Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Striverdi Respimat is contraindicated in patients with hypersensitivity to olodaterol or to any of the excipients listed in section 6.1.
Striverdi Respimat should not be used in asthma. The long-term efficacy and safety of olodaterol in asthma have not been studied.
Striverdi Respimat, as a once daily maintenance bronchodilator should not be used for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
As with all medications, immediate hypersensitivity reactions may occur after administration of Striverdi Respimat.
As with other inhaled medicines Striverdi Respimat may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Striverdi Respimat should be discontinued immediately and alternative therapy substituted.
Long acting beta2-adrenergic agonists should be administered with caution in patients with cardiovascular disorders, especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension, and aneurysm, in patients with convulsive disorders or thyrotoxicosis, in patients with known or suspected prolongation of the QT interval (e.g. QT>0.44s), and in patients who are unusually responsive to sympathomimetic amines.
Patients with a history of myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalized for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (>100 beats per minute) were excluded from the clinical trials. Therefore the experience in these patient groups is limited. Striverdi Respimat should be used with caution in these patient groups.
Like other beta2-adrenergic agonists, olodaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave and ST segment depression, although the clinical significance of these observations is unknown.
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5), which may increase the susceptibility to cardiac arrhythmias.
Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Caution needs to be taken in case of a planned operation with halogenated hydrocarbon anaesthetics due to an increased susceptibility to the adverse cardiac effects of beta agonist bronchodilators.
Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.
Striverdi Respimat should not be used in conjunction with any other medications containing long-acting beta2-adrenergic agonists.
Patients who have been taking inhaled, short-acting beta2-adrenergic agonists on a regular basis (e.g., four times a day) should be instructed to use them only for symptomatic relief of acute respiratory symptoms.
Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of Striverdi Respimat.
Concomitant treatment with xanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate any hypokalemic effect of adrenergic agonists (see section 4.4).
Beta-adrenergic blockers may weaken or antagonise the effect of Striverdi Respimat. Therefore Striverdi Respimat should only be given together with beta-adrenergic blockers (including eye-drops) if there are compelling reasons for their use. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of Striverdi Respimat on the cardiovascular system.
No relevant effect on systemic exposure to olodaterol has been observed in drug-drug interaction studies with co-administration of fluconazole, used as model inhibitor of CYP2C9.
Co-administration of ketoconazole as potent P-gp and CYP inhibitor increased systemic exposure to olodaterol by approximately 70%. No dose adjustment is necessary.
Co-administration of olodaterol and tiotropium had no relevant effect on the systemic exposure to either of the two drugs.
In vitro investigations have shown that olodaterol does not inhibit CYP enzymes or drug transporters at the plasma concentrations achieved in clinical practice.
There are no data from the use of Striverdi Respimat in pregnant women available.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Striverdi Respimat during pregnancy.
Like other beta2-adrenergic agonists, olodaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Clinical data from nursing women exposed to olodaterol are not available.
It is unknown whether olodaterol/metabolites are excreted in human milk. Available pharmacokinetic/toxicological data in animals have shown excretion of olodaterol and/or its metabolites in milk.
Since the systemic exposure of the breast-feeding woman to olodaterol/metabolites is negligible at the human dose of 5 µg per day, relevant effects on the breastfed newborn/infant are not expected.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Striverdi Respimat therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Clinical data on fertility are not available for Striverdi Respimat. Preclinical studies performed with olodaterol showed no adverse effect on fertility.
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that dizziness has been reported in clinical trials. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.
The most common adverse reactions at the recommended dose were nasopharyngitis, dizziness, hypertension, rash and arthralgia. These were usually mild or moderate in intensity.
The frequencies assigned to the undesirable effects listed below are based on the crude incidence rates of adverse drug reactions (i.e. events attributed to olodaterol) observed in the olodaterol 5 microgram dose group (1035 patients), pooled from 6 placebo-controlled, parallel group clinical trials in COPD patients with treatment periods ranging between 4 and 48 weeks.
Frequency is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data)
| System Organ Class / MedDRA Preferred Term | Frequency |
|---|---|
| Infections and infestations | |
| Nasopharyngitis | Uncommon |
| Nervous system disorders | |
| Dizziness | Uncommon |
| Vascular disorders | |
| Hypertension | Rare |
| Skin and subcutaneous tissue disorders | |
| Rash | Uncommon |
| Musculoskeletal and connective tissue disorders | |
| Arthralgia | Rare |
Occurrence of rash may be considered a hypersensitivity reaction with Striverdi Respimat; as with all topical absorbed medication, other hypersensitivity reactions may develop.
Striverdi Respimat is a member of the therapeutic class of long-acting beta2-adrenergic agonists. Therefore, the occurrence of undesirable effects related to the beta-adrenergic agonist class should be taken into consideration, such as tachycardia, arrhythmia, palpitations, myocardial ischaemia, angina pectoris, hypertension or hypotension, tremor, headache, nervousness, insomnia, dizziness, dry mouth, nausea, muscle spasms, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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