Teva Pharmaceuticals Announces Launch of Daily Maintenance Asthma Medication

The Asthma and Allergy Foundation of America is sharing this news from the Teva Pharmaceuticals to bring you the latest research news quickly.


QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is now available to patients by prescription! It is the first and only breath-actuated inhaled corticosteroid for the maintenance treatment of asthma in patients ages 4 and older. QVAR® RediHaler™ is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.Teva-announced-launch-of-new-daily-asthma-medicine

Recent research from the Annals of the American Thoracic Society found that approximately 76 percent of asthma patients struggle to use their metered-dose inhalers (MDIs) correctly.1 QVAR® RediHaler™ contains the exact same medication as QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, but utilizes innovative “breath-actuated” inhaler technology. That means the medicine is released when you breathe in, eliminating the need for hand-breath coordination during inhalation, a technique commonly associated with standard MDIs.2-4

QVAR® RediHaler™ was also designed to be “spacer-free” (do not use with a spacer) and does not require shaking or priming.

Furthermore, effective immediately, QVAR® will no longer be available. If you currently have a prescription for QVAR®, you should speak with your doctor and see if QVAR® RediHaler™ might be right for you.

For additional information, visit www.QVAR.com.

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 https://www.qvar.com/globalass...var-redihaler-pi.pdf



References
1. American Thoracic Society, Rescue Inhaler Study: New Approach Increases Mastery of Life-Saving Technique, March 18, 2016. Available at: https://www.thoracic.org/about...saving-technique.php. Accessed on May 25, 2016.
2. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC.
3. QVAR (beclomethasone dipropionate HFA) Prescribing Information. Frazer, PA: Teva Respiratory, LLC.
4. 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.

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I use the QVAR respihaler too and for me, not having propellant in it made a huge difference.  My lungs have never liked the prolellant but I've always managed because the steroid component took care of the issues I had but the new respihaler is MUCH better for me.

Ann - it's very frustrating when meds have potential long term side effects. It's are really hard position for everyone with asthma to have to balance the trade off of meds to manage their asthma and potential side effects.

Teva Pharmaceuticals and other inhaler manufacturers need to make an inhaler product that does NOT have these serious side effects. No Glaucoma, Cataracts, Adrenal Insufficiency, etc. wanted by me (SEE WARNINGS listed above).

Jenny H. - Please Note:  Product described above says 4 years of age and older.

My Qvar prescription is setup for auto-refill at Walgreens. A couple of days ago it was supposed to be refilled and the status changed to out of stock and backorder. A few days later it was filled and when I went in to pick it up, the pharmacist said something like the manufacturer changed. When I got home I discovered my prescription was changed to the new Qvar RediHaler.

I'm looking forward to trying it out but I won't know for another 20 days until I use up my old Qvar.

That would be a great question to ask your doc -- but I understand why you wouldn't want to have an appointment just for this question.

Why not put a call into the doctor's office and talk with the nurse? Or email your doctor through your portal? 

Another possibility: could you reach out to your pharmacist? Or if you guys use a respiratory therapist, to them?

My pediatrician talked to us about going to a dry powder inhaler that didn't require a spacer because so often parents and kids don't use a spacer. He said that the medicine will get down into the lungs even without a spacer. 

Ultimately our allergist decided to keep her on Ventolin (which does require a spacer), but it was for other reasons. 

Wow- this came as quite a surprise that the old inhaler is no longer available. The email and letter I received in the mail introducing the inhaler said NOTHING about discontinuing the old inhaler. Only through this post did I learn this.  Extremely upsetting business practice on behalf of Teva.  

Does anyone have experience with this inhaler? My daughter is only 3 years old and we use a spacer- since this can't be used with a spacer just wondering how well it works for the little ones.  Any feedback would be greatly appreciated. I hate to have to make a doctor visit specifically because of this.

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