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Table 3 Dose modification recommendations for key everolimus-related adverse events

From: Management of everolimus-associated adverse events in patients with tuberous sclerosis complex: a practical guide

Adverse event Grade 1 Grade 2 Grade 3 Grade 4
Non-infectious pneumonitis [19] Consider a 50% decrease in everolimus dose Consider interruption of therapy until symptoms improve to grade ≤1; re-initiate at 50% of previous dose. Discontinue if no recovery within 4 weeks Interrupt everolimus until symptoms resolve to grade ≤1; consider re-initiating at 50% of previous dose. If toxicity recurs at grade 3, consider discontinuation Discontinue everolimus
Infectionsa No change in everolimus dose Maintain dose if tolerated; interrupt if intolerable or grade 2 recurrence until recovery to grade ≤1 then restart at same dose. Interrupt dose until recovery to grade ≤1, then restart at reduced dose. If dose interrupted >21 days, consider discontinuation Discontinue everolimus
Stomatitis [19] - Temporary dose interruption until recovery to grade ≤1; re-initiate at same dose. If AE recurs at grade 2, interrupt dose until recovery to grade ≤1; re-initiate at 50% of previous dose Temporary dose interruption until recovery to grade ≤1; re-initiate at 50% of previous dose Discontinue everolimus
Rasha - If toxicity tolerable, no dose adjustment required. If intolerable, temporary dose interruption until recovery to grade ≤1; re-initiate at same dose. If AE recurs at grade 2, interrupt dose until recovery to grade ≤1; re-initiate at 50% of previous dose Temporary dose interruption until recovery to grade ≤1. Consider re-initiating at 50% of previous dose. If toxicity recurs at grade 3, consider discontinuation  
Metabolic events [19]
 Hypercholesterolaemia
 Hyperglycaemia
 Hypophosphataemia
 Hypertriglyceridaemia
 Hyperiuricaemia
- No dose adjustment required Temporary dose interruption; reinitiate at 50% of previous dose Discontinue everolimus
Myelosuppression [19]
 Platelets
 Neutrophils
  Temporary dose interruption until recovery to grade ≤1; reinitiate at same dose
No dose adjustment required
Temporary dose interruption until recovery to grade ≤1; reinitiate at 50% of previous dose
Temporary dose interruption until recovery to grade ≤2; reinitiate at same dose
Temporary dose interruption until recovery to grade ≤1; reinitiate at 50% of previous dose
Temporary dose interruption until recovery to grade ≤2; reinitiate at 50% of previous dose
Febrile neutropenia [19] - - Temporary dose interruption until recovery to grade ≤2 (≥1.25 × 109/L) and no fever; reinitiate at approximately 50% of previous dose Discontinue everolimus
  1. AE adverse event
  2. aAuthor recommendation