nivolumab (Rx)

Brand and Other Names:Opdivo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 10mg/mL (4mL, 10mL)
  • Further dilution required before administration

Adjuvant Treatment of Melanoma

Patients with involvement of lymph nodes or metastatic disease who have undergone complete resection

240 mg IV q2Weeks or 480 mg IV q4Weeks

Continue until disease progression or unacceptable toxicity for up to 1 year

Unresectable or Metastatic Melanoma

Indicated as a single agent or in combination with ipilimumab

Single agent

  • 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Combination with ipilimumab

  • Nivolumab 1 mg/kg IV q3Weeks PLUS  
  • Ipilimumab 3 mg/kg IV on the same day for maximum of 4 doses
  • After completing 4 doses of combination therapy: Administer nivolumab 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Non-Small Cell Lung Cancer (NSCLC)

Monotherapy

  • Indicated for metastatic NSCLC with progression in patients on or after platinum-based chemotherapy
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression prior to initiation
  • 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Combination therapy with ipilimumab

  • Indicated in combination with ipilimumab for first-line treatment of metastatic NSCLC in adults whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations
  • Nivolumab 3 mg/kg IV q2Weeks, PLUS  
  • Ipilimumab 1 mg/kg IV q6Weeks
  • Continue until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Combination with ipilimumab and platinum chemotherapy

  • Indicated in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for first-line treatment of metastatic or recurrent NSCLC in adults with no EGFR or ALK genomic tumor aberrations
  • Nivolumab 360 mg/kg IV q3Weeks, PLUS  
  • Ipilimumab 1 mg/kg IV q6Weeks, PLUS
  • Histology-based platinum doublet chemotherapy q3Weeks for 2 cycles
  • Continue until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Metastatic Small Cell Lung Cancer (SCLC)

Patients with progression after platinum-based chemotherapy and at least 1 other line of therapy

240 mg IV q2Weeks

Continue until disease progression or unacceptable toxicity

Advanced Renal Cell Carcinoma

Single agent

  • Patients who have received prior anti-angiogenic therapy
  • 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Combination with ipilimumab

  • Indicated for patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
  • Nivolumab 3 mg/kg IV q3Weeks PLUS  
  • Ipilimumab 1 mg/kg IV on the same day for 4 doses
  • After completing 4 doses of combination therapy: Administer nivolumab 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity
  • Also see ipilimumab drug monograph for dose

Hodgkin Lymphoma

Indicated for classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, or ≥3 lines of systemic therapy (eg, autologous HSCT)

240 mg IV q2Weeks or 480 mg IV q4Weeks

Continue until disease progression or unacceptable toxicity

Recurrent of Metastatic Squamous Head & Neck Carcinoma (SCCHN)

Patients with disease progression on or after a platinum-based therapy

240 mg IV q2Weeks or 480 mg IV q4Weeks

Continue until disease progression or unacceptable toxicity

Advanced or Metastatic Urothelial Carcinoma

Patients who have disease progression during or following platinum-containing chemotherapy

Patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

240 mg IV q2Weeks or 480 mg IV q4Weeks

Continue until disease progression or unacceptable toxicity

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

Indicated as a single agent or in combination with ipilimumab, is indicated for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) which progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Single agent

  • 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Combination with ipilimumab

  • Nivolumab 3 mg/kg IV q3Weeks PLUS  
  • Ipilimumab 1 mg/kg IV on the same day for 4 doses
  • After completing 4 doses of combination therapy: Administer nivolumab 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Hepatocellular Carcinoma

Indicated as a single agent or in combination with ipilimumab for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib

Single agent

  • 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Combination with ipilimumab

  • Nivolumab 1 mg/kg IV q3Weeks PLUS  
  • Ipilimumab 3 mg/kg IV on the same day for 4 doses
  • After completing 4 doses of combination therapy: Administer nivolumab 240 mg IV q2Weeks or 480 mg IV q4Weeks
  • Continue until disease progression or unacceptable toxicity

Esophageal Squamous Cell Carcinoma

Indicated for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in patients previously treated with fluoropyrimidine- and platinum-based chemotherapy

240 mg IV q2Weeks or 480 mg IV q4Weeks

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Hypothyroidism or hyperthyroidism: No recommended dose modifications

Renal impairment: No dosage modifications required

Note: When administered in combination with ipilimumab, if nivolumab is withheld, ipilimumab should also be withheld

Hepatic impairment

  • Mild or moderate: No dosage modifications required
  • Severe: Not studied

Infusion reactions

  • Mild or moderate: Interrupt or slow infusion rate
  • Severe or life-threatening: Discontinue

Withhold for any of the following

  • Grade 2 pneumonitis
  • Grade 2 diarrhea or colitis
  • Grade 3 diarrhea or colitis (single-agent nivolumab)
  • Grade 2 or 3 hypophysitis
  • Grade 2 adrenal insufficiency
  • Grade 3 hyperglycemia
  • Encephalitis, new-onset moderate or severe neurologic signs or symptoms
  • Grade 3 rash or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
  • Serum creatinine >1.5-6 x ULN or >1.5x baseline
  • Any other severe or grade 3 treatment-related adverse reaction
  • May resume treatment for patients whose adverse reactions recover to grade 0-1

Permanently discontinue for any of the following

  • Grade 3 or 4 pneumonitis
  • Grade 3 diarrhea or colitis (nivolumab in combination with ipilimumab)
  • Grade 4 diarrhea or colitis
  • Grade 4 hypophysitis
  • Grade 3 or 4 adrenal insufficiency
  • Grade 4 hyperglycemia
  • Grade 3 myocarditis
  • Immune-mediated encephalitis
  • Grade 4 rash or confirmed SJS or TEN
  • Serum creatinine >6x ULN
  • Recurrence of same grade 3 adverse reactions
  • Life-threatening or Grade 4 adverse reaction Inability to reduce corticosteroid dose to ≤10 mg/day of prednisone or equivalent within 12 weeks
  • Persistent grade 2 or 3 treatment-related adverse reactions within 12 weeks after the last dose

Hepatitis/non-HCC

  • AST or ALT >3 to 5x ULN, or total bilirubin >1.5 to 3xULN: Withhold dose
  • AST or ALT >5x ULN or total bilirubin >3x ULN: Permanently discontinue

Hepatitis/HCC

  • AST or ALT within normal limits at baseline and increases to >3 to 5x ULN: Withhold dose
  • AST or ALT >1 to 3x ULN at baseline and increases to >5 to 10x ULN: Withhold dose
  • AST or ALT >3 to 5x ULN at baseline and increases to >8 to 10x ULN: Withhold dose
  • AST or ALT increases to >10x ULN or total bilirubin increases to >3x ULN: Permanently discontinue

Dosing Considerations

Patient selection

  • Combination therapy with ipilimumab for metastatic NSCLC should be based on PD-L1 expression
  • Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics

Orphan Designations

Glioblastoma

Gastric cancer, including gastro-esophageal junction cancer

Anal cancer

Mesothelioma (with and without ipilimumab)

Primary mediastinal B-cell lymphoma

Orphan sponsor

  • Bristol-Myers Squibb Company; P. O. Box 4000; Princeton, New Jersey 08543

Dosage Forms & Strengths

IV solution

  • 10mg/mL (4mL, 10mL)
  • Further dilution required before administration

Microsatellite Instability-High Cancer

Indicated as a single agent or in combination with ipilimumab, is indicated for adult and pediatric patients (≥12 years) with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) which progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

<12 years: Safety and efficacy not established

≥12 year

  • Single agent
    • <40 kg: 3 mg/kg IV q2Weeks  
    • ≥40 kg: 240 mg IV q2Weeks or 480 mg IV q4Weeks
    • Continue until disease progression or unacceptable toxicity
  • Combination with ipilimumab
    • Nivolumab 3 mg/kg IV q3Weeks PLUS  
    • Ipilimumab 1 mg/kg IV on the same day for 4 doses
    • After completing 4 doses of combination therapy: Administer nivolumab 3 mg/kg IV q2Weeks (patients <40 kg); 240 mg IV q2Weeks or 480 mg IV q4Weeks (patients ≥40 kg)
    • Continue until disease progression or unacceptable toxicity
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Interactions

Interaction Checker

and nivolumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (All grades)

            Melanoma

            • Increased AST (28%)
            • Hyponatremia (25%)
            • Increased alkaline phosphatase (22%)
            • Rash (21%)
            • Pruritus (19%)
            • Cough (17%)
            • Increased ALT (16%)
            • Hyperkalemia (15%)
            • URTI (11%)

            NSCLC

            • Fatigue (50%)
            • Lymphopenia (47%)
            • Dyspnea, hyponatremia (38%)
            • Musculoskeletal pain (36%)
            • Cough (32%)
            • Nausea (29%)
            • Increases creatinine (22%)
            • Hypercalcemia, hypokalemia, hypomagnesemia (20%)
            • Vomiting, asthenia (19%)
            • Hypocalcemia, hyperkalemia, diarrhea (18%)
            • Edema, pyrexia (17%)
            • Abdominal pain, rash, increased AST (16%)
            • Increased alkaline phosphatase, thrombocytopenia (14%)
            • Chest pain, arthralgia, decreased appetite and weight (13%)
            • Increased ALT (12%)

            1-10% (all grades)

            Melanoma

            • Peripheral edema (10%)

            NSCLC

            • Pneumonia (10%)
            • Pain (10%)

            1-10% (grades 3-4)

            Melanoma

            • Hyponatremia (5%)
            • Increased AST (2.4%)
            • Increased alkaline phosphatase (2.4%)
            • Hyperkalemia (2%)
            • Increased ALT (1.6%)

            NSCLC

            • Dyspnea (9%)
            • Fatigue (7%)
            • Musculoskeletal pain (6%)
            • Pneumonia (5%)
            • Decreased appetite (2.6%)
            • Pain (2.6%)
            • Nausea (1.7%)
            • Abdominal pain (1.7%)
            • Asthenia (1.7%)
            • Edema (1.7%)
            • Cough (1.7%)

            1-10% (other clinically important adverse effects)

            Melanoma

            • Cardiac disorders: Ventricular arrhythmia
            • Eye disorders: Iridocyclitis
            • General disorders and administration site conditions: Infusion-related reactions
            • Immune-mediated disorders: Severe pneumonitis or interstitial lung disease, including fatal cases; colitis; hepatitis; nephritis; thyroid disorders; other immune disorders (pancreatitis, uveitis, demyelination, autoimmune neuropathy, adrenal insufficiency, facial and abducens nerve paresis, hypophysitis, polymyalgia rheumatica, diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome, myasthenic syndrome)
            • Investigations: Increased amylase, increased lipase
            • Nervous system disorders: Dizziness, peripheral and sensory neuropathy
            • Skin and subcutaneous tissue disorders: Exfoliative dermatitis, erythema multiforme, vitiligo, psoriasis

            NSCLC

            • General disorders and administration site conditions: Stomatitis
            • Nervous system disorders: Peripheral neuropathy
            • Infections and infestations: Bronchitis, upper respiratory tract infection

            Postmarketing Reports

            Eye disorders: Vogt-Koyanagi-Harada (VKH) syndrome

            Complications of treatment after allogeneic HSCT: Treatment refractory, severe acute and chronic graft versus host disease (GVHD)

            Pyrexia

            Ascites

            Back pain

            General physical health deterioration

            Abdominal pain

            Pneumonia

            Anemia

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            Warnings

            Contraindications

            None

            Cautions

            Immune-mediated colitis reported; withhold for moderate or severe and permanently discontinue for life-threatening colitis

            Immune-mediated hepatitis observed in clinical trials; monitor for changes in liver function; withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation

            Immune-mediated nephritis and renal dysfunction may occur; monitor for changes in renal function; withhold for moderate and permanently discontinue for severe or life-threatening serum creatinine elevation; withhold therapy for moderate (Grade 2) or severe (Grade 3) increased serum creatinine; permanently discontinue therapy for life-threatening (Grade 4) increased serum creatinine

            Immune-mediated encephalitis can occur; withhold therapy in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out infectious or other causes of moderate to severe neurologic deterioration; evaluation may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture; if other etiologies ruled out, administer corticosteroids at a dose of 1 - 2 mg/kg/day prednisone equivalents for patients with immune-mediated encephalitis, followed by corticosteroid taper; permanently discontinue therapy for immune-mediated encephalitis

            Other clinically significant and potentially fatal immune-mediated adverse reactions (eg, myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis) can occur after therapy discontinuation

            Severe infusion reactions reported (rare, <1%); discontinue if severe or life-threatening; interrupt or slow rate of infusion in patients with mild or moderate infusion reactions

            Can cause fetal harm; advise of potential risk to a fetus and use of effective contraception (see Pregnancy and Lactation)

            Monitor for hyperacute graft-versus-host-disease (GVHD), grade 3-4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions; transplant-related mortality has occurred

            Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody; complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT; consider benefit versus risks of treatment with a PD-1 receptor blocking antibody prior to or after allogeneic HSCT

            In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies; addition of an alternative immunosuppressive agent to corticosteroid therapy, or replacement of corticosteroid therapy should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded

            Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis

            If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt- Koyanagi-Harada-like syndrome, which has been observed in patients receiving drug alone or in combination with ipilimumab, which may require treatment with systemic steroids to reduce risk of permanent vision loss

            Immune-mediated pneumonitis

            • Immune-mediated pneumonitis reported; All patients with pneumonitis required systemic corticosteroids, including 90% who received high-dose corticosteroids (at least 40 mg prednisone equivalents per day) for a median duration of 1 month (5 days to 25 months)
            • Complete resolution occurred in 81% of patients; of the patients that had therapy withheld for pneumonitis, 61% reinitiated treatment after symptom improvement; of these, 18% had recurrence of pneumonitis
            • Withhold therapy for moderate and permanently discontinue for severe or life-threatening pneumonitis

            Immune-mediated endocrinopathies

            • Immune-mediated hypophysitis; monitor; withhold therapy for moderate (Grade 2) or severe (Grade 3); permanently discontinue therapy for life-threatening (Grade 4
            • Immune-mediated hypothyroidism and hyperthyroidism reported; monitor for changes in thyroid function and initiate thyroid hormone replacement as needed;administer hormone-replacement therapy for hypothyroidism; initiate medical management for control of hyperthyroidism
            • Adrenal insufficiency may occur; monitor for signs and symptoms of adrenal insufficiency during and after treatment
            • May cause type 1 diabetes mellitus; monitor for hyperglycemia, withhold if severe (Grade 3) hyperglycemia until metabolic control is achieved, permanently discontinue if life-threatening (Grade 4) hyperglycemia

            Immune-mediated skin reactions

            • May cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN); for symptoms or signs of SJS or TEN, withhold therapy and refer patient for specialized care for assessment and treatment; if SJS or TEN is confirmed, permanently discontinue therapy; for immune-mediated rash, administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by a corticosteroid taper for severe (Grade 3) or life-threatening (Grade 4) rash
            • Immune mediated rash reported in combination with ipilimumab; withhold for severe and permanently discontinue for life-threatening rash
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            Pregnancy & Lactation

            Pregnancy

            Based on its mechanism of action and data from animal studies, fetal harm may occur when administered to a pregnant woman

            There are no available human data informing the drug-associated risk

            Animal data

            • In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death
            • Human IgG4 is known to cross the placental barrier and nivolumab is an immunoglobulin G4 (IgG4); therefore, nivolumab has the potential to be transmitted from the mother to the developing fetus
            • Effects of nivolumab are likely to be greater during the second and third trimesters of pregnancy

            Contraception

            • Females of reproductive potential: Verify pregnancy status prior to initiating therapy; use effective contraception during treatment with nivolumab and for at least 5 months following last dose of therapy

            Lactation

            Unknown if distributed in human breast milk; advise women to discontinue breastfeeding during treatment

            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

            Monoclonal antibody to programmed cell death-1 protein (PD-1); blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2

            PD-1 and PD-L1

            • PD-1 and related target PD-ligand 1 (PD-L1) are expressed on the surface of activated T cells under normal conditions; PD-L1/PD-1 interaction inhibits immune activation and reduces T-cell cytotoxic activity when bound
            • This negative feedback loop is essential for maintaining normal immune responses and limits T-cell activity to protect normal cells during chronic inflammation
            • Tumor cells may circumvent T-cell–mediated cytotoxicity by expressing PD-L1 on the tumor itself or on tumor-infiltrating immune cells, resulting in the inhibition of immune-mediated killing of tumor cells

            Absorption

            Time to steady state: 12 wk (monotherapy)

            Distribution

            Vd: 6.8L (monotherapy); 7.92 L (combined with ipilimumab)

            Elimination

            Clearance: 8.2 mL/h (monotherapy); 10 mL/hr (combined with ipilimumab)

            Half-life: 25 days (monotherapy); 24.8 days (combined with ipilimumab)

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            Administration

            IV Preparation

            Visually inspect drug for particulate matter and discoloration; it should be a clear to opalescent, colorless to pale-yellow solution

            Discard vial if the solution is cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles

            Do not shake the vial

            Admixture

            • Withdraw required volume for calculated dose and transfer to an IV container
            • Dilute with either 0.9% NaCl or D5W to a final concentration ranging from 1-10 mg/mL
            • Total volume of infusion must not exceed 160 mL
            • Mix diluted solution by gentle inversion; do NOT shake
            • Discard partially used vials or empty vials

            IV Administration

            Infuse IV over 30-60 min in an IV line containing a sterile, nonpyrogenic, low protein-binding inline filter (pore size of 0.2-1.2 microns)

            For adult and pediatric patients (<40 kg): Total volume of infusion must not exceed 4 mL/kg of body weigh

            Do not coadminister other drugs through the same IV line

            When administered in combination with ipilimumab, infuse nivolumab first followed by ipilimumab on the same day; use separate infusion bags and filters for each infusion

            Flush the IV line at end of infusion

            Storage

            Does not contain preservatives

            Unopened vials

            • Refrigerate at 2-8°C (36-46°F)
            • Protect from light by storing in the original package
            • Do not freeze

            Diluted admixture

            • Room temperature: Store for up to 8 hr from time of preparation; this includes room temperature storage of the admixture in the IV container and time for administration of the infusion OR
            • Refrigerate at 2-8°C (36-46°F) for no more than 24 hr from the time of admixture preparation
            • Do not freeze
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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.

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            • View the formulary and any restrictions for each plan.
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            • 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.