Lovotibeglogene Autotemcel Injection

What is this medication?

LOVOTIBEGLOGENE AUTOTEMCEL (LOE voe tye BEG loe jeen AW toe TEM sel) treats sickle cell disease. It works by helping your body create healthy red blood cells that do not sickle. This can reduce symptoms, such as pain crises.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Lyfgenia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• HIV or AIDS
• Recent or upcoming vaccine
• An unusual or allergic reaction to lovotibeglogene autotemcel, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.

This therapy uses your own stem cells. Your care team will give you other medications as part of your treatment. Before therapy, your care team will give you a medication that helps move your stem cells from your bone marrow to the blood stream, so they can collect them. This is called mobilization. These cells will be used to make your treatment. Shortly before you receive treatment, you will receive another medication that helps prepare your body for the stem cell transplant. This is called conditioning.

A special MedGuide will be given to you before treatment. Be sure to read this information carefully.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

• Iron chelators, such as deferoxamine or deferasirox
• Live virus vaccines
• Medications that help your body make more white blood cells, such as filgrastim

Certain medications should be stopped weeks to months before starting any phase of treatment. Talk to your care team about all of the medications you take before you begin treatment.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular health checks while on this medication. It is important for you to have regular check-ups and blood work done every 6 months for at least 15 years after this treatment.

This medication may increase your risk of blood cancer. Blood cancer may cause no symptoms or general symptoms. Call your care team right away if you have unusual bruising or bleeding, severe headache, stomach or back pain, fever (38 degrees C or 100.4 degrees F or higher), swollen lymph nodes, or fatigue.

If you need an HIV test, talk to your care team about which test to use. This medication may cause a false-positive result if certain tests are used.

Do not donate blood, organs, tissues, or cells any time after receiving this treatment.

Talk to your care team if you may be pregnant. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for at least 6 months after your last dose. Your care team can help you find the option that works for you.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

If your partner can get pregnant, use a condom during sex while taking this medication and for at least 6 months after the last dose.

The conditioning medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Infection—fever, chills, cough, or sore throat
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Flushing
• Loss of appetite
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.