Aerospan

Name: Aerospan

Aerospan Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • fever, swollen gums, mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough; or
  • worsening asthma symptoms.

Common side effects may include:

  • indigestion;
  • runny or stuffy nose;
  • nosebleed; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aerospan Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Flunisolide inhalation will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don't work as well.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using flunisolide inhalation. Do not swallow.

Use flunisolide inhalation regularly to get the most benefit. Asthma is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication.

It may take up to 2 or more weeks before your symptoms improve. For best result, keep using the medicine as directed.

Call your doctor if your symptoms do not improve after 4 weeks of treatment.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

If you switched to flunisolide inhalation from an oral (taken by mouth) steroid, you may need to restart the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

Store at room temperature away from moisture and heat.

Do not try to clean or take apart the inhaler device. Do not float the medicine canister in water. Get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill.

Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of flunisolide inhalation is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before using Aerospan (flunisolide inhalation)?

You should not use flunisolide if you are allergic to it.

To make sure flunisolide inhalation is safe for you, tell your doctor if you have ever had:

  • tuberculosis or any other infection or illness;

  • herpes simplex infection of your eyes; or

  • glaucoma or cataracts.

Flunisolide can worsen an infection you already have, or reactivate an infection you recently had.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flunisolide inhalation passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Advice to Patients

  • Provide a copy of the manufacturer's patient information each time the drug is dispensed.105 Importance of instructing patients to read the patient information prior to initiation of therapy and each time the prescription is refilled.105

  • Importance of adequate understanding of proper storage, preparation, and administration techniques, including use of the oral aerosol inhaler.105

  • Importance of pediatric patients receiving therapy under adult supervision.105

  • Risk of localized fungal infections of the mouth and pharynx.105 Importance of rinsing the mouth after oral inhalation.105 Importance of informing clinician if mouth becomes sore or develops a rash.105

  • Importance of advising patients that flunisolide oral inhalation must be used at regular intervals to be therapeutically effective.105

  • Importance of advising patients that 2–4 weeks of continuous therapy may be required for optimum effects to be achieved.105

  • Importance of not exceeding the recommended dosage and of contacting clinician immediately if asthma symptoms worsen or fail to improve.105

  • Importance of not discontinuing therapy or changing dosage without consulting clinician.105

  • Importance of advising patients not to use orally inhaled flunisolide as a bronchodilator and that the drug is not indicated for relief of acute bronchospasm.105

  • Importance of gradual withdrawal from systemic corticosteroids during transfer to orally inhaled flunisolide and of monitoring by clinician during such transfer of therapy.105

  • Advise patients being transferred from systemic to orally inhaled corticosteroids to carry special identification (e.g., card) indicating the need for supplementary systemic corticosteroids during stressful periods.105

  • Advise patients receiving orally inhaled flunisolide therapy who are currently being withdrawn from systemic corticosteroids to immediately resume therapy with systemic corticosteroids and to contact clinician for further instructions during stressful periods.105

  • Risk of systemic corticosteroid effects (e.g., hypercorticism, potentially life-threatening adrenal suppression).105

  • Importance of informing patients of potential for decreased BMD.105

  • Risk of reduction in growth velocity in children.105

  • Increased risk for development of cataracts or glaucoma with long-term use of inhaled corticosteroids.105 Advise patients to consider the need for regular eye examinations.105

  • Importance of immunosuppressed patients avoiding exposure to chickenpox or measles, and if exposed, of immediately consulting clinician.105

  • Importance of advising immunosuppressed patients of potential worsening of existing tuberculosis; fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.105

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.105

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.105

  • Importance of informing patients of other precautionary information.105 (See Cautions.)

Uses For Aerospan

Flunisolide is used to help control symptoms of asthma and improve lung function. This medicine will not relieve an asthma attack that has already started.

Flunisolide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

This medicine is available only with your doctor's prescription.

Proper Use of flunisolide

This section provides information on the proper use of a number of products that contain flunisolide. It may not be specific to Aerospan. Please read with care.

This medicine is used with a special inhaler and comes with patient information leaflet. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for more than 2 weeks, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face.

How to use this medicine:

  • The inhaler contains a built-in spacer. Do not separate the purple actuator from the gray spacer. Do not use this medicine with other spacer or holding chamber devices.
  • Open and position the inhaler by pulling the built-in purple actuator out from the gray spacer and snap into an "L" shape before using it.
  • The first time you use the inhaler, or if you have not used the inhaler for 2 weeks or longer, prime the inhaler before use by shaking it well and then releasing a test spray away from your eyes and face. Press down on the metal canister two times for one second each in order to release 2 test sprays into the air.
  • To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright. Do not block the mouthpiece with your teeth or tongue.
  • While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
  • After 10 seconds, breathe out and breathe normally.
  • If your doctor has prescribed 2 or more sprays at each use, wait for 20 seconds, and follow exactly the same steps you used for the first puff.
  • Snap the purple actuator back to the straight position and gently push it back into the gray spacer.
  • Gargle and rinse your mouth with water after each dose. You may also want to brush your teeth.

Each inhaler comes with a Check-Off chart to track the number of puffs you have used. Mark off or check through each of your doses. Before you reach the last number of sprays, call your doctor to find out if you need a refill. You must discard the inhaler, actuator, and spacer after 60 sprays even if the canister is not empty. Do not place the canister under water to find out the amount of medicine still left in the canister.

If you are also taking oral corticosteroids (e.g., prednisone) together with this medicine, you doctor may want to adjust your dose of prednisone. Ask your doctor first before changing your dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For inhalation dosage form (aerosol):
    • For preventing an asthma attack:
      • Adults and children 12 years of age and older—At first, 2 puffs two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 puffs two times a day. Each puff contains 80 micrograms (mcg) of flunisolide.
      • Children 6 to 11 years of age—At first, 1 puff two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2 puffs two times a day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Aerospan

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 to 4 weeks or if they become worse, call your doctor.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

Do not change your doses or stop using this medicine without asking first your doctor.

Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem.

Check with your doctor right away if you or your child have blurred vision, difficulty with reading, or any other change in vision while using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are have a cough, difficulty with breathing, shortness of breath, or wheezing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

How do I store and/or throw out Aerospan?

  • Store at room temperature. Do not freeze.
  • Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection [see Warnings and Precautions (5.1)] • Immunosuppression, increased risk of infections [see Warnings and Precautions (5.3)] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5)] • Reduction in bone mineral density [see Warnings and Precautions (5.6)] • Effects on growth [see Warnings and Precautions (5.7)] • Glaucoma, increased intraocular pressure and cataracts [see Warnings and Precautions (5.8)] • Bronchospasm [see Warnings and Precautions (5.9)]

Clinical Trials Experience

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.

Table 1 shows the adverse reactions that were reported in patients previously receiving bronchodilators and/or orally inhaled corticosteroids in two double-blind, placebo- controlled US clinical trials, in which 519 adult and pediatric patients age 4-78 years (279 males and 240 females) were treated with the Aerospan (80 mcg to 320 mcg twice daily for 12 weeks) or placebo. The mean duration of exposure was 76.7, 78.2, 80.5, and 69.4 days for Aerospan 80 mcg, 160 mcg, 320 mcg, and placebo, all dosed twice daily, respectively. The table includes all reactions that occurred at a rate of >3% in any Aerospan Inhalation Aerosol group. In considering these data, the increased average duration of exposure for Aerospan patients should be taken into account, compared with placebo-treated patients.

Table 1. Adverse Reactions with >3% incidence reported in controlled clinical studies with Aerospan (% of patients)

ADVERSE REACTION

PLACEBO
(n = 220)

Aerospan Inhalation Aerosol

80 MCG
(n = 189)

160 MCG
(n = 217)

320 MCG
(n = 113)

BODY AS A WHOLE

    Headache

12.7

9.0

13.8

8.8

    Allergic Reaction

2.3

4.2

4.6

4.4

    Infection, Bacterial

0.9

3.7

0.9

0.9

DIGESTIVE SYSTEM

    Vomiting

4.1

4.2

4.6

0.0

    Dyspepsia

1.4

2.1

3.2

3.5

RESPIRATORY SYSTEM

    Pharyngitis

13.2

17.5

16.6

16.8

    Rhinitis

10.0

9.0

15.7

3.5

    Cough Increased

7.7

8.5

5.5

1.8

    Sinusitis

5.5

7.4

4.1

8.8

    Epistaxis

0.9

3.2

0.9

0.0

UROGENITAL SYSTEM

    Urinary Tract Infection

0.5

1.1

0.9

3.5

The following other adverse reactions occurred in patients in these clinical trials using Aerospan with an incidence of 1 to 3% and were more common in Aerospan than in the placebo group.

Body As A Whole: abdominal pain, chest pain, infection, neck pain
Digestive System: diarrhea, gastroenteritis, nausea, oral moniliasis
Metabolic And Nutritional Disorders: edema
Musculoskeletal System: myalgia
Nervous System: dizziness, insomnia, migraine
Respiratory System: bronchitis, laryngitis, voice alteration
Skin And Appendages: erythema multiforme
Special Senses: conjunctivitis, ear pain, taste perversion
Urogenital System: dysmenorrhea, vaginitis

Long-Term Clinical Trials

Two 52-week open label safety trials of Aerospan were conducted in 162 asthma patients 12 to 60 years of age and in 152 asthma patients 4 to 11 years of age. The adverse reaction profile exhibited in these trials was similar to that seen in the two 12-week studies.

Adverse Reactions from Other Sources

The following additional adverse reactions were derived from clinical trials conducted with flunisolide CFC inhalation aerosol with a frequency of ≥1% and not described above:

Body as a Whole: flu, decreased appetite, chills, increased appetite, weight gain, malaise, peripheral edema, sweating, weakness
Gastrointestinal System: upset stomach, heartburn, constipation, gas, abdominal fullness
Cardiovascular System: palpitations, hypertension, tachycardia
Nervous System: headache, irritability, shakiness, anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity, moodiness, numbness, vertigo
Respiratory System: cold symptoms, nasal congestion, upper respiratory tract infection, chest congestion, hoarseness, runny nose, sinus congestion, sinus drainage, sinus infection, sneezing, sputum, wheezing, chest tightness, bronchospasm, dyspnea, head stuffiness, nasal irritation, pleurisy, pneumonia, sinus discomfort
Skin and Appendages: eczema, pruritus, acne, urticaria
Special Senses: loss of smell, loss of taste, ear infection, blurred vision, eye discomfort, eye infection
Hemic and Lymph: capillary fragility, enlarged lymph nodes
Mouth and Throat: sore throat, dry throat, glossitis, mouth irritation, phlegm, throat irritation

Clinical Studies

The efficacy of Aerospan has been studied in two double-blind, parallel, placebo-and active-controlled clinical trials of 12 weeks duration involving more than 1250 patients, one in adults and adolescents 12 years of age and older, and one in patients 4-11 years of age. In adults and adolescents, efficacy was evaluated in patients previously treated with inhaled corticosteroids. In children 6 to 11 years of age, efficacy was evaluated in patients previously treated with bronchodilators alone or inhaled corticosteroids. Both trials had a 2- week run-in period followed by a 12-week randomized treatment period. During the run-in period all patients received flunisolide CFC inhalation aerosol 500 mcg twice daily. Patients were then randomized to double-blind treatment with different doses of Aerospan or flunisolide CFC inhalation aerosol and monitored for lung function changes to see if they maintained, improved, or lost stability. Baseline was assessed at the end of the run-in period. The primary endpoint was the change from baseline in percent predicted FEV1 after 12 weeks treatment.

Adult and Adolescent Patients 12 Years of Age and Older

Efficacy was evaluated in 669 asthma patients, 12 to 78 years of age, including 88 patients 12-17 years of age and 581 patients 18 years and older. Mean FEV1 at screening was 2.44 L and mean FEV1 at baseline was 2.72 L following the 2-week run-in period. Patients were randomized to Aerospan 80 mcg, 160 mcg or 320 mcg twice daily, flunisolide CFC inhalation aerosol 250 mcg, 500 mcg, or 1000 mcg twice daily, or placebo. Change from baseline in percent predicted FEV1 over 12 weeks treatment demonstrated that placebo patients deteriorated 4.3% from baseline after 12 weeks of treatment, whereas patients treated with Aerospan 160 mcg or 320 mcg twice daily maintained FEV1 over the course of the study. Results for the comparison to placebo were statistically significant for the 160 and 320 mcg twice daily Aerospan doses (see Figure 1), but not for the 80 mcg dose. Secondary endpoints of AM peak expiratory flow rate, AM and PM asthma symptoms, nocturnal awakenings requiring a β2 agonist, and as needed use of inhaled β2 agonists showed differences from baseline favoring Aerospan over placebo. Aerospan and flunisolide CFC inhalation aerosol gave comparable results.

Figure 1

 

Pediatric Patients 4 to 11 Years of Age

The trial enrolled 583 asthma patients, 4 to 11 years of age, although the primary efficacy parameter was evaluated only in the population of 513 patients 6 to 11 years of age. In these patients, the mean FEV1 at screening was 81.2% predicted, and the mean FEV1 at baseline following a two week run-in period was 87.5% predicted. Patients were randomized to Aerospan 80 mcg or 160 mcg twice daily, flunisolide CFC inhalation aerosol 250 mcg or 500 mcg twice daily, or placebo. Change from baseline in percent predicted FEV1 over 12 weeks in patients 6 years of age and older demonstrated that placebo patients deteriorated 4.0% from baseline after 12 weeks of treatment, whereas patients treated with Aerospan 80 mcg or 160 mcg twice daily maintained FEV1 over the course of the study. Results for the comparison to placebo were statistically significant for the 80 mcg and 160 mcg doses of Aerospan, but there was no added benefit for the 160 mcg BID dose over the 80 mcg BID dose (see Figure 2). Aerospan and flunisolide CFC inhalation aerosol gave comparable results in patients 6 years of age and older.

Figure 2

Geriatric

Although appropriate studies on the relationship of age to the effects of inhaled flunisolide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving inhaled flunisolide.

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