Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsules

  • 200mg
  • 250mg

Non-Small Cell Lung Cancer

Indicated for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors are anaplastic lymphoma kinase (ALK)- or ROS1-positive

250 mg PO BID

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Dosage reductions

  • First dose reduction: 200 mg PO BID
  • Second dose reduction: 250 mg PO qDay
  • Unable to tolerate 250 mg PO qDay: Permanently discontinue

Hematologic toxicities

  • For all hematologic toxicities except lymphopenia (unless associated with clinical events, eg, opportunistic infections)
  • Grade 3: Withhold until recovery to Grade ≤2, then resume at same dose
  • Grade 4: Withhold until recovery to Grade ≤2, then resume at next dose reduction

Hepatotoxicity

  • ALT or AST >5x ULN with total bilirubin [TB] ≤1.5x ULN: Withhold until recovery to baseline or ≤3x ULN, then resume at next dose reduction
  • ALT or AST >3x with concurrent TB >1.5x ULN (in the absence of cholestasis or hemolysis): Permanently discontinue

Interstitial lung disease

  • Any grade pneumonitis: Permanently discontinue

QT prolongation

  • Correct QT (QTc) >500 ms on at least 2 separate electrocardiograms (ECGs): Withhold until recovery to baseline or at QTc <481 ms, then resume at next dose reduction
  • QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia: Permanently discontinue

Bradycardia

Symptomatic, may be severe and medically intervention indicated
  • Withhold until recovery to asymptomatic bradycardia or HR ≥60 bpm
  • Evaluate concomitant medications known to cause bradycardia (eg, antihypertensives)
  • Discontinue or adjust dose of any contributing medication; resume at previous dose upon recovery to asymptomatic bradycardia or HR ≥60 bpm
  • Contributing medication not identified, or if contributing medications not discontinue or dose modified: Resume at next dose reduction upon recovery to asymptomatic bradycardia or to a HR ≥60 bpm
Life-threatening consequences, urgent intervention indicated
  • No contributing medications identified: Permanently discontinue
  • If contributing medication identified AND discontinued, or its dose adjusted: Resume at 250 mg qDay upon recovery to asymptomatic bradycardia or to a HR ≥60 bpm, closely monitor
  • Permanently discontinue for recurrence

Visual loss

  • Grade 4 ocular disorder: Discontinue during evaluation of severe visual loss

Strong CYP3A4 inhibitors

  • Avoid coadministration
  • If use is unavoidable, reduce crizotinib dose to 250 mg PO qDay
  • After discontinuation of strong CYP3A inhibitor, resume crizotinib dose used before initiating strong CYP3A inhibitor

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min) and not requiring dialysis: 250 mg PO qDay

Hepatic impairment

  • Mild (AST >ULN and TB ≤1x ULN or any AST and TB >1x to ≤1.5x ULN): Steady-state mean AUC and Cmax decreased by 9%
  • Moderate (any AST and TB >1.5x ULN and ≤3x ULN): 200 mg PO BID
  • Severe (any AST and TB>3x ULN): 250 mg PO qDay

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiation

Monitoring parameters

  • CBC including differential WBC counts: Monthly and as clinically indicated, more frequently test if Grade 3 or 4 abnormalities are observed or if fever or infection occurs
  • Liver function tests: Every 2 weeks during the first 2 months of treatment, then monthly, and as clinically needed

Limitation of use

  • Safety and efficacy not established in adults with relapsed or refractory, systemic ALK-positive ALCL

Patient selection

Dosage Forms & Strengths

capsules

  • 200mg
  • 250mg

Anaplastic Large Cell Lymphoma

Indicated for relapsed or refractory, systemic ALK-positive anaplastic large cell lymphoma (ALCL) in children and young adults aged ≥1 year

Assess the ability to swallow intact capsules before prescribing

280 mg/m2 PO BID

Continue until disease progression or unacceptable toxicity

Recommended dosage based on BSA

<0.6 m2: Dose not established

0.6-0.8 m2: 200 mg PO BID

0.81-1.16 m2: 250 mg PO BID

1.17-1.51 m2: 400 mg PO BID

1.52-1.69 m2: 450 mg PO BID

≥1.70 m2: 500 mg PO BID

Dosage Modifications

Dose reductions based on BSA

  • First dose reduction
    • 0.6-0.8 m2: 250 mg PO qDay
    • 0.81-1.16 m2: 200 mg PO BID
    • 1.17-1.69 m2: 250 mg PO BID
    • ≥1.70 m2: 400 mg PO BID
  • Second dose reduction
    • 0.6-0.8 m2: Permanently discontinue
    • 0.81-1.16 m2: 250 mg PO qDay
    • 1.17-1.69 m2: 200 mg PO BID
    • ≥1.70 m2: 250 mg PO BID
  • Unable to tolerate after 2 dose reductions
    • Permanently discontinue

Absolute neutrophil count (ANC)

  • ANC <0.5 x 109/L
  • First occurrence
    • Withhold until recovery to ANC >1 x 109/L, then resume at next dose reduction
  • Second occurrence
    • Recurrence complicated by febrile neutropenia: Permanently discontinue
    • Uncomplicated Grade 4: Either permanently discontinue or withhold until recovery to ANC >1 x 109/L, then resume at next dose reduction
    • Unable to tolerate 2 dose reductions: Permanently discontinue

Platelet count

  • 25-50 x 109/L with concurrent bleeding: Withhold until recovery to platelet count >50 x 109/L and bleeding resolves, then resume at same dose
  • <25 x 109/L: Withhold until recovery to platelet count >50 x 109/L and bleeding resolves, then resume at next dose reduction
  • Permanently discontinue for recurrence

Anemia

  • Hemoglobin (Hgb) <8 g/dL: Withhold until recovery to Hgb >8 g/dL, then resume at same dose
  • Life-threatening anemia (urgent intervention indicated): Withhold until recovery to Hgb >8 g/dL, then resume at next dose reduction
  • Permanently discontinue for recurrence

Hepatotoxicity

  • ALT or AST >5x ULN with total bilirubin [TB] ≤1.5x ULN: Withhold until recovery to baseline or ≤3x ULN, then resume at next dose reduction
  • ALT or AST >3x AND TB >1.5x ULN (in the absence of cholestasis or hemolysis): Permanently discontinue

Interstitial lung disease/pneumonitis

  • Any grade (drug-related): Permanently discontinue

QT prolongation

  • Correct QT (QTc) >500 ms on at least 2 separate ECG: Withhold until recovery to baseline or at QTc <481 ms, then resume at next dose reduction
  • QTc >500 ms or ≥60 ms change from baseline with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia: Permanently discontinue

Bradycardia

  • Resting HR <2.5th percentile per age-specific norms
    • 1 to <2 years: ≥91 bpm
    • 2-3 years: ≥82 bpm
    • 4-5 years: ≥72 bpm
    • 6-8 years: ≥64 bpm
    • >8 years: ≥60 bpm
  • Symptomatic, may be severe and medically intervention indicated
    • Withhold until recovery to resting HR according to age (based on 2.5th percentile per age-specific norms)
  • Life-threatening consequences (urgent intervention indicated)
  • No contributing medications identified: Permanently discontinue
  • If contributing medication is identified, and discontinued, or its dose adjusted: Resume at second dose reduction upon recovery to asymptomatic bradycardia or manage HR based on criteria of symptomatic or severe, medically significant bradycardia, with frequent monitoring
  • Permanently discontinue for recurrence

Ocular toxicity

  • Grade 1 or 2 (mild or moderate visual symptoms affecting ability to perform age-appropriate activities of daily living)
    • Monitor and report any symptoms to an eye specialist
    • Grade 2 visual disorders: Consider dose reduction
  • Grade 3 or 4 ocular disorder (marked decrease in vision)
    • Withhold pending evaluation of severe visual loss
    • Permanently discontinue, if no other cause found on evaluation

Gastrointestinal toxicity

  • Occurs despite maximum medical therapy
  • Grade 3 nausea (inadequate oral intake for >3 days, medical intervention required)
  • Grade 3 vomiting (> 6 episodes in 24 hr for >3 days, medical intervention required [eg, tube feeding or hospitalization)
  • Grade 3 diarrhea (increase of ≥7 stools/day over baseline; incontinence; hospitalization indicated)
  • Grade 4 vomiting or diarrhea (life-threatening consequences, urgent intervention indicated)
  • Withhold until resolved for any of of above descriptions, then resume at next dose reduction
  • Permanently discontinue if unable to tolerate after 2 dose reductions, unless otherwise indicated

Strong CYP3A4 inhibitors

  • Avoid coadministration
  • If use is unavoidable, reduce criztotinib dose to second dose reduction
  • After discontinuation of strong CYP3A inhibitor, resume crizotinib dose used before initiating strong CYP3A inhibitor

Renal impairment

  • Calculate CrCl with Schwartz equation
  • Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min) and not requiring dialysis: Second dose reduction

Hepatic impairment

  • Moderate (any AST and TB >1.5x ULN and ≤3x ULN): First dose reduction
  • Severe (any AST and TB >3x ULN): Second dose reduction

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiation

Monitoring parameters

  • CBC including differential WBC counts: Monthly and as clinically indicated, more frequently if Grade 3 or 4 abnormalities are observed or if fever or infection occurs
  • Ophthalmologic examination: Obtain at baseline before initiation; consider follow-up including retinal examination within 1 month of initiation, every 3 months thereafter, and upon any new visual symptoms; assess symptoms regularly during treatment
  • Liver function tests: Every 2 weeks during the first 2 months of treatment, then monthly, and as clinically needed

Supportive care

  • Provide standard antiemetic and antidiarrheal agents before and during treatment
  • Consider IV or oral hydration and replace electrolytes as clinically indicated

Limitation of use

  • Safety and efficacy not established in older adults with relapsed or refractory, systemic ALK-positive ALCL

No overall differences in safety or efficacy were observed in comparison with younger patients

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Interactions

Interaction Checker

and crizotinib

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            ALK- or ROS1-positive metastatic NSCLC

            • Vision disorders (≥25%)
            • Nausea (≥25%)
            • Diarrhea (≥25%)
            • Vomiting (≥25%)
            • Edema (≥25%)
            • Constipation (≥25%)
            • Elevated transaminases (≥25%)
            • Fatigue (≥25%)
            • Decreased appetite (≥25%)
            • Upper respiratory infection (≥25%)
            • Dizziness (≥25%)
            • Neuropathy (≥25%)

            ALK-positive metastatic NSCLC

            • All grades
              • Increased ALT (76-79%)
              • Vision disorder (60-71%)
              • Increased AST (61-66%)
              • Diarrhea (60-61%)
              • Nausea (55-56%)
              • Neutropenia (49-52%)
              • Lymphopenia (48-51%)
              • Edema (31-49%)
              • Vomiting (46-47%)
              • Constipation (42-43%)
              • Upper respiratory tract infection (26-32%)
              • Hypophosphatemia (28-32%)
              • Decreased appetite (27-30%)
              • Fatigue (27-29%)
              • Abdominal pain (26%)
              • Dysgeusia (26%)
              • Headache (22%)
              • Dizziness (18-22%)
              • Neuropathy (19-21%)
              • Pyrexia (19%)
              • Hypokalemia (18%)
              • Pain in extremity (16%)
              • Bradycardia (5-14%)
              • Dyspepsia (8-14%)
              • Rash (9-11%)
            • Grade 3-4
              • Increased ALT (15-17%)
              • Neutropenia (11-12%)

            ALCL

            • All grades
              • Neutropenia (100%)
              • Blood creatinine increased (100%)
              • Diarrhea (92%)
              • Vomiting (92%)
              • ALT increased (81%)
              • Nausea (77%)
              • AST increased (65%)
              • Vision disorders (65%)
              • Hypocalcemia (62%)
              • Lymphopenia (58%)
              • Headache (58%)
              • Musculoskeletal pain (58%)
              • Hypoalbuminemia (54%)
              • Anemia (54%)
              • Abdominal pain (50%)
              • Stomatitis (46%)
              • Hyperglycemia (46%)
              • Hypomagnesemia (46%)
              • Fatigue (46%)
              • Decreased appetite (42%)
              • Thrombocytopenia (38%)
              • Pyrexia (38%)
              • Hypoglycemia (35%)
              • Pruritus (35%)
              • Cough (35%)
              • Hypokalemia (31%)
              • Constipation (31%)
              • Upper respiratory tract infection (31%)
              • Hypertension (31%)
              • Hypermagnesemia (27%)
              • Edema (27%)
              • Chills (27%)
              • Hyperkalemia (23%)
              • Dysgeusia (23%)
              • Dizziness (23%)
              • Rash (23%)
              • Rhinitis allergic (23%)
              • Bradycardia (19%)
              • Hypotension (19%)
              • Alkaline phosphatase increase (19%)
              • Hypernatremia (19%)
              • Hyponatremia (12%)
              • Hyperuricemia (12%)
              • Hypophosphatemia (12%)
              • Peripheral neuropathy (12%)
            • Grade 3-4
              • Neutropenia (77%)
              • Lymphopenia (38%)
              • Thrombocytopenia (19%)
              • Diarrhea (12%)
              • Musculoskeletal pain (12%)

            1-10%

            ALK-positive metastatic NSCLC

            • All grades
              • Dysphagia (10%)
              • Decreased weight (10%)
              • Increased weight (8%)
              • Esophagitis (2-6%)
              • Pulmonary embolism (6%)
              • QT prolonged (5-6%)
              • Renal cyst (4-5%)
              • ILD/pneumonitis (1-4%)
              • Syncope (1-3%)
              • Decreased blood testosterone (1%)
              • Hepatic failure (1%)
            • Grade 3-4
              • Hypophosphatemia (5-10%)
              • Increased AST (8-9%)
              • Lymphopenia (7-9%)
              • Pulmonary embolism (5%)
              • Hypokalemia (4%)
              • Syncope (3%)
              • QT prolonged (2-3%)
              • Diarrhea (2%)
              • Vomiting (1-2%)
              • Constipation (2%)
              • Esophagitis (2%)
              • Bradycardia (1%)
              • Vision disorder (1%)
              • Dysphagia (1%)
              • Edema (1%)
              • Increased weight (1%)
              • Headache (1%)
              • Dizziness (1%)
              • Decreased weight (1%)
              • Nausea (1%)

            ALCL

            • Grade 3-4
              • Stomatitis (8%)
              • QT prolonged (8%)
              • GGT increase (8%)
              • Esophagitis (8%)
              • Muscular weakness (8%)
              • Acute renal injury (8%)
              • Febrile neutropenia (3.8%)
              • Vomiting (3.8%)
              • Nausea (3.8%)
              • Anemia (3.8%)
              • ALT increased (3.8%)
              • AST increased (3.8%)
              • Hypocalcemia (3.8%)
              • Hypokalemia (3.8%)

            Postmarketing Reports

            Increased blood creatine phosphokinase

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            Warnings

            Contraindications

            None

            Cautions

            Severe, including fatal, treatment-related ILD/pneumonitis reported; monitor for pulmonary symptoms indicative of pneumonitis; generally occurred within 3 months after initiation

            Drug-induced hepatoxicity reported; monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly, and as clinically needed; more frequently in patients who develop increased transaminases; withhold, reduce dose, or permanently discontinue for hepatotoxicity as recommended

            Symptomatic bradycardia reported, including syncope; monitor HR and blood pressure regularly

            Caution when driving or operating machinery because of vision disorder, dizziness, or fatigue associated with treatment

            May cause fetal harm when administered to pregnant females

            Interstitial lung disease (ILD)/Pneumonitis reported; permanently discontinue in patients with ILD/pneumonitis

            Visual loss

            • Visual field defect with vision loss reported; optic atrophy and optic nerve disorder have been reported as potential causes of vision loss; most common visual symptoms were blurred vision and visual impairment in ALCL patients
            • There is insufficient information to characterize risks of resumption of drug in patients who develop visual symptoms or visual loss; a decision to resume therapy should consider potential benefits versus risks to patient
            • Perform an ophthalmological evaluation consisting of best corrected visual acuity, retinal photographs, visual fields, optical coherence tomography (OCT), and other evaluations as appropriate for new onset of visual loss and for other visual symptoms as clinically warranted

            Gastrointestinal toxicity

            • Severe gastrointestinal toxicities (eg, diarrhea, nausea, vomiting, stomatitis) can occur in ALCL patients; provide standard antiemetic and antidiarrheal agents for gastrointestinal toxicities in patients with ALCL; antiemetics are recommended prior to and during treatment with drug to prevent nausea and vomiting; if patients develop Grade 3 nausea lasting 3 days or Grade 3 or 4 diarrhea or vomiting despite maximum medical therapy, withhold therapy until resolved, and then resume at next lower dose level; consider supportive care such as hydration, electrolyte supplementation, and nutritional support as clinically indicated

            QT interval prolongation

            • QTc prolongation reported
            • Avoid use with congenital long QT syndrome
            • Consider periodic ECG and electrolyte monitoring in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or taking medications known to prolong QT interval

            Drug interaction overview

            • CYP3A4/5 and P-gp substrate; CYP3A4 inhibitor
            • Strong or moderate CYP3A inhibitors
              • Avoid coadministration
              • Strong CYP3A inhibitors increases crizotinib plasma concentration and risk of adverse reactions of crizotinib
              • If unavoidable, reduce crizotinib dosage
              • Avoid grapefruit or grapefruit
              • Use caution with concomitant use of moderate CYP3A4 inhibitors
            • Strong CYP3A inducers
              • Avoid coadministration
              • Strong CYP3A inducers decreases crizotinib plasma concentrations and efficacy of crizotinib
            • CYP3A substrates
              • Avoid coadministration
              • Crizotinib may increases plasma concentrations and rise of adverse effects of CYP3A substrates
              • If unavoidable, decrease CYP3A substrate dosage according to prescribing information
            • Drugs that prolong the QT interval
              • Avoid coadministration
            • Drugs that cause bradycardia
              • Avoid coadministration
              • Drugs include beta-blockers, nondihydropyridine calcium channel blockers, clonidine, and digoxin
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            Pregnancy & Lactation

            Pregnancy

            Based on its mechanism of action, can cause fetal harm when administered to a pregnant woman

            Verify pregnancy status of females of reproductive potential before initiation

            Animal data

            • Oral administration in pregnant rats during organogenesis at exposures similar to those observed with maximum recommended human dose resulted in embryotoxicity and fetotoxicity

            Contraception

            • Females of reproductive potential: Use effective contraception during treatment and for at least 45 days following the final dose
            • Males with female partners of reproductive potential: Use condoms during treatment and for at least 90 days after final dose

            Infertility

            • Based on reproductive organ findings in animals, reduced fertility in females and males of reproductive potential may occur
            • Unknown whether these effects on fertility are reversible

            Lactation

            No information available on drug presence in human milk, effects on the breastfed infants, or effects on milk production

            Do not breastfeed during treatment and for 45 days after final dose

            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

            Inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and Recepteur d’Origine Nantais (RON)

            ALK gene expression and signaling that contribute to increased cell proliferation and survival of the tumors become activated following formation of ALK oncogenic fusion proteins

            Inhibits signaling that promotes the expression of these oncogenic fusion proteins, thereby inhibiting tumor cell proliferation

            Absorption

            Adults

            • Bioavailability: 43% (mean absolute bioavailability)
            • Mean accumulation ratio: 4.8
            • Peak plasma time: 4-6 hr
            • Steady-state reached at 15 days (250 mg PO BID)
            • Effect of food
              • High-fat meal reduced AUC and peak plasma concentration by ~14%

            Children and young adults

            • Peak plasma concentration: 621 ng/mL
            • AUC: 6530 ng⋅hr/mL

            Distribution

            Protein Bound: 91% to human plasma proteins, independent of drug concentration

            Vd (steady-state): 1772 L (50-mg IV dose)

            Blood-to-plasma ratio: 1

            P-glycoprotein (P-gp) substrate and inhibitor

            Metabolism

            Predominantly metabolized by CYP3A4/5

            Time-dependent inhibitor of CYP3A

            Primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites

            Elimination

            Half-life: 42 hr

            Total body clearance: 60 L/hr (250 mg PO q12hr at steady-state); 100 L/hr (250 mg PO qDay)

            Excretion: Feces 63%; urine 22%

            Pharmacogenomics

            Patient selection for treatment is based on presence of ALK fusion gene

            Verify presence of ALK fusion gene by using the diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit

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            Administration

            Oral Administration

            Take with or without food

            Swallow capsules whole

            ALCL

            • Administer under adult supervision
            • May combine different strengths capsules if necessary

            Before and during treatment

            • Provide standard antiemetic and antidiarrheal agents before and during treatment
            • Consider IV or oral hydration and replace electrolytes as clinically indicated

            Missed dose

            • Next dose >6 hr: Take as soon as possible
            • Next dose <6 hr: Skip missed dose; do NOT double dose to make up for missed dose
            • Vomited dose after administration: Do NOT take extra dose; take next dose at regularly scheduled time

            Storage

            Capsules: Store at room temperature (20-25ºC [68-77ºF]); excursions permitted to 15-30ºC (59-86ºF)

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            Images

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            Formulary

            FormularyPatient Discounts

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

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • 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.