Tiotropium and Olodaterol

• It is used to treat COPD (chronic obstructive pulmonary disease).
• It may be given to you for other reasons. Talk with the doctor.
• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Stiolto Respimat: Tiotropium 2.5 mcg and olodaterol 2.5 mcg per actuation (4 g) [contains benzalkonium chloride, edetate disodium]

• Anticholinergic Agent
• Anticholinergic Agent, Long-Acting
• Beta2 Agonist
• Beta2 Agonist, Long-Acting

Hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of the formulation; use in the treatment of asthma without a concomitant long-term asthma control medication.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to atropine.

Documentation of allergenic cross-reactivity for sympathomimetics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

COPD: Oral inhalation: Two inhalations once daily (maximum: 2 inhalations per day)

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid freezing. Discard 3 months after cartridge is inserted into inhaler or when the locking mechanism is engaged, whichever comes first.

>10%:

Respiratory: Nasopharyngitis (12%)

1% to 10%:

Neuromuscular & skeletal: Back pain (4%)

Respiratory: Cough (4%)

≤3% (Limited to important or life-threatening): Angioedema, atrial fibrillation, bronchospasm, constipation, dehydration, dermal ulcer, dysphagia, dysuria, epistaxis, gastroesophageal reflux disease, gingivitis, glaucoma, glossitis, hypersensitivity (including immediate reactions), hypertension, increased intraocular pressure, insomnia, intestinal obstruction (including paralytic ileus), joint swelling, laryngitis, oropharyngeal candidiasis, palpitations, pharyngitis, sinusitis, skin infection, skin rash, stomatitis, supraventricular tachycardia, tachycardia, urinary retention, urinary tract infection, voice disorder, xeroderma

Long-acting beta2-adrenergic agonists (LABA) such as olodaterol, one of the active ingredients in tiotropium/olodaterol, increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding of an increased risk of asthma-related death with salmeterol is considered a class effect of LABA, including olodaterol. The safety and efficacy of tiotropium/olodaterol in patients with asthma have not been established. Tiotropium/olodaterol is not indicated for the treatment of asthma.