Taltz

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.

Administer by subcutaneous injection.

Adult Plaque Psoriasis

• Recommended dosage 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 dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
• For patients weighing 25-50 kg, recommended dosage is 80 mg at Week 0, followed by 40 mg every 4 weeks.
• For patients weighing less than 25 kg, recommended dosage is 40 mg at Week 0, followed by 20 mg every 4 weeks.

Psoriatic Arthritis

• Recommended dosage 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 dosage 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 dosage is 80 mg by subcutaneous injection every 4 weeks.

TALTZ is a clear and colorless to slightly yellow solution available as:

• Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled autoinjector
• Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled syringe
• Injection: 40 mg/0.5 mL solution of TALTZ in a single-dose prefilled syringe
• Injection: 20 mg/0.25 mL solution of TALTZ in a single-dose prefilled syringe

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy. Pregnant women exposed to TALTZ are encouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on http://www.pregnancyregistry.lilly.com.

Available data from the published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Human IgG is known to cross the placental barrier; therefore, TALTZ may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.