QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol will become available by prescription on February 12, 2018. QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol will no longer be available to patients. 1,2

QVAR® RediHaler™ is the first and only breath-actuated aerosol inhaled corticosteroid for the maintenance treatment of asthma in patients ages 4 and older.1 While QVAR® RediHaler™ contains the exact same medicine as the currently-available QVAR®, its innovative “breath-actuated” inhaler technology means the medicine is released when you breathe in, eliminating the need for hand-breath coordination.3 QVAR® RediHaler™ also utilizes a “spacer-free” design (do not use with a spacer) and does not require shaking or priming.

Be sure to talk with your doctor about QVAR® RediHaler™ to learn more. For indication and important safety information please see below.

Approved Use

QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is a breath-actuated inhaled prescription medicine used as a maintenance treatment for the prevention and control of asthma in people 4 years of age and older.

QVAR RediHaler Inhalation Aerosol is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

Important Safety Information

  • Do not use QVAR RediHaler to treat sudden severe symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use QVAR RediHaler if you are allergic to beclomethasone dipropionate or any of the ingredients in QVAR RediHaler.
  • Do not use QVAR RediHaler more often than prescribed.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • QVAR RediHaler may cause serious side effects, including:
  • Fungal infections (thrush)in your mouth and throat. Rinse your mouth with water without swallowing after using QVAR RediHaler to help prevent an infection in your mouth or throat.
    • Worsening asthma or sudden asthma attacks. After using your rescue inhaler, contact your healthcare provider right away if you do not get relief from your sudden asthma attacks
  • Reduced adrenal function (adrenal insufficiency).This potentially life-threatening condition can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines (such as QVAR RediHaler). Tell your healthcare provider right away about any signs and symptoms of adrenal insufficiency such as: feeling tired or exhausted (fatigue); lack of energy; low blood pressure (hypotension); dizziness or feeling faint; nausea and vomiting; or weakness
  • Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs or symptoms of infection such as: fever, chills, pain, feeling tired, body aches, nausea, or vomiting
  • Increased wheezing (bronchospasm) right after using QVAR RediHaler. Always have a rescue inhaler with you to treat sudden wheezing.
  • Serious allergic reactions.Stop using QVAR RediHaler and call your healthcare provider or get emergency medical help right away if you get any of the following: hives; swelling of your lips, tongue, or face; rash; or breathing problems
  • Slowed growth in children.Children should have their growth checked regularly while using QVAR RediHaler.
  • Lower bone density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
  • Eye problems. If you have had glaucoma, cataracts or blurred vision in the past, you should have regular eye exams while using QVAR RediHaler.
  • Common side effects of QVAR RediHaler include: yeast infection in the mouth (oral candidiasis); cold symptoms (upper respiratory tract infection); pain in the throat (oropharyngeal pain); pain or swelling in your nose and throat (nasopharyngitis); sinus irritation (sinusitis); and hay fever (allergic rhinitis)
  • These are not all the possible side effects of QVAR RediHaler. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information at http://www.qvarredihaler.com/Pdf/PI.pdf

  1. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC.
  2. QVAR (beclomethasone dipropionate HFA) Prescribing Information. Frazer, PA: Teva Respiratory, LLC.
  3. 2.P.2 Pharmaceutical Development [beclomethasone dipropionate HFA breath actuated inhalation aerosol, pressurized inhalation solution]. Montvale, NJ: Teva Branded Pharmaceutical Products R&D, Inc; September 2016.