氟替美维吸入粉雾剂(Trelegy Ellipta)的注意事项和药物相互作用

During the use of flutimavir inhalation powder (TrelegyEllipta), attention should be paid to oral candida infection, pneumonia risk, immunosuppression and infection, systemic corticosteroid conversion, hypercorticoidemia and adrenal suppression, etc.

Indications of flutimavir inhalation powder (Trelegy Ellipta)

1. Maintenance treatment of chronic obstructive pulmonary disease

It is suitable for the maintenance treatment of patients with chronic obstructive pulmonary disease.

2. Maintenance treatment of asthma

Flutimavir inhalation powder is suitable for maintenance treatment of asthma patients aged 18 years and above.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Precautions for flutimavir inhalation powder (Trelegy Ellipta)

1. Disease exacerbation and acute exacerbation

Flutimavir inhalation powder should not be started during a rapidly exacerbating or potentially life-threatening exacerbation of chronic obstructive pulmonary disease or asthma. Flutimavir inhalation powder has not been studied in subjects with acute exacerbations of COPD or asthma.

When initiating flutimavir inhalation powder therapy, patients who are regularly (e.g., four times daily) taking oral or inhaled short-acting beta2-agonists should be instructed to discontinue regular use of these medications and to use them only for relief of acute respiratory symptoms. When prescribing flutimavir inhalation powder, health care providers should also prescribe an inhaled short-acting beta2-agonist and instruct patients on its use.

2. Candidiasis of the oropharynx

Flutimavir inhalation powder contains the ICS fluticasone furoate. Local infection of the oropharynx with Candida albicans has occurred in subjects treated with oral inhalation drug products containing fluticasone furoate.

When such an infection occurs, appropriate topical or systemic (i.e., oral) antifungal treatment should be used while continuing treatment with flutimavir inhalation powder. In some cases, it may be necessary to interrupt flutimavir inhalation powder therapy. Patients are advised to rinse their mouth with water (without swallowing) after inhaling flutimavir inhalation powder to help reduce the risk of oropharyngeal candidiasis.

3. Pneumonia

Lower respiratory tract infections, including pneumonia, have been reported after inhaled corticosteroids.

Physicians should be alert to the possibility of pneumonia in patients with COPD because the clinical features of pneumonia and exacerbations often overlap.

4. Immunosuppression and risk of infection

People who use drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles may have a more severe or even fatal course in susceptible children or adults taking corticosteroids. Special care should be taken to avoid exposure to such children or adults who have not had these illnesses or are not appropriately immunized. How the dose, route, and duration of corticosteroid administration affect the risk of developing disseminated infection is unclear.

ICS should be used with caution (if necessary) in patients with active or quiescent respiratory tuberculosis infection, systemic fungal, bacterial, viral or parasitic infection, or ocular herpes simplex.

5. Patients switching from systemic corticosteroid therapy

Special caution is needed in patients switching from systemically active corticosteroids to ICS, as there have been cases of death due to adrenal insufficiency during and after switching from systemic corticosteroids to less systemically available ICS. Recovery of hypothalamic-pituitary-adrenal axis function after discontinuation of systemic corticosteroids requires several months.

Patients who are switched from systemic corticosteroid therapy to flutimavir inhalation powder may develop allergic symptoms previously suppressed by systemic corticosteroid therapy, such as rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic disease.

6. Hypercortisolism and adrenal suppression

Because there may be significant systemic absorption of ICS in sensitive patients, patients treated with flutemevir inhalation powder should be carefully observed for any evidence of systemic corticosteroid effects. Special attention should be paid to observing patients postoperatively or during periods of stress for evidence of adrenal insufficiency.

Systemic corticosteroid effects such as hypercortisolism and adrenal suppression (including adrenal crisis) may occur in a small subset of patients who are susceptible to such effects. If such effects occur, the dose of flutimavir inhalation powder should be slowly reduced in accordance with accepted procedures for reducing systemic corticosteroids, and alternative treatments should be considered to control symptoms of COPD or asthma.

7. Paradoxical bronchospasm

Like other inhaled therapies, flutimavir inhalation powder may produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs after use of flutemevir inhalation powder, treatment should be immediate with an inhaled short-acting bronchodilator; flutemevir inhalation powder should be discontinued immediately, and alternative treatment should be initiated.

8. Hypersensitivity reaction

Hypersensitivity reactions, such as allergic reactions, angioedema, rash and urticaria, may occur after using flutimavir inhalation powder. If such a reaction occurs, flutimavir inhalation powder should be discontinued. Anaphylaxis has been reported in patients with severe milk protein allergy after inhalation of other lactose-containing powdered medicines; therefore, flutimavir inhalation powder should not be used in patients with severe milk protein allergy.

9. Cardiovascular effects

Like other β2-agonists, flutimavir inhalation powder may produce clinically significant cardiovascular effects in some patients, manifested as increases in pulse rate, systolic or diastolic blood pressure, and cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, flutimavir inhalation powder may need to be discontinued.

Flutimavir inhalation powder (Trelegy Ellipta) drug interactions

1. Cytochrome P4503A4 inhibitors

Fluticasone furoate and vilanterol are CYP3A4 substrates. Administration of strong CYP3A4 inhibitors will increase the systemic exposure of fluticasone furoate and vilanterol. Use caution when considering coadministration of flutimavir inhalation powder with ketoconazole and other known strong CYP3A4 inhibitors.

2. Monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval

Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients who are receiving monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuing such drugs. Drugs known to prolong the QTc interval increase the risk of ventricular arrhythmias.

3. Non-potassium-sparing diuretics

Electrolyte changes and/or hypokalemia that may be caused by the administration of non-potassium-sparing diuretics (such as loop diuretics or thiazide diuretics) may be acutely aggravated by beta-agonists, especially when the recommended dose of beta-agonists is exceeded. Although the clinical significance of these effects is unknown, caution is recommended when beta-agonists are coadministered with non-potassium sparing diuretics.

4. Anticholinergic drugs

There are potential interactions with anticholinergic drugs used at the same time. Avoid combining flutemevir inhalation powder with other drugs containing anticholinergic ingredients, which may lead to an increase in anticholinergic adverse reactions.