cuvposa

Prescribing Information
Caregivers Brochure

Important Safety Information
Contraindicated in conditions that preclude anticholinergic therapy
(e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis)
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*Indication

Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g. cerebral palsy).


Important Safety Information
  • Contraindicated in conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis)

  • Contraindicated in patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of Cuvposa

  • Constipation or intestinal pseudo-obstruction: Constipation is a common dose-limiting adverse reaction and may lead to discontinuation of Cuvposa. May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase.

  • Incomplete mechanical intestinal obstruction: Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If obstruction is suspected, discontinue Cuvposa.

  • Avoid high ambient temperatures. Heat prostration (fever and heat stroke due to decreased sweating) can occur with use of anticholinergic drugs such as Cuvposa.

  • Cuvposa may cause drowsiness or blurred vision, do not engage in age-appropriate activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking Cuvposa.

  • Use Cuvposa with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:
    • Autonomic neuropathy, renal disease, ulcerative colitis—large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate toxic megacolon, a serious complication of the disease; hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension; hiatal hernia associated with reflux esophagitis

  • Glycopyrrolate reduces GI transit time which may result in altered release of certain drugs when formulated in delayed or controlled-release forms. Cuvposa can increase serum levels of atenolol, metformin and digoxin (slow dissolution tablets; consider other dosage forms of digoxin). Dose reductions of atenolol or metformin may be needed.

  • Cuvposa may decrease serum levels of haloperidol or levodopa. Consider dose increase of levodopa and monitor haloperidol patients for worsening of schizophrenic symptoms and development of tardive dyskinesia

  • The anticholinergic effects of Cuvposa may be increased with concomitant administration of amantadine; Cuvposa dose reduction should be considered.

  • Use with caution in patients with renal impairment.

  • The most common adverse reactions (incidence ≥30%) are dry mouth (40%), vomiting (40%), constipation (35%), flushing (30%), and nasal congestion (30%).

*Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem
  drooling (e.g. cerebral palsy)


Cuvposa® (glycopyrrolate oral solution) has been classified by the FDA as an "Orphan Drug" that was developed to treat a rare condition (chronic severe drooling). Clinical studies of orphan drugs do not typically contain high numbers of study subjects.1


Please see Full Prescribing Information.


Reference: 1. Villarreal MA. Orphan Drug Act: Background and Proposed Legislation in the 107th Congress. CRS Report for Congress: Library of Congress. 2001; Order Code RS2097:1-6.

Cuvposa® is a registered trademark of Merz Pharmaceuticals, LLC.      © 2013 Merz Pharmaceuticals, LLC. All rights reserved.
5011924   Rev 10/2012