1 ML ixekizumab 80 MG/ML Auto-Injector

INDICATIONS AND USAGE TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis. ( 1.2 ) adults with active ankylosing spondylitis. ( 1.3 ) adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. ( 1.4 ) 1.1 Plaque Psoriasis TALTZ ® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis. 1.3 Ankylosing Spondylitis TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Non-radiographic Axial Spondyloarthritis TALTZ is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

DOSAGE AND ADMINISTRATION Administer by subcutaneous injection. Adult Plaque Psoriasis ( 2.2 ) Recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. Pediatric Plaque Psoriasis ( 2.3 ) For patients weighing greater than 50 kg, recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For patients weighing 25-50 kg, recommended dosage is 80 mg at Week 0, followed by 40 mg every 4 weeks. For patients weighing less than 25 kg, recommended dosage is 40 mg at Week 0, followed by 20 mg every 4 weeks. Psoriatic Arthritis ( 2.4 ) Recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis. ( 2.2 ) TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate). Ankylosing Spondylitis ( 2.5 ) Recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. Non-radiographic Axial Spondyloarthritis ( 2.6 ) Recommended dosage is 80 mg by subcutaneous injection every 4 weeks. 2.1 Testing and Procedures Prior to Treatment Initiation Perform the following evaluations prior to TALTZ initiation: Evaluate patients for tuberculosis (TB) infection. TALTZ initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of TALTZ [see Warnings and Precautions ( 5.2 )] . Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with TALTZ [see Warnings and Precautions ( 5.6 )] . 2.2 Recommended Dosage in Adult Plaque Psoriasis TALTZ is administered by subcutaneous injection. The recommended dosage in adults with moderate-to-severe plaque psoriasis is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. 2.3 Recommended Dosage in Pediatric Plaque Psoriasis TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dosage in pediatric patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis is based on the following weight categories. Table 1: Recommended Dosage for Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Pediatric Patient's Weight Starting Dose (Week 0) Dose every 4 weeks (Q4W) Thereafter Greater than 50 kg 160 mg (two 80 mg injections) 80 mg 25 to 50 kg 80 mg 40 mg Less than 25 kg 40 mg 20 mg 2.4 Recommended Dosage in Psoriatic Arthritis The recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis [see Dosage and Administration ( 2.2 )] . TALTZ may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). 2.5 Recommended Dosage in Ankylosing Spondylitis The recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. 2.6 Recommended Dosage in Non-radiographic Axial Spondyloarthritis The recommended dosage is 80 mg by subcutaneous injection every 4 weeks. 2.7 Preparation and Administration Instructions TALTZ is intended for use under the guidance and supervision of a healthcare provider. Adult patients may self-inject or caregivers may give injections of TALTZ after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Safety and effectiveness of pediatric self-administration has not been established. Therefore, TALTZ should be administered to pediatric patients by a healthcare provider or by a caregiver who has received training and demonstrated proper subcutaneous injection technique. TALTZ 20 mg and 40 mg doses prepared from the TALTZ 80 mg/mL prefilled syringe should only be administered by a qualified healthcare professional [see Dosage and Administration ( 2.8 )] . The TALTZ “Instructions for Use” contains more detailed instructions on the preparation and administration of TALTZ [see Instructions for Use] . Before injection, remove TALTZ autoinjector or TALTZ prefilled syringe from the refrigerator and allow TALTZ to reach room temperature (30 minutes) without removing the needle cap. Inspect TALTZ visually for particulate matter and discoloration prior to administration. TALTZ is a clear and colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow). Administer each injection at a different anatomic location (such as 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 of TALTZ in the upper, outer arm may be performed by a caregiver or healthcare provider [see Instructions for Use] . TALTZ does not contain preservatives, therefore discard any unused product. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 2.8 Alternative Preparation Instructions of TALTZ Doses for Pediatric Patients with Plaque Psoriasis Weighing 50 kg or Less If the 20 mg/0.25 mL or 40 mg/0.5 mL prefilled syringe is unavailable, TALTZ doses of 20 mg or 40 mg for pediatric patients with plaque psoriasis [see Dosage and Administration ( 2.3 )] must be manually prepared according to the steps below using only the TALTZ 80 mg/mL prefilled syringe. The preparation and administration of the 20 mg and 40 mg doses should only be performed by a qualified healthcare professional. For additional preparation and administration instructions, [see Dosage and Administration ( 2.7 )] . Gather the following necessary supplies for preparation: 0.5 mL or 1 mL disposable syringe Sterile needle for withdrawal 27-gauge sterile needle for administration Sterile, clear glass vial. Expel the entire contents of the prefilled syringe into the sterile vial. DO NOT shake or swirl the vial. Do not add other medications to solutions containing TALTZ. Using the 0.5 mL or 1 mL disposable syringe and sterile needle, withdraw the prescribed dose from the vial (0.25 mL for 20 mg; 0.5 mL for 40 mg). Remove the needle from the syringe and replace it with a 27-gauge needle prior to administering TALTZ. Storage of Prepared TALTZ If necessary, TALTZ 20 mg or 40 mg doses prepared from an 80 mg/mL prefilled syringe may be stored at room temperature for up to 4 hours from first puncturing the sterile vial.

WARNINGS AND PRECAUTIONS Infections : Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue TALTZ until the infection resolves. ( 5.1 ) Tuberculosis (TB) : Evaluate for TB prior to initiating treatment. ( 5.2 ) Hypersensitivity : If a serious allergic reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy. ( 5.3 ) Eczematous Eruptions: In the postmarketing setting, cases of severe eczematous eruptions were reported in patients receiving TALTZ. Treatment may need to be discontinued to resolve the eczematous eruption. ( 5.4 ) Inflammatory Bowel Disease : Crohn's disease and ulcerative colitis, including exacerbations, occurred during clinical trials. Monitor closely when prescribing TALTZ to patients with inflammatory bowel disease (IBD). Discontinue TALTZ and initiate appropriate medical management if IBD develops. ( 5.5 ) Immunizations : Avoid use of live vaccines. ( 5.6 ) 5.1 Infections TALTZ may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the TALTZ group had a higher rate of infections than the placebo group (27% vs. 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ group than in the placebo group. A similar increase in risk of infection was seen in placebo-controlled trials in patients with pediatric psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis [see Adverse Reactions ( 6.1 )] . In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors including TALTZ. Instruct patients treated with TALTZ to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TALTZ until the infection resolves. 5.2 Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TALTZ. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering TALTZ. Consider anti-TB therapy prior to initiating TALTZ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving TALTZ should be monitored closely for signs and symptoms of active TB during and after treatment. 5.3 Hypersensitivity Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the TALTZ group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post marketing use with TALTZ [see Adverse Reactions ( 6.1 , 6.3 )] . If a serious hypersensitivity reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy. 5.4 Eczematous Eruptions In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving TALTZ; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of TALTZ. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing TALTZ. 5.5 Inflammatory Bowel Disease Patients treated with TALTZ may be at increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the TALTZ group than the placebo control group [see Adverse Reactions ( 6.1 )] . During TALTZ treatment, monitor for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue TALTZ and initiate appropriate medical management. 5.6 Immunizations Prior to initiating therapy with TALTZ, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TALTZ. No data are available on the response to live vaccines.

CONTRAINDICATIONS TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients. ( 4 )

Mechanism of Action 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.