ASMANEX

ASMANEX- mometasone furoate inhalant
Organon LLC

1 INDICATIONS AND USAGE

ASMANEX® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older.

Limitations of Use

ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm.

ASMANEX TWISTHALER is not indicated in children less than 4 years of age.

2 DOSAGE AND ADMINISTRATION

Administration Information

Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. After administration, advise patients to rinse the mouth with water and spit out contents without swallowing. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.

2.1 Recommended Dosages in Adult and Pediatric Patients 4 Years of Age and Older

The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.

Table 1: Recommended Dosages for ASMANEX TWISTHALER Treatment
Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose
*
When administered once daily, ASMANEX TWISTHALER should be taken only in the evening.
The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily.
For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.5)].
§
Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy.
Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening * 440 mcg
Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening * 440 mcg
Patients ≥12 years who received oral corticosteroids 440 mcg twice daily 880 mcg
Children 4-11 years of age § 110 mcg once daily in the evening * 110 mcg *

3 DOSAGE FORMS AND STRENGTHS

Inhalation powder:

  • ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.
  • ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece.

4 CONTRAINDICATIONS

ASMANEX TWISTHALER is contraindicated:

  • Status Asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
  • Hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER [see Warnings and Precautions (5.3) and Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Oropharyngeal Candidiasis

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 195 of 3007 patients treated with ASMANEX TWISTHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX TWISTHALER therapy, but at times therapy with the ASMANEX TWISTHALER may need to be interrupted. After administration, advise patients to rinse the mouth with water and spit out contents without swallowing.

5.2 Acute Asthma Episodes

ASMANEX TWISTHALER is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. A short acting beta2 -agonist, such as albuterol, should be available at all times to treat acute asthma 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 ASMANEX TWISTHALER. During such episodes, patients may require therapy with oral corticosteroids.

5.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including rash, pruritus, angioedema, and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur [see Contraindications (4) and Adverse Reactions (6.2)].

ASMANEX TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with ASMANEX TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4) and Adverse Reactions (6.2)].

5.4 Immunosuppression and Risk of Infections

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

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, viral, or parasitic infections; or ocular herpes simplex.

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