Active Ingredient: Sirolimus
Sirolimus is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
2 - 2 mg
From 2 To 2 mg once every day
Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist.
For patients with S-LAM, the initial sirolimus dose should be 2 mg/day. Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 to 15 ng/mL.
In most patients, dose adjustments can be based on simple proportion: new sirolimus dose=current dose x (target concentration/current concentration). Frequent sirolimus dose adjustments based on non-steady-state sirolimus concentrations can lead to overdosing or underdosing because sirolimus has a long half-life. Once sirolimus maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring. Once a stable dose is achieved, therapeutic drug monitoring should be performed at least every 3 months.
Data from controlled studies for treatment of S-LAM longer than one year are currently not available, therefore the benefit of treatment should be reassessed when used long-term.
To minimise variability, sirolimus should consistently be taken either with or without food.
Grapefruit juice should be avoided.
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