brodalumab (Rx)

Brand and Other Names:Siliq
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

  • 210mg/1.5mL (single-dose prefilled syringe)

Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

210 mg SC at Weeks 0, 1, and 2, THEN

210 mg SC q2wk

If an adequate response has not been achieved after 12-16 weeks, consider discontinuing therapy; continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success

Dosing Considerations

Evaluate patients for tuberculosis (TB) prior to initiating (see Cautions)

Safety and efficacy not established

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Interactions

Interaction Checker

and brodalumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (3.5%)

            Arthralgia (3.3%)

            Fungal infections (2.4%)

            Injection site reaction (1.3%)

            Fatigue (1.1%)

            Diarrhea (1.1%)

            Oropharyngeal pain (1.1%)

            Nausea (1.1%)

            <1%

            Serious infections (0.5%)

            Influenza (0.5%)

            Neutropenia (0.5%)

            Tinea infections (0.2%)

            Conjunctivitis

            Candida infections

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            Warnings

            Black Box Warnings

            Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab

            Prior to prescribing, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior

            Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate

            Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new-onset or worsening depression, anxiety, or other mood changes

            Because of the observed suicidal behavior, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program

            Patient wallet card

            • Give patients the Patient Wallet Card and instruct them to carry it with them at all times
            • Patients should seek medical evaluation and show the card, to the treating healthcare provider, if they experience symptoms of suicide or depression described on the card
            • They should also call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts

            Contraindications

            Crohn disease

            Cautions

            Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated in the psoriasis clinical trials; there were no completed suicides in the 12-week placebo-controlled portion of the trials; brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared with users without such a history (see Black Box Warnings)

            Available only through a restricted access program (see Black Box Warnings)

            May increase risk of infections; in patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing; if a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue the drug until the infection resolves

            Evaluate patients for TB before initiating; do not administer to patients with active TB; initiate treatment for latent TB prior to administering brodalumab; closely monitor patients for signs and symptoms of active TB during and after treatment

            In psoriasis trials, which excluded subjects with active Crohn disease, Crohn disease occurred in 1 subject during treatment and led to brodalumab discontinuation; in other trials, exacerbation of Crohn disease was observed with brodalumab (see Contraindications)

            Drug interaction overview

            • Avoid use of live vaccines; no data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab
            • CYP450 substrates
              • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
              • Brodalumab may modulate serum levels of some cytokines
              • Therefore, upon initiating or discontinuing brodalumab 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 are no human data regarding use in pregnant women to inform a drug-associated risk

            Human IgG antibodies are known to cross the placental barrier; therefore, brodalumab 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 26 times the maximum recommended human dose

            Lactation

            Unknown if distributed in human breast milk

            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

            Human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25

            IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes used by multiple IL-17 family cytokines

            Blocking IL­17RA inhibits IL-17 cytokine-induced responses, including the release of proinflammatory cytokines and chemokines

            Absorption

            Bioavailability (SC): ~55%

            Peak plasma time: ~3 days

            Peak plasma concentration: 13.4 mcg/mL

            AUC: 111 mcg·day/mL

            Distribution

            Vd: 8.9 L

            Metabolism

            The metabolic pathway has not been characterized

            As a human monoclonal IgG2 antibody, brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG

            Elimination

            Total clearance: 3 L/day

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            Administration

            SC Preparation

            Allow syringe to reach room temperature (~30 minutes) before injecting

            Do not warm in any other way

            Do not remove the gray needle cap on the prefilled syringe while allowing it to reach room temperature

            Visually inspect for particles and discoloration prior to administration; should appear as a clear to slightly opalescent, colorless to slightly yellow solution; a few translucent to white, amorphous proteinaceous particles may be present

            Do not use if solution is cloudy or discolored or if foreign matter is present

            Instruct patients to use the prefilled syringe and to inject the full amount (1.5 mL), which provides 210 mg, according to the directions provided

            SC Administration

            Administer SC

            Each prefilled syringe is for single dose only

            Instruct patients to review the Medication Guide before use

            Intended for use under the guidance and supervision of a healthcare professional

            Patients may self-inject when deemed appropriate by a healthcare professional and after proper training in SC injection technique using the prefilled syringe

            Advise patients who are self-administering to inject the full dose

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

            Storage

            Store refrigerated at 2-8°C (36-46°F) in the original carton to protect from light and physical damage during storage

            When necessary, prefilled syringes can be stored at room temperature up to a maximum of 77°F (25°C) in the original carton for a maximum single period of 14 days with protection from light and sources of heat

            Once the prefilled syringe has reached room temperature, do not place back into the refrigerator

            Discard after 14 days at room temperature

            Do not freeze

            Do not shake

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            Formulary

            FormularyPatient Discounts

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            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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