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Drug Interactions between exagamglogene autotemcel and Xromi

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

hydroxyurea exagamglogene autotemcel

Applies to: Xromi (hydroxyurea) and exagamglogene autotemcel

GENERALLY AVOID: Hydroxyurea may affect the manufacturing and efficacy of the autologous genome edited hematopoietic stem cell (HSC)-based gene therapy, exagamglogene autotemcel. The exact mechanism has not been described, but could be related to hydroxyurea's ability to interfere with DNA synthesis and/or its bone marrow suppressive effects, potentially reducing the number of HSCs. HSC mobilization followed by apheresis is required to isolate the CD34+ cells needed for exagamglogene autotemcel production. Previous studies available in the medical literature have shown that hydroxyurea treatment is associated with a decreased level of CD34+ cells in both the peripheral blood and bone marrow. One study revealed that the number of peripheral blood CD34+ cells was 2.5 cells/microL of blood in hydroxyurea treated patients (n=31), 19 cells/microL in treatment naive patients (n=19) and those receiving chronic transfusions (n=19), and 7.3 cells/microL in the control group (individuals without sickle cell disease, n=25). Clinical data evaluating the use of hydroxyurea 8 weeks prior to the planned start of mobilization and conditioning as well as after the receipt of exagamglogene autotemcel are not available.

MANAGEMENT: The manufacturer of exagamglogene autotemcel recommends discontinuation of hydroxyurea at least 8 weeks prior to the start of each mobilization cycle and conditioning. Additionally, there is no experience with the use of hydroxyurea after a patient receives treatment with exagamglogene autotemcel.

References

  1. (2023) "Product Information. Casgevy (exagamglogene autotemcel)." Vertex Pharmaceuticals
  2. Vertex Pharmaceuticals (Europe) Limited (2024) Casgevy 4-13 x 10Exp6 cells/mL dispersion for infusion https://www.medicines.org.uk/emc/product/15296
  3. (2023) "Product Information. Hydroxyurea (hydroxyurea)." Leading Pharma, LLC
  4. Tolu SS, Wang K, Yan Z, et al. (2019) "Long-term hydroxyurea use is associated with lower levels of hematopoietic stem and progenitor cells in patients with sickle cell disease." Blood, 134, p. 985
  5. Vertex Pharmaceuticals Incorporated (2024) Be invested the CASGEVY treatment journey. https://www.casgevy.com/sickle-cell-disease/treatment-journey
View all 5 references

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Drug and food interactions

No alcohol/food interactions were found. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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