Pronunciation:

loe-voe-tye-BEG-loe-jeen aw-toe-TEM-sel

Brand Names:

• Lyfgenia

Dosage Forms:

• Suspension

Warnings:

Hematologic malignancy has occurred in patients treated with lovotibeglogene autotemcel. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted .

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Lovotibeglogene autotemcel injection is a one-time gene therapy used to treat sickle cell disease (red blood cell disease) in patients who have a history of vaso-occlusive events.

Sickle cell disease is a genetic, inherited, lifelong disease caused by an alteration in one of the genes in the red blood cell, the beta-globin gene that causes the normal disc-shaped red cells to take the shape of a sickle, causing anemia and vaso-occlusive events, like a pain crisis.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lovotibeglogene autotemcel injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of lovotibeglogene autotemcel injection have not been performed in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Amprenavir
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Darunavir
• Deferasirox
• Deferiprone
• Deferoxamine Mesylate
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Fosamprenavir
• Hydroxyurea
• Indinavir
• Influenza Virus Vaccine, Live
• Lopinavir
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Nelfinavir
• Poliovirus Vaccine, Live
• Ritonavir
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Saquinavir
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tipranavir
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to dimethyl sulfoxide (DMSO), history of—Use with caution. May increase the risk of an allergic reaction.

• Kidney disease or
• Liver disease—Use with caution. This medicine has not been studied in patients with these conditions.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed in a vein. This medicine must be given slowly, so your IV tube will need to stay in place for at least 30 minutes.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is made specifically for each patient, using the patient's own blood cells. Your doctor will collect your blood through a procedure called mobilization and apheresis. Talk with your doctor if you have any concerns about this.

Do not use crizanlizumab, hydroxyurea, L-glutamine, and voxelotor for at least 2 months, medicine to treat HIV for at least 1 month, and an iron chelator for at least 7 days before having a procedure to collect your blood.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before having a procedure to collect your blood. Female patients and male patients with female partners should use an effective form of birth control before having a procedure to collect your blood and for at least 6 months after the last dose.

This medicine may cause blood cancer (eg, myelodysplastic syndrome, acute myeloid leukemia). Check with your doctor right away if you have bone pain, chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause serious allergic reaction, including anaphylaxis, which may be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

Do not donate blood, organs, tissues, or cells at any time in the future.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chills

cough

diarrhea

fever

lower back or side pain

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

sore throat

stomach pain

swollen glands

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Bone pain

chest pain or tightness

difficulty swallowing

dizziness

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.