Alvesco Aerosol

Alvesco Aerosol is a glucocorticoid used to treat obstructive airway diseases. It is marketed under the brand name Alvesco Aerosol.

Treatment of Asthma

Alvesco Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Important Limitations of Use:

Alvesco Aerosol is used to help prevent the symptoms of asthma. When used regularly every day, inhaled Alvesco Aerosol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Alvesco Aerosol is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe.

Alvesco Aerosol is available only with your doctor's prescription.

Alvesco Aerosol should be administered by the orally inhaled route. Prime Alvesco Aerosol Inhalation Aerosol before using for the first time by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for four weeks or longer after initiation. 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 who do not respond adequately to the starting dose after 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of Alvesco Aerosol when administered in excess of the highest recommended doses has not been established.

Recommended Dosages

The recommended starting dose and the highest recommended dose of Alvesco Aerosol Inhalation Aerosol are listed in the following table.

How supplied

Dosage Forms And Strengths

Alvesco Aerosol Inhalation Aerosol is available in the following two strengths: 80 mcg/actuation, and 160 mcg/actuation. The 80 mcg/actuation strength contains 60 actuations fill/canister, and the 160 mcg/actuation strength contains 60 actuations fill/canister.

Alvesco Aerosol 80 mcg Inhalation Aerosol is supplied with a brown plastic actuator with a red dust cap.

Alvesco Aerosol 160 mcg Inhalation Aerosol is supplied with a red plastic actuator with a red dust cap.

Storage And Handling

Alvesco Aerosol is available in the following strengths and canister presentations.

Alvesco Aerosol 80 mcg Inhalation Aerosol is supplied with a brown plastic actuator with a red dust cap. Each actuation of the inhaler delivers 80 mcg of Alvesco Aerosol from the actuator.

Alvesco Aerosol 160 mcg Inhalation Aerosol is supplied with a red plastic actuator with a red dust cap. Each actuation of the inhaler delivers 160 mcg of Alvesco Aerosol from the actuator.

Alvesco Aerosol canisters are for use with Alvesco Aerosol Inhalation Aerosol actuators only. The actuators are fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero.

Store at 25°C (77°F).

Excursions between 15° and 30°C (59° and 86°F) are permitted. For optimal results, the canister should be at room temperature when used. Keep out of reach of children.

CONTENTS UNDER PRESSURE

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.

Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. Made in the United Kingdom.

See also:
What is the most important information I should know about Alvesco Aerosol?

Do not use Alvesco Aerosol inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

You should not use this medication if you are allergic to Alvesco Aerosol.

Before using Alvesco Aerosol, tell your doctor if you have tuberculosis, an infection of your mouth or throat (such as oral thrush), glaucoma or history of cataracts, herpes infection of your eyes, or a personal or family history of osteoporosis.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

Call your doctor right away if you feel that Alvesco Aerosol inhalation makes your condition worse.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Use Alvesco Aerosol aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Alvesco Aerosol aerosol. Talk to your pharmacist if you have questions about this information.
• Avoid spraying Alvesco Aerosol aerosol into your eyes or directly onto the nasal septum (the wall between your nostrils).
• You will need to prime Alvesco Aerosol aerosol before you use it for the first time. To prime Alvesco Aerosol aerosol, spray 3 test sprays into the air away from your face. You will need to re-prime the medicine if it is not used for 10 days or longer.
• To use Alvesco Aerosol aerosol, gently blow your nose. Remove the purple plastic dust cap. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose, pointing it toward the outside nostril wall away from the nasal septum. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe in gently through the open nostril and press down on the canister. Hold your breath for a few seconds then breathe out slowly through your mouth. If your dose requires 2 sprays, repeat these steps for the other nostril. After using the medicine, wipe the nozzle with a clean, dry tissue or cloth and replace the cap.
• Do not use more than 1 spray in each nostril daily.
• Do not blow your nose for 15 minutes after using Alvesco Aerosol aerosol.
• If Alvesco Aerosol aerosol is dropped and comes apart, put the canister and actuator back together and test spray in the air once before using.
• Throw the bottle away after 60 sprays (not counting the 3 sprays used to prime the pump) or when the display window shows a red color and the dose indicator reads zero. You may no longer receive the correct amount of medicine with each spray. Do not transfer any remaining medicine to another bottle.
• Clean the inside of the outside of the nose piece once a week with a clean, dry tissue or cloth. Do not wash or put any part of Alvesco Aerosol aerosol in water.
• Do not use or store Alvesco Aerosol aerosol near heat or an open flame.
• Use Alvesco Aerosol aerosol on a regular schedule to get the most benefit from it. Using Alvesco Aerosol aerosol at the same time each day will help you remember to use it.
• Continue to use Alvesco Aerosol aerosol even if you feel well. Do not miss any doses.
• If you miss a dose of Alvesco Aerosol aerosol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Alvesco Aerosol aerosol.

Alvesco Aerosol is used to prevent asthma attacks, nasal congestion, sneezing, runny nose caused by seasonal allergies.

See also:
What other drugs will affect Alvesco Aerosol?

In clinical studies, concurrent administration of Alvesco Aerosol and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of desciclesonide.

In vitro studies and clinical pharmacology studies suggested that des-Alvesco Aerosol has no potential for metabolic drug interactions or protein binding-based drug interactions.

In a drug interaction study, co-administration of orally inhaled Alvesco Aerosol and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of desciclesonide by approximately 3.6-fold at steady state, while levels of Alvesco Aerosol remained unchanged.

See also:
What are the possible side effects of Alvesco Aerosol?

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection
• Immunosupression
• Hypercorticism and adrenal suppression
• Growth effects
• Glaucoma and cataracts

Clinical Trial Experience

The safety data described below for adults and adolescents 12 years of age and older reflect exposure to Alvesco Aerosol in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are omitted from the safety database because the doses studied once daily are lower than the highest recommended twice daily doses. The five studies were of 12 to 16 weeks treatment duration, one of which included a safety extension follow up of one year. In the 12 to 16 week treatment studies, 720 patients (298 males and 422 females) aged 12 years and older were exposed to Alvesco Aerosol. In the long-term safety trial, 197 patients (82 males and 115 females) with severe persistent asthma from one of the 12-week trials were re-randomized and treated for up to one year with Alvesco Aerosol 320 mcg twice daily. Safety information for pediatric patients 4 to 11 years of age, is obtained from once daily dosing studies. Two of these studies were designed with a 12-week double-blind treatment period followed by a long-term open label safety extension of one year, and one study was an open label safety study of one year duration.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult and Adolescent 12 Years of Age and Older

Four of the five trials included a total of 624 patients ages 12 years and older (359 females and 265 males) with asthma of varying severity who were treated with Alvesco Aerosol 80 mcg, 160 mcg, or 320 mcg twice daily for 12 to 16 weeks. These studies included patients previously using either controller therapy (predominantly inhaled corticosteroids) or reliever therapy (bronchodilator therapy alone). In these trials, the mean age was 39.1 years, and the majority of the patients (79.0%) were Caucasian. In these trials, 52.3%, 59.8% and 54.1% of the patients in the Alvesco Aerosol 80 mcg, 160 mcg, and 320 mcg treatment groups, respectively, had at least one adverse event compared to 58.0% in the placebo group.

Table 1 includes adverse reactions for the recommended doses of Alvesco Aerosol that occurred at an incidence of ≥ 3% in any of the Alvesco Aerosol groups and which were more frequent with Alvesco Aerosol compared to placebo.

Table 1: Adverse Reactions with ≥ 3% Incidence Reported in Patients ≥ 12 Years of Age with Alvesco Aerosol in US Placebo-Controlled Clinical Trials in Patients Previously on Bronchodilators and/or Inhaled Corticosteroids

The following adverse reactions occurred in these clinical trials using Alvesco Aerosol with an incidence of less than 1% and occurred at a greater incidence with Alvesco Aerosol than with placebo.

Infections and Infestations:

Oral

Respiratory Disorders: Cough

Gastrointestinal Disorders: Dry mouth, nausea

General disorders and administrative site conditions: Chest discomfort

Respiratory, Thoracic, and Mediastinal Disorders: Dysphonia, dry throat

The fifth study was a 12-week clinical trial in asthma patients 12 years of age and older who previously required oral corticosteroids (average daily dose of oral prednisone of 12 mg/day), in which the effects of Alvesco Aerosol 320 mcg twice daily (n = 47) and 640 mcg twice daily (n = 49) were compared with placebo (n = 45) for the frequency of reported adverse reactions. The following adverse reactions occurred at an incidence of ≥ 3% in the Alvesco Aerosol-treated patients and were more frequent compared to placebo: sinusitis, hoarseness, oral candidiasis, influenza, pneumonia, nasopharyngitis, arthralgia, back pain, musculoskeletal chest pain, headache, urticaria, dizziness, gastroenteritis, face edema, fatigue, and conjunctivitis.

Pediatric Patients less than 12 Years of Age

The safety of Alvesco Aerosol in pediatric patients 4 to 11 years of age was evaluated in two studies in which Alvesco Aerosol 40 mcg, 80 mcg, and 160 mcg was administered once daily for 12 weeks and in one study in pediatric patients 2 to 6 years of age in which Alvesco Aerosol 40 mcg, 80 mcg, and 160 mcg was administered once daily for 24 weeks. Studies have not been conducted in patients less than 2 years of age.

Long-Term Clinical Trials Experience

A total of 197 patients 12 years of age and older (82 males and 115 females) from one of the 12-week treatment placebo-controlled studies were re-randomized to Alvesco Aerosol 320 mcg twice daily and followed for one year. The safety profile from the one-year follow up was similar to that seen in the 12- and 16-week treatment studies. Long term safety information for pediatric patients 4 to 11 years of age is obtained from three open label one year safety studies.

Post-marketing Experience

In addition to adverse reactions identified from clinical trials, the following adverse reactions have been identified during worldwide post-marketing use of Alvesco Aerosol oral inhalation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue and pharynx.