Lenmeldy Side Effects

Generic name: atidarsagene autotemcel

Note: This document contains side effect information about atidarsagene autotemcel. Some dosage forms listed on this page may not apply to the brand name Lenmeldy.

Applies to atidarsagene autotemcel: intravenous suspension.

General

The most common adverse reactions occurring in at least 10% of all pediatric patients within the first year of treatment included febrile neutropenia, stomatitis, elevated D-dimer, respiratory tract infections, rash, device-related infections, other viral infections, neutropenia, elevated liver enzymes, pyrexia, gastroenteritis, and hepatomegaly. The reported adverse effects include events potentially related to busulfan-based myeloablative conditioning.^[Ref]

Cardiovascular

Frequency not reported: Veno-occlusive disease

Dermatologic

Very common (10% or more): Rash (33%)

Rash also includes dermatitis, bullous dermatitis, erythematous rash, drug eruption, and maculopapular rash.

Gastrointestinal

Very common (10% or more): Stomatitis (77%), gastroenteritis (21%)

Gastroenteritis also includes enteritis, Aeromonas gastroenteritis, and rotavirus gastroenteritis.

Hematologic

Very common (10% or more): Febrile neutropenia (85%), elevated levels of D-dimer greater than 4.2 nmol/L (67%), neutropenia following conditioning (28%)

Common (1% to 10%): Anemia

Frequency not reported: Delayed platelet engraftment

Hepatic

Very common (10% or more): Hepatomegaly (18%), elevated liver enzymes (23%)

Frequency not reported: Elevated liver enzymes (AST/ALT)

Immunologic

Frequency not reported: Anti-arylsulfatase A antibodies

Nervous system

Frequency not reported: Encephalitis, cerebral infarction secondary to a thrombotic event

Other

Very common (10% or more): Pyrexia (21%), device-related infections (31%), other viral infections (28%)

Device-related infections also includes events of bacterial sepsis, catheter-site cellulitis, catheter-site infection, sepsis, and vascular-device infection.

Other viral infections also includes adenovirus infection, cytomegalovirus infection, cytomegalovirus test positive, cytomegalovirus viremia, enterovirus infection, hand-foot-and-mouth disease, herpes zoster, positive SARS-CoV-2 test, and viral infection (excluding rotavirus gastroenteritis).

Respiratory

Very common (10% or more): Respiratory infections (54%)

Respiratory infections also includes bronchitis, nasopharyngitis, pharyngitis, pneumonia, rhinitis, tonsillitis, upper respiratory fungal infection, and upper respiratory tract infection.

Further information

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

Some side effects may not be reported. You may report them to the FDA.

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