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.