WIXELA INHUB
Clinical safety rating: caution
Comprehensive clinical and safety monograph for WIXELA INHUB (WIXELA INHUB).
Wixela Inhub is an inhaled corticosteroid (fluticasone propionate) and long-acting beta2-adrenergic agonist (salmeterol) combination. Fluticasone propionate reduces inflammation by binding to glucocorticoid receptors, inhibiting pro-inflammatory mediators. Salmeterol stimulates beta2-receptors in bronchial smooth muscle, leading to bronchodilation via activation of adenylate cyclase and increased cAMP.
| Metabolism | Fluticasone propionate is primarily metabolized by CYP3A4. Salmeterol is metabolized by hydroxylation via CYP3A4 and to a lesser extent by CYP2D6, and undergoes extensive first-pass metabolism. |
| Excretion | Primarily renal excretion (70-80%) as unchanged drug; biliary/fecal (20-30%) as parent and metabolites. |
| Half-life | Terminal elimination half-life is 12-15 hours in patients with normal renal function; prolonged (up to 30-50 hours) in renal impairment. |
| Protein binding | Approximately 99% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is 10 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Inhalation: approximately 30-40% systemic bioavailability; oral: less than 5% due to first-pass metabolism. |
| Onset of Action | Inhalation: 15-30 minutes for bronchodilation. |
| Duration of Action | Duration of bronchodilation is 12 hours; clinical effect lasts 12 hours with twice-daily dosing. |
| Molecular Weight | 398.46 |
| Action Class | Corticosteroid/Long-Acting Muscarinic Antagonist/Long-Acting Beta2-Agonist (ICS/LAMA/LABA) Combination |
2 inhalations (total dose 50 mcg indacaterol/110 mcg glycopyrrolate) once daily via oral inhalation.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, use with caution; not recommended due to limited data. |
| Liver impairment | No dose adjustment required for Child-Pugh A or B. Not recommended for Child-Pugh C due to lack of data. |
| Pediatric use | Not indicated for pediatric patients (safety and efficacy not established). |
| Geriatric use | No specific dose adjustment; use with caution due to potential for increased anticholinergic adverse effects and reduced renal function. |
| 1st trimester | No adequate studies in pregnant women; potential teratogenic risk based on animal data. Avoid use unless benefit outweighs risk. |
| 2nd trimester | May be used if clearly needed; monitor fetal growth and amniotic fluid volume. |
| 3rd trimester | May cause fetal harm (e.g., oligohydramnios) and neonatal toxicity near term. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for WIXELA INHUB (WIXELA INHUB).
| Placental transfer | Crosses placenta; fetal exposure confirmed in animal studies and limited human data. |
| Breastfeeding | Excreted in human milk in low amounts; however, potential for serious adverse reactions in nursing infants. Caution advised, consider discontinuing drug or breastfeeding. |
■ FDA Black Box Warning
Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Wixela Inhub is contraindicated in asthma without concomitant use of a long-term asthma control medication. In pediatric and adolescent patients with asthma, LABAs should only be used as additional therapy for those not adequately controlled on other asthma controller medications or whose disease severity warrants initiation of both an inhaled corticosteroid and a LABA.
| Common Effects | Nasopharyngitis, Headache, Upper respiratory tract infection, Cough, Throat irritation, Dysphonia, Oral candidiasis, Musculoskeletal pain, Diarrhea, Nausea |
| Serious Effects | Increased risk of asthma-related death (LABA component), Adrenal insufficiency (with high doses or prolonged use), Pneumonia in patients with COPD, Paradoxical bronchospasm, Hypersensitivity reactions (anaphylaxis, angioedema), Cardiovascular effects (tachycardia, arrhythmias, hypertension), Hypercorticism (Cushing's syndrome) with excessive use, Osteoporosis with long-term use, Glaucoma and cataracts, Urinary retention (anticholinergic effect) |
Hypersensitivity to WIXELA INHUB or any componentSevere hepatic impairment
| Precautions |
Loading safety data…
| Lactation Rating |
| L4 - Possibly Hazardous |
| Teratogenic Risk | Pregnancy Category N; no adequate human studies; animal studies not conducted; first trimester: unknown risk; second and third trimesters: unknown risk; potential for fetal harm based on drug class (prostaglandin analog); contraindicated in pregnancy. |
| Fetal Monitoring | Monitor for uterine hyperstimulation and fetal distress if used inadvertently in pregnancy; no routine monitoring indicated. |
| Fertility Effects | May impair fertility due to prostaglandin-mediated effects on ovulation and implantation; reversible upon discontinuation. |
| Risk of asthma-related death associated with LABAs, Increased risk of pneumonia in patients with COPD, Adrenal insufficiency with corticosteroid use, Systemic corticosteroid withdrawal symptoms, Candidiasis of mouth and pharynx, Paradoxical bronchospasm, Hypersensitivity reactions including anaphylaxis, Cardiovascular effects: increased blood pressure, tachycardia, QT prolongation, Hypokalemia and hyperglycemia with high doses, Decreased bone mineral density with long-term corticosteroid use, Glaucoma and cataracts with corticosteroid use, Growth suppression in pediatric patients, Ketoacidosis in diabetic patients |
| Food/Dietary | No specific food restrictions. Grapefruit juice may increase fluticasone levels via CYP3A4 inhibition; avoid excessive consumption. |
| Clinical Pearls | Wixela Inhub (fluticasone propionate and salmeterol) is a dry powder inhaler for maintenance treatment of asthma or COPD. Not for acute bronchospasm. Rinse mouth after use to prevent oral candidiasis. Monitor for increased pneumonia risk in COPD patients. Do not use with strong CYP3A4 inhibitors like ketoconazole due to increased systemic corticosteroid effects. |
| Patient Advice | Do not use for sudden breathing problems; always have a rescue inhaler (e.g., albuterol) available. · Use exactly as prescribed; do not stop suddenly as it may cause adrenal insufficiency. · Rinse mouth with water without swallowing after each dose to reduce risk of thrush. · Store inhaler in a cool, dry place; do not wash the device or expose to moisture. · If asthma worsens (increased use of rescue inhaler, night-time awakenings), seek medical advice immediately. |