Lenmeldy Disease Interactions

Atidarsagene autotemcel has not been studied in patients with hepatic impairment. Patients should be assessed for hepatic impairment prior to treatment to ensure that hematopoietic stem cell transplantation is appropriate.

Atidarsagene autotemcel has not been studied in patients with HIV-1/2, human T-lymphotrophic virus 1 and 2 (HTLV-1/2), HBV, HCV, or mycoplasma infection. Patients should be screened for these infectious disease before collection of cells for the manufacturing of atidarsagene autotemcel. Patients should not take prophylactic HIV anti-retroviral medications for at least 1 month prior to mobilization, or for the expected duration of time needed for the elimination of the medications. If a patient requires anti-retrovirals for HIV prophylaxis, initiation of atidarsagene autotemcel should be delayed until confirmation of a negative test for HIV.

Atidarsagene autotemcel has not been studied in patients with renal impairment. Patients should be assessed for renal impairment prior to treatment with atidarsagene autotemcel to ensure that hematopoietic stem cell transplantation is appropriate.

Thrombosis, thromboembolic events, and veno-occlusive disease have occurred in patients treated with atidarsagene autotemcel. Some patients received anti-thrombotic prophylaxis in clinical trials. Evaluate patients for preexisting risk factors for thrombosis prior to and after infusion of atidarsagene autotemcel. Consider prophylaxis with anti-thrombotic agents based on risk factors and best clinical practice.