Version May 2024
Dosage guidance:
Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and ensure age-appropriate vaccinations are up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.
Ankylosing spondylitis: SubQ: 160 mg once, followed by 80 mg every 4 weeks.
Non radiographic 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. Note: Some patients may require a maintenance dose of 80 mg every 2 weeks (Ref).
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Ixekizumab: Pediatric drug information")
Note: Patients should be current with all age-appropriate immunizations prior to initiation. Evaluate for tuberculosis infection prior to initiating treatment with ixekizumab.
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reaction incidences reported in adults unless otherwise indicated.
>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%; including erythema at injection site, pain at injection site)
Respiratory: Upper respiratory tract infection (14%)
1% to 10%:
Dermatologic: Tinea (2%), urticaria (children, adolescents, and adults: ≤2%)
Gastrointestinal: Crohn disease (children, adolescents, and adults: ≤2%; including exacerbation of Crohn disease), nausea (2%)
Hematologic & oncologic: Thrombocytopenia (3%)
Infection: Influenza (children, adolescents, and adults: ≤2%)
Ophthalmic: Conjunctivitis (adults: ≤1%; children and adolescents: 3%)
<1%:
Gastrointestinal: Inflammatory bowel disease (including ulcerative colitis and exacerbation of ulcerative colitis), oral candidiasis
Hypersensitivity: Angioedema, severe hypersensitivity reaction
Respiratory: Rhinitis
Postmarketing:
Gastrointestinal: Esophageal candidiasis
Hypersensitivity: Anaphylaxis
Serious hypersensitivity reaction (eg, anaphylaxis) to ixekizumab or any component of the formulation
Concerns related to adverse effects:
• Antibody formation: Formation of neutralizing anti-drug antibodies may occur with ixekizumab and may be associated with loss of efficacy (AAD/NPF [Menter 2019]).
• 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 (latent TB) prior to initiating therapy; do not initiate therapy in patients with TB disease (active TB). Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of TB infection or disease. Monitor all patients for signs and symptoms of TB disease 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.
Special populations:
• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently.
Reactivation of tuberculosis (TB) has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test; ≥5 years of age: interferon gamma release assay [IGRA]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016]).
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]
No
Solution Auto-injector (Taltz Subcutaneous)
80 mg/mL (per mL): $8,298.86
Solution Prefilled Syringe (Taltz Subcutaneous)
80 mg/mL (per mL): $8,298.86
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Taltz: 80 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Taltz: 80 mg/mL (1 mL) [contains polysorbate 80]
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.
Parenteral: Ixekizumab is intended for use under the guidance and supervision of a physician.
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. Initial dose (160 mg) requires 2 separate 80 mg injections to administer full dose. Administration in the upper, outer arm may be performed by a caregiver or health care provider. Self-injected should be reserved for patients weighing ≥50 kg only and 80 mg doses following proper training in SubQ injection technique.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Taltz: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf#page=21
Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adult patients.
Non radiographic 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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Anifrolumab: Biologic Anti-Psoriasis Agents may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Data following paternal use of ixekizumab are available from 91 pregnancies of 86 male patients collected from clinical trials, and 3 reported postmarketing (Egeberg 2021). The American Academy of Dermatology considers ixekizumab for the treatment of psoriasis to be likely compatible for use in patients planning to father a child (AAD-NPF [Menter 2019]).
Females and males 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).
Ixekizumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Data following maternal use of ixekizumab during pregnancy are available from 58 patients exposed during clinical trials (56 exposed during the first trimester) and 41 patients from postmarketing reports (all with first trimester exposure). Based on the limited data collected by the manufacturer, safety signals were not identified following maternal use during pregnancy. Outcome data were not available for all pregnancies (Egeberg 2021). Outcome data are also available from 29 pregnancies with ixekizumab exposure reported to the EudraVigilance database (Ghalandari 2022).
Until additional data are available, use of agents other than ixekizumab is recommended for the treatment of psoriasis in pregnant patients (AAD-NPF [Menter 2019]; Yeung 2020).
Data collection to monitor pregnancy and infant outcomes following exposure to ixekizumab is ongoing. Patients exposed to ixekizumab during pregnancy are encouraged to enroll in the registry (1-800-284-1695).
It is not known if ixekizumab is present in breast milk.
Ixekizumab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Prior to therapy start:
• Evaluate for malignancy (especially skin cancer), current or latent infection, lymphadenopathy, signs and symptoms of inflammatory bowel disease, and ensure age-appropriate vaccinations are up to date (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]). In general, do not administer live vaccines within 4 weeks of starting therapy (AAD [Menter 2019]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.
• Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB for patients who have had Bacillus Calmette-Guérin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody), hepatitis C virus antibody, HIV; pregnancy test, C-reactive protein (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).
During therapy:
• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection site reactions, exacerbation, or development of inflammatory bowel disease (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).
• Labs: CBC and LFTs after 3 to 6 months or as clinically indicated, pregnancy test as needed; yearly testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).
After therapy:
• Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).
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.
Onset of action: Psoriasis: Response best determined after 12 weeks (AAD-NPF [Menter 2019]).
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.
Bioavailability: 60% to 81%.
Half-life elimination: 13 days.
Time to peak: ~4 days.
Body weight: In adult patients, clearance and volume of distribution increase as body weight increases.
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