bluebird bio's LYFGENIA: Pregnancy, Reproductive Guidelines, and Company Overview

LYFGENIA and Pregnancy/Lactation Considerations

Patients undergoing treatment with LYFGENIA should be informed about the risks associated with myeloablative conditioning agents, particularly concerning pregnancy and fertility. LYFGENIA is contraindicated for pregnant women, and any pregnancy post-infusion should be discussed with a healthcare provider. Similarly, breastfeeding is not advised during LYFGENIA treatment, and decisions regarding breastfeeding post-treatment should involve a physician's guidance.

Recommendations for Reproductive Potential

Before starting mobilization, a negative serum pregnancy test is required and must be reconfirmed prior to conditioning and LYFGENIA administration. Women of childbearing potential and men who can father children should employ effective contraception methods, such as intra-uterine devices or combined hormonal and barrier contraception, from the beginning of mobilization through at least six months following LYFGENIA administration. Patients should also be informed about fertility preservation options.

About bluebird bio, Inc.

bluebird bio, Inc. is dedicated to developing curative gene therapies to enhance patient lives. Established in 2010, bluebird bio has set a benchmark in gene therapy, transitioning from a research pioneer to a commercial leader. The company has achieved FDA approvals for three therapies within a two-year span and continues to advance gene therapy commercialization and accessibility.

bluebird bio focuses on severe genetic diseases, holding the most extensive ex-vivo gene therapy data in the industry. Their programs target conditions such as sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. Each therapy is tailored to address the root cause of the disease, utilizing sophisticated analytical methods to ensure the safety of lentiviral vector technologies.

Forward-Looking Statements

This release includes forward-looking statements as per the Private Securities Litigation Reform Act of 1995, concerning LYFGENIA's therapeutic potential. These statements are based on past performance and current projections, involving risks and uncertainties that could alter future outcomes. They should be considered alongside bluebird bio's risk disclosures in their SEC filings. Risks include the potential lack of patient demand or reimbursement for LYFGENIA, safety concerns related to lentiviral vectors, and the challenge of successful commercialization.