Lovotibeglogene autotemcel

Lovotibeglogene autotemcel is used to treat sickle cell disease in adults and children who are at least 12 years old and have frequent vaso-occlusive crises (pain caused by blocked small blood vessels).

Lovotibeglogene autotemcel may also be used for other reasons that are not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets.

Lovotibeglogene autotemcel is part of a treatment plan used after a procedure called apheresis, where cells from the blood are removed for stem cell transplant.

Lovotibeglogene autotemcel is injected into a vein by a healthcare provider.

You may need to stay in the hospital for 3 to 6 weeks after your treatment with lovotibeglogene autotemcel. Talk with your doctor if you have any questions.

You may be given other medications before your treatment.

Your blood will be tested before and after treatment with lovotibeglogene autotemcel.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use lovotibeglogene autotemcel.

Tell your doctor if you are taking other medicines, have other medical conditions, or have allergies.

Using lovotibeglogene autotemcel may raise your chance of getting blood cancer. Ask your doctor about your specific risk.

You may be more likely to get infections or bleed easily. Contact your doctor if you have a severe headache, unusual bleeding, or signs of infection (fever, cough, skin sores, painful urination).

Tell your doctor if you have or have ever had:

• hepatitis, HIV or AIDS;
• stem cell transplant; or
• liver or kidney disease.

Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine.

Using lovotibeglogene autotemcel may increase your risk of developing blood cancer. Ask your doctor about your individual risk.

Lovotibeglogene autotemcel may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using lovotibeglogene autotemcel. Talk to your doctor about options for fertility preservation, like sperm banking or egg preservation.

Lovotibeglogene autotemcel can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine. Ask a doctor if it is safe to breastfeed after using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• chills, fever, infections;
• swollen glands;
• severe headache;
• stomach or back pain;
• tiredness;
• unusual bruising or bleeding; or
• nosebleeds, bleeding gums, blood in your urine or vomit, bloody or tarry stools, or coughing up blood.

Common side effects of lovotibeglogene autotemcel may include:

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• easy bruising, unusual bleeding, purple or red spots under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Sickle Cell Disease:

Minimum dose: Single IV dose of 3 × 10(6) CD34+ cells/kg, infused over a period of less than 30 minutes.Comments:-This drug is provided in one to four infusion bags. Refer to the Lot Information Sheet for actual dose.-Patients with alpha-thalassemia trait may experience anemia with erythroid dysplasia, after treatment with this drug. They may need chronic red blood cell transfusions.-For autologous and one-time single-dose intravenous use only.Use: For the treatment of patients with sickle cell disease and a history of vaso-occlusive events

Usual Pediatric Dose for Sickle Cell Disease:

12 years or older:Minimum dose: Single IV dose of 3 × 10(6) CD34+ cells/kg, infused over a period of less than 30 minutes.Comments:-This drug is provided in one to four infusion bags. Refer to the Lot Information Sheet for actual dose.-Patients with alpha-thalassemia trait may experience anemia with erythroid dysplasia, after treatment with this drug. They may need chronic red blood cell transfusions.-For autologous and one-time single-dose intravenous use only.Use: For the treatment of patients with sickle cell disease and a history of vaso-occlusive events

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose will be treated quickly.

Do not donate blood, organs, tissues, or cells for transplantation after receiving lovotibeglogene autotemcel.

Tell your doctor about all your other medicines, especially:

• disease modifying drugs such as: hydroxyurea, crizanlizumab, voxelotor, and others; or
• iron chelating agents such as: deferasirox, deferiprone, and deferoxamine.

This list is not complete. Other drugs may affect lovotibeglogene autotemcel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.