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Ixekizumab

Pronunciation

(ix ee KIZ ue mab)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous [preservative free]:

Taltz: 80 mg/mL (1 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Taltz: 80 mg/mL (1 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Taltz

Pharmacologic Category

  • Antipsoriatic Agent
  • Interleukin-17A Receptor Antagonist
  • Monoclonal Antibody

Pharmacology

Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.

Distribution

Vdss: 7.1 L

Metabolism

Expected to be degraded into small peptides and amino acids via catabolic pathways similar to that which is seen with endogenous IgG

Time to Peak

~4 days

Half-Life Elimination

13 days

Special Populations Note

Body weight: Clearance and volume of distribution increase as body weight increases.

Use: Labeled Indications

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Contraindications

Serious hypersensitivity reaction (eg, anaphylaxis) to ixekizumab or any component of the formulation

Dosing: Adult

Plaque psoriasis: SubQ: 160 mg once, followed by 80 mg at weeks 2, 4, 6, 8, 10 and 12, and then 80 mg every 4 weeks.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Reconstitution

Remove autoinjector or prefilled syringe from the refrigerator prior to use and allow to stand for 30 minutes to reach room temperature. Do not remove the needle cap. Inspect visually for particulate matter and discoloration. The liquid should be essentially free of visible particles and colorless to slightly yellow. Do not shake.

Administration

Subcutaneous: Allow to reach room temperature prior to injection. Do not shake. Inject full amount into the upper arms, thighs or any quadrant of the abdomen; administer each injection at a different anatomic location than a previous injection and avoid 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 health care provider. Ixekizumab is intended for use under the guidance and supervision of a physician; may be self-injected by the patient following proper training in SubQ injection technique.

Storage

Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Discard any unused portion.

Drug Interactions

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Adverse Reactions

Frequency not always defined.

Dermatologic: Tinea (2%)

Gastrointestinal: Nausea (2%)

Hematologic & oncologic: Neutropenia (11%), thrombocytopenia (3%)

Immunologic: Immunogenicity (22%), antibody development (neutralizing: 2%; associated with decreased drug concentration and loss of drug efficacy)

Infection: Infection (26% to 38%; maintenance period: 57%)

Local: Injection site reaction (17%; most frequently, erythema and pain)

Respiratory: Upper respiratory tract infection (14%)

<1% (Limited to important or life-threatening): Angioedema, Crohn's disease, conjunctivitis, influenza, oral candidiasis, rhinitis, serious infection (maintenance period), ulcerative colitis, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Urticaria and angioedema have been reported; discontinue immediately if signs/symptoms of a serious hypersensitivity reaction develop and initiate appropriate treatment.

• Infections: May increase the risk of infections. A higher rate of infections was observed with ixekizumab treatment in clinical trials, including upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections. Use with caution in patients with a chronic infection or a history of recurrent infection. In patients who develop a serious infection, monitor closely and discontinue use until the infection resolves.

• Tuberculosis: Patients should be evaluated for tuberculosis infection prior to initiating therapy; do not initiate therapy in patients with an active tuberculosis infection. Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of latent or active tuberculosis. Monitor all patients for signs and symptoms of active tuberculosis during and after treatment.

Disease-related concerns:

• Inflammatory bowel disease: Treatment with ixekizumab may cause Crohn disease and ulcerative colitis, including exacerbations; monitor patients for signs and symptoms of inflammatory bowel disease.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently.

Monitoring Parameters

Signs and symptoms of infection, active tuberculosis (during and after treatment), and signs/symptoms of inflammatory bowel disease

Pregnancy Considerations

Adverse events were not observed in animal reproduction study, however an increase in neonatal deaths was observed when dosing continued throughout pregnancy. Human IgG is known to cross the placenta.

In general, maternal use of monoclonal antibodies during pregnancy may increase the risk of infection to the exposed infant or interfere with vaccine administration in the newborn (Mervic 2014). Other agents are currently preferred for the treatment of plaque psoriasis in pregnant women (Hsu 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea or injection site irritation. Have patient report immediately to prescriber signs of infection, signs of skin infection, redness or white patches in mouth or throat, eye redness, abdominal pain, diarrhea, bloody diarrhea, or weight loss (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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