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Budesonide has an established safety profile1

Adverse reactions occurring at an incidence of ≥1% and more common than placebo in the PULMICORT FLEXHALER group (pooled data from two 12-week, double-blind, placebo-controlled clinical trials in asthma patients ≥6 years of age)*1

*In non-placebo-controlled long-term studies in children (at doses up to 360 mcg daily) and adolescent and adult subjects (at doses up to 720 mcg daily) treated for up to 1 year with PULMICORT FLEXHALER, a similar pattern and incidence of adverse reactions were revealed.

PULMICORT FLEXHALER® (budesonide inhalation powder, 90 mcg & 180 mcg)
contains budesonide – the only ICS for the treatment of asthma with a
Pregnancy Category B rating

PULMICORT FLEXHALER contains budesonide, the ONLY ICS with a Pregnancy Category B rating.

Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed.

Animal reproduction studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. Nevertheless, because the studies in humans cannot rule out the possibility of harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed.1,2

Inhaled corticosteroid

HPA*-axis function in adult and pediatric patients taking budesonide over 52 weeks2,3

VIEW STUDY DESIGN

  • Since budesonide is absorbed into the circulation and can be systemically active, the beneficial effects of PULMICORT FLEXHALER in minimizing HPA-axis dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose
  • Since individual sensitivity to effects on cortisol production varies, physicians should consider this information when prescribing PULMICORT FLEXHALER
  • Because of the possibility of systemic absorption of ICSs, patients treated with PULMICORT FLEXHALER should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response
  • It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of PULMICORT FLEXHALER should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms

STUDY DESIGN

A 52-week efficacy and safety study in adult and pediatric patients with mild to severe asthma

A 52-week, multicenter, open-label extension trial of 1133 patients (aged 6 to 70 years) with mild to severe asthma who received budesonide via a different DPI (dose range: 200 mcg/day to 1600 mcg/day). Patients included adults (n=249) who did not receive corticosteroids, adults (n=384) and children (n=356) previously maintained on ICSs, and adults (n=144) previously maintained on oral corticosteroids.The primary efficacy endpoint was mean change from baseline in percent predicted FEV1.2

Growth in patients taking budesonide and placebo over 4 years1,2

*Administered twice daily

VIEW STUDY DESIGN

Children treated with inhaled budesonide had a 1.1-cm reduction in growth compared with those receiving placebo.1,2

The difference between these treatment groups did not increase further.1,2

Similar growth velocities between the 2 treatment groups.1,2

  • Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study
  • Controlled clinical trials have shown that orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity in pediatric patients. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown
  • The growth of pediatric patients receiving orally inhaled corticosteroids, including PULMICORT FLEXHALER, should be monitored routinely, and the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks and benefits associated with alternative therapies. Each patient should be titrated to his or her lowest effective dose

STUDY DESIGN

Childhood Asthma Management Program (CAMP) study in pediatric patients with mild to moderate asthma

A double-blind, multicenter trial of 1041 patients (aged 5 to 12 years) with mild to moderate asthma randomized to receive budesonide via a different DPI 200 mcg BID (n=311), a mast-cell stabilizer (n=312), or placebo (n=418) over a 4- to 6-year period. The primary efficacy endpoint of mean change in percent predicted FEV1 after administration of a bronchodilator was not met. Physical growth was a secondary endpoint.2 Note: Recommended starting dosage of PULMICORT FLEXHALER for pediatric patients aged 6 to 17 years is 180 mcg, BID.1

References:

1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.

2. US Food and Drug Administration. CFR-Code of Federal Regulations Title 21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57. Accessed September 16, 2015.

References:

1.   PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.

2. Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40(3):225-236.

3.   Data on File, 268208, AZPLP.

References:

1.  PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.

2. Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000;343(15):1054-1063.

IMPORTANT SAFETY INFORMATION AND INDICATION

  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.
  • Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT FLEXHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses.
  • Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.
  • Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide.
  • PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur.
  • Adverse reactions that occurred at a rate of ≥ 1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis.

INDICATION

  • PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Please click here for full Prescribing Information for PULMICORT FLEXHALER.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.