Atidarsagene autotemcel

Generic name: atidarsagene autotemcel
Brand name: Lenmeldy
Dosage form: intravenous suspension (-)
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Drugs.com on May 7, 2024. Written by Cerner Multum.

What is atidarsagene autotemcel?

Atidarsagene autotemcel is used to treat metachromatic leukodystrophy in children.

Atidarsagene autotemcel may also be used for purposes not listed in this medication guide.

Atidarsagene autotemcel side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• unusual bruising or bleeding;

• sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;

• problems with thinking or memory, muscle movement problems, weakness, vomiting, trouble swallowing; or

• chills, fever, infections.

Common side effects of atidarsagene autotemcel may include:

• fever, mouth sores, skin sores, sore throat, cough;

• swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing, stomach upset;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• rash; or

• abnormal lab results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

You may get infections or bleed more easily. Call your doctor if you have unusual bleeding or signs of infection (fever, cough, skin sores, painful urination).

Before taking this medicine

Tell your doctor if you have or have ever had:

• hepatitis, HIV or AIDS;

• stem cell transplant;

• an allergy to dimethyl sulfoxide (DMSO); or

• liver or kidney disease.

Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine.

Make sure you are current on all vaccines before you start using atidarsagene autotemcel.

Using atidarsagene autotemcel may increase your risk of developing blood cancer. Ask your doctor about your individual risk.

Atidarsagene autotemcel may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using atidarsagene autotemcel. Talk to your doctor about options for fertility preservation, like sperm banking or egg preservation.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Atidarsagene autotemcel may harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 6 months after your last dose. Tell your doctor right away if pregnancy occurs.

Do not breastfeed while using this medicine. Ask a doctor if it is safe to breastfeed after using this medicine.

How is atidarsagene autotemcel given?

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Atidarsagene autotemcel is part of a treatment plan used after a procedure called apheresis, where cells from the blood are removed for stem cell transplant.

Atidarsagene autotemcel is injected into a vein by a healthcare provider.

You will be watched for a short time to make sure you do not have an allergic reaction.

You may be given other medications before your treatment.

Your blood will be tested before and after treatment with atidarsagene autotemcel.

You will need frequent blood tests to check your liver function during the first month after infusion with atidarsagene autotemcel.

This medicine may cause false-positive results on a HIV test. Tell the laboratory staff that you use atidarsagene autotemcel.

Atidarsagene autotemcel dosing information

Usual Pediatric Dose for Leukocytoclastic Vasculitis:

Dosing is based on metachromatic leukodystrophy subtype and patient weight at time of infusion:
-Pre-symptomatic late infantile (PSLI): 4.2 x 10(6) to 30 x 10(6) CD34+ cells/kg IV once as a single dose
-Pre-symptomatic early juvenile (PSEJ): 9 x 10(6) to 30 x 10(6) CD34+ cells/kg IV once as a single dose
-Early symptomatic early juvenile (ESEJ): 6.6 x 10(6) to 30 x 10(6) CD34+ cells/kg IV once as a single dose

Comments:
-Administer each infusion bag IV within 30 minutes via a central venous catheter; calculate the infusion rate based on the volume in each bag.
-Complete infusion within 2 hours of thawing product.
-Mobilization, apheresis, and myeloablative conditioning are required prior to administering this drug.
-Confirm that hematopoietic stem cell (HSC) gene therapy is appropriate for the patient before starting pre-treatment procedures.
-Refer to the manufacturer's Lot Information Sheet for additional information pertaining to the dose.
-Safety and efficacy have not yet been established in children with the late juvenile form of MLD.

Use: For the treatment of children with PSLI, PSEJ, or ESEJ metachromatic leukodystrophy

What happens if I miss a dose?

In a medical setting you are not likely to miss a dose.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving atidarsagene autotemcel?

Do not donate blood, organs, tissues, or cells for transplantation after receiving atidarsagene autotemcel.

What other drugs will affect atidarsagene autotemcel?

Tell your doctor about all your other medicines, especially:

• antiviral medicines to treat hepatitis C or HIV.

Other drugs may affect atidarsagene autotemcel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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