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«HIGHLIGHTS OF PRESCRIBING INFORMATION Wean patients slowly from systemic corticosteroids if transferring These highlights do not include all the ...»

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HIGHLIGHTS OF PRESCRIBING INFORMATION Wean patients slowly from systemic corticosteroids if transferring

These highlights do not include all the information needed to use to ASMANEX HFA. (5.4)

ASMANEX HFA safely and effectively. See full prescribing  Hypercorticism and adrenal suppression: May occur with very high

information for ASMANEX HFA. dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ASMANEX HFA slowly. (5.5) ASMANEX® HFA (mometasone furoate) inhalation aerosol, for  Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of oral inhalation use increased systemic corticosteroid effects. Exercise caution when Initial U.S. Approval: 1987 used with ASMANEX HFA. (5.6)  Paradoxical bronchospasm: Discontinue ASMANEX HFA and

----------------------------INDICATIONS AND USAGE ---------------------------- institute alternative therapy if paradoxical bronchospasm occurs.

ASMANEX HFA is a corticosteroid indicated for:

(5.7)  Maintenance treatment of asthma as prophylactic therapy in  Hypersensitivity reactions including anaphylaxis: Hypersensitivity patients 12 years of age and older. (1.1) reactions, such as urticaria, flushing, allergic dermatitis,

Important limitations:

bronchospasm, rash, pruritus, angioedema, and anaphylactic  Not indicated for the relief of acute bronchospasm. (1.1) reaction may occur. Discontinue ASMANEX HFA if such reactions occur. (5.8)

----------------------- DOSAGE AND ADMINISTRATION -----------------------  Decreases in bone mineral density: Monitor patients with major For oral inhalation only. (2.1) risk factor

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Important Limitations of Use  ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.


2.1 General ASMANEX HFA should be administered only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet]. After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.

The cap from the mouthpiece of the actuator should be removed before using ASMANEX HFA.

ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.

2.2 Dosing ASMANEX HFA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.

Shake well prior to each inhalation.

The recommended doses for ASMANEX HFA treatment based on prior asthma therapy are provided in Table 1.

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If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids, should be considered.

2 The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

The maximum benefit may not be achieved for 1 week or longer after beginning treatment.

Individual patients may experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.


ASMANEX HFA is a pressurized metered dose inhaler that is available in 2 strengths.

ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.

ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation.


4.1 Status Asthmaticus ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

4.2 Hypersensitivity ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA [see Warnings and Precautions (5.8)].


5.1 Deterioration of Asthma and Acute Episodes ASMANEX HFA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath. When prescribing ASMANEX HFA, the physician must also provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of ASMANEX HFA. 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 HFA. During such episodes, patients may require therapy with oral corticosteroids.

5.2 Local Effects In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with ASMANEX HFA. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX HFA therapy, but at times therapy with ASMANEX HFA may need to be interrupted. Advise patients to rinse the mouth after inhalation of ASMANEX HFA.

5.3 Immunosuppression 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) or pooled intravenous immunoglobulin (IVIG) 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.

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5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX HFA because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamicpituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although ASMANEX HFA may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.

During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.

Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to ASMANEX HFA. Lung function (FEV1 or PEF), betaagonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to ASMANEX HFA may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

5.5 Hypercorticism and Adrenal Suppression ASMANEX HFA will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since mometasone furoate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of ASMANEX HFA in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with ASMANEX HFA should be observed carefully for any evidence of systemic corticosteroid effects.

Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ASMANEX HFA should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

5.6 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ASMANEX HFA with ketoconazole, and other known strong cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, 4 telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

5.7 Paradoxical Bronchospasm and Upper Airway Symptoms ASMANEX HFA may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. ASMANEX HFA should be discontinued immediately and alternative therapy instituted.

5.8 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm, may occur after administration of ASMANEX HFA. Discontinue ASMANEX HFA if such reactions occur [see Contraindications (4.2)].

The following additional hypersensitivity reactions, such as rash, pruritus, angioedema, and anaphylactic reaction, have been reported after administration of mometasone furoate dry powder inhaler [see Adverse Reactions (6.2)].

5.9 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

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