Atidarsagene autotemcel Side Effects

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.