Full Prescribing Information

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IMPORTANT SAFETY INFORMATION

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INDICATION

RYTARY is a combination of carbidopa and levodopa indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

RYTARY is contraindicated in patients who are currently taking or have recently (within 2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine). Hypertension can occur if these drugs are used concurrently.

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with levodopa (a component of RYTARY) 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 that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment. Before initiating treatment with RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY, such as concomitant sedating medications or the presence of a sleep disorder. Prescribers should consider discontinuing RYTARY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating). If a decision is made to continue RYTARY, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent.
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 of, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking RYTARY. If the decision is made to discontinue RYTARY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion.
Cardiovascular Ischemic Events: Cardiovascular ischemic events have occurred in patients taking RYTARY. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the period of initial dosage adjustment.
Hallucinations/Psychosis: There is an increased risk for hallucinations and psychosis in patients taking RYTARY. Hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with RYTARY. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of RYTARY.
Impulse Control/Compulsive Behaviors: Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including RYTARY, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with RYTARY. Consider a dose reduction or stopping the medication if a patient develops such urges while taking RYTARY.
Dyskinesia: RYTARY can cause dyskinesias that may require a dosage reduction of RYTARY or other medications used for the treatment of Parkinson’s disease.
Peptic Ulcer Disease: Treatment with RYTARY may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
Glaucoma: RYTARY may cause increased intraocular pressure in patients with glaucoma. Monitor intraocular pressure in patients with glaucoma after starting RYTARY.
Melanoma: Patients with Parkinson’s disease have a higher risk of developing melanoma than the general population. Patients and providers are advised to monitor for melanoma frequently and on a regular basis when using RYTARY.

ADVERSE REACTIONS: Clinical Trials Experience:

Early Parkinson’s Disease: Most common adverse reactions (incidence ≥ 5 % and greater than placebo) are nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.
Advanced Parkinson’s Disease: Most common adverse reactions (incidence ≥ 5 % and greater than oral immediate-release carbidopa-levodopa) are nausea and headache.

Postmarketing Experience: Reported adverse reactions identified during post approval use of RYTARY include suicide attempt and ideation. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to RYTARY exposure.

DRUG INTERACTIONS:

Monitor patients taking selective MAO-B inhibitors and RYTARY. The combination may be associated with orthostatic hypotension. Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts may reduce the effectiveness of RYTARY. Monitor patients for worsening Parkinson’s symptoms.

USE IN SPECIFIC POPULATIONS:

Pregnancy and nursing mothers: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses. RYTARY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Carbidopa is excreted in rat milk. Excretion of levodopa in human milk was reported in one nursing mother. Caution should be exercised when RYTARY is administered to a nursing woman.
Pediatrics: Safety and effectiveness in pediatric populations have not been established.

OVERDOSAGE:

The acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation. Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses.

GENERAL DOSING AND ADMINISTRATION INFORMATION:

See Full Prescribing Information for instructions for starting levodopa-naïve patients on RYTARY and converting patients from immediate-release carbidopa and levodopa to RYTARY (Table 1). The dosages of other carbidopa and levodopa products are not interchangeable on a 1:1 basis with the dosages of RYTARY.
RYTARY should not be chewed, divided, or crushed. Swallow RYTARY whole with or without food. A high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours.
For patients who have difficulty swallowing capsules, administer RYTARY by carefully twisting apart both halves of the capsule. Sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons) and consume the mixture immediately. Do not store the drug/food mixture for future use.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information.

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RYTARY® is a registered trademark of Impax Laboratories, LLC.
© 2019 Amneal Pharmaceuticals LLC.
Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC. All rights reserved.
PP-ADO-RYT-US-0008 11/2019

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