SEREVENT DISKUS Inhalation powder (2020)

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GlaxoSmithKline LLC

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BOXED WARNING SECTION

WARNING: ASTHMA-RELATED DEATH Long-acting beta-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) ...

1. Indications and Usage

1.1 Treatment of Asthma SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ICS in patients aged 4 years and older with reversible ...

2. Dosage and Administration

SEREVENT DISKUS should be administered by the orally inhaled route only. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) is not recommended as some ...

3. Dosage Forms and Strengths

Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains salmeterol 50 mcg per blister.

4. Contraindications

Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated [see Warnings and Precautions (5.1)]. The use of SEREVENT DISKUS is contraindicated ...

5. Warnings and Precautions

5.1 Asthma-Related Death LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. When LABA are used in fixed-dose ...

6. Adverse Reactions

LABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. Data from a large 28-week placebo-controlled U.S. trial ...

6.1. Clinical Trials Experience

Clinical Trials Experience in Asthma Adult and Adolescent Subjects Aged 12 Years and Older Two multicenter, 12-week, placebo-controlled clinical trials evaluated twice-daily doses of SEREVENT DISKUS in ...

6.3. Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of salmeterol. Because these reactions are reported voluntarily ...

7. Drug Interactions

7.1 Inhibitors of Cytochrome P450 3A4 Salmeterol is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ...

8.1. Pregnancy

Risk Summary The available data from published epidemiological studies and case reports with use of SEREVENT DISKUS in pregnant women have not identified a drug-associated risk of major birth defects, ...

8.2. Lactation

Risk Summary There is no information regarding the presence of salmeterol in human milk, the effects on the breastfed child, or the effects on milk production. Salmeterol is detected in rat milk (see ...

8.4. Pediatric Use

Available data from controlled clinical trials suggest that LABA used as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent ...

8.5. Geriatric Use

Of the total number of adult and adolescent subjects with asthma who received SEREVENT DISKUS in chronic dosing clinical trials, 209 were aged 65 years and older. Of the total number of subjects with COPD ...

8.6. Hepatic Impairment

Formal pharmacokinetic studies using SEREVENT DISKUS have not been conducted in patients with hepatic impairment. Since salmeterol is predominantly cleared by hepatic metabolism, impairment of liver function ...

10. Overdosage

The expected signs and symptoms with overdosage of SEREVENT DISKUS are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic ...

11. Description

The active component of SEREVENT DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. ...

12.1. Mechanism of Action

Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the ...

12.2. Pharmacodynamics

Inhaled salmeterol, like other beta-adrenergic agonist drugs, can produce dose-related cardiovascular effects and effects on blood glucose and/or serum potassium [see Warnings and Precautions (5.6, ...

12.3. Pharmacokinetics

Salmeterol xinafoate, an ionic salt, dissociates in solution so that the salmeterol and 1-hydroxy-2-naphthoic acid (xinafoate) moieties are absorbed, distributed, metabolized, and eliminated independently. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an 18-month carcinogenicity study in CD-mice, salmeterol at oral doses of 1,400 mcg/kg and above (approximately 20 times the MRHDID for adults and children based on comparison of the plasma AUCs) caused ...

13.2. Animal Toxicology and/or Pharmacology

Preclinical Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists ...

14. Clinical Studies

14.1 Asthma The initial trials supporting the approval of SEREVENT DISKUS for the treatment of asthma did not require the regular use of ICS. However, for the treatment of asthma, SEREVENT DISKUS is currently ...

16.1. How Supplied

SEREVENT DISKUS is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC ...

16.2. Storage and Handling

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Asthma-Related Death Inform patients that salmeterol when used alone increases the risk of asthma-related ...