Lovotibeglogene Autotemcel Dosage

Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• Hematologic malignancy was observed in patients treated with this drug.
• Monitor patients 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.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The prescriber should ensure that autologous hematopoietic stem cell (HSC) transplantation is appropriate for the patient before mobilization and apheresis, and before myeloablative conditioning is initiated.
• Screening for infectious diseases, specifically human immunodeficiency virus 1 and 2 (HIV-1 or HIV-2), should be performed in accordance with clinical guidelines before collection of cells for manufacturing.
• Patients should be prepared for mobilization with at least 2 cycles of scheduled transfusions (one each month), with erythrocytapheresis being preferred.
• The manufacturer product information should be consulted for mobilization, apheresis, and myeloablative conditioning.
• Confirm patient identifiers on product label(s) and lot information sheet within the shipper before administration. Do not use the product if the patient information does not match.
• An in-line blood filter or infusion pump should not be used.
• If more than one infusion bag is provided, administer the contents of each infusion bag completely before proceeding to thaw and infuse the contents of the next infusion bag.
• Each infusion bag must be completely administered within 4 hours after thawing.
• After administration of each drug product, the infusion bag and any associated tubing should be flushed with at least 50 mL of 0.9% sodium chloride solution to ensure as many cells as possible are infused into the patient.

Storage requirements:

• Store infusion bags in metal cassette(s) at minus 140C (minus 220F) or less until ready for thaw and administration.
• Do not re-freeze after thawing.
• Do not irradiate this drug, as this could lead to inactivation.

Reconstitution/preparation techniques:
The manufacturer product information should be consulted.

General:

• This drug has not been studied in patients with more than two alpha-globin gene deletions.
• There are no data on use of this drug in HIV-positive patients.
• If there are any concerns about the product or packaging upon receipt, contact bluebird bio at 1-833-999-6378.
• Standard procedures for patient management after HSC transplantation should be followed after administering this drug.
• Irradiate any blood products required for at least the first 3 months after infusing this drug and as per the transplant physician's recommendation.
• Avoid use of myelosuppressive iron chelators for 6 months.
• G-CSF is not recommended for 21 days after infusing this drug.
• Follow universal precautions and local biosafety guidelines for handling and disposal of this drug to avoid potential transmission of infectious diseases.

Monitoring:
Hematologic: Thrombocytopenia, neutrophil counts, and bleeding
Hypersensitivity: Hypersensitivity reactions
Oncologic: Malignancy

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Additional cell collection and manufacturing of this drug would be needed in case of manufacturing failure or if additional cells are needed.
• Ask your physician to contact bluebird bio at 1-833-999-6378 if malignancy is detected.
• Monitor for signs and symptoms of bleeding and have frequent blood draws for platelet counts, until platelet recovery has been achieved.
• Patients treated with this drug may test positive for HIV if tested using a PCR assay, potentially leading to a false-positive result.
• Do not donate blood, organs, tissues, or cells at any time in the future.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer