Everolimus Use in Children With Tuberous Sclerosis Complex

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Everolimus Use in Children With Tuberous Sclerosis Complex

Contraindications and Warnings


Everolimus can produce severe hypersensitivity reactions, including anaphylaxis and angioedema. Further treatment with everolimus or other rapamycin derivatives is considered contraindicated in patients experiencing these reactions. As with other rapamycin derivatives, everolimus has been associated with the development of non-infectious pneumonitis. In clinical trials, this has been reported in 19% of patients, with 2–4% having severe disease (grade 3 or 4). Patients and their families should be aware of the need to contact their health care provider for signs of cough, dyspnea, or hypoxia. Everolimus may be continued at a reduced dose in patients with grade 1 or 2 pneumonitis, but should be discontinued in cases classified as grade 4 and held until resolution or significant improvement in grade 3 pneumonitis.

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