About This Information

This content provides supporting information for the Taltz® (ixekizumab) Dosing Calculator. It clarifies the inputs required, the outputs generated, and offers a general overview of dosing principles based on the FDA-approved prescribing information. This information is for educational purposes and should not replace clinical judgment.

Outputs Explained

The calculator provides a patient-specific dosing regimen based on the selected criteria. The output includes:

• Loading Dose: The initial, higher-dose schedule designed to quickly achieve therapeutic levels of the medication. This often involves a higher starting dose followed by several doses at shorter intervals.
• Maintenance Dose: The ongoing, regular dosing schedule used after the initial loading phase to maintain therapeutic levels.
• Dosing Summary: A set of tags that summarize the inputs, such as patient population (Adult/Pediatric), indication, and any special conditions (e.g., patient weight, coexistent psoriasis).

How to Use the Calculator

To generate a dosing schedule, follow these steps:

1. Select Indication: Choose the appropriate FDA-approved condition: Plaque Psoriasis (PsO), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), or Non-radiographic Axial Spondyloarthritis (nr-axSpA).
2. Select Patient Population: Choose "Adult" or "Pediatric." Note that the pediatric option is only available for Plaque Psoriasis.
3. Enter Patient Weight (if applicable): For pediatric plaque psoriasis, patient weight is required as the dosage is weight-based. The tool allows entry in kilograms (kg) or pounds (lbs).
4. Specify Coexistent Condition (if applicable): For adult Psoriatic Arthritis, specify if the patient has coexistent moderate-to-severe plaque psoriasis, as this affects the recommended loading dose.

Dosing Overview

Taltz (ixekizumab) is administered as a subcutaneous injection. Dosing varies significantly by indication and patient population:

• Adult Plaque Psoriasis & PsA with coexistent PsO: Involves an extended loading dose schedule over 12 weeks (160 mg at Week 0, then 80 mg every 2 weeks), followed by a maintenance dose of 80 mg every 4 weeks.
• Adult PsA (without coexistent PsO), AS, and nr-axSpA: Uses a simpler loading dose of 160 mg at Week 0, followed by a maintenance dose of 80 mg every 4 weeks.
• Pediatric Plaque Psoriasis (6 to <18 years): Dosing is based on weight categories (<25 kg, 25-50 kg, and >50 kg), with specific loading and maintenance doses for each tier.

Switching Therapies

The decision to switch a patient to Taltz from another biologic or systemic therapy requires careful clinical consideration. Factors include the reason for switching (e.g., lack of efficacy, adverse events), the half-life of the previous medication, and the patient's overall clinical status. There is no one-size-fits-all washout period. Consult the full prescribing information and relevant clinical guidelines when planning a switch.

Missed Dose Instructions

If a patient misses a dose, they should be instructed to take it as soon as they remember. The subsequent dose should then be rescheduled from the date of the most recent injection to maintain the correct dosing interval. Patients should be advised to contact their healthcare provider for specific instructions.

Safety Alerts

Before initiating Taltz, it is crucial to evaluate patients for tuberculosis (TB) infection. Patients should not receive Taltz if they have any clinically important active infection. Treatment may increase the risk of infections. For a complete list of warnings, precautions, and contraindications, refer to the full Prescribing Information.

Frequently Asked Questions (FAQ)

Why is patient weight required for pediatric plaque psoriasis?
The FDA-approved dosing for Taltz in pediatric patients (ages 6 to <18) with plaque psoriasis is based on body weight. The calculator uses the weight to place the patient into the correct dosing tier (<25 kg, 25-50 kg, or >50 kg).

Why is the pediatric option disabled for PsA, AS, and nr-axSpA?
The calculator only enables the pediatric option for indications where Taltz is FDA-approved for that age group. As of the last update, this is limited to moderate-to-severe plaque psoriasis.

What is the dose for an adult with Psoriatic Arthritis who also has Plaque Psoriasis?
Patients with both conditions should receive the dosing regimen for Plaque Psoriasis, which includes a 160 mg dose at Week 0 followed by 80 mg every two weeks through Week 12, then 80 mg every four weeks for maintenance.

Is the dosing for Ankylosing Spondylitis and nr-axSpA the same?
Yes, according to the prescribing information, the recommended adult dosage for both AS and nr-axSpA is 160 mg at Week 0, followed by 80 mg every 4 weeks.

What does "loading dose" mean?
A loading dose is a higher initial dose of a drug given at the beginning of a course of treatment before dropping down to a lower maintenance dose. It is used to quickly achieve the target therapeutic concentration in the body.

How is Taltz administered?
Taltz is administered via subcutaneous (under the skin) injection. It is available in prefilled syringes and autoinjectors for patient convenience.

Are all doses available in the autoinjector?
The 80 mg dose is available in both an autoinjector and a prefilled syringe. The lower pediatric doses (20 mg and 40 mg) are available only in prefilled syringes.

Does this tool provide information for off-label use?
No. The calculator and this supporting information are strictly based on FDA-approved indications and dosing regimens. It is not intended to guide off-label use.

References

1. TALTZ® (ixekizumab) Prescribing Information. Eli Lilly and Company. Accessed October 2023. Available at: FDA.gov
2. TaltzHCP.com. Official Healthcare Professional Website. Eli Lilly and Company. Accessed October 2023. Available at: www.taltzhcp.com
3. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. Available at: rheumatology.org
4. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. Available at: rheumatology.org