Lovotibeglogene autotemcel Injection

Hematological malignancy (cancers of the blood) have occurred in people who have received lovotibeglogene autotemcel. Your doctor will monitor you closely for development of malignancy by ordering blood work at least every 6 months and also through integration site analysis at 6 and 12 months and then as needed thereafter. If any of the following symptoms appear after treatment, be sure and discuss them with your doctor: abnormal bruising or bleeding (such as a nosebleed), blood in urine, stool or vomit, coughing up blood, severe headache, unusual stomach or back pain, fever, swollen glands, abnormal tiredness.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to lovotibeglogene autotemcel.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lovotibeglogene autotemcel and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) {or the manufacturer's website} to obtain the Medication Guide.

Talk to your doctor about the risks of receiving lovotibeglogene autotemcel.

Lovotibeglogene autotemcel is used in adults and children 12 years of age and older who have sickle cell disease (SCD; inherited disease of the red blood cells that cause them to not move as well causing disruption of blood flow) with a history of vaso-occlusive events (complications from SCD that may include pain crises, chest pain, and stroke). Lovotibeglogene is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by helping the body to start producing normal red blood cells.

Lovotibeglogene autotemcel comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or infusion center. It is usually given over a period of 30 minutes per bag needed to complete treatment as a one-time dose. Before you receive your lovotibeglogene autotemcel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for lovotibeglogene autotemcel.

Before your dose of lovotibeglogene autotemcel injection is to be given, a sample of your blood stem cells will be taken at a hospital or treatment center using a process called mobilization and apheresis (a process that removes blood stem cells from the body). This process usually takes about 1 week and may need to be repeated. The sample will be sent to the manufacturer to prepare a dose of lovotibeglogene autotemcel injection. It will take about 10-15 weeks from the time that your blood stem cells are collected before they are ready to be given to you. Because this medication is made from your own cells, it must be given only to you.

You will have to stay in the hospital for about 3-6 weeks after you receive your lovotibeglogene autotemcel dose to monitor you for any side effects. Talk to your doctor about how to prepare for mobilization and apheresis and what to expect during and after the procedure.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving lovotibeglogene autotemcel,

• tell your doctor and pharmacist if you are allergic to lovotibeglogene autotemcel, dimethyl sulfoxide (DMSO), any other medications, or any of the ingredients in lovotibeglogene autotemcel injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• The following nonprescription or herbal products may interact with lovotibeglogene autotemcel: iron chelators. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking lovotibeglogene autotemcel. Do not start any of these medications while taking lovotibeglogene autotemcel without discussing with your healthcare provider.
• tell your doctor if you have or have ever had low platelets, human immunodeficiency virus (HIV), or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving lovotibeglogene autotemcel injection. You will need to have a pregnancy test before mobilization, and you should use birth control to prevent pregnancy starting with mobilization and for 6 months after you receive lovotibeglogene autotemcel injection. If you are a male with a female partner who may become pregnant, you should use birth control to prevent pregnancy during you treatment and for 6 months after you receive lovotibeglogene autotemcel injection. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while receiving lovotibeglogene autotemcel injection, call your doctor immediately. Lovotibeglogene autotemcel injection may cause fetal harm.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while your are receiving lovotibeglogene autotemcel injection therapy.
• do not donate blood, organs, tissues, or cells for transplantation after you receive lovotibeglogene autotemcel injection.
• do not have any vaccinations without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Lovotibeglogene autotemcel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• dizziness or weakness
• flushing during infusion
• mouth sores
• fevers
• yellowing of skin or whites of eyes
• decreased appetite
• sore or swollen throat

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, tell your doctor immediately:

• unusual bruising or bleeding, nose bleeding, severe headache, blood in urine, stool, or vomit, coughing up blood, or unusual abdominal or back pain
• fever, sore throat, ongoing cough and congestion, or other signs of infection
• hives; rash; itching; swelling of the lips, tongue, or throat; shortness of breath or difficulty breathing

Lovotibeglogene autotemcel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will may order certain lab tests to check your body's response to lovotibeglogene autotemcel injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving lovotibeglogene autotemcel injection. You should know that you may have a false-positive test for HIV after you receive lovotibeglogene autotemcel injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Lyfgenia^®