Generic name: ixekizumab 80mg in 1mL
Dosage form: injection, solution
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TALTZ is administered by subcutaneous injection. The recommended dose 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.
2.2 Psoriatic Arthritis
The recommended dose 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 plaque psoriasis [see Dosage and Administration (2.1)].
TALTZ may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
Tuberculosis Assessment Prior to Initiation of TALTZ
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TALTZ [see Warnings and Precautions (5.2)].
Important Administration Instructions
There are two presentations for TALTZ (i.e., autoinjector and prefilled syringe). The TALTZ “Instructions for Use” for each presentation contains more detailed instructions on the preparation and administration of TALTZ [see Instructions for Use].
TALTZ is intended for use under the guidance and supervision of a physician. Patients may self-inject after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Administer each injection at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of TALTZ in the upper, outer arm may be performed by a caregiver or healthcare provider.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Preparation for Use of TALTZ Autoinjector and Prefilled Syringe
Before injection, remove TALTZ autoinjector or TALTZ prefilled syringe from the refrigerator and allow TALTZ to reach room temperature (30 minutes) without removing the needle cap.
Inspect TALTZ visually for particulate matter and discoloration prior to administration. TALTZ is a clear and colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow). TALTZ does not contain preservatives, therefore discard any unused product remaining in the autoinjector or prefilled syringe.
Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of TALTZ, according to the directions provided in the Instructions for Use [see Instructions for Use].
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- Drug class: interleukin inhibitors