Marnetegragene Autotemcel Injection

Marnetegragene autotemcel injection is used to treat leukocyte adhesion deficiency-I (LAD-I; an inherited condition in which the body makes immune cells that cannot fight infections). Marnetegragene autotemcel 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 your body make certain immune cells to help fight infections.

Marnetegragene autotemcel comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital. Marnetegragene autotemcel injection is given as a one-time dose, which is contained in 1 or 2 infusion bags. Each infusion bag is usually given over no more than 10 minutes. Before you receive your marnetegragene autotemcel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for marnetegragene autotemcel.

Before your dose of marnetegragene 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 marnetegragene autotemcel injection. It will take about 4–5 months 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 after you receive your marnetegragene 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 marnetegragene autotemcel injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving marnetegragene autotemcel injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have any type of infection now or if you have or have ever had an infection with or exposure to HIV. Also, tell your doctor if you have or have ever had low platelets, or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You may have to take a pregnancy test before starting treatment. If you become pregnant while receiving marnetegragene autotemcel injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving marnetegragene autotemcel injection.
• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting treatment, during your treatment, and until your doctor tells you that your immune system has recovered.
• you should know that you should not donate blood, tissue, cells or organs after receiving marnetegragene autotemcel injection at any time in the future.

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

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

• nausea
• vomiting
• constipation
• sores in the mouth or throat
• hair loss
• darkening of the skin

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever; sore throat; swollen glands; ongoing cough and congestion; warm, red, or painful skin; or other signs of infection
• rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; or difficulty breathing or swallowing
• yellowing of the skin or whites of the eyes, stomach pain or tenderness, or unusual weight gain
• unusual bruising or bleeding; nosebleed; severe headache; blood in urine, stool, or vomit; or coughing up blood

Marnetegragene autotemcel injection may increase the risk that you will develop blood cancer. Your blood will be monitored at least every 12 months for at least 15 years after your treatment with marnetegragene autotemcel injection. Talk to your doctor about the risks of receiving this medication.

Marnetegragene autotemcel injection 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Kresladi^®