Spiolto Respimat Adverse Reactions

The clinical development program of SPIOLTO RESPIMAT encompassed more than 19000 patients with COPD, of which more than 5900 COPD patients received a dose of 5 microgram tiotropium and 5 microgram olodaterol.
Side effects of SPIOLTO RESPIMAT were primarily identified from data obtained in 2 active-controlled, parallel-group, long-term treatment (52 weeks) clinical trials in COPD patients comparing SPIOLTO RESPIMAT with tiotropium and olodaterol. Additionally, a third active-controlled, parallel-group, long-term treatment (52 weeks) clinical trial in COPD patients comparing SPIOLTO RESPIMAT with tiotropium was conducted (Trial 9).
In the two pivotal trials (Trials 1 and 2) the overall incidence of AEs in patients treated with SPIOLTO RESPIMAT was comparable to patients treated with the mono compound olodaterol at a dose of 5 microgram (74% and 76.6% respectively). In the pooled analysis of all three long-term clinical trials (Trial 1, 2 and Trial 9) the overall incidence of AEs in patients treated with SPIOLTO RESPIMAT was comparable to patients treated with the mono components tiotropium at a dose of 5 microgram (74.1% and 74.3% respectively). All undesirable effects previously reported with one of the individual components are considered undesirable effects with SPIOLTO RESPIMAT and are included in the adverse reactions listed below. In Trial 9, no new side effects were identified contributing more than 3900 COPD patients treated with SPIOLTO RESPIMAT; furthermore the safety profile was consistent with that documented in the pivotal trials.
In addition undesirable effects reported with SPIOLTO RESPIMAT, but not with the individual components are included: Infections and infestations: Nasopharyngitis.
Metabolism and nutrition disorders: Dehydration.
Nervous system disorders: Dizziness, insomnia.
Eye disorders: Glaucoma, intraocular pressure increased, vision blurred.
Cardiac disorders: Atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia.
Vascular disorders: Hypertension.
Respiratory, thoracic and mediastinal disorders: Cough, epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis.
Gastrointestinal disorders: Dry mouth, usually mild, constipation, oropharyngaeal candidiasis, dysphagia, gastrooesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction incl. ileus paralytic.
Skin and subcutaneous disorders: Rash, pruritus, angioneurotic oedema, urticaria, skin infection and skin ulcer, dry skin, hypersensitivity (including immediate reactions).
Musculoskeletal and connective tissue disorders: Arthralgia, joint swelling, back pain¹.
Renal and urinary disorders: Urinary retention (usually in men with predisposing factors), dysuria, urinary tract infection.
¹Undesirable effects reported with SPIOLTO RESPIMAT, but not with the individual components.
Many of the listed undesirable effects can be assigned to either the anticholinergic properties of tiotropium or to the ß-adrenergic properties of olodaterol, the components of SPIOLTO RESPIMAT.
In addition the occurrence of other undesirable effects related to the beta-adrenergic agonist class, which are not listed above, should be taken into consideration, such as arrhythmia, myocardial ischemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalaemia, hyperglycaemia and metabolic acidosis.