Indications and Usage
QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. QVAR® is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR® may reduce or eliminate the need for the systemic corticosteroids.
Beclomethasone dipropionate is NOT indicated for the relief of acute bronchospasm.
Contraindications
QVAR® is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
Warnings and Precautions
Transferring Patients From Systemic Corticosteroids
Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR® because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.
Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis) or other conditions with severe electrolyte loss. Although QVAR® may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies.
During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack.
Transfer of patients from systemic steroid therapy to QVAR® may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, and eczema.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection. Nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Acute Bronchospasm
QVAR® is not a bronchodilator and is not indicated for rapid relief of bronchospasm. It is important that patients understand this and that they are prescribed a quick-relief inhaler for acute asthma symptoms.
As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with QVAR® , it should be treated immediately with a short acting inhaled bronchodilator. Treatment with QVAR® should be discontinued and alternate therapy instituted. Patients should be instructed to contact their physician immediately when episodes of asthma, which are not responsive to bronchodilators, occur during the course of treatment with QVAR® . During such episodes, patients may require therapy with oral corticosteroids.
Effects on Growth
A reduction in growth velocity in growing children may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of all pediatric patients taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression.
General Precautions
During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function. Although suppression of HPA function below the clinical normal range did not occur with doses of QVAR® up to and including 640 mcg/day, a dose dependent reduction of adrenal cortisol production was observed. Since inhaled beclomethasone dipropionate is absorbed into the circulation and can be systemically active, HPA axis suppression by QVAR® could occur when recommended doses are exceeded or in particularly sensitive individuals. Since individual sensitivity to effects on cortisol production exist, physicians should consider this information when prescribing QVAR®. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effect. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects, such as hypercorticism and adrenal suppression, may appear in a small number of patients, particularly at higher doses. If such changes occur, QVAR® should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic steroids.
A 12 month randomized controlled clinical trial evaluated the effects of HFA beclomethasone dipropionate without spacer versus CFC beclomethasone dipropionate with large volume spacer on growth in children age 5-11. A total of 520 patients were enrolled, of whom 394 received HFA-BDP (100 – 400 mcg/day ex-valve) and 126 received CFC-BDP (200 – 800 mcg/day ex-valve). Similar control of asthma was noted in each treatment arm. When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-BDP was approximately 0.5 cm/year less than that noted with children treated with CFC-BDP via large volume spacer.
The long-term and systemic effects of QVAR® in humans are still not fully known. In particular, the effects resulting from chronic use of the agent on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown.
Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.
Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.
Information for Patients
- Patients being treated with QVAR®should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
- Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed to these diseases, medical advice should be sought without delay.
- Patients should use QVAR® at regular intervals as directed. Results of clinical trials indicated significant improvements may occur within the first 24 hours of treatment in some patients; however, the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks, or longer. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens.
- Patients should be advised that QVAR® is not intended for use in the treatment of acute asthma. The patient should be instructed to contact their physician immediately if there is any deterioration of their asthma.
- Patients should be instructed on the proper use of their inhaler. Patients may wish to rinse their mouth after QVAR® use. The patient should also be advised that QVAR® may have a different taste and inhalation sensation than that of an inhaler containing CFC propellant.
- QVAR® use should not be stopped abruptly. The patient should contact their physician immediately if use of QVAR® is discontinued.
Additional Precautions
Please see full Prescribing Information for:
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy: Teratogenic Effects and Non-teratogenic Effects
- Nursing Mothers
- Pediatric Use
- Geriatric Use
Adverse Reactions®
Common side effects associated with the use of QVAR® and placebo in clinical trials include, but are not limited to, headache (12% and 9%, respectively) and pharyngitis (8% and 4%, respectively).1
Events reported by patients taking QVAR® (whether considered drug related or not) that occurred in clinical trials at a rate over 3% for either QVAR® or CFC-beclomethasone dipropionate include:1
- Headache
- Pharyngitis
- Upper respiratory tract infection
- Rhinitis
- Increased asthma symptoms
- Oral symptoms inhalation route
- Sinusitis
- Pain
- Back pain
- Nausea
- Dysphonia
Other adverse events that occurred in these clinical trials using QVAR® with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were dysphonia, dysmenorrhea, and coughing.1