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Reducing out-of-pocket costs for your patients

To help cover the out-of-pocket costs of CUVPOSA, the CUVPOSA Co-Pay Program may help qualified patients pay as little as $0 each time they fill a prescription.

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*Eligibility, Terms and Conditions, and Program Limitations

From and after January 1, 2018, the Program covers eligible patients’ actual out-of-pocket CUVPOSA medication costs up to a maximum amount of $100 per valid prescription issued and filled during a 12 month period beginning on January 1. The Program card maximum usage is limited to twelve (12) thirty (30) day supply uses or twenty-four (24) fifteen (15) day supply uses per card. The Program card will expire at the end of the calendar year and patients will need to re-enroll into the program as of January 1 of the following calendar year. The Program does not cover (a) office visit co-pays; (b) facility co-pays; or (c) any other costs excluded by the Program guidelines not specifically mentioned herein, which are subject to change.

Original Program card must be presented to the pharmacist at the time each prescription is filled and is good for use only with a valid prescription for CUVPOSA. Not valid if reproduced. It is a violation of law to buy, sell, or counterfeit the CUVPOSA Program Card.

Eligible patients must be clinically appropriate patients for therapeutic treatment with CUVPOSA. Patient must be prescribed CUVPOSA by a licensed healthcare provider. Eligible patients must be at least 3 years of age and less than 17 years of age.

This offer is valid only in the United States, Puerto Rico and in U.S. territories, excluding where it is otherwise prohibited by law. Patients residing in the states of Massachusetts, Michigan, Rhode Island, and Minnesota are eligible for drug co-payment assistance only and are not eligible for other types of co-payment assistance, including but not limited to costs related to administration of the drug. Void where prohibited by law, taxed or restricted.

Eligible patients must have private commercial insurance that covers medication costs for CUVPOSA, and acceptance of this offer must be consistent with the terms of that insurer’s drug benefit. Eligible patients must not have coverage for CUVPOSA through Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, TRICARE, Veterans Affairs (VA), the Department of Defense (DoD), or other federally funded or state funded healthcare programs. Patients who move from commercial to federally funded or state funded insurance will no longer be eligible for the Program. If a patient is enrolled in a state or federally funded prescription insurance program, then the patient is not eligible even if the patient elects to be processed as an uninsured (cash-paying) patient. If a patient is enrolled in a private indemnity or HMO insurance plan that reimburses the patient for the entire cost of the patient’s prescription drugs, then the patient is not eligible to participate even if the patient elects to be processed as an uninsured (cash-paying) patient. This offer is not valid for cash-paying patients.

Patient may not seek reimbursement for value received from the Program from any third-party payers, including flexible spending accounts or healthcare savings accounts.

If at any time Patient begins receiving coverage under any federal, state or government funded healthcare program, Patient is no longer eligible to participate in the Program and Patient’s legal guardian must call at 1-855-740-3040 between 8 AM and 5 PM (ET) to stop participation. Restrictions may apply. This is not health insurance.

Patient’s legal guardian and Patient’s pharmacist is responsible for notifying insurance carriers or any other third party who pays for or reimburses any part of the prescription filled using the Program as may be required by the insurance carrier’s terms and conditions and applicable law.

Enrollment in the Program may be reviewed on an annual basis to determine continued eligibility. This offer may not be combined with any other coupon, discount, prescription savings card, free trial, or other offer for CUVPOSA.

This is a limited time offer, and Merz reserves the right to rescind, revoke, amend, or terminate this offer, or the program in its entirety, at any time without notice.

INDICATIONS AND USAGE

CUVPOSA (glycopyrrolate) oral solution is indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

CUVPOSA is contraindicated in:

  • Patients with medical 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).
  • Patients taking solid oral dosage forms of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of CUVPOSA.

WARNINGS AND PRECAUTIONS

  • Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea, or vomiting.
  • Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with CUVPOSA and evaluate for intestinal obstruction.
  • In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as CUVPOSA. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.
  • CUVPOSA may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in 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 tachyarrhythmia, tachycardia, and hypertension
    • Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition

ADVERSE REACTIONS

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

The most commonly observed adverse reactions reported by ≥15% of CUVPOSA-treated patients for the placebo-controlled clinical trial were:

  • dry mouth (40%)
  • vomiting (40%)
  • constipation (35%)
  • flushing (30%)
  • nasal congestion (30%)
  • headache (15%)
  • sinusitis (15%)
  • upper respiratory tract infection (15%)
  • urinary retention (15%)

The most commonly observed adverse reactions which occurred at a rate of <2% of CUVPOSA-treated patients in the open label study were:

  • Gastrointestinal: abdominal distension, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue
  • General Disorders: irritability, pain
  • Infections: pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection
  • Investigations: heart rate increase
  • Metabolism and Nutrition: dehydration
  • Nervous System: headache, convulsion, dysgeusia, nystagmus
  • Psychiatric: agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered
  • Respiratory: increased viscosity of bronchial secretion, nasal congestion, nasal dryness
  • Skin: dry skin, pruritus, rash
  • Vascular: pallor

Additional adverse reactions identified during post approval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.

DRUG INTERACTIONS

Drugs Affected by Reduced GI Transit Time

Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.

  • The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are contraindicated.
  • Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is administered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules).

Amantadine

The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine.

Drugs Whose Plasma Levels May be Increased by Glycopyrrolate

Coadministration of glycopyrrolate may result in increased levels of certain drugs.

  • Atenolol's bioavailability may be increased with coadministration of glycopyrrolate. A reduction in the atenolol dose may be needed.
  • Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin's pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted.

Drugs Whose Plasma Levels May be Decreased by Glycopyrrolate

Coadministration of glycopyrrolate may result in decreased levels of certain drugs.

  • Haloperidol's serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia. Closely monitor patients if coadministration cannot be avoided.
  • Levodopa's therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa.

USE IN PREGNANCY

There are no available data in pregnant women for CUVPOSA to inform decisions concerning any drug-associated risks.

PEDIATRIC USE

CUVPOSA was evaluated for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling. CUVPOSA has not been studied in subjects under the age of 3 years.

Please see full Prescribing Information.