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Ixekizumab

Medically reviewed by Drugs.com. Last updated on Aug 10, 2020.

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

  • Anti-interleukin 17A Monoclonal Antibody
  • Antipsoriatic Agent
  • 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: In adult patients, clearance and volume of distribution increase as body weight increases.

Use: Labeled Indications

Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adult patients.

Nonradiographic axial spondyloarthritis: Treatment of active nonradiographic axial spondyloarthritis with objective signs of inflammation in adult patients.

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adult and pediatric patients ≥6 years of age who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adult patients.

Contraindications

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

Dosing: Adult

Ankylosing spondylitis: SubQ: 160 mg once, followed by 80 mg every 4 weeks.

Nonradiographic axial spondyloarthritis: SubQ: 80 mg every 4 weeks.

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.

Psoriatic arthritis: SubQ: 160 mg once, followed by 80 mg every 4 weeks; may administer alone or in combination with conventional disease-modifying antirheumatic drugs (eg, methotrexate). Note: For psoriatic arthritis patients with coexisting moderate to severe plaque psoriasis, use the dosing regimen for plaque psoriasis.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Plaque psoriasis, moderate to severe:

Children ≥6 years and Adolescents <18 years:

<25 kg: SubQ: 40 mg once, followed by 20 mg every 4 weeks.

25 to 50 kg: SubQ: 80 mg once, followed by 40 mg every 4 weeks.

≥50 kg: SubQ: 160 mg once (administered as 2 separate 80 mg injections), followed by 80 mg every 4 weeks.

Adolescents ≥18 years: SubQ: 160 mg once (week 0; administered as 2 separate 80 mg injections), followed by 80 mg every 2 weeks (at weeks 2, 4, 6, 8, 10, and 12) for 6 doses, and then 80 mg every 4 weeks.

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

SubQ: Allow to reach room temperature prior to injection (30 minutes). 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 or caregiver following proper training in SubQ injection technique.

Storage

Store at 2°C to 8°C (36°F to 46°F). May be stored at room temperature (≤30°C [86°F]) for ≤5 days in original carton; do not return to refrigerator. Discard, if unused, within 5 days. Record date removed from refrigerator on carton. For multi-pack cartons, remove a single autoinjector at a time from the refrigerator. Do not freeze. Protect from light.

Drug Interactions

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

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

Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. 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. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. 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

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

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. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

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

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

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

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

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. Consider therapy modification

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Management: Concomitant use of upadacitinib with potent immunosuppressants is not recommended. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. Avoid combination

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. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

Adverse Reactions

>10%:

Hematologic & oncologic: Neutropenia (11%; grades ≥3: <1%)

Immunologic: Antibody development (5% to 22%; neutralizing antibodies associated with decreased drug concentration and loss of efficacy: 2%)

Infection: Infection (27% to 38%; maintenance period: 57%; serious infection: <1%)

Local: Injection site reaction (17%; includes erythema at injection site, pain at injection site)

Respiratory: Upper respiratory tract infection (14%)

1% to 10%:

Dermatologic: Tinea (2%)

Gastrointestinal: Crohn's disease (≤1%), nausea (2%)

Hematologic & oncologic: Thrombocytopenia (3%)

Infection: Influenza (≤1%)

Ophthalmic: Conjunctivitis (adults: ≤1%; children and adolescents: 3%)

<1%:

Dermatologic: Urticaria

Gastrointestinal: Inflammatory bowel disease, oral candidiasis, ulcerative colitis

Hypersensitivity: Angioedema, severe hypersensitivity reaction

Respiratory: Rhinitis

Postmarketing: Hypersensitivity: Anaphylaxis

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious hypersensitivity reactions, including urticaria, angioedema, and anaphylaxis (which may lead to hospitalization), 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 (TB) infection prior to initiating therapy; do not initiate therapy in patients with an active TB infection. Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of latent or active TB. Monitor all patients for signs and symptoms of active TB 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 onset or exacerbation of inflammatory bowel disease (IBD); discontinue use and initiate appropriate treatment if IBD occurs.

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; hypersensitivity reactions

Reproductive Considerations

The American Academy of Dermatology considers ixekizumab for the treatment of psoriasis to be likely compatible for use in male patients planning to father a child (AAD-NPF [Menter 2019]).

Women and men with well-controlled psoriasis who are planning a pregnancy and wish to avoid fetal exposure can consider discontinuing ixekizumab 9 weeks prior to attempting pregnancy (Rademaker 2018).

Pregnancy Considerations

Ixekizumab is a humanized monoclonal antibody (IgG4). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Patient Education

What is this drug used for?

• It is used to treat plaque psoriasis.

• It is used to treat psoriatic arthritis.

• It is used to treat ankylosing spondylitis.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Common cold symptoms

• Nausea

• Injection site irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Infection

• Skin sores

• Thrush

• Eye redness

• Abdominal pain

• Diarrhea

• Bloody diarrhea

• Weight loss

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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