New Indication for Spiriva Respimat
February 15, 2017 - The U.S. FDA approved a pediatric indication for Spiriva® Respimat® (tiotropium – Boehringer Ingelheim). Spiriva Respimat is a long-acting muscarinic antagonist (LAMA) that uses a propellant-free device to deliver the drug as a fine, slow mist, which helps patients inhale the medication. Originally approved in September 2014 for treating chronic obstructive pulmonary disease (COPD), it was granted an additional FDA approval a year later for long-term maintenance treatment of asthma patients at least 12 years old. The new indication allows its use as a controller (maintenance) treatment for asthma patients as young as six years old. Recommended dosing is two inhalations once a day. It may take four weeks to eight weeks of therapy to achieve the highest level of improvement.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.