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Indications & Usage

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.

·         adults with active psoriatic arthritis.

·         adults with active ankylosing spondylitis.

·         adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.


Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Dosage & Administration

DOSAGE AND ADMINISTRATION

Administer by subcutaneous injection.

Adult Plaque Psoriasis

·         Recommended dose 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

·         For patients weighing greater than 50 kg, recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

·         For patients weighing 25-50 kg, recommended dose is 80 mg at Week 0, followed by 40 mg every 4 weeks.

·         For patients weighing less than 25 kg, recommended dose is 40 mg at Week 0, followed by 20 mg every 4 weeks.

Psoriatic Arthritis

·         Recommended dose 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.

·         TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate).

Ankylosing Spondylitis

·         Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

Non-radiographic Axial Spondyloarthritis

·         Recommended dose is 80 mg by subcutaneous injection every 4 weeks.

Tuberculosis Assessment Prior to Initiation of TALTZ

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TALTZ [see Warnings and Precautions].

Important Administration Instructions

TALTZ is intended for use under the guidance and supervision of a physician. Adult patients may self-inject or caregivers may give injections of TALTZ 80 mg after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Caregivers may give injections of TALTZ 80 mg to pediatric patients weighing more than 50 kg using the autoinjector or prefilled syringe after training and demonstration of proper subcutaneous injection technique.

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.

Pediatric Patients Weighing 50 kg or Less

TALTZ doses of 20 mg or 40 mg [see Dosage and Administration (2.2)] must be prepared and administered by a qualified healthcare professional. Use only the commercial TALTZ 80 mg/1 mL prefilled syringe when preparing the prescribed 20 mg and 40 mg pediatric dose.

  1. 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.
  2. Expel the entire contents of the prefilled syringe into the sterile vial. DO NOT shake or swirl the vial. No other medications should be added to solutions containing TALTZ.
  3. 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).
  4. Remove the needle from the syringe and replace it with a 27-gauge needle prior to administering TALTZ to the patient.

Storage

If necessary, the prepared TALTZ may be stored at room temperature for up to 4 hours from first puncturing the sterile vial.

 


Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Dosage Forms and Strengths

DOSAGE FORMS AND STRENGTHS

Autoinjector

·         Injection: 80 mg/mL solution in a single-dose prefilled autoinjector.

Prefilled Syringe

·         Injection: 80 mg/mL solution in a single-dose prefilled syringe.


Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Contraindications

CONTRAINDICATIONS

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients


Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

Warnings & Precautions

WARNINGS AND PRECAUTIONS


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)].

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.

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.

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 (6.16.3)]. If a serious hypersensitivity reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy.

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.

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.



Please click to access the Prescribing Information and Medication Guide

Adverse Reactions

ADVERSE REACTIONS

Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 (1-800-LillyRx) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.




Taltz® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries and affiliates.
Taltz Together and Companion in Care are trademarks of Eli Lilly and Company.
PP-IX-US-4136 08/2020

 © Lilly USA, LLC 2020. All rights reserved.

This site is intended for US healthcare providers only.


Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

INDICATIONS AND IMPORTANT SAFETY INFORMATION


Taltz is indicated for:

  • Adult patients and pediatric patients 6 years of age and older with severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
  • Adult patients with active psoriatic arthritis (PsA)
  • Adult patients with active ankylosing spondylitis (AS)
  • Adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

  

IMPORTANT SAFETY INFORMATION for Taltz (ixekizimab) 

 

CONTRAINDICATIONS

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections

Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. 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.

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. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

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. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease

Patients treated with Taltz may be at an 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 group.  During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

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.

ADVERSE REACTIONS

Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

 

 IX HCP ISI 07MAY2020