ALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution available in a single-dose prefilled autoinjector or a single-dose prefilled syringe to deliver 80 mg ixekizumab.
TALTZ is supplied as:
Pack Size NDC Code
Autoinjector
80 mg single-dose Carton of 1 0002-1445-11
80 mg single-dose Carton of 2 0002-1445-27
80 mg single-dose Carton of 3 0002-1445-09
Prefilled syringe
80 mg single-dose Carton of 1 0002-7724-11
16.2 Storage and Handling
TALTZ is sterile and preservative-free. Discard any unused portion.
TALTZ must be protected from light until use.
Store refrigerated at 2�C to 8�C (36�F to 46�F).
If needed, patients/caregivers may store TALTZ at room temperature up to 30�C (86�F) for up to 5 days in the original carton to protect from light. Once TALTZ has been stored at room temperature, do not return to the refrigerator and discard, if unused, within 5 days.
Record the date when TALTZ is first removed from the refrigerator in the spaces provided on the carton.
For the 2 or 3 autoinjector pack, remove a single autoinjector at a time leaving the remaining autoinjector(s) in the original carton in the refrigerator. Ensure the unrefrigerated TALTZ is protected from light.
Do not freeze. Do not use TALTZ if it has been frozen.
Do not shake.
Discard the TALTZ single-dose autoinjector or syringe after use in a puncture-resistant container.
Not made with natural rubber latex.
These highlights do not include all the information needed to use TALTZ safely and effectively. See full prescribing information for TALTZ.
TALTZ (ixekizumab) injection, for subcutaneous use
Initial U.S. Approval: 2016
RECENT MAJOR CHANGES
Indications and Usage:
Ankylosing Spondylitis (1.3) 08/2019
Dosage and Administration:
Ankylosing Spondylitis (2.3) 08/2019
Warnings and Precautions:
Infections (5.1) 08/2019
Inflammatory Bowel Disease (5.4) 08/2019
INDICATIONS AND USAGE
TALTZ� is a humanized interleukin-17A antagonist indicated for the treatment of adults with:
moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1)
active psoriatic arthritis. (1.2)
active ankylosing spondylitis. (1.3)
DOSAGE AND ADMINISTRATION
Plaque Psoriasis
Administer by subcutaneous injection. (2.1)
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. (2.1)
Psoriatic Arthritis
Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. (2.2)
For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis. (2.1)
TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate). (2.2)
Ankylosing Spondylitis
Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. (2.3)
DOSAGE FORMS AND STRENGTHS
Autoinjector
Injection: 80 mg/mL solution in a single-dose prefilled autoinjector. (3)
Prefilled Syringe
Injection: 80 mg/mL solution in a single-dose prefilled syringe. (3)
CONTRAINDICATIONS
Serious hypersensitivity reaction to ixekizumab or to any of the excipients. (4)
WARNINGS AND PRECAUTIONS
Infections: Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue TALTZ until the infection resolves. (5.1)
Tuberculosis (TB): Evaluate for TB prior to initiating treatment. (5.2)
Hypersensitivity: If a serious allergic reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy. (5.3)
Inflammatory Bowel Disease: Crohn's disease and ulcerative colitis, including exacerbations, occurred during clinical trials. Patients who are treated with TALTZ and have inflammatory bowel disease should be monitored closely. (5.4)
ADVERSE REACTIONS
Most common (?1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 (1-800-LillyRx) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Live Vaccines: Live vaccines should not be given with TALTZ. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2019
