hepatitis A vaccine inactivated (Rx)

Brand and Other Names:Havrix, Vaqta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection

  • 50 units/mL (Vaqta adult dose)
  • 1440 ELISA units/mL (Havrix adult dose)

Hepatitis A Immunization

Indicated as active immunization for any person seeking protection and for persons at risk for HAV infection

At risk populations

  • Chronic liver disease (eg, hepatitis B infection, hepatitis C infection, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST >2x ULN)
  • HIV infection
  • Men who have sex with men
  • Injection or noninjection drug use
  • Persons who are homeless
  • Work with hepatitis A virus (eg, research laboratory, work with nonhuman primates with HAV infection)
  • Travel in countries with high or intermediate endemic HAV infection
  • Close, personal contact with international adoptee (eg, household or regular babysitting) in first 60 days after arrival from country with high or intermediate endemic HAV infection (administer dose 1 as soon as adoption planned, at least 2 weeks before adoptee’s arrival)
  • Pregnancy if at risk for infection or severe outcome from infection during pregnancy
  • Setting for exposure, including healthcare settings targeting services to injection or noninjection drugs users or group homes; nonresidential day care facilities for developmentally disabled persons

2-dose vaccination series

  • ≥19 years: 1 mL IM (primary dose)
  • Administer primary dose at least 2 weeks before expected exposure to HAV
  • Havrix: Administer booster dose 6-12 mo after primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose

Preexposure protection against HAV for travelers (ACIP guidelines)

  • 1 mL IM given at least 2 weeks before expected exposure to HAV
  • For persons not previously vaccinated with hepatitis A vaccine, administer dose as soon as travel is considered, and complete 2-dose series according to routine schedule
  • Also consider giving immune globulin for patients who are immunocompromised or have chronic liver disease, or those 40 yr or older who are otherwise healthy

Postexposure prophylaxis (PEP) for HAV

  • 1 mL IM
  • A second dose is not required for PEP; however, for long-term immunity, ACIP recommends completing the 2-dose series
  • Age ≥40 years: Consider the need to also give immunoglobulin
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites

Additional Information

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/default.htm

Dosage Forms & Strengths

injection

  • 25 units/0.5 mL (Vaqta pediatric dose)
  • 720 ELISA units/0.5mL (Havrix pediatric dose)

Hepatitis A Immunization

Indicated as routine vaccination for children at least 12 months of age (ACIP guidelines)

<12 months: Not indicated; if administered, not counted toward the routine 2-dose series

≥12 months through 18 years (2-dose series)

  • Primary dose: 0.5 mL IM
  • Havrix: Administer booster dose 6-12 mo after primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose
  • Children who have received 1 dose before age 24 months, should receive a second dose 6-18 months after the first dose

Catch up schedule

  • For any person ≥2 yr who has not already received hepatitis A vaccine series, give 2 doses separated by 6-18 months if immunity against hepatitis A virus infection is desired
  • Minimum interval between the 2-dose series is 6 months

Preexposure protection against HAV for travelers (ACIP guidelines)

  • <6 months: Do not administer hepatitis A vaccine, but do administer immune globulin
  • 6-11 months: 0.5 mL IM; this dose does not count toward routine 2-dose vaccination series
  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
  • Immunocompromised or chronic liver disease: 0.5 mL IM; also consider giving immune globulin

Postexposure prophylaxis (PEP) for HAV

  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites

International travel

  • Persons traveling to or working in countries with high or intermediate endemic hepatitis A
    • Infants age 6-11 months: 1 dose before departure; revaccinate with 2 doses, separated by at least 6 months, between 12 and 23 months of age
    • Unvaccinated >12 months: Administer dose 1 as soon as travel is considered; give dose 2 after 6 months
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Interactions

Interaction Checker

and hepatitis A vaccine inactivated

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (1)

            • belimumab

              belimumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

            Serious - Use Alternative (36)

            • adalimumab

              adalimumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • alefacept

              alefacept decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • anakinra

              anakinra decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • azathioprine

              azathioprine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • basiliximab

              basiliximab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • budesonide

              budesonide decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • canakinumab

              canakinumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • cortisone

              cortisone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • deflazacort

              deflazacort decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • dexamethasone

              dexamethasone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • etanercept

              etanercept decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • everolimus

              everolimus decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • fludrocortisone

              fludrocortisone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • glatiramer

              glatiramer decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • golimumab

              golimumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hydrocortisone

              hydrocortisone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • infliximab

              infliximab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • leflunomide

              leflunomide decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methylprednisolone

              methylprednisolone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              muromonab CD3 decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mycophenolate

              mycophenolate decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ocrelizumab

              ocrelizumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.

            • ofatumumab SC

              ofatumumab SC decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

            • prednisolone

              prednisolone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • prednisone

              prednisone decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • rilonacept

              rilonacept decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • secukinumab

              secukinumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

            • siponimod

              siponimod decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • sirolimus

              sirolimus decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              tacrolimus decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • temsirolimus

              temsirolimus decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tocilizumab

              tocilizumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            Monitor Closely (18)

            • certolizumab pegol

              certolizumab pegol decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor.

            • cyclosporine

              cyclosporine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

            • dengue vaccine

              dengue vaccine, hepatitis A vaccine inactivated. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.

            • ibrutinib

              ibrutinib decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ifosfamide

              ifosfamide decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • lomustine

              lomustine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine

              mechlorethamine decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • melphalan

              melphalan decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mercaptopurine

              mercaptopurine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methotrexate

              methotrexate decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor. Concomitant administration of methotrexate can decrease the immunological response of vaccines.

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

            • oxaliplatin

              oxaliplatin decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ponesimod

              ponesimod decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.

            • procarbazine

              procarbazine decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • rituximab

              rituximab, hepatitis A vaccine inactivated. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            • rituximab-hyaluronidase

              rituximab-hyaluronidase, hepatitis A vaccine inactivated. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

            • ustekinumab

              ustekinumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor. Inactivated vaccinations administered during ustekinumab treatment may not elicit an immune response sufficient to prevent disease.

            • voclosporin

              voclosporin decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.

            Minor (2)

            • chloroquine

              chloroquine decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Minor/Significance Unknown.

            • ozanimod

              ozanimod decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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            Adverse Effects

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            >10%

            Injection site tenderness (3-56%), erythema (1-22%), warmth (1-17%), swelling (9-11%)

            Irritability (11-36%)

            Anorexia (1-19%)

            Drowsiness (15-17%)

            Headache (1-16%)

            Fever > 100.4 F (9-11%)

            1-10%

            URI (1-10%)

            Otitis media (8%)

            Rhinorrhea (6%)

            Diarrhea (1-6%)

            Cough (1-5%)

            Rash (1-5%)

            Weakness/fatigue (4%)

            Vomiting (1-4%)

            Fever > 102 F (3%)

            Crying (2%)

            <1%

            Hematoma

            Incr. CPK

            Photophobia

            Vertigo

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            Warnings

            Contraindications

            Documented hypersensitivity

            Cautions

            First dose at least 2 wk before exposure to HAV

            Current exposure to HAV: may co-administer IG

            The tip caps of prefilled syringes contain natural rubber latex which may cause allergic reactions

            Syncope (fainting) can occur in association with administration of injectable vaccines; syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

            Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of vaccine

            Immunocompromised persons may have diminished immune response to drug, including individuals receiving immunosuppressant therapy

            Hepatitis A virus has a relatively long incubation period (15 to 50 days); therapy may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at time of vaccination; additionally, vaccination may not protect all individuals

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not established

            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

            Attenuated strain of hepatitis A virus (HAV) which stimulates active immunity

            Pharmacokinetics

            Onset: 4 wk

            Duration: unknown

            These products convey active immunity via stimulation of production of endogenously produced antibodies

            The onset of protection from disease is relatively slow, but duration is long lasting (years)

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            Administration

            IM Preparation

            Do not dilute

            Shake vial or syringe well to obtain a slightly opaque, white suspension before administering

            Discard if suspension does not appear homogenous or if extraneous particulate matter remains or discoloration observed

            IM Administration

            Adults, adolescents, and children aged ≥2 years: Administer in deltoid region

            Children aged 12-23 months: Administer in anterolateral area of the thigh

            Storage

            Refrigerate at 2-8°C (36-46°F)

            Do not freeze; discard if vaccine has been frozen (freezing destroys potency)

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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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.