ixekizumab (Rx)

Brand and Other Names:Taltz
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for subcutaneous injection

  • 80mg/mL
  • Available as autoinjector or prefilled syringe

Psoriasis

Indicated for adults with moderate-to-severe plaque psoriasis

Week 0: 160 mg SC (ie, as two 80-mg injections), THEN

80 mg SC q2wks at weeks 2, 4, 6, 8, 10, and 12, THEN

80 mg SC q4wks

Psoriatic Arthritis

Indicated for adults with active psoriatic arthritis; may be administered alone or in combination with a conventional DMARD (eg, methotrexate)

160 mg SC (ie, as two 80-mg injections) once, THEN 80 mg SC q4wk

For patients with coexisting moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis

Dosage Modifications

Hepatic or renal impairmen

  • No dosage adjustment required

Dosing Considerations

Evaluate patients for tuberculosis (TB) prior to initiating treatment

Safety and efficacy not established

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Interactions

Interaction Checker

and ixekizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site reactions (17%)

            Upper respiratory tract infections (14%)

            1-10%

            Thrombocytopenia, Grade 1 (3%)

            Nausea (2%)

            Tinea infections (2%)

            <1%

            Serious hypersensitivity reactions

            Serious infections

            Neutropenia

            Postmarketing Reports

            Immune system disorders: Anaphylaxis

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            Warnings

            Contraindications

            Previous serious hypersensitivity reaction (eg, anaphylaxis) to drug or excipients

            Cautions

            May increase the risk of infection; upper respiratory tract infections, oral candidiasis, conjunctivitis, and tinea infections occurred more frequently with ixekizumab compared with placebo; instruct patients to seek medical advice if signs or symptoms of infection occur; if a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves

            Evaluate patients for TB prior to initiating treatment; do not administer to patients with active TB; initiate treatment of latent TB prior to administering ixekizumab; consider anti-TB therapy prior to initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed; monitor closely for signs and symptoms of active TB during and after ixekizumab treatment

            Serious hypersensitivity reactions reported, including angioedema and urticaria; anaphylaxis reported, some requiring hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy

            Monitor for onset or exacerbation of Crohn disease and ulcerative colitis

            Drug interaction overview

            • Prior to initiating drug, consider completion of all age-appropriate immunizations; avoid use of live vaccines; no data are available on the response to live vaccines while taking ixekizumab
            • Altering CYP450 enzymes
              • 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; thus, ixekizumab, an IL-17A antagonist, could normalize the formation of CYP450 enzymes
              • Upon initiating or discontinuing ixekizumab in patients receiving concomitant 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 available data regarding use in pregnant women to inform any drug-associated risks

            Human IgG is known to cross the placental barrier; therefore, ixekizumab may be transmitted from the mother to the developing fetus

            Animal studies

            • Unknown if distributed in human breast milk
            • 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

            Lactation

            Unknown if distributed in human breast milk

            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

            Humanized monoclonal IgG4 antibody that targets interleukin-17A (IL-17A) and neutralizes the proinflammatory effects of IL-17A

            IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis

            Absorption

            Bioavailability: 60-81%; higher when administered in thigh vs arm or abdomen

            Peak plasma time: 4 days

            Peak plasma concentration: 16.2 mcg/mL

            Trough plasma concentration (steady-state at ~10 wk): 9.3 mcg/mL

            Distribution

            Vd (steady-state): 7.11 L (increased with increased weight)

            Metabolism

            The metabolic pathway has not been characterized

            Humanized IgG4 monoclonal antibodies are expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG

            Elimination

            Half-life: 13 days

            Systemic clearance: 0.39 L/day (increased with increased weight)

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            Administration

            SC Preparation

            Before injection, remove autoinjector or prefilled syringe from the refrigerator and allow to reach room temperature (30 minutes) without removing the needle cap

            Inspect visually for particulate matter and discoloration prior to administration

            Should appear as a clear and colorless to slightly yellow solution

            Do not use if the liquid contains visible particles or is discolored or cloudy (other than clear and colorless to slightly yellow)

            Does not contain preservatives; therefore, discard any unused product remaining in the autoinjector or prefilled syringe

            SC Administration

            Intended for use under the guidance and supervision of a physician

            Patients may self-inject after training in SC injection technique using the autoinjector or prefilled syringe

            Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg, according to the directions provided in the Instructions for Use provided in the Medication Guide supplied with the drug

            Administer each injection at a different anatomic location (eg, upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis

            Administration in the upper, outer arm may be performed by a caregiver or healthcare provider

            Missed dose: Administer as soon as possible; thereafter, resume dosing at the regular scheduled time

            Storage

            Sterile and preservative-free solution

            Protect from light until use

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

            Do not freeze

            Do not use if drug has been frozen

            Do not shake

            Discard used syringe/autoinjector in a puncture-resistant container

            Not made with natural rubber latex

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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.

            Adding plans allows you to:

            • 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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