Lovotibeglogene Autotemcel (loe-voe-tye-BEG-loe-jeen aw-toe-TEM-sel)

Treats sickle cell disease.

Brand Name(s):

Lyfgenia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so your IV tube will need to stay in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• This medicine is made specifically for each patient, using the patient's own blood cells. Your doctor will collect your blood through a procedure called mobilization and apheresis. Talk with your doctor if you have any concerns about this.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use crizanlizumab, hydroxyurea, L-glutamine, and voxelotor for at least 2 months, medicine to treat HIV for at least 1 month, and an iron chelator for at least 7 days before having a procedure to collect your blood.

Warnings While Using This Medicine:

• If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before having a procedure to collect your blood. Female patients and male patients with female partners should use an effective form of birth control before having a procedure to collect your blood and for at least 6 months after the last dose.
• Tell your doctor if you are breastfeeding or if you have kidney disease, liver disease, or a history of dimethyl sulfoxide (DMSO) allergy.
• This medicine may cause blood cancer, including myelodysplastic syndrome (MDS) and acute myeloid leukemia.
• Do not donate blood, organs, tissues, or cells at any time in the future.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088