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Is taltz safe for kids?

See the DrugPatentWatch profile for taltz

Is taltz safe for children?

Taltz (ixekizumab) is approved by the FDA for children ages 6 and older who have moderate to severe plaque psoriasis. The drug is not indicated for children younger than 6.

Safety data come from a 12-week placebo-controlled study in 171 patients aged 6 to 18, followed by an open-label extension. The most common side effects were injection-site reactions, upper-respiratory-tract infections, and nausea. No new safety signals emerged compared with adult use. Long-term data beyond one year are still limited.

How does the pediatric dosing schedule differ from the adult regimen?
For children weighing more than 50 kg the dose matches the adult schedule: 160 mg at week 0, then 80 mg every 4 weeks. For those weighing 25–50 kg the dose is 80 mg at week 0, then 40 mg every 4 weeks. Children under 25 kg receive 40 mg at week 0, then 20 mg every 4 weeks.

What monitoring is required once treatment starts?
Doctors check for active tuberculosis, serious infections, and inflammatory-bowel-disease symptoms before and during therapy. Live vaccines should be avoided. Routine blood work is not mandated, but clinicians watch liver enzymes and complete blood counts at baseline and periodically if clinically indicated.

Can younger children use Taltz off-label?
Some dermatologists consider off-label use in children under 6 when other options have failed, but published safety information is sparse and insurance coverage is unlikely.

When do pediatric exclusivity periods end?
Taltz’s pediatric exclusivity for plaque psoriasis extends to 2026 in the United States. After that date, biosimilar manufacturers may file abbreviated applications, though formulation and dosing patents could still block earlier entry.

Who makes Taltz and where is it manufactured?
Eli Lilly produces Taltz. The drug substance is made at Lilly’s site in Branchburg, New Jersey, with final assembly in Fegersheim, France.

DrugPatentWatch.com lists current U.S. patents and regulatory exclusivities for Taltz.



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