Elivaldogene autotemcel injection may raise your risk of developing a potentially fatal blood malignancy. For at least 15 years following your elivaldogene autotemcel injection treatment, your blood will be checked at least every six months. Call your doctor right away if you have any of the following symptoms: Blood in the urine, stool, or vomit; coughing up blood; unusual bruising or bleeding; nasal bleeding; severe headache; or unusual abdomen or back pain. The dangers of using this drug should be discussed with your doctor.

Keep all of your appointments with your physician and the lab. In order to monitor your body’s reaction to the elivaldogene autotemcel injection, your doctor will request specific tests.

When you start receiving therapy with elivaldogene autotemcel injection, your doctor or pharmacist will provide you the medication guide (patient information sheet) from the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Elivaldogene autotemcel injection is used to treat males with early, active cerebral adrenoleukodystrophy (CALD), an inherited condition in which fatty acid buildup in the brain causes nerve and brain damage, in order to slow the progression of brain damage and slow the decline of nerve function. Elivaldogene autotemcel injection belongs to a group of drugs known as autologous cellular immunotherapy, a category of drugs created utilizing the patient’s own blood cells. It functions by helping your body’s fatty acid breakdown and delaying the onset of nerve and brain damage.

Elivaldogene autotemcel injection is given intravenously (into a vein) by a doctor or nurse at a hospital. It is available as a suspension (liquid). One or two infusion bags containing a single dosage of elivaldogene autotemcel injection are administered. Usually, no more than 60 minutes are spent administering each infusion bag. In order to get your body ready for elivaldogene autotemcel, your doctor or nurse will give you other chemotherapy drugs before you get your dose.

A hospital or treatment facility will use a procedure called mobilization and apheresis (which removes blood stem cells from the body) to take a sample of your blood stem cells prior to administering your dosage of elivaldogene autotemcel injection. Usually taking a week, this procedure could need to be repeated. The manufacturer will use the sample to make an elivaldogene autotemcel injectable dosage. Your blood stem cells won’t be ready to be given to you until 51 to 65 days after they are first obtained. This drug must only be administered to you because it is created from your own cells.

During treatment with the drug, Elivaldogene autotemcel injection may produce nausea and vomiting. To assist you avoid nausea and vomiting, your doctor could prescribe you additional drugs.

After receiving your elivaldogene autotemcel dose, you will need to stay in the hospital for around 2 months so that staff members can keep an eye out for any side effects. Speak with your doctor about mobilization and apheresis preparation, as well as what to expect during and after the treatment.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving elivaldogene autotemcel injection,

• If you have any allergies, including to elivaldogene autotemcel, dimethyl sulfoxide (DMSO), other drugs, or any of the chemicals in elivaldogene autotemcel injection, notify your doctor right away. Request a list of the components from your pharmacist.
• Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you have ever had kidney or liver issues, the human immunodeficiency virus (HIV), or both.
• Elivaldogene autotemcel injection is exclusively used in males, which you should be aware of. In order to avoid getting pregnant while undergoing treatment and for at least six months after receiving elivaldogene autotemcel injection, male patients should utilize birth control with their female partners. Discuss effective birth control options with your doctor. Call your doctor if your partner falls pregnant while you are receiving an injection of elivaldogene.
• It’s important to be aware that elivaldogene autotemcel injection may reduce male fertility. Discuss the dangers of obtaining an injection of elivaldogene autotemcel with your doctor.
• After receiving an elivaldogene autotemcel injection, avoid donating blood, organs, tissues, or cells for transplantation.
• To find out if you require any immunizations, consult with your doctor. Prior to starting chemotherapy, for at least six weeks, during your elivaldogene autotemcel treatment, and until your doctor indicates that your immune system has healed, avoid getting any vaccinations without first consulting a medical professional.

Keep eating normally unless your doctor instructs you otherwise.

The injection of erivaltogene may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Nausea
• Vomiting
• Constipation
• Diarrhea
• Abdominal pain
• Reduction in appetite
• Oral sores
• Fuzzy vision
• Headache
• Hair fall
• Lowering of skin tone

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

• Chest pain, a fast heartbeat, a rash, itching, hives, swelling of the face, mouth, tongue, or throat, or trouble breathing or swallowing
• Blood in the urine, stool, or vomit, unusual bruising or bleeding, nose bleeding, severe headaches, coughing up blood; or uncommon back or abdominal pain
• Infection-related symptoms such a fever, sore throat, swollen glands, persistent coughing, and congestion
• A sense of weakness, exhaustion, or shortness of breath
• Seizure

Other negative effects from elivaldogene autotemcel injection are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Inform your doctor and the lab staff that you are receiving an elivaldogene autotemcel injection before undergoing any laboratory tests. You should be aware that after receiving an injection of elivaldogene autotemcel, you can experience a false-positive HIV test.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.