ment and Management Recommendation for Adverse Reactions a Severity grade description: 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
b If dose reduction is required, the suggested dose is approximately 50% lower than the dose previously administered.
c Activities of daily living (ADL)
d Avoid using agents containing alcohol, hydrogen peroxide, iodine, and thyme derivatives in management of stomatitis as they may worsen mouth ulcers.
Adverse Reaction Severitya AFINITOR Dose Adjustmentb and Management Recommendations
Non-infectious pneumonitis Grade 1
Asymptomatic, radiographic findings only No dose adjustment required.
Initiate appropriate monitoring.
Grade 2
Symptomatic,
not interfering with ADLc Consider interruption of therapy, rule out infection and consider treatment with corticosteroids until symptoms improve to ≤ Grade 1.
Re-initiate AFINITOR at a lower dose.
Discontinue treatment if failure to recover within 4 weeks.
Grade 3
Symptomatic,
interfering with ADLc;
O2 indicated Interrupt AFINITOR until symptoms resolve to ≤ Grade 1.
Rule out infection, and consider treatment with corticosteroids.
Consider re-initiating AFINITOR at a lower dose. If toxicity recurs at Grade 3, consider discontinuation.
Grade 4
Life-threatening,
ventilatory support indicated Discontinue AFINITOR, rule out infection, and consider treatment with corticosteroids.
Stomatitis Grade 1
Minimal symptoms,
normal diet No dose adjustment required.
Manage with non-alcoholic or salt water (0.9%) mouth wash several times a day.
Grade 2
Symptomatic but can eat and swallow modified diet Temporary dose interruption until recovery to Grade ≤1.
Re-initiate AFINITOR at the same dose.
If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade ≤1. Re-initiate AFINITOR at a lower dose.
Manage with topical analgesic mouth treatments (e.g., benzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol or phenol) with or without topical corticosteroids (i.e., triamcinolone oral paste).d
Grade 3
Symptomatic and unable to adequately aliment or hydrate orally Temporary dose interruption until recovery to Grade ≤1.
Re-initiate AFINITOR at a lower dose.
Manage with topical analgesic mouth treatments (i.e., benzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol or phenol) with or without topical corticosteroids (i.e., triamcinolone oral paste).d
Grade 4
Symptoms associated with life-threatening consequences Discontinue AFINITOR and treat with appropriate medical therapy.
Other non-hematologic toxicities
(excluding metabolic events) Grade 1 If toxicity is tolerable, no dose adjustment required.
Initiate appropriate medical therapy and monitor.
Grade 2 If toxicity is tolerable, no dose adjustment required.
Initiate appropriate medical therapy and monitor.
If toxicity becomes intolerable, temporary dose interruption until recovery to Grade ≤1. Reinitiate AFINITOR at the same dose.
If toxicity recurs at Grade 2, interrupt AFINITOR until recovery to Grade ≤1. Reinitiate AFINITOR at a lower dose.
Grade 3 Temporary dose interruption until recovery to Grade ≤1.
Initiate appropriate medical therapy and monitor.
Consider reinitiating AFINITOR at a lower |
