-800-FDA-1088.
Warnings
Consult your child's physician immediately if you notice bleeding, bruising, or bloody stool or urine, extreme back or stomach pain or fever, swelling of the glands, fatigue, sickness, or coughing up blood.
Before you take this drug
Inform the doctor if your child has ever suffered from:
- Kidney or liver disease
- An allergic reaction or sensitivity to dimethyl sulfoxide (DMSO, an anti-inflammatory agent) or an allergy to dimethyl sulfoxide (DMSO, a preserving agent)
- If your child is suffering from an infection that is active,
It could be more difficult for the child with whom you are trying to become pregnant when taking autotemcel elivaldogene. Your child must utilize birth control to avoid pregnancy for a minimum of six months after the administration of the autotemcel of elivaldogene.
How to take Elivaldogene Autotemcel?
Follow the instructions printed on prescription labels, and review all prescription guides or instructions sheets.Elivaldogene autotemcel injections are made directly into an artery by a medical doctor. Your child may be prescribed other medications in conjunction with the treatment using elivaldogene autotemcel.After receiving elivaldogene autotemcel Your child could remain in the ER for up to 2 months to track the healing process. The doctor of your child will decide when your child is able to be discharged. This medicine could result in false results in an HIV (human immunodeficiency virus) test. Inform the lab staff that your child is taking autotemcel elivaldogene. It is essential to have your blood regularly tested. Elivaldogene autotemcel can raise the chance of developing cancer. Consult a physician about the risk your child is at.
Details on dosage
Usual Pediatric Dose for Cerebral Adrenoleukodystrophy:
The recommended minimum dose is 5.0*10(6) CD34+ cells/kg as a single dose to be used for intravenous infusion.
Comments:
The indication has been approved under accelerated approval based on a 24-month-long significant functional impairment (MFD)-free survival.
A continued approval for this indication could depend on verification and a description of clinical benefits in a confirmation trial(s).
The eligibility criteria for active, early cerebral adrenoleukodystrophy (CALD) will be determined as mildly or asymptomatic affected (neurologic function score NFS 1 or less) patients who show gadolinium enhancements on magnetic resonance imaging (MRI) as well as a Loes score of 0.5–9.
The calculation of a dose is dependent on the body weight of each individual prior to the first apheresis. See the product information of the manufacturer for a more specific calculation.
This drug product is not indicated for the prevention, development, or treatment of adrenal insufficiency due to adrenoleukodystrophy.
The product hasn't been tested on patients suffering from the condition of cerebral adrenoleukodystrophy (CALD) as a result of head trauma.
Usage: For males aged 4 to 17 years old with active, early cerebral adrenoleukodystrophy
What happens if I miss the dose?
Consult your doctor about instructions if your child isn't able to make an appointment to receive the autotemcel injection of elivaldogene.
What happens if I overdose?
Get medical attention in an emergency or contact the Poison Help Line toll-free at 1-800-222-1222.
What should be avoided?
Your child should not give organs, blood, tissue, or cells.
Interaction with other drug
Discuss with the doctor any other medications for your child, including:
- HIV/AIDS medications.
This list isn't exhaustive. Other medications can influence elivaldogene autotemcel. These include medications that are prescribed and available over the counter, vitamins, and herbal products. The interactions of all drugs are listed here.
