fentanyl transdermal (Rx)

Brand and Other Names:Duragesic
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch: Schedule II

  • 12.5mcg/hr
  • 25mcg/hr
  • 50mcg/hr
  • 75mcg/hr
  • 100mcg/hr
more...

Chronic Severe Pain

Indicated for chronic pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Discontinue or taper all other extended-release opioids when beginning fentanyl transdermal therapy

25-100 mcg/hr, reapplied q72hr until adequate analgesia is achieved

Also see Administration

Opioid-tolerant definition

  • Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day morphine, 25 mcg/day transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, 60 mg/day PO hydrocodone, or an equianalgesic dose of another opioid

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate (Child Pugh A to B): Start with one half of the usual dose; closely monitor for signs of respiratory and central nervous system depression (see Cautions)
  • Severe (Child C): Avoid use

Renal impairment

  • Mild-to-moderate: Start with one half of the usual dose; closely monitor for signs of respiratory and central nervous system depression (see Cautions)
  • Severe: Avoid use

Dosing Considerations

Limitations of use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain

Conversion oral/IV opioids to fentanyl transdermal

  • Each transdermal system is worn continuously for up to 72 hr (see Administration)
  • Tables found in prescribing information cannot be used to convert from fentanyl transdermal to another opioid because conversions will result in an overestimation of the dose of new opioid and may result in fatal overdosage
  • Calculate 24-hr morphine dose and find the corresponding recommended initial fentanyl transdermal dose
  • Initiate recommended dose and titrate dose no more frequently than 3 days after initial dose and every 6 days thereafter until analgesic efficacy is attained
  • For patients that require >100 mcg/hr, several transdermal systems may be used

Discontinuation of fentanyl transdermal

  • Significant amounts of fentanyl continue to be absorbed from the skin for ≥24 hr after the patch is removed
  • Convert to another opioid
    • Remove transdermal and titrate dose of new analgesic based upon patient’s report of pain until adequate analgesia has been attained
    • Upon system removal, ≥17 hr are required for a 50% decrease in serum fentanyl concentrations
    • Withdrawal symptoms are possible in some patients after conversion or dose adjustment
  • Not converting to another opioid
    • Gradually titrate the dose, (eg, 50% dosage reduction q6days), while monitoring carefully for signs and symptoms of withdrawal
    • If patient develops these signs or symptoms, raise dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both
    • Do not abruptly discontinue fentanyl patch It is unknown at what dose level the fentanyl transdermal may be discontinued without producing the signs and symptoms of opioid withdrawal

Dosage Forms & Strengths

transdermal patch: Schedule II

  • 12.5mcg/hr
  • 25mcg/hr
  • 50mcg/hr
  • 75mcg/hr
  • 100mcg/hr
more...

Chronic Pain (Off-label)

Treatment of chronic pain in children who are opioid-tolerant and receiving ≥60 mg/day PO of morphine or equivalent

<2 years: Safety not established

≥2 years: 25-100 mcg/hr, reapplied q72hr until adequate analgesia is achieved

Dosing Considerations

Limitations of use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain

Conversion oral/IV opioids to fentanyl transdermal

  • Each transdermal system is worn continuously for up to 72 hr (see Administration)
  • Tables found in prescribing information cannot be used to convert from fentanyl transdermal to another opioid because conversions will result in an overestimation of the dose of new opioid and may result in fatal overdosage
  • Calculate 24-hr morphine dose and find the corresponding recommended initial fentanyl transdermal dose
  • Initiate recommended dose and titrate dose no more frequently than 3 days after initial dose and every 6 days thereafter until analgesic efficacy is attained
  • For patients that require >100 mcg/hr, several transdermal systems may be used

Discontinuation of fentanyl transdermal

  • Significant amounts of fentanyl continue to be absorbed from the skin for ≥24 hr after the patch is removed
  • Convert to another opioid
    • Remove transdermal and titrate dose of new analgesic based upon patient’s report of pain until adequate analgesia has been attained
    • Upon system removal, ≥17 hr are required for a 50% decrease in serum fentanyl concentrations
    • Withdrawal symptoms are possible in some patients after conversion or dose adjustment
  • Not converting to another opioid
    • Gradually titrate the dose, (eg, 50% dosage reduction q6days), while monitoring carefully for signs and symptoms of withdrawal
    • If patient develops these signs or symptoms, raise dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both
    • Do not abruptly discontinue fentanyl patch It is unknown at what dose level the fentanyl transdermal may be discontinued without producing the signs and symptoms of opioid withdrawal
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Interactions

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            Adverse Effects

            Frequency Not Defined

            Asthenia

            Confusion

            Constipation

            Dry mouth

            Nausea

            Somnolence

            Sweating

            Vomiting

            Abdominal pain

            Anorexia

            Anxiety

            Apnea

            Depression

            Diarrhea

            Dizziness

            Dyspepsia

            Dyspnea

            Euphoria

            Fatigue

            Hallucinations

            Headache

            Hemoptysis

            Hypoventilation

            Influenzalike symptoms

            Nervousness

            Pharyngitis

            Pruritus

            Upper respiratory tract infection Urinary retention

            Abnormal coordination, thinking, gait, dreams

            Accidental injury

            Agitation

            Amnesia

            Angina pectoris

            Application-site reaction

            Back pain

            Bradycardia

            Bronchitis

            Cardiac arrest, ST-segment elevation

            Coma

            Dysphoria

            Faintness

            Fever

            Flatulence

            Flushing

            Hiccups

            Mental clouding

            Micturition disorder

            Myocardial infarction

            Oliguria

            Paranoid reaction

            Paresthesia

            Rash

            Respiratory arrest

            Respiratory/circulatory depression

            Rhinitis

            Sedation

            Seizures

            Severe cardiac arrhythmias

            Shock

            Sinusitis

            Speech disorder

            Syncope

            Tremor

            Urinary retention

            Ventricular tachycardia

            Visual disturbances

            Warmness of face/neck/upper thorax, urticaria

            Weakness

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            Warnings

            Black Box Warnings

            Addiction, abuse, and misuse

            • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
            • Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase
            • Instruct patients to swallow tablet/capsule whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose
            • Benzodiazepines or other CNS depressants
              • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; follow patients for signs and symptoms of respiratory depression and sedation
              • Reserve concomitant use of fentanyl transdermal and benzodiazepines or other CNS depressants for patients whom alternative treatment options are inadequate
              • Limit treatment to the minimum effective dosages and durations
              • Monitor patients for signs and symptoms of respiratory depression and sedation

            Accidental exposure

            • Accidental of even 1 dose, especially by children, can result in a fatal overdose

            Neonatal opioid withdrawal syndrome

            • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
            • Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
            • Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
            • If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

            CYP3A4 inhibitors

            • Concomitant use of transdermal fentanyl with all cytochrome CYP450 3A4 inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil) may result in increased fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression
            • Patients receiving fentanyl transdermally and any CYP34A inhibitors should be carefully monitored for extended period, and dosage adjustments should be made if warranted

            Exposure to heat

            • Exposure of the application site and surrounding area to direct external heat sources (eg, heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds) may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death
            • Patients wearing a fentanyl patch who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose to avoid overdose and death

            Contraindications

            Hypersensitivity to drug or components of the formulation

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Significant respiratory depression

            Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

            Within 2 weeks of monoamine oxidase inhibitor (MAOI) therapy

            Management of postoperative, mild, or intermittent pain

            Opioid-naive or non-opioid-tolerant patients

            Cautions

            Use caution in acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervous system (CNS) depression, drug abuse or dependence, emotional lability, gallbladder disease, gastrointestinal (GI) disorder, pseudomembranous colitis, GI surgery, head injury, hypothyroidism or untreated myxedema, intracranial hypertension, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock, cor pulmonale, chronic pulmonary disease, emphysema, hypercapnia, kyphoscoliosis, severe obesity, renal or hepatic impairment, elderly or debilitated patients

            Increased risk of potentially fatal respiratory depression, pruritus (despite little histamine release), and abuse or addiction

            May impair physical or mental abilities; use caution when operating machinery or driving

            Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Black Box Warnings); addiction can occur at recommended dosages and if drug is misused or abused

            Severe hypotension may occur including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock

            In patients who may be susceptible to intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

            Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary (see Black Box Warnings)

            Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Serious, life-threatening, or fatal respiratory depression reported (see Black Box Warnings)

            Accidental exposure reported, including fatalities (see Black Box Warnings)

            Bradycardia may occur; monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy

            Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

            Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Black Box Warnings)

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients

            While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within first 24-72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid

            Deaths have occurred in nursing infants exposed to high levels of opioid in breast milk because mothers were ultra-rapid metabolizers of opioid (see Lactation)

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            Use caution when selecting dosage for an elderly patient, usually starting at low end of dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and may be useful to monitor renal function

            Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension

            Drug interactions overview

            • Also see Black Box Warnings
            • Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
            • Coadministration with anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus
            • Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
            • Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs
            • Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected
            • Avoid use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients
            • Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir), may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of fentanyl injection is achieved; similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in fentanyl-injection treated patients may increase fentanyl plasma concentrations and prolong opioid adverse reactions; when using fentanyl Injection with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in fentanyl-Injection treated patients, monitor patients closely at frequent intervals and consider dosage reduction of fentanyl injection until stable drug effects are achieved
            • Concomitant use of fentanyl injection with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease fentanyl plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to fentanyl; when using fentanyl injection with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur
            • Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension
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            Pregnancy & Lactation

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly; opioids cross placenta and may produce respiratory depression and psychophysiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; opioid sulfate is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions which temporarily reduce strength, duration, and frequency of uterine contractions

            Fertility

            • Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible

            Lactation

            Opioid is secreted into human milk; in women with normal opioid metabolism (normal CYP2D6 activity), the amount of opioid secreted into human milk is low and dose-dependent; some women are ultra-rapid metabolizers of opioid; these women achieve higher-than-expected serum levels of opioid's active metabolite, opioid, leading to higher-than-expected levels of opioid in breast milk and potentially dangerously high serum opioid levels in their breastfed infants that can potentially lead to serious adverse reactions, including death, in nursing infants

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy 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

            Narcotic agonist-analgesic of opiate receptors; inhibits ascending pain pathways; alters pain perception, thus altering response to pain; produces analgesia, respiratory depression, and sedation

            Absorption

            After patch removal, continued systemic absorption occurs from residual fentanyl in skin, so that serum concentrations fall by average of 50% in ~20-27 hr

            Onset: 6 hr

            Duration: 72-96 hr

            Peak plasma time: 28.8-35.8 hr (dose dependent; following first application)

            Peak plasma concentration: 0.38-3.36 ng/mL (dose dependent; following first application)

            Distribution

            Vd: 4-6 L/kg

            Protein binding: 80-85%

            Metabolism

            Metabolized in liver by CYP3A4

            Elimination

            Half-life: 20-27 hr

            Excretion: Urine (75% mostly as metabolites), feces (9% as metabolites)

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            Administration

            Transdermal Preparation

            Hair at application site may be clipped (not shaved) prior to system application

            If application site must be cleaned prior to application of the patch, do so with clear water; do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics

            Allow skin to dry completely prior to patch application

            Patch must not be altered (eg, cut) in any way prior to application

            Do not use if the pouch seal is broken or if the patch is cut or damaged

            Transdermal Administration

            Transdermal use only

            Apply to intact, non-irritated, and non-irradiated skin on a flat surface (eg, chest, back, flank, or upper arm)

            In young children and persons with cognitive impairment, monitor adhesion an upper back is the preferred location to minimize the potential of inappropriate patch removal

            Avoid exposing application site and surrounding area to direct external heat sources (see Black Box Warnings)

            Apply immediately upon removal from sealed package

            Firmly press in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges

            Each patch may be worn continuously for 72 hr; rotate application sites to a different skin site after removal of the previous transdermal system

            Patients or caregivers who apply the patch should wash their hands immediately with soap and water after applying; contact with unwashed or unclothed application sites can result in secondary exposure to drug and should be avoided

            Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others

            Resolutions to adhesion issues

            • If problems with adhesion of the patch occur, edges of the patch may be taped with first aid tape
            • If problems with adhesion persist, patch may be overlaid with a transparent adhesive film dressing
            • If patch falls off before 72 hr, dispose of it by folding in half and flushing down the toilet

            Disposal

            • Dispose of used patches immediately upon removal by folding the adhesive side of the patch to itself, then flushing down the toilet
            • Remove unused patches from their pouches, remove the release liners, fold patches so that the adhesive side of the patch adheres to itself, and to immediately flush the patches down the toilet
            • Dispose of any patches remaining from a prescription as soon as they are no longer needed

            Storage

            Unopened pouches: Store up to 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

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            Formulary

            FormularyPatient Discounts

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            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.
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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.