Pregnancy & Lactation: Risk data not available
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.
Warnings
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 this medicine. 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 should I use Atidarsagene Autotemcel
Use Atidarsagene Autotemcel (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
In a medical setting you are not likely to miss a dose.
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 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.
What other drugs will affect Atidarsagene Autotemcel?
Do not donate blood, organs, tissues, or cells for transplantation after receiving this medicine.