Association of PAs in Allergy, Asthma & Immunology

An important announcement from Teva!

Posted 3 months ago by Chloe Mohr

This announcement has 1 attachment:

Hi all –

 

Teva Pharmaceuticals would like to share an important update with you regarding QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol and QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol.

 

QVAR® RediHaler™ is the first and only breath-actuated aerosol inhaled corticosteroid for the maintenance treatment of asthma as prophylactic therapy in patients ages 4 and older. Important limitation of use: QVAR® RediHaler™ is not indicated for the relief of acute bronchospasm.1 QVAR® RediHaler™ contains the exact same medication as QVAR® Inhalation Aerosol but utilizes innovative breath-actuated inhaler technology to deliver it via a spacer-free design (do not use with a spacer) and does not require priming or shaking.2

 

As of May 2018, QVAR® was discontinued. Patients and caregivers are encouraged to speak with their doctors to learn more about how this discontinuation may affect their current treatment plans and how to start using QVAR® RediHaler™. Over 70% of patients with commercial insurance have preferred coverage for QVAR® RediHaler™.3

 

I wanted to share this information with you in the event you would like to pass it along to your constituents and/or members. Please visit www.QVAR.com for more information, and feel free to let me know if you have any questions.

 

Please see below for the Indication and Important Safety Information.

 

Indication

QVAR® RediHaler ™ (beclomethasone dipropionate HFA) Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age or older.

Important Limitation of Use: QVAR RediHaler Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

Important Safety Information

  • Contraindications: QVAR RediHaler is contraindicated in:
  • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
  • Patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR RediHaler
  • Localized infections: Infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR RediHaler. Advise rinsing of mouth with water without swallowing after use. If oropharyngeal candidiasis develops, QVAR RediHaler may need to be temporarily interrupted under close medical supervision
  • Deterioration of asthma and acute episodes: Do not use QVAR RediHaler for the relief of acute symptoms. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR RediHaler
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR RediHaler because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to QVAR RediHaler
  • Immunosuppression: Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. 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
  • Paradoxical Bronchospasm: Inhaled corticosteroids may produce inhalation-induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If this occurs with QVAR RediHaler, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with QVAR RediHaler should be discontinued and alternate therapy instituted
  • Hypersensitivity reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of QVAR RediHaler. Discontinue QVAR RediHaler if such reactions occur
  • Hypercorticism and Adrenal Suppression: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher than recommended doses. If such changes occur, reduce the QVAR RediHaler dose slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms
  • Effects on Growth: Orally inhaled corticosteroids, including QVAR RediHaler, may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QVAR RediHaler. To minimize the systemic effects, titrate to the lowest dosage that effectively controls symptoms
  • Reduction in Bone Mineral Density (BMD): Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care
  • Eye Disorders: Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts
  • Adverse Reactions: Most common adverse reactions (incidence >3% and >placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.

Please click here for full Prescribing Information: http://www.qvarredihaler.com/pdf/PI.pdf 

 

References

  1. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC.
  2. 2.P.2 Pharmaceutical Development [beclomethasone dipropionate HFA breathactuated inhalation aerosol, pressurized inhalation solution]. Montvale, NJ: Teva Branded Pharmaceutical Products R&D, Inc; September 2016.
  3. Allergy/asthma coverage by tier summary, [May 2018]. DR/Decision Resources, LLC. All rights reserved.

 

 

Regards, Greg.