Asmanex HFA (mometasone furoate) Inhalation Aerosol is a corticosteroid used as maintenance treatment for the prevention and control of asthma symptoms in people 12 years of age and older.
Asmanex HFA comes in 2 strengths. The dose of Asmanex HFA is 2 puffs in the morning and 2 puffs in the evening.
What Drugs, Substances, or Supplements Interact with Asmanex?
Asmanex HFA may interact with antifungal medicines and anti-HIV medicines. Tell your doctor all medications and supplements you use.
Asmanex During Pregnancy and Breastfeeding
It is unknown if Asmanex HFA would affect a fetus. Tell your doctor if you are pregnant or plan to become pregnant before using Asmanex HFA. It is unknown if Asmanex HFA passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Asmanex HFA (mometasone furoate) Inhalation Aerosol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Asmanex Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
wheezing, choking, or other breathing problems after using this medication;
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
worsening asthma symptoms;
signs of infection--fever, feeling tired, body aches, pain, chills;
signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing; or
symptoms of low adrenal gland hormones--extreme tiredness or weakness, nausea, vomiting, a light-headed feeling (like you might pass out);
Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another drug
and may not reflect the rates observed in practice. The safety of ASMANEX HFA
was evaluated in 2 randomized placebo and active-controlled trials of 12 and 26
weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate
combination product asthma program, which enrolled 1509 patients with
persistent asthma. Patient ages ranged from 12 to 84 years of age, 41% were
male and 59% female, 73% were Caucasian and 27% non-Caucasian. Of the total
population enrolled in the 2 trials, 432 patients received two inhalations
twice daily of either ASMANEX HFA, 100 mcg or 200 mcg/actuation. In the 26-week
trial (Trial 1) 192 patients received two inhalations twice daily of ASMANEX HFA
100 mcg/actuation and 196 patients received placebo. In the 12 week trial (Trial
2) 240 patients received two inhalations twice daily of ASMANEX HFA 200
mcg/actuation and 233 and 255 patients received mometasone furoate and
formoterol fumarate 100 mcg/5 mcg and 200 mcg/5 mcg/actuation combination
products, respectively, as comparators.
In these trials, the proportion of patients who
discontinued study treatment early due to adverse reactions was 3% and 2% for
ASMANEX HFA 100 and 200 mcg treated patients, respectively, and 4% for
placebo-treated patients. Serious adverse reactions, whether considered
drug-related or not by the investigators, which occurred more frequently in
ASMANEX HFA-treated patients included colitis ulcerative, colonicpolyp, chest
pain, gastroenteritis, endometriosis, asthma, and hemoptysis; all events occurred
at rates less than 1%.
The incidence of treatment emergent adverse reactions
associated with ASMANEX HFA are shown in Tables 2 and 3. These are based upon
data from each of the 2 clinical trials of 12 or 26 weeks in duration in
patients 12 years and older treated with two inhalations twice daily of ASMANEX
HFA (100 mcg or 200 mcg), mometasone furoate/formoterol fumarate (100 mcg/5 mcg
or 200 mcg/5 mcg), or placebo.
TABLE 2: Trial 1: Treatment-Emergent Adverse Reactions
Occurring at an Incidence of ≥ 3% and More Commonly than Placebo Over 26
Weeks
ASMANEX HFA 100 mcg
N=192
n (%)
Placebo
N=196
n (%)
Nasopharyngitis
15 (8)
7 (4)
Headache
10 (5)
7 (4)
Influenza
7 (4)
5 (3)
Sinusitis
6 (3)
2 (1)
TABLE 3: Trial 2: Treatment-Emergent Adverse Reactions
Occurring at an Incidence of ≥ 3% Over 12 Weeks
ASMANEX HFA 200 mcg
N=240
n (%)
MF/F* 100/5 mcg
N=233
n (%)
MF/F* 200/5 mcg
N=255
n (%)
Nasopharyngitis
13 (5)
8 (3)
12 (5)
Headache
8 (3)
10 (4)
5 (2)
Bronchitis
6 (3)
2 (1)
7 (3)
*MF/F = mometasone furoate/formoterol fumarate
Oral candidiasis has been reported in clinical trials at
an incidence of 0.5% in patients using ASMANEX HFA 100 mcg, 0.8% in patients
using ASMANEX HFA 200 mcg and 0.5% in the placebo group.
Postmarketing Experience
There are no postmarketing adverse experiences reported
to date with ASMANEX HFA. However, the postmarketing safety experience with
mometasone furoate dry powder inhaler is relevant to ASMANEX HFA since they
contain the same active ingredient. The following adverse reactions have been
reported during post-approval use of mometasone furoate dry powder inhaler.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
&Copy; Asmanex Patient Information is supplied by Cerner Multum, Inc. and Asmanex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
