Lyfgenia 1.7 x to 20 x 10exp6 cell/mL intravenous suspension

Generic name:
Lovotibeglogene autotemcel - injection

Brand name(s)
Lyfgenia

This product may increase your risk of developing blood cancer. Blood cancer may occur many years after your treatment. Your doctor should do regular blood tests for at least 15 years to monitor for any changes to your blood. Tell your doctor right away if you develop symptoms of blood cancer, such as unusual tiredness, easy bruising/bleeding, or swollen lymph nodes. Talk to your doctor about the risks and benefits of this product.

Lovotibeglogene autotemcel is used to treat sickle cell disease. This disease causes your body to make red blood cells that are stiff and irregularly shaped (sickle- or crescent moon-shaped), which can lead to anemia and painful crises. This type of treatment is known as gene therapy. Your lovotibeglogene autotemcel is made from your own blood stem cells and is given only to you. The blood stem cells have been changed to have genes that help your body make regular-shaped red blood cells and limit the amount of sickle-shaped red blood cells. This may help to reduce the number of painful crises caused by the disease.

Read the Medication Guide from your pharmacist before you receive this product. If you have any questions, ask your doctor or pharmacist.

Your doctor will give you other medications (such as chemotherapy) before treatment with this product to prepare your body.

This product is given by slow injection into a vein as directed by your doctor. The dosage is based on your medical condition and weight.

After you receive this product, you will stay in the hospital for about 3 to 6 weeks so your doctor can check to see if your treatment is working and help you manage any side effects.

See also Warning section.

Nausea, flushing, dizziness, or decreased appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Treatment with this product may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms:

• unusual tiredness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• easy bruising/bleeding

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving lovotibeglogene autotemcel, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• past/current/recent infection (including hepatitis, HIV)
• kidney problems
• liver problems

This product can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you have received this product before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lovotibeglogene autotemcel. This medication may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for at least 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Certain medications (such as anti-retroviral drugs, hydroxyurea) may interfere with how this product is made. If you are using any of these, your doctor may have you stop taking them for at least 1 to 2 months before the procedure to collect your blood stem cells.

This medication may interfere with certain lab tests (such as some HIV tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this product.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts) should be done before and after you receive this product. Keep all medical and lab appointments.

After receiving this treatment, do not donate blood, organs, tissues, or cells.

Not applicable.

Not applicable. This product is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.