Cuvposa

Cuvposa

Generic Name: glycopyrrolate

Company: Shionogi Inc.

Treatment for: Drooling

FDA Approves Cuvposa

The U.S. Food and Drug Administration has approved Cuvposa (glycopyrrolate), the first liquid treatment for patients ages 3-16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy.

Cuvposa is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Cuvposa indirectly reduces the rate of salivation by preventing stimulation of these receptors. Cuvposa is available as a 1mg/5ml clear, cherry flavored oral solution.

This approval is based on the results of a randomized, double-blind, placebo-controlled Phase III study which showed that 75% of children and adolescents treated with Cuvposa experienced an improvement in symptoms, versus 11% who received placebo. Dry mouth, vomiting, constipation, flushing and nasal congestion were the most commonly reported adverse reactions.

Important Safety Information for Cuvposa

Contraindications

Medical conditions that preclude anticholinergic therapy.

Concomitant use of solid oral dosage forms of potassium chloride.

Warnings and Precautions

Constipation or intestinal pseudo-obstruction: 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: May present as diarrhea. If obstruction is suspected, discontinue Cuvposa and evaluate.

High ambient temperature: To reduce risk of heat prostration, avoid high temperatures.

Cuvposa side effects

The most common adverse reactions are dry mouth, vomiting, constipation, flushing, and nasal congestion.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Drug Safety Department at 1-800-849-9707 ext. 1454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See also: Cuvposa side effects (in more detail)

Drug Interactions

Digoxin tablets: Use with glycopyrrolate can increase digoxin serum levels. Monitor patients and consider use of alternative dosage forms of digoxin.

Amantadine: Effects of glycopyrrolate may be increased with concomitant administration of amantadine. Healthcare providers should consider decreasing the dose of glycopyrrolate during concomitant use.

Atenolol or metformin: Glycopyrrolate may increase serum levels of atenolol or metformin. Healthcare providers should consider dose reduction when used with glycopyrrolate.

Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of haloperidol or levodopa. Healthcare providers should consider a dose increase when used with glycopyrrolate.

Use in Specific Populations

Pediatric use: The safety and effectiveness of glycopyrrolate has not been established in patients under 3 years of age.

Renal impairment: Use Cuvposa with caution in patients with renal impairment.