guselkumab (Rx)

Brand and Other Names:Tremfya
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection (prefilled syringe)

  • 100mg/mL

Plaque Psoriasis

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

100 mg SC at week 0, week 4, and q8wk thereafter

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and guselkumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Infections, general (23%); compared with 21% in placebo group

            Upper respiratory tract infections (14.3%)

            1-10%

            Headache (4.6%)

            Injection site reactions (4.5%)

            Arthralgia (2.7%)

            Diarrhea (1.6%)

            Gastroenteritis (1.3%)

            Tinea infections (1.1%)

            Herpes simplex infections (1.1%)

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            Warnings

            Contraindications

            None

            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

            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

            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

            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; each prefilled syringe is single dose 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)

            Store in original carton until time of use

            Protect from light until use

            Do not freeze

            Do not shake

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            Images

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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.