guselkumab (Rx)

Brand and Other Names:Tremfya
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • prefilled syringe, single-dose
    • 100mg/mL
  • one-Press patient-controlled injector, single-dose
    • 100mg/mL

Plaque Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

100 mg SC at Week 0, Week 4, and q8Weeks thereafter

Psoriatic Arthritis

Indicated for active psoriatic arthritis

100 mg SC at Week 0, Week 4, and q8Weeks thereafter

May be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (eg, methotrexate)

Safety and efficacy not established

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Interactions

Interaction Checker

and guselkumab

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            Contraindicated (0)

              Serious - Use Alternative (15)

              • adenovirus types 4 and 7 live, oral

                guselkumab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • BCG vaccine live

                guselkumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • cholera vaccine

                guselkumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • influenza virus vaccine quadrivalent, intranasal

                guselkumab, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • measles (rubeola) vaccine

                guselkumab, measles (rubeola) vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • measles mumps and rubella vaccine, live

                guselkumab, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • measles, mumps, rubella and varicella vaccine, live

                guselkumab, measles, mumps, rubella and varicella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • rotavirus oral vaccine, live

                guselkumab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • rubella vaccine

                guselkumab, rubella vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • smallpox (vaccinia) vaccine, live

                guselkumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • typhoid polysaccharide vaccine

                guselkumab, typhoid polysaccharide vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • typhoid vaccine live

                guselkumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • varicella virus vaccine live

                guselkumab, varicella virus vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • yellow fever vaccine

                guselkumab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              • zoster vaccine live

                guselkumab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

              Monitor Closely (31)

              • caffeine

                guselkumab, caffeine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • carbamazepine

                guselkumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • cyclosporine

                guselkumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • dengue vaccine

                guselkumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • disopyramide

                guselkumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • fentanyl

                guselkumab, fentanyl. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • fentanyl intranasal

                guselkumab, fentanyl intranasal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • fentanyl transdermal

                guselkumab, fentanyl transdermal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • fentanyl transmucosal

                guselkumab, fentanyl transmucosal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • fosphenytoin

                guselkumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • ifosfamide

                ifosfamide, guselkumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • isavuconazonium sulfate

                guselkumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • lomustine

                lomustine and guselkumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • mechlorethamine

                mechlorethamine, guselkumab. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • midazolam

                guselkumab, midazolam. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • ofatumumab SC

                ofatumumab SC, guselkumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • oxaliplatin

                oxaliplatin and guselkumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

              • phenobarbital

                guselkumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • phenytoin

                guselkumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • pimozide

                guselkumab, pimozide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • primidone

                guselkumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • quinidine

                guselkumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • quinine

                guselkumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • tacrolimus

                guselkumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • theophylline

                guselkumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • thioridazine

                guselkumab, thioridazine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • trastuzumab

                trastuzumab, guselkumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, guselkumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • valproic acid

                guselkumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • warfarin

                guselkumab, warfarin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              • zoster vaccine recombinant

                guselkumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

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                Adverse Effects

                >10%

                Infections (23%)

                Upper respiratory tract infections (14.3%)

                1-10%

                Headache (4.6%)

                Injection site reactions (4.5%)

                Arthralgia (2.7%)

                Elevated liver enzymes (2.6%)

                Diarrhea (1.6%)

                Gastroenteritis (1.3%)

                Tinea infections (1.1%)

                Herpes simplex infections (1.1%)

                Postmarketing Reports

                Immune system disorders: Hypersensitivity, including anaphylaxis

                Skin and subcutaneous tissue disorders: Rash

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                Warnings

                Contraindications

                History of serious hypersensitivity reaction to guselkumab or to any of the excipients

                Cautions

                May increase infection risk; consider risks and benefits in patients with a chronic infection or history of recurrent infection; discontinue drug if patient develops serious infection or is not responding to therapy; treatment should not be initiated in patients with any clinically important active infection until infection resolves or is adequately treated

                Serious hypersensitivity reactions, including anaphylaxis, reported with postmarket use; some cases required hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug and initiate appropriate therapy

                Do not initiate in patients with clinically important active infection until infection resolves or is adequately treated

                Screen for tuberculosis (TB) before initiating treatment; initiate treatment for latent TB prior to administering guselkumab; monitor patients for signs and symptoms of active TB during and after treatment

                Consider completion of all age-appropriate immunizations before initiating guselkumab; avoid live vaccines

                Drug interaction overview

                • Avoid use of live vaccines
                • CYP450 substrates
                  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, tumor necrosis factor-alpha, interferon) during chronic inflammation
                  • Guselkumab may modulate serum levels of some cytokines
                  • Therefore, upon initiating or discontinuing guselkumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate
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                Pregnancy

                Pregnancy

                There is a pregnancy registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; encourage patients to enroll by calling 1-877-311- 8972

                No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes

                Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus

                Animal studies

                • In a combined embryofetal development and prenatal and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after SC administration during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD)
                • Neonatal deaths were observed at 6-to 30-times the MRHD

                Lactation

                Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk

                Guselkumab was not detected in the milk of lactating cynomolgus monkeys

                Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Monoclonal antibody (IgG1-lambda) that inhibits IL-23 by selectively binding to p19 subunit of IL-23; IL-23 is a natural cytokine associated with inflammatory and immune responses; guselkumab inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release

                Absorption

                Bioavailability: 49%

                Peak plasma time (100-mg dose): 5.5 days

                Peak plasma concentration: 8.09 mcg/mL

                Distribution

                Vd: 13.5 L

                Metabolism

                Exact pathway not characterized; expected to degrade into small peptides and amino acids via catabolic pathways similarly to endogenous IgG

                Elimination

                Half-life: 15-18 days

                Total body clearance: 0.516 L/day

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                Administration

                SC Preparation

                Remove from refrigerator; allow syringe to reach room temperature (~30 min) before removing syringe cap

                Preservative free; visually inspect syringe for any particulates or discoloration prior to administration

                SC Administration

                For SC use only; inject full amount (1 mL)

                Do not inject areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis

                Discard unused drug and syringes in a puncture resistant container

                Intended for use under physician supervision and guidance; administer SC by a healthcare professional or patient may self-inject after proper training

                If dose was missed, inject as soon as possible, then adjust dosing schedule accordingly

                Storage

                Store refrigerated at 2-8°C (36-46°F)

                Protect from light until use

                Do not freeze

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Tremfya subcutaneous
                -
                100 mg/mL solution

                Copyright © 2010 First DataBank, Inc.

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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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                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.