SPIRIVA® RESPIMAT®
For Asthma
Side effects and safety
Description of selected adverse reactions
In clinical studies in asthma, the commonly observed undesirable effects were anticholinergic undesirable effects. Total of 1,930 subjects received SPIRIVA® RESPIMAT® in the 12 placebo-controlled clinical trials in asthma ranging from 12 weeks to 1 year, which translated into 1,128 person-years of exposure.1
Adverse reactions reported for SPIRIVA® RESPIMAT® included dehydration, dizziness, insomnia, glaucoma, increased intraocular pressure, blurred vision, atrial fibrillation, heart palpitations, supraventricular tachycardia, tachycardia, cough, nose bleed, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis, dry mouth, constipation, oropharyngeal candidiasis, difficulty swallowing, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic, rash, pruritus, angioedema, urticaria, skin infection and skin ulcer, dry skin, other allergic reactions (including anaphylactic reaction), joint swelling, urinary retention, dysuria and urinary tract infection.1
The frequency, types and severity of adverse reactions for pediatric patients were comparable to that observed in adult patients.1
Add SPIRIVA® RESPIMAT® for a broad age range of patients1
SPIRIVA® RESPIMAT® has a demonstrated safety profile for patients as young as 6 years of age1
Drug interactions with concomitant respiratory medications
Although no formal drug interaction studies have been performed, tiotropium bromide has been used concomitantly with other drugs commonly used in the treatment of COPD and asthma, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, antihistamines, mucolytics, leucotriene modifiers, cromones and anti-IgE treatment without clinical evidence of drug interactions.1
Drug interactions with other anticholinergics
The chronic co-administration of tiotropium bromide with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of other anticholinergic drugs with SPIRIVA® RESPIMAT® is not recommended.1
Adult patients
In two replicate, randomized, placebo-controlled trials of SPIRIVA® RESPIMAT® in adult patients with severe, symptomatic asthma over 48 weeks, the following adverse events were reported.2
SPIRIVA® RESPIMAT® demonstrated a safety profile comparable with control* in adult patients taking at least ICS/LABA2
Most common adverse events2
Among the adverse events reported by at least 2% of patients in any study group, only allergic rhinitis occurred at a significantly higher rate in the tiotropium group; asthma events and insomnia were significantly more common in the placebo group.2 Dry mouth was reported by 11 patients: 8 (1.8%) in the tiotropium group and 3 (0.7%) in the placebo group.2
For full safety information, please refer to the SPIRIVA® RESPIMAT® Summary of Product Characteristics.
Pediatric patients
SPIRIVA® RESPIMAT® demonstrated a safety profile comparable with control† in patients with severe asthma aged 6−17 years3
Most common adverse events in patients with severe asthma from studies VivaTinAasthma® (patients 6−11 years) and PensieTinA-asthma® (patients 12−17 years).3
Treated set. 12 weeks plus 30 days. Percentages are calculated using total number of patients per treatment as the denomination.3
For full safety information, please refer to the SPIRIVA® RESPIMAT® Summary of Product Characteristics.
Footnotes:
-
* Placebo RESPIMAT®. In both the SPIRIVA® RESPIMAT® and control groups, ICS and LABA maintenance therapy was continued. Other asthma medications were also allowed if the doses remained stable for at least 4 weeks before study entry and for the duration of the trial.2
-
† Placebo RESPIMAT®. In both the SPIRIVA® RESPIMAT® and control groups, patients also received ICS plus at least one other controller medication (e.g. LABA or LTRA).3
-
ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; LTRA, leukotriene receptor antagonist; PEF, peak expiratory flow.
References:
-
SPIRIVA® RESPIMAT® Summary of Product Characteristics.
-
Kerstjens HAM et al. N Engl J Med. 2012;367(13):1198−207 and supplementary material.
-
Hamelmann E, Szefler SJ. Drugs 2018;78(3):327−38.
