IMPORTANT SAFETY INFORMATION1-3
Contraindications
DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.
Warnings and Precautions
Gastrointestinal and Gastrointestinal Procedure-Related Risks: Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including abscess; bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; intussusception; pancreatitis; peritonitis; pneumonia (including aspiration pneumonia); pneumoperitoneum; post-operative wound infection; and sepsis, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess DUOPA-treated patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patient becomes somnolent.
Orthostatic Hypotension: Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.
Hallucinations/Psychosis/Confusion: There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.
Impulse Control/Compulsive Behaviors: Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.
Depression and Suicidality: Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.
Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.
Dyskinesia: DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson’s disease medications.
Vitamin B6 Deficiency and Seizures: Treatment with carbidopa/levodopa, including DUOPA, may contribute to reduced vitamin B6 levels and higher doses of carbidopa/levodopa may increase the risk. Seizures associated with vitamin B6 deficiency have been reported in patients taking DUOPA. Evaluate vitamin B6 levels prior to initiation of DUOPA and during treatment or if symptoms of vitamin B6 deficiency are identified, and supplement with vitamin B6 as necessary.
Neuropathy: Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.
Cardiovascular Ischemic Events: Myocardial infarction and arrhythmia were reported in patients taking carbidopa/levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.
Laboratory Test Abnormalities: DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.
Glaucoma: Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.
Adverse Reactions
The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa/levodopa immediate release (CLIR), were (DUOPA vs CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).
Drug Interactions
- Monitor patients taking selective MAO-B inhibitors and carbidopa/levodopa for orthostatic hypotension.
- Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive.
- Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.
US-DUOP-260013
Please see full Prescribing Information.
