Asmanex Twisthaler

Last updated on RxList: 5/26/2021
Asmanex Twisthaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Asmanex Twisthaler?

Asmanex Twisthaler 110 mcg, 220 mcg (mometasone furoate inhalation powder) is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. Asmanex Twisthaler is not a bronchodilator and should not be used for sudden symptoms of shortness of breath.

What Are Side Effects of Asmanex Twisthaler?

Common side effects of Asmanex Twisthaler include:

Dosage for Asmanex Twisthaler

The recommended starting dose of Asmanex Twisthaler ranges from 220 mcg once daily to 440 mcg twice daily.

What Drugs, Substances, or Supplements Interact with Asmanex Twisthaler?

Asmanex Twisthaler may interact with antivirals, cobicistat-containing products, clarithromycin, itraconazole, nefazodone, and telithromycin. Tell your doctor all medications and supplements you use.

Asmanex Twisthaler During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Asmanex Twisthaler; it is unknown hot it would affect a fetus. Poorly controlled asthma during pregnancy is associated with adverse outcomes for mother and fetus. It is unknown if Asmanex Twisthaler passes into breast milk. Because other corticosteroids pass into breast milk, caution should be used when Asmanex Twisthaler is administered to nursing women. Consult your doctor before breastfeeding.

Additional Information

Our Asmanex Twisthaler 110 mcg, 220 mcg (mometasone furoate inhalation powder) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
Asmanex Twisthaler 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.

Common side effects may include:

  • fungal infection;
  • increased sinus allergy symptoms (runny nose, stuffy nose, sinus pain), sore throat, nosebleed;
  • headache;
  • muscle or bone pain, back pain;
  • flu symptoms;
  • indigestion, upset stomach;
  • menstrual pain; or
  • hoarseness or deepened voice.

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.

Read the entire detailed patient monograph for Asmanex Twisthaler (Mometasone Furoate Inhalation Powder)

QUESTION

Asthma is a chronic respiratory disease. See Answer
Asmanex Twisthaler Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Growth effects [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]
  • Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

The safety data described below reflect exposure to ASMANEX TWISTHALER in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials.

In adult and adolescent patients 12 years of age and older, ASMANEX TWISTHALER was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving ASMANEX TWISTHALER. There were also 3 trials with a total of 475 patients receiving ASMANEX TWISTHALER for 1 year. In the 8- to 12-week clinical trials, the population was 12 to 83 years of age; 38% males and 62% females; and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). In 3 long-term safety trials (two 9-month extensions of efficacy trials and one 52-week active-controlled safety trial), 475 patients with asthma (12-83 years of age, 44% males, 56% females, 87% Caucasian, 8% black, 4% Hispanic, and 1% other race/ethnicity) received various doses of ASMANEX TWISTHALER for 1 year.

In pediatric patients 4 to 11 years of age, ASMANEX TWISTHALER was studied in 3 placebo-controlled clinical trials of 12 weeks duration with a total of 630 patients receiving ASMANEX TWISTHALER and a 52-week, active-controlled safety trial with a total of 152 patients receiving ASMANEX TWISTHALER. In the 12-week clinical trials, the population was 4 to 11 years of age; 63% males and 37% females; and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). In the long-term active-controlled safety trial (n=152), patients with asthma (4 to 11 years of age, 60% males and 40% females, 84% Caucasian, 11% Black, and 5% Hispanic) received ASMANEX TWISTHALER 110 mcg twice daily or 220 mcg once daily in the morning for 52 weeks.

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.

Adults And Adolescents 12 Years Of Age And Older

The safety results of the 10 trials that were 8 to 12 weeks in duration were pooled because patients with asthma in these studies were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results of the one 12-week clinical trial in patients with asthma previously treated with oral corticosteroids are presented separately.

In the pooled 8- to 12-week clinical trials, adverse reactions were reported in 70% of patients treated with ASMANEX TWISTHALER (n=1750) compared to 65% of patients taking placebo (n=720). Table 2 displays the common adverse reactions (≥3% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients treated with ASMANEX TWISTHALER compared to patients treated with placebo.

Table 2: Adverse Reactions with ≥3% Incidence in 10 Controlled Clinical Trials with ASMANEX TWISTHALER in Patients 12 Years of Age and Older Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction(%) of Patients
ASMANEX TWISTHALERPlacebo
(n=720)
220 mcg twice daily
(n=433)
440 mcg once daily
(n=497)
220 mcg once dailyin the evening
(n=232)
Headache22172020
Allergic Rhinitis15111413
Pharyngitis118137
Upper Respiratory Infection108157
Sinusitis6655
Candidiasis, oral6442
Dysmenorrhea*9444
Musculoskeletal Pain8445
Back Pain6334
Dyspepsia5333
Myalgia3232
Abdominal Pain3232
Nausea3132
Average Durationof Exposure (Days)81708062
* Percentages are based on the number of female patients.

The following other adverse reactions occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on ASMANEX TWISTHALER therapy than on placebo:

Body as a Whole: fatigue, flu-like symptoms, pain

Gastrointestinal: gastroenteritis, vomiting, anorexia

Hearing, Vestibular: earache

Resistance Mechanism: infection

Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry

In the 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of ASMANEX TWISTHALER therapy administered as two 220-mcg inhalations twice daily (n=46) were compared with those of placebo (n=43). Adverse reactions, whether considered drug-related or not by the investigators, reported in more than 3 patients in the ASMANEX TWISTHALER treatment group, and which occurred more frequently than in placebo were (ASMANEX TWISTHALER % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on ASMANEX TWISTHALER treatment (77 days vs. 58 days on placebo) should be taken into account.

Long-Term Clinical Trials Experience

12 Years of Age and Older

In 3 long-term safety trials, 475 patients with asthma 12 years of age and older were treated with ASMANEX TWISTHALER 220 mcg twice daily (n=60), 220 mcg once daily in the morning (n=41), 220 mcg once daily in the evening (n=40), 440 mcg once daily in the morning (n=44), 440 mcg once daily in the evening (n=41), 440 mcg twice daily (n=62), 880 mcg once daily (n=59), or at variable doses (n=128) for 52 weeks. The safety profile of ASMANEX TWISTHALER in the 52-week trials was similar to the findings in the 8- to 12-week clinical trials. In patients previously on inhaled corticosteroids, cataracts were reported in 3 patients (0.9%) treated with ASMANEX TWISTHALER, compared to 1 patient (1.7%) treated with the active comparator medication. Increased ocular pressure at the end of the study was observed in 2 patients, both on ASMANEX TWISTHALER 880 mcg once daily in the morning. Oral candidiasis, dysphonia, and dysmenorrhea were seen at a higher frequency with long-term administration than in the 8- to 12-week trials.

Pediatric Patients 4 To 11 Years Of Age

In the three 12-week clinical trials in pediatric patients 4 to 11 years of age, patients with asthma were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results from 1 trial are described in Table 3 for ASMANEX TWISTHALER 110 mcg once daily in the evening. The safety results from the other 2 trials showed similar findings.

Overall adverse reactions were reported with approximately the same frequency by patients treated with ASMANEX TWISTHALER and those receiving placebo. Table 3 displays the common adverse reactions (≥2% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients 4 to 11 years of age treated with ASMANEX TWISTHALER compared with placebo-treated patients.

Table 3: Adverse Reactions with ≥2% Incidence in a 12-Week Study with ASMANEX TWISTHALER in Patients 4 to 11 Years of Age Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction(%) of Patients
ASMANEX TWISTHALER
110 mcgonce daily in the evening
(n=98)
Placebo
(n=99)
Fever75
Allergic Rhinitis43
Abdominal Pain62
Vomiting32
Urinary Tract Infection21
Bruise20
Average Durationof Exposure (Days)7268

Long-Term Clinical Trials Experience In Children 4 To 11 Years Of Age

In a 52-week, active-controlled, long-term safety trial, 152 patients with asthma 4 to 11 years of age were treated with ASMANEX TWISTHALER 110 mcg twice daily (n=74) or 220 mcg once daily (n=78). The safety profile for ASMANEX TWISTHALER in the 52-week trial was similar to the findings in the 12-week clinical trials.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of ASMANEX TWISTHALER. Because they 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.

Eye disorders: Vision blurred [see WARNINGS AND PRECAUTIONS].

Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS].

Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

Read the entire FDA prescribing information for Asmanex Twisthaler (Mometasone Furoate Inhalation Powder)

© Asmanex Twisthaler Patient Information is supplied by Cerner Multum, Inc. and Asmanex Twisthaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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