Safety

SPIOLTO® RESPIMAT® (tiotropium/olodaterol) has a comparable adverse event profile to the component monotherapies.1

SPIOLTO® RESPIMAT® safety and tolerability profile was established in patients treated for up to 52 weeks.1

The proportion of patients who discontinued due to adverse events with SPIOLTO® RESPIMAT® was comparable to that of SPIRIVA® (tiotropium) and STRIVERDI® (olodaterol).1

Percentage of patients discontinuing therapy in clinical trials

Drug interactions2

Anticholinergic agents: The co-administration of tiotropium with other anticholinergic drugs has not been studied and therefore is not recommended.

Adrenergic agents: Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of SPIOLTO® RESPIMAT®.

Xanthine derivatives, steroids or diuretics: Concomitant treatment with xanthine derivatives, steroids or non-potassium sparing diuretics may potentiate any hypokalemic effect of SPIOLTO® RESPIMAT®.

Beta-blockers: Beta-adrenergic blockers may weaken or antagonise the effect of olodaterol. Cardioselective beta-blockers could be considered, although they should be administered with caution.

MAO inhibitors and tricyclic antidepressants, QTc prolonging drugs: Monamine oxidase inhibitors, tricyclic antidepressants or other drugs known to prolong the QTc interval may increase the action of SPIOLTO® RESPIMAT® on the cardiovascular system. 

Side effects

The most common adverse reactions with SPIOLTO® RESPIMAT® (>3% incidence and higher than either of the comparators – tiotropium and/or olodaterol)1

 

Adapted from reference 1

Contraindications2

SPIOLTO® RESPIMAT® is contraindicated in patients with hypersensitivity to tiotropium, atropine or its derivatives, e.g. ipratropium or oxitropium, olodaterol, or any component of this product.

Pregnancy and lactation2

Pregnancy

As a precautionary measure, it is preferable to avoid the use of SPIOLTO® RESPIMAT® during pregnancy and like other beta2-adrenergic agonists, olodaterol a component of SPIOLTO® RESPIMAT® may inhibit labour due to a relaxant effect on uterine smooth muscle. 

Breast-feeding

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with SPIOLTO® RESPIMAT® should be made taking into account the benefit of breast-feeding to the child and the benefit of SPIOLTO® RESPIMAT® therapy to the woman.

For information on warnings and precautions please see section 4.4 of the Summary of Product Characteristics.

References

  1. Buhl R, et al. Eur Respir J. 2015;45:969-979.
  2. SPIOLTO® RESPIMAT® Summary of Product Characteristics February 2017.
  3. SPIRIVA® RESPIMAT® Summary of Product Characteristics January 2017.
  4. STRIVERDI® RESPIMAT® Summary of Product Characteristics March 2016.