What is the dosing regimen for Taltz® (ixekizumab) in pediatric psoriasis?

Recommended Pediatric Plaque Psoriasis Dosing Regimen

Table 1. The recommended dose given by subcutaneous injection in children is based on the following weight categories¹

For children prescribed 80 mg, ixekizumab can be used directly from the prefilled syringe.¹

Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional using the commercial Taltz 80 mg/1 ml prefilled syringe.¹

Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg and do not require dose preparation.¹

Ixekizumab is not recommended for use in children with a body weight below 25 kg. Paediatric body weights must be recorded and regularly re-checked prior to dosing.¹

There is no relevant use of ixekizumab in children below a body weight of 25 kg and below the age of 6 years in the treatment of moderate to severe plaque psoriasis.¹

Method of Administration

Ixekizumab is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the syringe must not be shaken.¹

After proper training in subcutaneous injection technique, patients may self-inject ixekizumab if a healthcare professional determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Comprehensive instructions for administration are given in the package leaflet and the user manual.¹

Doses less than 80 mg which require dose preparation should only be administered by a healthcare professional.¹

Ixekizumab 40 mg Dose Preparation and Administration for Children 25-50 kg Body Weight

Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional. Use only the Taltz 80 mg/1 ml prefilled syringe when preparing the prescribed 40 mg paediatric doses.

1. Expel the entire contents of the prefilled syringe into a sterile, clear glass vial. DO NOT shake or swirl the vial.

2. Use a 0.5 mL or 1 mL disposable syringe and sterile needle to withdraw the prescribed dose (0.5 ml for 40 mg) from the vial.

3. Change the needle and use a 27‑gauge, sterile needle to inject the patient. Discard any unused ixekizumab in the vial.

The prepared ixekizumab must be administered within 4 hours of puncturing the sterile vial at room temperature.¹

Necessary supplies (not provided with ixekizumab PFS) and dosing preparation steps for pediatric psoriasis patients weighing 25-50 kg are detailed in Figure 1 and Figure 2.

Figure 1. Necessary supplies for 40 mg dose preparation of ixekizumab for children 25-50 kg body weight

Necessary supplies:
1.) Sterile, clear glass vial
2.) Disposable syringe (0.5 ml or 1 ml)
3.) Sterile needle for withdrawal
4.) Sterile needle for administration (27-gauge)

Figure 2. Instructions for 40 mg dose preparation of ixekizumab for children 25-50 kg body weight

Step 1:
Expel the entire contents of the prefilled syringe into a sterile, clear glass vial. DO NOT shake or swirl the vial.

Step 2:
Use a 0.5 ml or 1 ml disposable syringe and sterile needle to withdraw the prescribed dose (0.5 ml for 40 mg) from the vial.

Step 3:
Change the needle and use a 27‑gauge, sterile needle to inject the patient. Discard any unused ixekizumab in the vial.

Weight Category Changes

In the IXORA-PEDS clinical trial, if a subject changed weight category, the ixekizumab dose associated with the most current weight was administered for all periods except the 12-week double-blind treatment period.²

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

PFS = prefilled syringe

SC = subcutaneous