Wixela Inhub (Page 4 of 20)

5.15 Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of ICS, including fluticasone propionate, a component of Wixela Inhub®. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Wixela Inhub® long term.

Effects of treatment with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, fluticasone propionate 500 mcg, salmeterol 50 mcg, or placebo on development of cataracts or glaucoma was evaluated in a subset of 658 subjects with COPD in the 3-year survival trial. Ophthalmic examinations were conducted at baseline and at 48, 108, and 158 weeks. Conclusions about cataracts cannot be drawn from this trial because the high incidence of cataracts at baseline (61% to 71%) resulted in an inadequate number of subjects treated with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg who were eligible and available for evaluation of cataracts at the end of the trial (n = 53). The incidence of newly diagnosed glaucoma was 2% with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, 5% with fluticasone propionate, 0% with salmeterol, and 2% with placebo.

5.16 Eosinophilic Conditions and Churg-Strauss Syndrome

In rare cases, patients on inhaled fluticasone propionate, a component of Wixela Inhub® , may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established.

5.17 Coexisting Conditions

Wixela Inhub® , like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2 -adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.18 Hypokalemia and Hyperglycemia

Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical trials with fluticasone propionate and salmeterol inhalation powder at recommended doses.

6 ADVERSE REACTIONS

Use of LABA may result in the following:

Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)]
Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12)]

Systemic and local corticosteroid use may result in the following:

Candida albicans infection [see Warnings and Precautions (5.4)]
Pneumonia in patients with COPD [see Warnings and Precautions (5.5)]
Immunosuppression [see Warnings and Precautions (5.6)]
Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8)]
Reduction in bone mineral density [see Warnings and Precautions (5.13)]
Growth effects [see Warnings and Precautions (5.14)]
Glaucoma and cataracts [see Warnings and Precautions (5.15)]

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

6.1 Clinical Trials Experience in Asthma

Adult and Adolescent Subjects Aged 12 Years and Older

The incidence of adverse reactions associated with fluticasone propionate and salmeterol inhalation powder in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 2). A total of 705 adult and adolescent subjects (349 females and 356 males) previously treated with salmeterol or ICS were treated twice daily with fluticasone propionate and salmeterol inhalation powder (100 mcg/50 mcg or 250 mcg/50 mcg doses), fluticasone propionate inhalation powder (100 or 250 mcg doses), salmeterol inhalation powder 50 mcg, or placebo. The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group.

Table 2. Adverse Reactions with Fluticasone Propionate and Salmeterol Inhalation Powder with ≥ 3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma

Adverse Event

Fluticasone Propionate and Salmeterol Inhalation Powder

100 mcg/50 mcg

(n = 92)

%

Fluticasone Propionate and Salmeterol Inhalation Powder

250 mcg/50 mcg

(n = 84)

%

Fluticasone Propionate 100 mcg

(n = 90)

%

Fluticasone Propionate 250 mcg

(n = 84)

%

Salmeterol 50 mcg

(n = 180)

%

Placebo

(n = 175)

%

Ear, nose, and throat

Upper respiratory tract infection

27

21

29

25

19

14

Pharyngitis

13

10

7

12

8

6

Upper respiratory inflammation

7

6

7

8

8

5

Sinusitis

4

5

6

1

3

4

Hoarseness/dysphonia

5

2

2

4

< 1

< 1

Oral candidiasis

1

4

2

2

0

0

Lower respiratory

Viral respiratory infections

4

4

4

10

6

3

Bronchitis

2

8

1

2

2

2

Cough

3

6

0

0

3

2

Neurology

Headaches

12

13

14

8

10

7

Gastrointestinal

Nausea and vomiting

4

6

3

4

1

1

Gastrointestinal discomfort and pain

4

1

0

2

1

1

Diarrhea

4

2

2

2

1

1

Viral gastrointestinal infections

3

0

3

1

2

2

Non-site specific

Candidiasis unspecified

site

3

0

1

4

0

1

Musculoskeletal

Musculoskeletal pain

4

2

1

5

3

3

The types of adverse reactions and events reported in Trial 3, a 28-week non-U.S. clinical trial in 503 subjects previously treated with ICS who were treated twice daily with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, fluticasone propionate inhalation powder 500 mcg and salmeterol inhalation powder 50 mcg used concurrently, or fluticasone propionate inhalation powder 500 mcg, were similar to those reported in Table 2.

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