Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

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

160 mg at week 0, then 80 mg every 4 weeks for children greater than 50 kg body weight or 80 mg at week 0, then 40 mg every 4 weeks for children 25-50 kg body weight.

Recommended Pediatric Plaque Psoriasis Dosing Regimen

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

Children’s Body Weight

Recommended Starting Dose (Week 0)

Recommended 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

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: May 14, 2020


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