QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol is indicated for the maintenance
treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR® is also indicated for
asthma patients requiring systemic corticosteroid administration,
where adding QVAR® may reduce or eliminate the need for systemic corticosteroids.
Important Limitation of Use: QVAR Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
Important Safety Information
- QVAR is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
- QVAR is also contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR
- Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR. Advise rinsing of mouth after use. If oropharyngeal candidiasis develops, QVAR may need to be temporarily interrupted under close medical supervision
- Instruct patients to contact their physicians immediately for re-evaluation if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR
- Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR because of the possibility of deaths due to adrenal insufficiency. Patients should be tapered when switching from systemic corticosteroids to QVAR
- Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. Inhaled corticosteroids should be used with caution, if at all, in patients with untreated active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex
- Inhaled corticosteroids may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If this occurs with QVAR, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with QVAR should be discontinued and alternate therapy instituted
- Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of QVAR. Discontinue QVAR if such reactions occur
- It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher than recommended doses. If such changes occur, reduce the QVAR dose slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms
- Orally inhaled corticosteroids, including QVAR, may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QVAR. To minimize the systemic effects, titrate to the lowest dosage that effectively controls symptoms
- Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care
- Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts
- Common side effects of QVAR and placebo in clinical trials included, but were not limited to, headache (12% and 9% respectively), pharyngitis (8% and 4% respectively), oral symptoms inhalation route (3% and 2% respectively), and sinusitis (3% and 2% respectively)
Please see full Prescribing Information.