Drug Detail:Taltz (Ixekizumab [ ix-ee-kiz-ue-mab ])
Generic Name: ixekizumab 80mg in 1mL
Dosage Form: injection, solution
Drug Class: Interleukin inhibitors
2.1 Testing and Procedures Prior to Treatment Initiation
Perform the following evaluations prior to TALTZ initiation:
- Evaluate patients for tuberculosis (TB) infection. TALTZ initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of TALTZ [see Warnings and Precautions (5.2)].
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with TALTZ [see Warnings and Precautions (5.5)].
Adult Plaque Psoriasis
TALTZ is administered by subcutaneous injection. The 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
TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dosage in pediatric patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis is based on the following weight categories.
| Pediatric Patient's Weight | Starting Dose (Week 0) | 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 |
| Less than 25 kg | 40 mg | 20 mg |
Psoriatic Arthritis
The 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 [see Dosage and Administration (2.2)].
TALTZ may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
Ankylosing Spondylitis
The 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
The recommended dosage is 80 mg by subcutaneous injection every 4 weeks.
Important Administration Instructions
TALTZ is intended for use under the guidance and supervision of a physician. Adult patients may self-inject or caregivers may give injections of TALTZ 80 mg after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Caregivers may give injections of TALTZ 80 mg to pediatric patients weighing more than 50 kg using the autoinjector or prefilled syringe after training and demonstration of proper subcutaneous injection technique.
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.
Pediatric Patients Weighing 50 kg or Less
TALTZ doses of 20 mg or 40 mg [see Dosage and Administration (2.3)] must be prepared and administered by a qualified healthcare professional. Use only the commercial TALTZ 80 mg/1 mL prefilled syringe when preparing the prescribed 20 mg and 40 mg pediatric dose [see Instructions for Use].
- 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. No other medications should be added 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 to the patient.
Storage
If necessary, the prepared TALTZ may be stored at room temperature for up to 4 hours from first puncturing the sterile vial.
