rotigotine (Rx)

Brand and Other Names:Neupro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch

  • 1mg/24 hr
  • 2mg/24 hr
  • 3mg/24 hr
  • 4mg/24 hr
  • 6mg/24 hr
  • 8mg/24 hr

Parkinson Disease

Initial: Apply 2 mg/24 hr transdermal patch qDay for early-stage disease or 4 mg/24 hr for advanced-stage disease

May be increased as needed by increments of 2 mg/24 hr at weekly intervals

Not to exceed 6 mg/24 hr patch qDay for early-stage disease or 8 mg/24 hr for advanced-stage disease

To discontinue treatment, reduce dose gradually (no faster than 2 mg/24 hr every other day) until completely withdrawn

Restless Legs Syndrome

Initial: Apply 1 mg/24 hr transdermal patch qDay

May be increased as needed by increments of 1 mg/24 hr at weekly intervals and as tolerated

Not to exceed 3 mg/24 hr patch qDay

To discontinue treatment, reduce dose gradually (no faster than 1 mg/24 hr every other day) until completely withdrawn

Safety and efficacy not established

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Interactions

Interaction Checker

and rotigotine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (4)

              • calcium/magnesium/potassium/sodium oxybates

                rotigotine, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • loxapine inhaled

                loxapine inhaled decreases effects of rotigotine by pharmacodynamic antagonism. Contraindicated.

              • metoclopramide intranasal

                rotigotine, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

                metoclopramide intranasal, rotigotine. dopaminergic effects. Avoid or Use Alternate Drug. Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (eg, parkinsonian symptoms) or decreased therapeutic effects of metoclopramide.

              • sodium oxybate

                rotigotine, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              Monitor Closely (11)

              • buprenorphine buccal

                buprenorphine buccal and rotigotine both increase sedation. Use Caution/Monitor.

              • cenobamate

                cenobamate, rotigotine. Either increases effects of the other by sedation. Use Caution/Monitor.

              • clobazam

                rotigotine, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clonidine

                clonidine, rotigotine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.

              • ketotifen, ophthalmic

                ketotifen, ophthalmic and rotigotine both increase sedation. Use Caution/Monitor.

              • loxapine inhaled

                loxapine inhaled and rotigotine both increase sedation. Use Caution/Monitor.

              • methylphenidate

                rotigotine, methylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Potential for additive CNS stimulation.

              • midazolam intranasal

                midazolam intranasal, rotigotine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • phenylephrine PO

                rotigotine increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

              • solriamfetol

                rotigotine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • stiripentol

                stiripentol, rotigotine. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

              Minor (2)

              • benazepril

                rotigotine, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

              • captopril

                rotigotine, captopril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

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              Adverse Effects

              >10% (Early-stage Parkinson Disease)

              Nausea (34-48%)

              Application site reactions (including erythema, pruritus, irritation, burning, dermatitis, inflammation, papulae, vesicle, pain) (21-46%)

              Dizziness (14-22%)

              Somnolence (12-20%)

              Vomiting (10-20%)

              Fatigue (6-18%)

              Insomnia (5-11%)

              Hyperhidrosis (3-11%)

              1-10% (Advanced-stage Parkinson Disease)

              Application site reactions (36-46%)

              Somnolence (32%)

              Nausea (22-28%)

              Dizziness (14-23%)

              Dyskinesia (14-17%)

              Edema peripheral (9-14%)

              Insomnia (9-14%)

              Hallucinations (7-14%)

              Arthralgia (8-11%)

              1-10% (Restless Legs Syndrome)

              Application site reactions (23-43%)

              Nausea (15-23%)

              Headache (15-21%)

              Asthenia (7-14%)

              1-10% (Early-stage Parkinson Disease)

              Abnormal dreams (2-7%)

              Erythema (3-6%)

              Anorexia (2-6%)

              Depression (2-5%)

              Edema peripheral (2-4%)

              Dyspepsia (2-3%)

              EKG, T- ave abnormal (2-3%)

              Weight loss (2-3%)

              Balance disorder (2-3%)

              Tinnitus (2-3%)

              Hiccups (2-3%)

              Pruritic rash (2-3%)

              Erectile dysfunction (2-3%)

              Lethargy (1-2%)

              Orthostatic hypotension (1-2%)

              1-10% (Advanced-stage Parkinson Disease)

              Vomiting (8-10%)

              Headache (8-10%)

              Constipation (5-9%)

              Diarrhea (5-7%)

              Hypertension (3-5%)

              Nightmares (3-5%)

              Paraesthesias/Dysesthesias (3-4%)

              Tremor (3-4%)

              Asthenia (3-4%)

              Cough (3%)

              Nasal Congestion (3%)

              Sinus congestion (2-3%)

              Erythema (2-3%)

              Hyperhidrosis (1-3%)

              Musculoskeletal pain (2%)

              1-10% (Restless Legs Syndrome)

              Nasopharyngitis (5-10%)

              Somnolence (5-10%)

              Insomnia (2-10%)

              Dizziness (5-9%)

              Pruritus (3-9%)

              Xerostomia (3-7%)

              Constipation (2-6%)

              Hyperhidrosis (1-5%)

              Vomiting (2-4%)

              Muscle spasms (1-4%)

              Hypertension (1-4%)

              Hot flushes (1-4%)

              Dyspepsia (1-3%)

              Vertigo (1-3%)

              Sinusitis (1-3%)

              Abnormal dreams (1-3%)

              Sleep attacks (1-2%)

              Erythema (1-2%)

              Postmarketing Reports

              Rhabdomyolysis

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              Warnings

              Contraindications

              Hypersensitivity

              Cautions

              Patients with Parkinson disease or RLS may experience new or worsening mental status and behavioral changes; these may include sudden onset of sleep while engaging in activities of daily living, consider dose reduction or discontinuation of treatment if patient develops compulsive behavior

              May also experience hallucinations, symptoms of mania (eg, insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, delirium, and psychotic-like behavior

              Contains sodium metabisulfite that may cause allergic-type reactions Somnolence is common; falling asleep during activities of daily living observed

              Symptomatic postural hypotension and syncope may occur, especially during dose escalation

              May increase blood pressure and heart rate

              Dose dependent increases in weight and fluid retention observed

              May potentiate dopaminergic side effects of levodopa and cause or exacerbate dyskinesia

              Application site reactions are frequent and dose related

              Restless leg syndrome rebound/augmentation may occur as dose wears off

              Remove patch before MRI; backing layer of patch contains aluminum

              Heat may increase absorption; avoid exposure to external heat sources (eg, heating pads, electric blankets, sauna)

              Fibrotic complication reported (eg, retroperitoneal fibrosis, pleural effusion, pericarditis)

              Binding to melanin-pigmented tissues reported

              Hallucinations/psychotic -like behavior and dyskinesia may occur

              Monitor for melanoma; increased risk reported for patients receiving therapy

              Withdrawal symptoms

              • Avoid abrupt withdrawal; symptoms resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, rhabdomyolysis, and/or autonomic instability) with no other obvious etiology, has been reported in association with rapid dose reduction
              • Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa
              • Prior to discontinuation, patients should be informed about potential withdrawal symptoms, and monitored during and after discontinuation; in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at lowest effective dose may be considered

              Impulse control/ compulsive behaviors

              • Patients may 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 that increase central dopaminergic tone
              • In some cases, although not all, these urges were reported to have stopped when the dose was reduced or 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 for Parkinson’s disease or RLS
              • Dopamine dysregulation syndrome, repeated use of more drug than as prescribed to manage their symptoms of Parkinson’s disease or RLS, observed in some patients during treatment
              • Physicians should consider dose reduction or stopping the medication if a patient develops such urges while receiving therapy
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate data on developmental risk associated with use in pregnant women

              Animal data

              • In animal studies, drug was shown to have adverse effects on embryofetal development when administered during pregnancy at doses similar to or lower than those used clinically

              Lactation

              There are no data on presence of drug in human milk, effects on the breastfed infant, or on milk production; however, inhibition of lactation may occur because drug decreases secretion of prolactin in humans; studies have shown that rotigotine and/or its metabolite(s) are excreted in rat milk

              The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Non-ergolinic D3/D2/D1 dopamine agonist

              Effective in treating Parkinson disease by stimulating D2 receptors within the caudate-putamen in the brain

              The precise mechanism of action for treating restless legs syndrome is unknown; thought to be related dopamine receptor stimulation

              Absorption

              Bioavailability: 37%

              Peak plasma time: 15-18 hr

              Release rate: 45% in 24 hr (0.2 mg/sq.cm/24 hr)

              Distribution

              Protein Bound: 92% (in vitro); 89.5% (in vivo)

              Vd: 84 L/kg

              Metabolism

              Metabolized by N-dealkylation and direct/secondary conjugation

              Elimination

              Half-life, biphasic: 3 hr (initial); 5-7 hr (terminal)

              Excretion: 71% urine; 23% feces

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              Administration

              Topical Administration

              Apply patch at same time qDay

              Apply to clean, dry, intact skin on front of abdomen, high, hip, flank, shoulder, or upper arm

              Press the patch firmly to the skin for 30 seconds; check the adherence to the skin, particularly around the edges

              Rotate application site each day

              Do not apply to the same site more than once every 14 days

              Monitor: BP, ophthalmic function

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Neupro transdermal
              -
              6 mg/24 hour transdermal system
              Neupro transdermal
              -
              4 mg/24 hour transdermal system
              Neupro transdermal
              -
              3 mg/24 hour transdermal system
              Neupro transdermal
              -
              2 mg/24 hour transdermal system
              Neupro transdermal
              -
              1 mg/24 hour transdermal system
              Neupro transdermal
              -
              8 mg/24 hour transdermal system

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              rotigotine transdermal

              ROTIGOTINE PATCH - TRANSDERMAL

              (roe-TIG-oh-teen)

              COMMON BRAND NAME(S): Neupro

              USES: Rotigotine is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Rotigotine is also used to treat restless legs syndrome (RLS).Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using rotigotine and each time you get a refill. Learn how to use this patch properly. If you have any questions, ask your doctor or pharmacist.Do not open the sealed pouch until ready to use. Do not cut the patch or use the patch if it appears broken, cut, or damaged. Open the pouch and remove the patch. Peel off the backing from the patch as directed and apply the patch to a clean, dry, and hairless area of the skin on the front of the abdomen, thigh, hip, side of the lower back (flank), shoulder, or upper arm. Press the patch firmly in place for about 30 seconds to make sure it stays on. Do not apply the patch on oily, broken, or irritated skin. Do not use creams, lotions, ointments, oils, or powders on skin where you are applying the patch. Avoid applying the patch to areas of the skin where it might be easily rubbed off (such as on skin folds or under tight clothing). If applying to a hairy area, shave the area at least 3 days before applying the patch. Wash your hands with soap and water after handling the patch. Do not touch your eyes or other objects until your hands are washed.The patch is usually worn for 1 day and replaced. Apply the patch to a different area on your body each time to avoid irritation. Wait at least 14 days before applying the patch to the same area. If the patch irritates the skin, protect the area from direct sunlight until the skin is completely healed. Sunlight may cause the irritated skin to change color.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as nausea, dizziness), your doctor may direct you to start at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Use this medication regularly to get the most benefit from it. To help you remember, change your patch at the same time each day.To prevent the patch from coming off, use care while showering, bathing, and exercising. If the edges of the patch start to loosen, you may tape it in place with bandage tape. If the patch falls off, apply a new patch to a different area, and change the patch at your usual time the next day.When changing your patch, carefully remove the old patch, fold it in half with the sticky side together, and throw it away in the trash away from children and pets. Do not touch the sticky side with your fingers. Wash the application area with soap and water. Use baby oil or mineral oil to remove any leftover stickiness. Do not use solvents such as alcohol or nail polish remover. Always wash your hands after handling the patch, being careful not to touch your eyes or other objects until after you have washed your hands.Do not stop using this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used rotigotine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Nausea, vomiting, loss of appetite, dizziness, drowsiness, lightheadedness, tiredness, trouble sleeping, increased sweating, headache, or redness/itching/swelling at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, agitation, hallucinations), severe dizziness, fainting, unusual strong urges (such as increased gambling, increased sexual urges), swelling ankles/feet, unusual weight gain, fast heartbeat, new or worsening uncontrolled movements.Some people using rotigotine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with rotigotine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.This medication may increase or decrease your blood pressure. You may develop a sudden drop in blood pressure that can cause dizziness, lightheadedness, nausea, sweating, and fainting. This is more likely when you first start the medication, when your dose is increased, or when you get up suddenly. To reduce your risk, get up slowly when rising from a sitting or lying position. Talk to your doctor if you need to check your blood pressure while using this medication.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using rotigotine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, sleep disorders (such as sleep apnea, narcolepsy), low/high blood pressure, heart disease (such as heart failure), kidney disease, mental/mood disorders (such as schizophrenia).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.While wearing your patch, avoid exposing it to direct heat (such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds, or prolonged direct sunlight). Heat may cause more drug to be released into your body, increasing the risk of side effects.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are going to have an MRI test or cardioversion, tell the health care provider that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI or cardioversion. Ask your doctor whether you will need to remove your patch before the procedure and apply a new patch afterward, and how to do so properly.Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations)During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. This drug may reduce the amount of breast milk you make. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

              OVERDOSE: This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: mental/mood changes (such as confusion, hallucinations), uncontrolled movements, seizures.

              NOTES: Do not share this medication with others.People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

              MISSED DOSE: If you forget to change the patch, change it as soon as you remember. Do not double the dose to catch up. Then go back to your usual schedule for changing your patch.

              STORAGE: Store the patches in their original pouch at room temperature. Do not open the pouch until you are ready to use the patch. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. (See also How to Use section.)

              Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

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              • View the formulary and any restrictions for each plan.
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              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.