Download Asmanex® HFA (mometasone furoate)

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Asmanex HFA (mometasone furoate) — New Drug Approval
• On December 10, 2014, Merck launched Asmanex HFA (mometasone furoate) inhalation aerosol,
for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and
older.
— Asmanex HFA is not indicated for the relief of acute bronchospasm.
— Asmanex HFA contains a hydrofluoroalkane propellant.
• Asthma is a chronic lung disease characterized by airway inflammation and defined by a history of
respiratory symptoms.
— According to the National Heart, Lung, and Blood Institute, over 22 million Americans are
known to have asthma.
— Common symptoms include wheezing, shortness of breath, chest tightness, and cough.
• Asmanex HFA is an inhalation aerosol and contains the corticosteroid, mometasone furoate.
Corticosteroids exhibit potent anti-inflammatory activity.
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— Asmanex Twisthaler is a related product. In contrast to Asmanex HFA, Asmanex Twisthaler
is a cap-activated, inhalation-driven dry powder inhaler, for the maintenance treatment of
asthma as prophylactic therapy in patients 4 years of age and older.
• The safety and efficacy of Asmanex HFA were based on placebo-controlled trials in patients 12
years of age and older with persistent asthma.
— From baseline to week 12, the change in mean trough forced expiratory volume in 1 second
(FEV1) was greater among patients receiving Asmanex HFA vs. placebo (treatment difference
from placebo = 0.12L; 95% CI: 0.05, 0.20).
— Fewer patients in the Asmanex HFA arm reported deteriorations in asthma or reductions in
lung function compared to placebo (34% vs. 56%).
• Asmanex HFA is contraindicated in the primary treatment of status asthmaticus or other acute
episodes of asthma where intensive measures are required.
• Warnings and precautions of Asmanex HFA include: deterioration of asthma and acute episodes,
local effects, immunosuppression, transferring patients from systemic corticosteroid therapy,
hypercorticism and adrenal suppression, drug interactions with strong cytochrome P450 3A4
inhibitors, paradoxical bronchospasm and upper airway symptoms, hypersensitivity reactions
including anaphylaxis, reduction in bone mineral density, effect on growth, glaucoma, and cataracts.
• The most common adverse reactions (≥ 3%) with Asmanex HFA use were nasopharyngitis,
headache, sinusitis, bronchitis, and influenza.
Continued . . .
• The recommended dose of Asmanex HFA is 2 inhalations twice daily (morning and evening). The
specific dose should be based on each patient’s prior asthma therapy.
Previous Therapy
Inhaled medium-dose corticosteroids
Inhaled high-dose corticosteroids
Oral corticosteroids
Recommended Dose of Asmanex HFA
100 mcg: 2 inhalations twice daily
200 mcg: 2 inhalations twice daily
200 mcg: 2 inhalations twice daily
— Asmanex HFA requires priming with 4 actuations (puffs) before initial use and if more than 5
days have elapsed since the last use of Asmanex HFA.
• Asmanex HFA is available as a pressurized metered dose inhaler in 100 mcg and 200 mcg
strengths.
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