Lovotibeglogene-autotemcel

Lovotibeglogene Autotemcel is a prescription medication indicated for the treatment of sickle cell disease in patients aged 12 years and older with a history of vaso-occlusive events.

• Lovotibeglogene Autotemcel is available under the following different brand names: Lyfgenia.

Common side effects of Lovotibeglogene Autotemcel include:

• inflammation and sores inside the mouth
• low blood platelets (thrombocytopenia)
• low white blood cells (neutropenia, leukopenia)
• febrile neutropenia
• anemia

Serious side effects of Lovotibeglogene Autotemcel include:

• abnormal bruising or bleeding (including nosebleeds)
• blood in urine, stool, or vomit
• coughing up blood
• severe headache
• unusual stomach or back pain
• fever (100.4°f/38°c or higher)
• swollen glands
• abnormal tiredness

Rare side effects of Lovotibeglogene Autotemcel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, suspension

• single dose contains a minimum of 3 x 106 CD34+ cells/kg of body weight, in 1-4 infusion bags

Sickle cell disease

Adult and pediatric dosage

• Administer as a single dose for infusion containing a suspension of CD34+ cells in 1-4 infusion bags
• The minimum recommended dose is 3 x 106 CD34+ cells/kg IV at least 48 hours following myeloablative conditioning

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Lovotibeglogene Autotemcel has severe interactions with no other drugs
• Lovotibeglogene Autotemcel has serious interactions with at least 36 other drugs
• Lovotibeglogene Autotemcel has moderate interactions with no other drugs
• Lovotibeglogene Autotemcel has minor interactions with at least 21 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lovotibeglogene Autotemcel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lovotibeglogene Autotemcel?”

Cautions

• Hematologic malignancy has occurred
• There may be a potential risk of neutrophil engraftment failure after treatment; monitor neutrophil counts until engraftment has been achieved; if neutrophil engraftment failure occurs in a patient treated with lovotibeglogene Autotemcel, provide rescue treatment with the back-up collection of CD34+ cells
• There is a potential risk of lentiviral vector–mediated insertional oncogenesis after treatment
• Allergic reactions may occur; dimethyl sulfoxide (DMSO) or dextran 40 in drug products may cause hypersensitivity reactions, including anaphylaxis
• Delayed platelet engraftment
  • Delayed platelet engraftment reported; bleeding risk is increased before platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia
  • Inform patients of the risk of bleeding until platelet recovery has been achieved
  • Monitor for thrombocytopenia and bleeding according to standard guidelines
  • Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved
  • Perform a blood cell count and other appropriate tests whenever clinical symptoms suggestive of bleeding arise
• Interaction overview
  • Live vaccines
    • Not studied
    • Follow institutional guidelines for vaccine administration
    • Follow guideline recommendations for vaccination of patients post autologous hematopoietic stem cell transplantation and with functional asplenia
• Antiretrovirals
  • Do not take prophylactic HIV antiretroviral medications for at least 1 month before mobilization and until all cycles of apheresis are completed
  • Some long-acting antiretroviral medications may require a longer duration of discontinuation for the elimination of the medication
  • If a patient is taking antiretrovirals for HIV prevention, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells
• Hydroxyurea
  • Do not take hydroxyurea for at least 2 months before mobilization and until all cycles of apheresis are completed
  • If hydroxyurea is administered between mobilization and conditioning, discontinue 2 days before initiation of conditioning
• Iron chelation
  • Do not administer myelosuppressive iron chelators for 6 months post-treatment
  • Polymerase chain reaction (PCR) testing H5
  • Treated patients are likely to test positive by PCR assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive result for HIV
  • Therefore, do not screen for HIV infection using a PCR-based assay

Pregnancy and Lactation

• There are no available data on administration in pregnant women
• Consider risks associated with myeloablative conditioning agents on pregnancy and fertility
• Confirm a negative serum pregnancy test before the start of mobilization and reconfirm before condition procedures and before administration
• Contraception
  • Insufficient exposure data are available to provide any recommendations on the duration of contraception following treatment
  • Women of childbearing potential and men capable of fathering a child: Use an effective method of contraception (intrauterine device or combination of hormonal and barrier contraception) from the start of mobilization through at least 6 months after administration
  • Advise patients of risks associated with conditioning agents
• Infertility
  • No data available on fertility
  • Data are available on the risk of infertility with myeloablative conditioning
  • Advise patients of risks and the options for fertility preservation
• Lactation
  • There is no information regarding the presence of lovotibeglogene Autotemcel in human milk, its effect on breastfed infants, and its effects on milk production
  • Not recommended for women who are breastfeeding, and breastfeeding after infusion should be discussed with a treating physician