Class Name(s):
Brand Name(s):
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.
WHY is this medicine prescribed?
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.
HOW should this medicine be used?
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.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving lovotibeglogene autotemcel,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Lovotibeglogene autotemcel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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:
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).
What OTHER INFORMATION should I know?
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.
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.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 20, 2024.