Alvesco

Name: Alvesco

Manufacturer

  • Sunovion Pharmaceuticals Inc.

Alvesco Precautions

Some serious side effects have occurred with Alvesco inhalation include:

  • Fungal infection of the mouth and throat. Be sure to rinse your mouth following each inhalation.
  • Immune system effects may increase your risk of infection. You should avoid being around people with Chicken Pox or Measles. Symptoms of an infection may include:
    • ​fever
    • pain
    • aches
    • chills
    • feeling tired
    • nausea
    • vomiting
  • Slow growth in children. A child taking Alvesco should have his/her growth checked regularly.
  • Eye problems, including glaucoma and cataracts. You should have regular eye exams. Tell your doctor if you notice a change in vision while using Alvesco.
  • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Your healthcare provider will follow you closely if you take steroids by mouth and are having them decreased (tapered) or you are being switched to Alvesco inhalation. People have died while steroids are being decreased and when people have been switched from steroids by mouth to inhaled steroids like Alvesco. If you are under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again. Call your healthcare provider right away if you have the following symptoms of adrenal insufficiency:
    • tiredness
    • weakness
    • dizziness
    • nausea that does not go away
    • vomiting that does not go away
  • Increased wheezing (bronchospasm) can happen right away after using Alvesco inhalation. Stop using Alvesco inhalation and use an inhaled fast-acting bronchodilator (rescue inhaler) right away. Tell your healthcare provider right away so that a new medicine can be prescribed to control your asthma.
  • Decreased bone mass (bone mineral density). People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength. Talk to your healthcare provider about any concerns you may have about bone health.

Inform MD

Before using Alvesco, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Alvesco or any other medication
  • have or have ever had:
    • tuberculosis
    • cataracts
    • glaucoma
    • untreated infection
    • herpes infection
  • are pregnant or plan to become pregnant
  • are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Introduction

Synthetic, non-halogenated glucocorticoid.1 3 4 7 9 10 12

Uses for Alvesco

Asthma

Long-term prevention of bronchospasm in patients with asthma.1

In corticosteroid-dependent patients, may permit a reduction in dosage or discontinuance of systemic corticosteroids.1 2

Not indicated for management of acute bronchospasm.1 6

Interactions for Alvesco

Inhibitory potential of ciclesonide on CYP isoenzymes not evaluated; however des-ciclesonide (active metabolite) does not inhibit or induce the metabolism of other drugs metabolized by CYP isoenzymes in vitro.1

Ciclesonide and des-ciclesonide do not induce CYP isoenzymes in vitro.1

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma des-ciclesonide concentrations).1

Protein-bound Drugs

Pharmacokinetic interaction unlikely.1

Specific Drugs

Drug

Interaction

Comments

Albuterol

Pharmacokinetic interaction with des-ciclesonide not observed1

Erythromycin

Pharmacokinetic interaction not observed1

Formoterol

Pharmacokinetic interaction with des-ciclesonide not observed1

Ketoconazole

Increased plasma des-ciclesonide concentrations; however, plasma ciclesonide concentrations unchanged1 11

Use concomitantly with caution; no specific dosage recommendations at this time12

Salicylic acid

Pharmacokinetic interactions unlikely1

Plasma protein binding of des-ciclesonide not altered by salicylic acid in vitro 1 8

Warfarin

Pharmacokinetic interactions unlikely1

Plasma protein binding of des-ciclesonide not altered by warfarin in vitro1

Commonly used brand name(s)

In the U.S.

  • Alvesco

Available Dosage Forms:

  • Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Before Using Alvesco

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ciclesonide in children below 12 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ciclesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving ciclesonide .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bemiparin
  • Nadroparin
  • Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute—Should not be used in patients with this condition .
  • Cataracts, history of or
  • Glaucoma, history of—May make these conditions worse. Regular eye examinations are suggested .
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections, active or untreated (fungus, bacteria, virus, or parasite) or
  • Measles (including recent exposure) or
  • Tuberculosis, active or history of—This medicine can reduce the body's ability to fight these infections .
  • Gastroenteritis (inflamed stomach or intestine with diarrhea or vomiting) or
  • Stress or
  • Surgery or
  • Trauma—Oral steroids may be needed .
  • Osteoporosis (bone disease)—High doses may make this condition worse .

What do I need to tell my doctor BEFORE I take Alvesco?

  • If you have an allergy to ciclesonide or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with Alvesco.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Alvesco or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Alvesco. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Adverse Reactions

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see Warnings and Precautions (5.1)]
  • Immunosuppression [see Warnings and Precautions (5.3)]
  • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5)]
  • Growth effects [see Warnings and Precautions (5.7)]
  • Glaucoma and cataracts [see Warnings and Precautions (5.8)]

Clinical Trial Experience

The safety data described below for adults and adolescents 12 years of age and older reflect exposure to Alvesco 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. 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 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 [see Pediatric Use (8.4)].

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.

Adults and Adolescents 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 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 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 that occurred at an incidence of ≥ 3% in any of the Alvesco groups and which were more frequent with Alvesco compared to placebo.

Table 1: Adverse Reactions with ≥ 3% Incidence Reported in Patients ≥ 12 Years of Age with Alvesco in US Placebo-Controlled Clinical Trials in Patients Previously on Bronchodilators and/or Inhaled Corticosteroids
Adverse Reaction
Placebo
(N=507)
%
Alvesco
80 mcg BID
(N=325)
%
160 mcg BID
(N=127)
%
320 mcg BID
(N=172)
%
Headache 7.3 4.9 11.0 8.7
Nasopharyngitis 7.5 10.5 8.7 7.0
Sinusitis 3.0 3.1 5.5 5.2
Pharyngolaryngeal pain 4.3 4.3 2.4 4.7
Upper respiratory Inf. 6.5 7.1 8.7 4.1
Arthralgia 1.0 0.9 2.4 3.5
Nasal congestion 1.6 1.8 5.5 2.9
Pain in extremity 1.0 0.3 3.1 2.3
Back pain 2.0 0.6 3.1 1.2

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

Infections and Infestations: Oral candidiasis

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 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-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 in pediatric patients 4 to 11 years of age was evaluated in two studies in which Alvesco 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 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 [see Pediatric Use (8.4)].

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 ciclesonide 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 [see Pediatric Use (8.4)].

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 ciclesonide 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.

Ciclesonide Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control in pregnant women. -Infants exposed to corticosteroids in utero should be observed for signs and symptoms of hypoadrenalism.

(web3)