Rx Product Profile: Spiriva Respimat
The FDA has approved an expanded indication for Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma in patients 6 years and older.
The FDA has approved an expanded indication for Spiriva Respimat (tiotropium bromide, by Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in patients 6 years and older. The approval carries the limitation that Spiriva Respimat should not be used for relief of acute bronchospasm.1
Over 24 million Americans are affected by asthma, approximately 6.3 million of whom are younger than 18 years. Even with maintenance treatment, 50% of adults and more than 38% of children continue to have asthma symptoms.2
Spiriva Respimat was initially approved for the treatment of chronic obstructive pulmonary disease.3 In September 2015, an indication was added for longterm, once-daily maintenance treatment of asthma in patients 12 years and older.2
PHARMACOLOGY AND PHARMACOKINETICS
Spiriva Respimat is a long-acting antimuscarinic agent. It displays similar affinity at the M1 through M5 muscarinic subtype receptors and exerts its effect through inhibition of M3 receptors at the smooth muscle, leading to bronchodilation.
After 4 weeks of once-daily dosing, Spiriva Respimat reaches maximum plasma concentrations 5 to 7 minutes after inhalation. Its terminal half-life in is 44 hours.1
DOSAGE AND ADMINISTRATION
Spiriva Respimat should only be used for oral inhalation. For patients to receive the full dose of the medication, it must be given as 2 inhalations once daily. Patients 6 years and older should receive Spiriva Respimat as 2 inhalations, at 1.25 mcg per actuation, once daily.1 Up to 4 to 8 weeks of treatment may be needed to achieve the maximum benefit in lung function.1,2
The efficacy of Spiriva Respimat in children aged 6 through 11 years was evaluated in 2 randomized, double-blind, placebo-controlled trials of 12 weeks and 48 weeks. Patients received Spiriva Respimat 2.5 or 5 mcg once daily or placebo. Compared with placebo, Spiriva Respimat 2.5 mcg demonstrated a significant effect on the change from the pretreatment baseline in peak forced expiratory volume in 1 second within 3 hours after dose administration for the 48-week trial. These results, in combination with previously established efficacy in adults and adolescents, supported the efficacy of Spiriva Respimat 2.5 mcg once daily in pediatric patients with asthma.1
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
The use of Spiriva Respimat is contraindicated in patients with hypersensitivity to tiotropium, ipratropium, or any component of the medication. It also is not a rescue medication and should not be used in acute cases of asthma.
If an immediate hypersensitivity reaction occurs, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, immediately discontinue treatment and consider alternative medications. Inhaled medications, such as Spiriva Respimat, may cause paradoxical bronchospasm. If this occurs, an inhaled short-acting beta2-agonist, such as albuterol, should be administered immediately and treatment with Spiriva Respimat should be discontinued.
Spiriva Respimat should be used cautiously in patients with narrow-angle glaucoma, as worsening of the condition may occur, and in those with prostatic hyperplasia or bladder-neck obstruction, as worsening of urinary retention may occur. The use of Spiriva Respimat with other anticholinergic medications should be avoided, as this combination may result in an additive effect. Patients with moderate to severe renal impairment should be monitored closely for potential anticholinergic adverse effects (AEs).
In patients with asthma, the most common AEs were pharyngitis, headache, bronchitis, and sinusitis.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
- Spiriva Respimat [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; 2017.
- FDA expands approval of Spiriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children [press release]. Ridgefield, CT: Boehringer Ingelheim; February 16, 2017. boehringer-ingelheim.us/press-release/fda-expands-approval-spiriva-respimat-tiotropium-bromide-inhalation-spray. Accessed May 15, 2017.
- Boehringer Ingelheim announces FDA approval of Spiriva Respimat (tiotropium bromide) inhalation spray for the maintenance treatment of COPD [press release]. Ridgefield, CT: Boehringer Ingelheim; September 25, 2014. boehringer-ingelheim.us/press-release/boehringer-ingelheim-announces-fda-approval-spiriva-respimat-tiotropium-bromide. Accessed May 15, 2017.