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Prescribing OSMOLEX® ER (amantadine) for Your Patients

OSMOLEX® ER is not available in retail pharmacies. Each patient must be enrolled through AccessOsmolex™, a program designed to provide access and financial support to eligible patients.

Instructions for Healthcare Providers

Once you have identified an OSMOLEX® ER patient, follow these steps to process a prescription through the AccessOsmolex Support Center.

STEPS

  • 1 Ensure patient consent is given to enroll in the AccessOsmolex program. You have the option of having the patient sign the patient consent form to send along with the enrollment and prescription form, or AccessOsmolex will call the patient to gain verbal consent.
  • 2 Fill out enrollment and prescription form completely and include a copy of the patient’s insurance card (front and back).
  • 3 Include Medical Information on the form or accompanying the form.
  • 4 Ensure the Prescription Information portion is completed for Initial and/or Maintenance Dose. If one dose will not be utilized, check the box indicating that the dose will not be utilized.
  • 5 Ensure the Prescriber Named in Section 3 has signed the Enrollment and Prescription form. Stamps are not permitted.
  • 6 Fax all necessary documents (patient’s insurance card, prescription form and consent form) to AccessOsmolex at 1-866-750-9516.
Patient enrollment and prescription form

Do you typically prescribe electronically?

Electronic form icon
E-prescribe in your patient’s electronic medical record (EMR) and choose to print the Rx form instead of electronically submit. EMR will have a record of the prescription.
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Scan in the AccessOsmolex Enrollment and Prescription form and it will be a part of the medical record.
Patient enrollment and prescription downloadable form

Download OSMOLEX® ER
prescription form

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Patient consent downloadable form

Download the patient
consent form

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References:

  1. Data source: UBC, January-October 16th 2019. Data set size: 474 patients.
  2. Medicare Part D: A First Look at Prescription Drug Plans in 2018. Henry J. Kaiser Family Foundation website. https://www.kff.org/report-section/medicare-part-d-a-first-look-at-prescription-drug-plans-in-2018-findings/. Published October 13, 2017. Accessed April 12, 2018.
  3. 2017 Employer Health Benefits Survey. Henry J. Kaiser Family Foundation website. https://www.kff.org/report-section/ehbs-2017-section-9-prescription-drug-benefits/. Published September 19, 2017. Accessed April 12, 2018. 

INDICATION

OSMOLEX® ER (amantadine) extended-release tablets is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m 2).

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents.

Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Before initiating treatment with OSMOLEX ER, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk of somnolence with OSMOLEX ER, such as concomitant sedating medications, alcohol, or the presence of a sleep disorder. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (eg, driving a motor vehicle, conversations, eating), OSMOLEX ER should ordinarily be discontinued. If a decision is made to continue OSMOLEX ER, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if they become somnolent.

Suicidality and Depression: Suicide, suicide attempts, and suicidal ideation have been reported in patients with and without prior history of psychiatric illness while treated with amantadine. Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits of treatment with OSMOLEX ER outweigh the risks in patients with a history of suicidality or depression.

Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER due to the risk of exacerbating psychosis. Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased.

Dizziness and Orthostatic Hypotension: Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose.

Withdrawal-Emergent Hyperpyrexia and Confusion: Abrupt discontinuation of OSMOLEX ER may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech . It is recommended that patients avoid sudden discontinuation of OSMOLEX ER.

Impulse Control/Compulsive Behaviors: Patients can experience increased sexual urges, and intense urges to gamble, spend money, binge eat, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, including OSMOLEX ER. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.

ADVERSE REACTIONS

The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

DRUG INTERACTIONS

Other Anticholinergic Drugs: The dose of anticholinergic drugs or of OSMOLEX ER should be reduced if atropine-like effects appear when these drugs are used concurrently.

Drugs Affecting Urinary pH: The pH of urine has been reported to influence the excretion rate of amantadine. Alterations in urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Monitor for efficacy or adverse reactions under conditions that alter the urine pH to more acidic or alkaline, respectively.

Live Attenuated Influenza Vaccines: Amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live vaccines are not recommended during treatment with OSMOLEX ER. Inactivated influenza vaccines may be used as appropriate.

Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for central nervous system effects such as somnolence, dizziness, confusion, lightheadedness, and orthostatic hypotension.

Please see full Prescribing Information.