40 mcg inhaled twice daily, approximately 12 hours apart, is the recommended starting dose. For patients who do not respond adequately to 40 mcg after 2 weeks of therapy, increasing the dosage to 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage is 80 mcg twice daily. The starting dosage is based on the severity of asthma, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. Improvement in asthma symptoms can occur within 24 hours of the beginning of treatment and should be expected within the first or second week, but maximum benefit should not be expected until 3 to 4 weeks of therapy. Improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma (GINA) guidelines define low dose therapy as 100 mcg/day in this age group. Titrate to the lowest effective dose once asthma stability is achieved.
This press release contains forward looking statements. Forward looking statements include statements about our future plans and other potential future events and may be indicated by words such as, “anticipate,” “plan,” “expect”, “aim” or other similar words, including the expected launch of XHANCE in the second quarter of 2018. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this press release (September 18, 2017). We are not obligating ourselves to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events.
Administration advice :
-This drug should be administered by the intranasal route only.
-The nasal spray should be primed before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face.
-When the nasal spray has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, the pump should be primed again until a fine mist appears.
-The nasal spray should be shaken well before each use.
Storage requirements :
-The nasal device should be stored in the upright position with the cap in place between 15 and 30 C.
-Do not freeze or refrigerate.
-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)