Ixekizumab

Preparation and Administration Instructions TALTZ is intended for use under the guidance and supervision of a healthcare provider. Adult patients may self-inject or caregivers may give injections of TALTZ after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Safety and effectiveness of pediatric self-administration has not been established.

Therefore, TALTZ should be administered to pediatric patients by a healthcare provider or by a caregiver who has received training and demonstrated proper subcutaneous injection technique. TALTZ 20 mg and 40 mg doses prepared from the TALTZ 80 mg/mL prefilled syringe should only be administered by a qualified healthcare professional [see Dosage and Administration] .

The TALTZ “Instructions for Use” contains more detailed instructions on the preparation and administration of TALTZ [see Instructions for Use] . 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). 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 [see Instructions for Use] . TALTZ does not contain preservatives, therefore discard any unused product. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Alternative Preparation Instructions of TALTZ Doses for Pediatric Patients with Plaque Psoriasis Weighing 50 kg or Less If the 20 mg/0.25 mL or 40 mg/0.5 mL prefilled syringe is unavailable, TALTZ doses of 20 mg or 40 mg for pediatric patients with plaque psoriasis [see Dosage and Administration] must be manually prepared according to the steps below using only the TALTZ 80 mg/mL prefilled syringe.

The preparation and administration of the 20 mg and 40 mg doses should only be performed by a qualified healthcare professional. For additional preparation and administration instructions, [see Dosage and Administration] . Gather the following necessary supplies for preparation: 0.5 mL or 1 mL disposable syringe Sterile needle for withdrawal 27-gauge sterile needle for administration Sterile, clear glass vial.

Expel the entire contents of the prefilled syringe into the sterile vial. DO NOT shake or swirl the vial. Do not add other medications to solutions containing TALTZ. Using the 0.5 mL or 1 mL disposable syringe and sterile needle, withdraw the prescribed dose from the vial (0.25 mL for 20 mg; 0.5 mL for 40 mg). Remove the needle from the syringe and replace it with a 27-gauge needle prior to administering TALTZ.

Storage of Prepared TALTZ If necessary, TALTZ 20 mg or 40 mg doses prepared from an 80 mg/mL prefilled syringe may be stored at room temperature for up to 4 hours from first puncturing the sterile vial.