Wixela Inhub

Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder) side effects drug center

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CONSUMER

SIDE EFFECTS

• Overview
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Wixela Inhub Side Effects Center
What Is Wixela Inhub?
Wixela Inhub (fluticasone propionate and salmeterol inhalation powder) contains a combination of a corticosteroid and a long-acting beta-adrenergic agonist (LABA) indicated for twice-daily treatment of asthma in patients aged 4 years and older or maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Wixela Inhub is available in generic form.
What Are Side Effects of Wixela Inhub?
Common side effects of Wixela Inhub include:
• upper respiratory tract infection or inflammation,
• sore throat,
• hoarseness,
• oral thrush,
• bronchitis,
• cough,
• headaches,
• nausea and vomiting,
• pneumonia,
• viral respiratory infections, and
• musculoskeletal pain
Dosage for Wixela Inhub?
The dose of Wixela Inhub for treatment of asthma in patients aged 12 years and older is 1 inhalation of Wixela Inhub 100/50, Wixela Inhub 250/50, or Wixela Inhub 500/50 twice daily. The dose of Wixela Inhub for treatment of asthma in patients aged 4 to 11 years is 1 inhalation of Wixela Inhub 100/50 twice daily. The dose of Wixela Inhub for maintenance treatment of COPD is 1 inhalation of Wixela Inhub 250/50 twice daily.
What Drugs, Substances, or Supplements Interact with Wixela Inhub?
Wixela Inhub may interact with additional medicines containing a LABA, ritonavir, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, and diuretics. Tell your doctor all medications and supplements you use.
Wixela Inhub During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Wixela Inhub; it is unknown how it would affect a fetus. It is unknown if Wixela Inhub passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Wixela Inhub (fluticasone propionate and salmeterol inhalation powder), for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
 
Wixela Inhub Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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;
• fever, chills, cough with mucus, feeling short of breath;
• chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
• tremors, nervousness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--worsening tiredness or weakness, feeling light-headed, nausea, vomiting.
Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
Common side effects may include:
• headache, muscle pain, bone pain, back pain;
• nausea, vomiting;
• thrush, throat irritation;
• ongoing cough, hoarseness or deepened voice;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• ear infection (in a child)--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.
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.
Read the entire detailed patient monograph for Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder)
 
Wixela Inhub Professional Information
SIDE EFFECTS
Use of LABA may result in the following:
• Serious asthma-related events - hospitalizations, intubations, death [see WARNINGS AND PRECAUTIONS]
• Cardiovascular and central nervous system effects [see WARNINGS AND PRECAUTIONS]
• Systemic and local corticosteroid use may result in the following:
• Candida albicans infection [see WARNINGS AND PRECAUTIONS]
• Pneumonia in patients with COPD [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
• Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
• Growth effects [see WARNINGS AND PRECAUTIONS]
• Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]
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.
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.
Additional Adverse Reactions
Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with fluticasone propionate and salmeterol inhalation powder compared with subjects treated with placebo include the following: lymphatic signs and symptoms; muscle injuries; fractures; wounds and lacerations; contusions and hematomas; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; keratitis and conjunctivitis; dental discomfort and pain; gastrointestinal signs and symptoms; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; pneumonia; muscle stiffness, tightness, and rigidity; bone and cartilage disorders; sleep disorders; compressed nerve syndromes; viral infections; pain; chest symptoms; fluid retention; bacterial infections; unusual taste; viral skin infections; skin flakiness and acquired ichthyosis; disorders of sweat and sebum.
Pediatric Subjects Aged 4 To 11 Years
The safety data for pediatric subjects aged 4 to 11 years is based upon 1 U.S. trial of 12 weeks' treatment duration. A total of 203 subjects (74 females and 129 males) who were receiving ICS at trial entry were randomized to either fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg or fluticasone propionate inhalation powder 100 mcg twice daily. Common adverse reactions (≥ 3% and greater than placebo) seen in the pediatric subjects but not reported in the adult and adolescent clinical trials include: throat irritation and ear, nose, and throat infections.
Laboratory Test Abnormalities
Elevation of hepatic enzymes was reported in ≥ 1% of subjects in clinical trials. The elevations were transient and did not lead to discontinuation from the trials. In addition, there were no clinically relevant changes noted in glucose or potassium.
Clinical Trials Experience In Chronic Obstructive Pulmonary Disease
Short-Term (6 Months to 1 Year) Trials
The short-term safety data are based on exposure to fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily in one 6-month and two 1-year clinical trials. In the 6-month trial, a total of 723 adult subjects (266 females and 457 males) were treated twice daily with fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, fluticasone propionate inhalation powder 250 mcg, salmeterol inhalation powder, or placebo. The mean age of the subjects was 64, and the majority (93%) was Caucasian. In this trial, 70% of the subjects treated with fluticasone propionate and salmeterol inhalation powder reported an adverse reaction compared with 64% on placebo. The average duration of exposure to fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg was 141.3 days compared with 131.6 days for placebo. The incidence of adverse reactions in the 6-month trial is shown in Table 3.
Table 3: Overall Adverse Reactions with Fluticas one Propionate and Salmeterol Inhalation Powder 250 mcg/50 mcg with ≥ 3% Incidence in Subjects with Chronic Obstructive Pulmonary Disease Associated with Chronic Bronchitis

Adverse Event	Fluticasone Propionate and Salmeterol Inhalation Powder 250 mcg /50 mcg (n = 178) %	Fluticasone Propionate 250 mcg (n = 183) %	Salmeterol 50 mcg (n = 177) %	Placebo (n = 185) %
Ear, nose, and throat
Candidiasis mouth/throat	10	6	3	1
Throat irritation	8	5	4	7
Hoarseness/dysphonia	5	3	< 1	0
Sinusitis	3	8	5	3
Lower respiratory
Viral respiratory infections	6	4	3	3
Neurology
Headaches	16	11	10	12
Dizziness	4	< 1	3	2
Non-site specific
Fever	4	3	0	3
Malaise and fatigue	3	2	2	3
Musculoskeletal
Musculoskeletal pain	9	8	12	9
Muscle cramps and spasms	3	3	1	1
In the two 1-year trials, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg was compared with salmeterol in 1,579 subjects (863 males and 716 females). The mean age of the subjects was 65 years, and the majority (94%) was Caucasian. To be enrolled, all of the subjects had to have had a COPD exacerbation in the previous 12 months. In this trial, 88% of the subjects treated with fluticasone propionate and salmeterol inhalation powder and 86% of the subjects treated with salmeterol reported an adverse event. The most common events that occurred with a frequency of > 5% and more frequently in the subjects treated with fluticasone propionate and salmeterol inhalation powder were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia. Overall, 55 (7%) of the subjects treated with fluticasone propionate and salmeterol inhalation powder and 25 (3%) of the subjects treated with salmeterol developed pneumonia.
The incidence of pneumonia was higher in subjects older than 65 years, 9% in the subjects treated with fluticasone propionate and salmeterol inhalation powder compared with 4% in the subjects treated with fluticasone propionate and salmeterol inhalation powder younger than 65 years. In the subjects treated with salmeterol, the incidence of pneumonia was the same (3%) in both age groups. [See WARNINGS AND PRECAUTIONS, Use In Specific Populations]
Long-Term (3 Years) Trial
The safety of fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg was evaluated in a randomized, double-blind, placebo-controlled, multicenter, international, 3-year trial in 6,184 adult subjects with COPD (4,684 males and 1,500 females). The mean age of the subjects was 65 years, and the majority (82%) was Caucasian. The distribution of adverse events was similar to that seen in the 1- year trials with fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg. In addition, pneumonia was reported in a significantly increased number of subjects treated with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg and fluticasone propionate 500 mcg (16% and 14%, respectively) compared with subjects treated with salmeterol 50 mcg or placebo (11% and 9%, respectively). When adjusted for time on treatment, the rates of pneumonia were 84 and 88 events per 1,000 treatment-years in the groups treated with fluticasone propionate 500 mcg and with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, compared with 52 events per 1,000 treatment-years in the salmeterol and placebo groups. Similar to what was seen in the 1-year trials with fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, the incidence of pneumonia was higher in subjects older than 65 years (18% with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg versus 10% with placebo) compared with subjects younger than 65 years (14% with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg versus 8% with placebo). [See WARNINGS AND PRECAUTIONS, Use In Specific Populations]
Additional Adverse Reactions
Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with COPD treated with fluticasone propionate and salmeterol inhalation powder compared with subjects treated with placebo include the following: syncope; ear, nose, and throat infections; ear signs and symptoms; laryngitis; nasal congestion/blockage; nasal sinus disorders; pharyngitis/throat infection; hypothyroidism; dry eyes; eye infections; gastrointestinal signs and symptoms; oral lesions; abnormal liver function tests; bacterial infections; edema and swelling; viral infections.
Laboratory Abnormalities
There were no clinically relevant changes in these trials. Specifically, no increased reporting of neutrophilia or changes in glucose or potassium was noted.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of any formulation of fluticasone propionate and salmeterol, fluticasone propionate, and/or salmeterol regardless of indication. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate and salmeterol inhalation powder, fluticasone propionate, and/or salmeterol or a combination of these factors.
Cardiac Disorders: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.
Endocrine Disorders: Cushing's syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism.
Eye Disorders: Glaucoma.
Gastrointestinal Disorders: Abdominal pain, dyspepsia, xerostomia.
Immune System Disorders: Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy.
Infections and Infestations: Esophageal candidiasis.
Metabolic and Nutrition Disorders: Hyperglycemia, weight gain.
Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, cramps, myositis, osteoporosis.
Nervous System Disorders: Paresthesia, restlessness.
Psychiatric Disorders: Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
Reproductive System and Breast Disorders: Dysmenorrhea.
Respiratory, Thoracic, and Mediastinal Disorders: Chest congestion; chest tightness; dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.
Skin and Subcutaneous Tissue Disorders: Ecchymoses, photodermatitis.
Vascular Disorders: Pallor.
Read the entire FDA prescribing information for Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder)
&Copy; Wixela Inhub Patient Information is supplied by Cerner Multum, Inc. and Wixela Inhub Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.