Fluticasone Propionate and Salmeterol (Page 9 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-3271

NDC: 50090-3271-0 1 POWDER, METERED in a POUCH / 1 in a CARTON

Product: 50090-3272

NDC: 50090-3272-0 1 POWDER, METERED in a POUCH / 1 in a CARTON

Product: 50090-3387

NDC: 50090-3387-0 1 POWDER, METERED in a POUCH / 1 in a CARTON

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Patients should be given the following information:

Serious Asthma Events

Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization and asthma-related death. Available data show that when ICS and LABA are used together, such as with Fluticasone Propionate/Salmeterol MDPI, there is not a significant increase in the risk of these events [see Warnings and Precautions (5.1)].

Not for Acute Symptoms

Inform patients that Fluticasone Propionate/Salmeterol MDPI is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, short‑acting beta2 ‑agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used [see Warnings and Precautions (5.2)].

Instruct patients to seek medical attention if they experience any of the following:

  • Decreasing effectiveness of inhaled, short‑acting beta2 ‑agonists

  • Need for more inhalations than usual of inhaled, short‑acting beta2 ‑agonists

  • Significant decrease in lung function as outlined by the physician

Tell patients they should not stop therapy with Fluticasone Propionate/Salmeterol without physician/provider guidance since symptoms may recur after discontinuation.

Avoid Use Additional Long-Acting Beta2 ‑Agonists

Instruct patients not to use other LABA for asthma [see Warnings and Precautions (5.3)].

Oropharyngeal Candidiasis

Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with Fluticasone Propionate/Salmeterol MDPI, but at times therapy with Fluticasone Propionate/Salmeterol MDPI may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush [see Warnings and Precautions (5.4)].

Immunosuppression and Infections

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.5)].

Hypercorticism and Adrenal Suppression

Advise patients that Fluticasone Propionate/Salmeterol MDPI may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol MDPI [see Warnings and Precautions (5.7)].

Immediate Hypersensitivity Reactions

Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Fluticasone Propionate/Salmeterol MDPI. Patients should discontinue Fluticasone Propionate/Salmeterol MDPI if such reactions occur and contact their healthcare provider or get emergency medical help. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take Fluticasone Propionate/Salmeterol MDPI [see Warnings and Precautions (5.10)].

Reduction in Bone Mineral Density

Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk [see Warnings and Precautions (5.12)].

Reduced Growth Velocity

Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to adolescent patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route [see Warnings and Precautions (5.13)].

Ocular Effects

Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations [see Warnings and Precautions (5.14)].

Risks Associated with Beta‑Agonist Therapy

Inform patients of adverse effects associated with beta2 ‑agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness [see Warnings and Precautions (5.11)].

Pregnancy

Inform patients who are pregnant or nursing that they should contact their physician about the use of Fluticasone Propionate/Salmeterol MDPI [see Use in Specific Populations (8.1)].

Use Daily for Best Effect

Patients should use Fluticasone Propionate/Salmeterol MDPI at regular intervals as directed. The daily dosage of Fluticasone Propionate/Salmeterol MDPI should not exceed 1 inhalation twice a day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do and to not take 2 doses at one time. Individual patients will experience a variable time to onset and degree of symptom relief and full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients not to stop use of Fluticasone Propionate/Salmeterol MDPI abruptly. Patients should contact their physicians immediately if they discontinue use of Fluticasone Propionate/Salmeterol MDPI.

Dose Counter

Instruct patients that Fluticasone Propionate/Salmeterol MDPI has a dose counter that displays the number of actuations (inhalations) left in the inhaler. When the patient receives a new inhaler, the number 60 will be displayed. The dose counter will count down each time the mouthpiece is opened and closed. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist or healthcare provider for a refill of their medication. When the dose counter reaches 0, the patient should stop using the inhaler, and dispose of it in accordance with state and local regulations.

Caring for and Storing the Inhaler

Instruct patients to not open their inhaler unless they are taking a dose. Repeated opening and closing the cover without taking medication will waste medication and may damage the inhaler.

Advise patients to keep their inhaler dry and clean at all times. Never wash or put any part of the inhaler in water. Patient should replace inhaler if washed or placed in water. Advise patients to immediately replace inhaler if mouthpiece cover is damaged or broken.

Gently wipe the mouthpiece with a dry cloth or tissue as needed.

Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat, cold, or humidity.

Instruct patients to never take the inhaler apart.

Inform patients to discard this product when the dose counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first.

Distributed by:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

©2021 Teva Respiratory, LLC. All rights reserved.

United States Patent Nos. 6701917, 6718972, 6748947, 6871646, 7540282, 8006690, 8651103, 8714149, 8978966, 9066957, 9216260, 9415008, 9463288, 9616024, 9731087, 9987229, 10022510, 10124131, 10195375, 10561808, 10765820.

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FPSPI-005

Revised: July 2021

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