QVAR REDIHALER (Page 2 of 8)

5.4 Immunosuppression and Risk of Infections

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune patients on corticosteroids. In such patients who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection, and nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

5.5 Paradoxical Bronchospasm

Inhaled corticosteroids may produce inhalation‑induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs following dosing with QVAR REDIHALER, it should be treated immediately with an inhaled, short‑acting bronchodilator. Treatment with QVAR REDIHALER should be discontinued and alternate therapy instituted.

5.6 Immediate Hypersensitivity Reactions

Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of QVAR REDIHALER. Discontinue QVAR REDIHALER if such reactions occur [see Contraindications (4)].

5.7 Hypercorticism and Adrenal Suppression

QVAR REDIHALER will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of QVAR REDIHALER in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with QVAR REDIHALER 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 beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of QVAR REDIHALER should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

5.8 Effects on Growth

Orally inhaled corticosteroids, including QVAR REDIHALER, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving QVAR REDIHALER routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including QVAR REDIHALER, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

5.9 Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long‑term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long‑term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

5.10 Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts while using QVAR REDIHALER.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Oropharyngeal candidiasis [see Warnings and Precautions (5.1)]
  • Immunosuppression and risk of infections [see Warnings and Precautions (5.4)]
  • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7)]
  • Reduction in bone mineral density [see Warnings and Precautions (5.9)]
  • Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4)]
  • Glaucoma and cataracts [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

A total of 1858 subjects participated in the QVAR REDIHALER clinical development program. 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 Adolescent Patients 12 years of Age and Older: The adverse reaction information presented in Table 1 is derived from 3 double-blind, placebo-controlled clinical trials in which 1230 patients (751 female and 479 male adults previously treated with as‑needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR REDIHALER (doses of 40, 80, 160, or 320 mcg twice daily) or QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol (QVAR MDI; doses of 160 or 320 mcg twice daily) or placebo. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.

Table 1: Adverse Reactions Experienced by at Least 3% of Adult and Adolescent Patients in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose

Preferred

Term

Number (%) of patients

QVAR REDIHALER

QVAR MDI

Placebo

80 mcg

N=90

160 mcg

N=92

320 mcg

N=214

640 mcg

N=211

320 mcg

N=212

640 mcg

N=107

N=304

Oral Candidiasis

0

2 (2)

7 (3)

15 (7)

6 (3)

9 (8)

1 (<1)

Upper Respiratory Tract Infection

3 (3)

3 (3)

9 (4)

6 (3)

17 (8)

4 (4)

6 (2)

Nasopharyngitis

4 (4)

2 (2)

3 (1)

3 (1)

6 (3)

4 (4)

4 (1)

Oropharyngeal Pain

2 (2)

2 (2)

1 (<1)

3 (1)

6 (3)

4 (4)

2 (<1)

Viral Upper Respiratory Tract Infection

3 (3)

0

1 (<1)

3 (1)

4 (2)

2 (<1)

4 (1)

Sinusitis

3 (3)

0

1 (<1)

2 (<1)

1 (<1)

1 (<1)

2 (<1)

Rhinitis Allergic

0

3 (3)

0

2 (<1)

0

1 (<1)

0

*QVAR MDI=QVAR Inhalation Aerosol

Other adverse reactions that occurred in clinical trials using QVAR REDIHALER with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were back pain, headache, pain, nausea and cough.

Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 concerning QVAR REDIHALER and QVAR MDI is derived from one 12‑week placebo-controlled study in pediatric patients 4 to 11 years of age with persistent asthma.

Table 2: Adverse Reactions Experienced by at Least 3% of Patients 4 to 11 Years of Age in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose

Preferred Term

Number (%) of patients

QVAR REDIHALER

QVAR MDI

Placebo

80 mcg

N=126

160 mcg N=125

80 mcg

N=125

160 mcg

N=125

N=127

Upper Respiratory Tract Infection

3 (2.4)

1 (0.8)

6 (4.8)

5 (4.0)

5 (3.9)

Nasopharyngitis

5 (4.0)

11 (8.8)

6 (4.8)

6 (4.8)

4 (3.1)

Viral Upper Respiratory Tract Infection

5 (4.0)

5 (4.0)

3 (2.4)

1 (0.8)

4 (3.1)

Pharyngitis

4 (3.2)

4 (3.2)

4 (3.2)

4 (3.2)

2 (1.6)

Cough

1 (0.8)

3 (2.4)

9 (7.2)

6 (4.8)

4 (3.1)

Vomiting

2 (1.6)

2 (1.6)

4 (3.2)

0

2 (1.6)

Headache

2 (1.6)

5 (4.0)

0

4 (3.2)

5 (3.9)

Pyrexia

1 (0.8)

4 (3.2)

4 (3.2)

3 (2.4)

3 (2.4)

*QVAR MDI=QVAR Inhalation Aerosol

Other adverse reactions that occurred in clinical trials using QVAR REDIHALER with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were influenza, gastroenteritis viral, ear infection, oral candidiasis, diarrhea, and myalgia.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.