Product Dossier
ALVESCO
Product Dossier for ALVESCO (ciclesonide, Chiesi). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Chiesi
- Active ingredient: ciclesonide
- Therapeutic area: Respiratory
- Related brand: OMNARIS
- Same area: NUCALA
- Same area: VENTOLIN
What it is
ALVESCO is a ciclesonide pressurised metered dose inhaler. It is available in two strengths: 80 micrograms and 160 micrograms ciclesonide per actuation. The drug is dissolved in a non-halogenated solution and delivered via a pressurised metered dose inhaler, resulting in an extra fine aerosol with a main particle fraction of 1.1 to 2.1 microns, which ensures high lung deposition of more than 50% of the ex-actuator dose and less deposition in the oropharynx than suspension formulations of other inhaled corticosteroids.
Approved indications
— Prophylactic treatment of asthma in adults and adolescents. — Prophylactic treatment of asthma in children 6 years of age and older.
Dosing overview
For children aged 6 to 11 years, the recommended dose of ALVESCO is 80 micrograms or 160 micrograms once daily, administered as 1 or 2 puffs once daily either in the morning or evening. The dose should be adjusted to the lowest dose at which effective control of asthma is maintained. For adults and adolescents aged 12 years and older, the recommended dose range is 80 to 320 micrograms per day. Patients should be given a starting dose appropriate to the severity of their disease. Symptoms start to improve within 24 hours of treatment, but ALVESCO should be taken regularly even when patients are asymptomatic due to its prophylactic nature.
PBS listing
ALVESCO 80 micrograms per dose is listed on the PBS in a pack of 120 doses with an ex-manufacturer price of A$10.08, available with both unrestricted and restricted supply restrictions. ALVESCO 160 micrograms per dose is listed on the PBS in a pack of 120 doses with an ex-manufacturer price of A$18.40, available with both restricted and unrestricted supply restrictions.
Regulatory history
ALVESCO was first registered on the ARTG on 24 February 2004, with both the 80 micrograms per actuation and 160 micrograms per actuation formulations listed simultaneously.