Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the use of QVAR® (beclomethasone dipropionate HFA) with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients 5 years of age and older.
The dose counter is designed to help asthma patients, as well as their caregivers, keep track of the number of doses remaining in the canister. The new product will be commercially available later this year.
“Bringing QVAR® with a dose counter to market reaffirms Teva’s commitment to addressing unmet needs by providing high-quality and innovative solutions to patients,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “Adding to our rich heritage within the respiratory space, we are pleased that all Teva Respiratory brands in the U.S. will soon include a dose counter, which will help patients and caregivers track how many doses of their medication remain.”
QVAR® is an inhaled corticosteroid (ICS) recommended as a twice-daily treatment for long-term asthma control. Adherence to daily control medications, like QVAR®, is important because when asthma is well controlled, fewer asthma attacks may occur.
“Inhaled corticosteroid treatments, like QVAR®, should be taken daily by patients with mild-to-moderate persistent asthma to reduce inflammation in the airways and prevent asthma symptoms,” said Dr. Gene Colice, Director of Pulmonary, Critical Care and Respiratory Services at Washington Hospital Center in Washington, DC. “By using QVAR® with a dose counter, patients will be able to easily track their daily doses of medication and help ensure that they are taking QVAR® as prescribed by their doctor.”
Over the last decade, the Asthma and Allergy Network Mothers of Asthmatics (AANMA) has conducted several surveys that found patients with asthma do not have a reliable means of monitoring the contents of their metered-dose inhalers (MDIs) resulting in serious problems for many patients. Thus, AANMA recommends that all manufacturers should include dose counters as a standard feature of every metered-dose inhaler (MDI).
In 2003, the FDA issued guidance recommending that MDIs should have a clear indication of when an MDI is approaching the end of its recommended number of actuations, as well as when it has reached or exceeded that number. QVAR® with a dose counter clearly displays the remaining doses of medication in the inhaler.
QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR® is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR® may reduce or eliminate the need for systemic corticosteroids.
Important Safety Information
QVAR® does not replace quick-relief inhalers for sudden symptoms.
CAUTION: If you are stopping or switching from an oral corticosteroid to QVAR®, follow your doctor's instructions to avoid health risks.
Inhaled corticosteroids may cause a reduction in growth rate, so children taking QVAR® should have their growth checked regularly. The long-term effect on final adult growth is unknown.
Do not stop taking QVAR® abruptly without talking to your doctor.
In clinical studies, common side effects included headache and sore throat. These are not all of the possible side effects of QVAR®. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA.