vigabatrin (Rx)

Brand and Other Names:Sabril, Vigadrone
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 500mg (Sabril, generic)

powder for oral solution

  • 500mg/packet (Sabril, Vigadrone, generic)

Partial Seizures

Indicated as adjunctive therapy for refractory complex partial seizures in patients who have inadequately responded to several seizure treatments and for whom the potential benefits of vigabatrin outweigh the risk of vision loss

500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

No additional benefit shown with 6 g daily compared with 3 g daily; higher incidence of adverse effects associated with 6 g daily

Dosage Modifications

Renal impairment

  • Mild (CrCl >50 to 80 mL/min): Decrease dose by 25%
  • Moderate (CrCl >30 to 50 mL/min): Decrease dose by 50%
  • Severe (CrCl >10 to 30 mL/min): Decrease dose by 75%
  • Hemodialysis: Clearance not adequately studied

Dosage Forms & Strengths

tablet

  • 500mg (Sabril, generic)

powder for oral solution

  • 500mg/packet (Sabril, Vigadrone, generic)

Partial Seizures

Indicated as adjunctive therapy for refractory complex partial seizures in children aged ≥2 years who have inadequately responded to several seizure treatments and for whom the potential benefits of vigabatrin outweigh the risk of vision loss

<2 years: Safety and efficacy not established

2-16 years

  • 10-15 kg: 175 mg PO q12hr initially, THEN increase by weekly intervals to total maintenance dose of 525 mg q12hr
  • >15-20 kg: 225 mg PO q12hr initially, THEN increase by weekly intervals to total maintenance dose of 650 mg q12hr
  • >20-25 kg: 250 mg PO q12hr initially, THEN increase by weekly intervals to total maintenance dose of 750 mg q12hr
  • >25-60 kg: 250 mg PO q12hr initially, THEN increase by weekly intervals to total maintenance dose of 1000 mg q12hr
  • >60 kg: 500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

>16 years

  • 500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

Infantile Spasms

Indicated as monotherapy for pediatric patients with infantile spasms aged 1 month to 2 years for whom the potential benefits outweigh the potential risk of vision loss

<1 month: Not established

1 month to 2 years: 50 mg/kg/day PO divided q12hr initially; if needed, may increase dose by 25-50 mg/kg/day increments every 3 days; not to exceed 150 mg/kg/day  

Dosage Modifications

Renal impairment

  • Infants: Information about how to adjust dose not available
  • ≥10 years
    • Mild (CrCl >50-80 mL/min): Decrease dose by 25%
    • Moderate (CrCl >30-50 mL/min): Decrease dose by 50%
    • Severe (CrCl >10 to 30 mL/min): Decrease dose by 75%
    • Hemodialysis: Clearance not adequately studied

Infantile Spasms (Orphan)

Orphan designation for combination therapy with cosyntropin for treatment of infantile spasms

Sponsor

  • West Therapeutic Development, LLC; 540 Ziegler Drive; Grayslake, Illinois 60030

Initiate at low end of dosing range and consider dose adjustment with renal impairment

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Interactions

Interaction Checker

and vigabatrin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • metoclopramide intranasal

                vigabatrin, 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.

              Monitor Closely (12)

              • brexanolone

                brexanolone, vigabatrin. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • cenobamate

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

              • clobazam

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

              • deutetrabenazine

                vigabatrin and deutetrabenazine both increase sedation. Use Caution/Monitor.

              • esketamine intranasal

                esketamine intranasal, vigabatrin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • lasmiditan

                lasmiditan, vigabatrin. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • lemborexant

                lemborexant will increase the level or effect of vigabatrin by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

              • lurasidone

                lurasidone, vigabatrin. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

              • midazolam intranasal

                midazolam intranasal, vigabatrin. 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.

              • orlistat

                orlistat decreases levels of vigabatrin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • rufinamide

                vigabatrin decreases levels of rufinamide by increasing metabolism. Use Caution/Monitor.

              • stiripentol

                stiripentol, vigabatrin. 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 (3)

              • ethotoin

                vigabatrin decreases levels of ethotoin by unknown mechanism. Minor/Significance Unknown.

              • fosphenytoin

                vigabatrin decreases levels of fosphenytoin by unknown mechanism. Minor/Significance Unknown.

              • phenytoin

                vigabatrin decreases levels of phenytoin by unknown mechanism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Weight gain, children (47%)

              Permanent bilateral concentric visual field constriction (>30%)

              Fatigue (28%)

              Somnolence (24%)

              Headache (18%)

              Weight gain, adults (17%)

              Dizziness (15%)

              Convulsion (11%)

              Hyperactivity, in children (11%)

              1-10%

              Nasopharyngitis (10%)

              Weight increased (10%)

              Upper respiratory tract infection (10%)

              Visual field defect (9%)

              Depression (8%)

              Tremor (7%)

              Nystagmus (7%)

              Nausea (7%)

              Diarrhea (7%)

              Memory impairment (7%)

              Insomnia (7%)

              Irritability (7%)

              Coordination abnormal (7%)

              Vision blurred (6%)

              Diplopia (6%)

              Vomiting (6%)

              Influenza (6%)

              Pyrexia (6%)

              Rash (6%)

              Postmarketing Reports

              Birth defects: Congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, talipes

              Ear disorders: Deafness

              Endocrine disorders: Delayed puberty

              Gastrointestinal disorders: Gastrointestinal hemorrhage, esophagitis

              General disorders: Developmental delay, facial edema, malignant hyperthermia, multiorgan failure

              Hepatobiliary disorders: Cholestasis

              Nervous system disorders: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis

              Psychiatric disorders: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder

              Respiratory disorders: Laryngeal edema, pulmonary embolism, respiratory failure, stridor

              Skin and subcutaneous tissue disorders: Angioedema, maculopapular rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia

              Vision disorders: Permanent vision loss

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              Warnings

              Black Box Warnings

              Can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability; in some cases, can damage the central retina and may decrease visual acuity

              Onset of vision loss is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even months or years)

              Symptoms of vision loss are unlikely to be recognized by patients or caregivers before vision loss is severe; vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function

              Risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss

              Vision assessment is recommended at baseline (no later than 4 weeks after initiating therapy), at least every 3 months during therapy, and about 3-6 months after discontinuation of therapy

              Once detected, vision loss is not reversible; it is expected that, even with frequent monitoring, some patients will develop severe vision loss

              Consider drug discontinuation, balancing benefit and risk, if vision loss documented

              Risk of new or worsening vision loss continues throughout therapy; it is possible that vision loss can worsen despite discontinuation of therapy

              Because of the risk of vision loss, discontinue in patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2-4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious; patients who response to and continued need for vigabatrin should be periodically reassessed

              Should not be administered to patients with, or at high risk of, other types of irreversible vision loss unless benefits of treatment clearly outweigh risks

              Should not be used with other drugs associated with serious adverse ophthalmic effects (eg, retinopathy, glaucoma) unless benefits clearly outweigh risks

              Use lowest dosage and shortest exposure to drug consistent with clinical objectives

              Because of risk of permanent vision loss, therapy is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SABRIL REMS Program; www.vigabatrinREMS.com or 1-866-244-8175

              Contraindications

              None

              Cautions

              Can cause permanent vision loss; because of this risk and because, when it is effective, vigabatrin provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed (see Black Box Warnings)

              Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants

              Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for infantile seizures with vigabatrin

              Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication; patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

              Withdraw drug gradually; however, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered; patients and caregivers should be told not to suddenly discontinue vigabatrin

              Anemia reported

              May cause somnolence and fatigue; advise patients not to drive or operate complex machinery until they are familiar with how the drug affects them

              Peripheral neuropathy reported in adults

              Causes weight gain in adults and children

              Edema reported in adults

              Drug interaction overview

              • P450 CYP2C inducer; coadministration with CYP2C substrates (eg, phenytoin) result in decreased plasma levels, phenytoin levels decreased 16-20% when coadministered and therefore may require dosage adjustments
              • Vigabatrin increased clonazepam Cmax by 30% and decreased Tmax by 45%
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              Pregnancy & Lactation

              Pregnancy

              No adequate and well-controlled studies in pregnant women

              Limited available data from case reports and cohort studies pertaining to drug use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, based on animal data, drug use in pregnant women may result in fetal harm; should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

              Advised pregnant patients taking vigabatrin to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; 1-888-233-2334 or http://www.aedpregnancyregistry.org/

              Animal studies

              • Vigabatrin produced developmental toxicity, including teratogenic and neurohistopathological effects, when administered to pregnant animals at clinically relevant doses
              • In addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy

              Lactation

              Excreted in human milk

              Because of the potential for serious adverse reactions from vigabatrin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

              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

              Irreversible inhibitor of gamma aminobutyric acid (GABA) transaminase, thereby increases the level of the inhibitory neurotransmitter GABA within the brain

              Pharmacokinetics

              Half-Life: 5.7 hr in infants; 5-8 hr in young adults; 7.5 hr in adults; 12-14 hr in geriatric patients

              Absorption: 100% (solution and tablets are bioequivalent to one another and may be interchanged)

              Vd: 1.1 L/kg

              Peak Plasma Time: [fasting] 2.5 hr; [with food] 2 hr

              Protein Bound: Negligible

              Metabolism: Not extensively metabolized

              Clearance: [adults] 7 L/hr; [infants] 2.4 L/hr; [children] 5.7 L/hr

              Excretion: Urine: 95%

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              Administration

              Oral Solution Preparation

              Dissolve powder content from each 500 mg packet in 10 mL cold or room temp water (final concentration 50 mg/mL)

              Pepare immediately before use

              Oral Administration

              May take with or without food

              Discontinue gradually

              • Infantile spasms: Taper by decreasing daily dose at a rate of 25-50 mg/kg q3-4 days
              • Pediatric patients aged 10-16 yr with complex partial seizures: Taper by decreasing daily dose by one-third qWeek for 3 wk
              • >16 yr with complex partial seizures: Taper by decreasing daily dose 1000 mg/day on a weekly basis until discontinued
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              vigabatrin oral
              -
              500 mg powder
              vigabatrin oral
              -
              500 mg powder
              vigabatrin oral
              -
              500 mg powder
              vigabatrin oral
              -
              500 mg tablet
              Vigadrone oral
              -
              500 mg powder
              Vigadrone oral
              -
              500 mg powder

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              vigabatrin oral

              VIGABATRIN - ORAL

              (vye-GA-ba-trin)

              COMMON BRAND NAME(S): Sabril

              WARNING: Serious vision problems may occur while taking this medication and may be permanent even after you stop taking the medication. To prevent vision problems from getting worse, your doctor must find any eye problems as early as possible. Also, tell your doctor if you have a history of vision problems. It is very important that you have an eye exam before or within 4 weeks of starting this medication, then every 3 months thereafter while you are taking this medication. You should also have an eye exam 3 to 6 months after stopping this medication. Follow your doctor's directions carefully and keep all medical/eye/lab appointments. Tell your doctor right away if you have any changes in vision (such as loss of vision, blurred vision, double vision, sensitivity to light, eye pain).Only patients who have signed an informed consent and agree to the requirements of the REMS program may obtain and use vigabatrin. Only physicians enrolled in REMS may prescribe vigabatrin, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the REMS program and for more information about the risk and benefits of using this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

              USES: This medication is used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment. Vigabatrin is an anticonvulsant. It is thought to work by stopping the breakdown of a natural calming substance (GABA) in the brain.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking vigabatrin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually twice a day.The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on their weight. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as drowsiness and confusion. Your doctor will adjust your dose to find the best dose for you. Follow your doctor's directions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Do not stop taking this medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your seizures worsen or have not improved within 3 months.

              SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, and difficulty concentrating may occur, especially during the first few days as your body adjusts to the medication. Children may become restless or excited. Nausea, vomiting, stomach upset, diarrhea, headache, weight gain, and tiredness may also 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 any of these unlikely but serious side effects occur: shakiness (tremor), swelling ankles/feet, tingling/numbness, shortness of breath, fast heartbeat.A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.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 taking vigabatrin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: eye problems (such as visual field defect, glaucoma, macular degeneration, optic nerve problem), mental/mood problems (such as depression, psychosis), kidney disease, low red blood cell count (anemia).This drug may make you dizzy or drowsy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).MRI tests of the brain in infants have shown changes after they are given vigabatrin. It is not known if these changes are harmful. Consult your doctor for more details. If your infant is going to have an MRI test, notify testing personnel that your infant is using this medication.Older adults may be at greater risk for side effects (such as confusion) while using this drug. Confusion can increase the risk of falling.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vigabatrin. Vigabatrin may harm an unborn baby. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.This medication passes into breast milk in small amounts. 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.Some products that may interact with this drug include: drugs that can harm the eye (retinotoxic drugs such as chloroquine, hydroxychloroquine, phenothiazines including thioridazine), orlistat.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, clonazepam, 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.This product can affect the results of certain lab tests (such as liver function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

              OVERDOSE: If someone has overdosed and has 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: slow/shallow breathing, loss of consciousness.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as eye exams, kidney function, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 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

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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.
              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.