Teva Pharmaceutical Industries Ltd has released Qvar Redihaler (beclomethasone dipropionate HFA).
Teva Pharmaceutical Industries Ltd has released QVAR Redihaler (beclomethasone dipropionate HFA). The medication is an inhaled corticosteroid indicated as prophylactic therapy for maintenance treatment of asthma in patients aged 4 years and older. It should not be used for the relief of acute bronchospasm.1 QVAR RediHaler is supplied as a breath-actuated inhaler, which eliminates the need for hand-breath coordination during administration. About 68% of patients with asthma do not use their metered dose inhaler (MDI) correctly.2 The QVAR MDI, approved by the FDA in 2014, will no longer be available.3
PHARMACOLOGY AND PHARMACOKINETICS
Although their exact mechanism is unknown, corticosteroids have demonstrated multiple anti-inflammatory effects in asthma. Corticosteroids inhibit both inflammatory cells and the release of inflammatory mediators, which contribute to their efficacy in asthma. QVAR RediHaler is extensively and rapidly converted to an active metabolite. It displays a mean peak plasma concentration 10 minutes after administration and a mean terminal half-life of about 4 hours.1
DOSAGE AND ADMINISTRATION
The dose of QVAR RediHaler depends on asthma severity and previous treatment. For patients 4 to 11 years, it should be given as 40 or 80 mcg by oral inhalation twice daily. For patients 12 years and older, it should be given as 40, 80, 160, or 320 mcg by oral inhalation twice daily. The medication should be discarded when the dosage counter displays 0 or it has passed its expiration date, whichever comes first. QVAR RediHaler should not be used with a spacer or volume holding chamber. It does not require priming or shaking before administration.1
The efficacy and safety of QVAR RediHaler were evaluated in 1858 patients with asthma. A 12-week confirmatory trial of patients aged 12 years and older found QVAR RediHaler to be more effective than placebo. A 6-week confirmatory trial of patients 12 years and older found QVAR RediHaler to be more effective than the placebo and similar in efficacy to the QVAR MDI. A 12-week confirmatory trial of children 4 to 11 years noted a change in weekly average of daily peak expiratory flow.1
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
QVAR RediHaler is contraindicated as a primary treatment of status asthmaticus or other acute episodes in which intensive measures are required. It is also contraindicated in patients with hypersensitivity to any of its components.
Candida albicans infection of the mouth and throat may occur during treatment with QVAR RediHaler. To reduce this risk, patients should rinse with water after inhalation and spit. When transferring from systemic corticosteroids to QVAR RediHaler, the dose of systemic corticosteroids should be tapered slowly to minimize the risk of impaired adrenal function. Caution should be used in patients with bacterial, fungal, ocular herpes simplex, parasitic, tuberculosis, or viral infections and in patients with chickenpox or measles. If paradoxical bronchospasm occurs, an inhaled, short-acting bronchodilator should be administered immediately and QVAR RediHaler should be discontinued. Hypersensitivity reactions may occur, including angioedema, bronchospasm, rash, and urticaria. If this occurs, QVAR Redihaler should be discontinued. Adrenal suppression and hypercorticism may occur and warrant slow discontinuation of the medication. Pediatric patients should have their growth monitored, and those with major risk factors for decreased bone mineral content should have their bone mineral density monitored. Patients with a change in vision or a history of blurred vision, cataracts, glaucoma, or increased intraocular pressure should be monitored closely.
The most common adverse reactions (incidence ≥3% and greater than placebo) include allergic rhinitis, nasopharyngitis, oral candidiasis, oropharyngeal pain, sinusitis, and upper respiratory tract infection.1
Monica Holmberg, PharmD, BCPS, earned her PharmD at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.
- Qvar RediHaler [prescribing information]. Frazer, PA: Teva Respiratory LLC. qvar.com/globalassets/qvar/qvar-redihaler-pi.pdf. Accessed June 4, 2018.
- Teva announces U.S. launch of QVAR RediHaler (Beclomethasone Dipropionate HFA) Inhalation Aerosol [news release]. Jerusalem; February 16, 2018. tevapharm.com/news/teva_announces_u_s_launch_of_qvar_redihaler_beclomethasone_dipropionate_hfa_inhalation_aerosol_02_18.aspx. Accessed June 4, 2018.
- Teva announces FDA approval of QVAR RediHaler (Beclomethasone Dipropionate HFA) Inhalation Aerosol [news release]. Jerusalem; August 7, 2017. tevapharm.com/news/teva_announces_fda_approval_of_qvar_redihaler_beclomethasone_dipropionate_hfa_inhalation_aerosol_08_17.aspx. Accessed June 4, 2018.