TALTZ 20 mg/.25mL
ixekizumab · INJECTION, SOLUTION · Eli Lilly and Company
Taltz (ixekizumab) is an injectable medication that blocks a protein called interleukin-17A to treat inflammatory conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis. It is given as a subcutaneous injection and works by reducing the immune system's inflammatory response.
Key Facts
- Brand Name
- TALTZ
- Generic Name
- ixekizumab
- NDC Code (Product)
0002-8900- Manufacturer
- Eli Lilly and Company
- Strength
- 20 mg/.25mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125521
- Drug Class
- Interleukin-17A Antagonist [EPC]
- Marketing Start
- 03/22/2016
Recall History
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) adults with active psoriatic arthritis. ( 1.2 ) adults with active ankylosing spondylitis. ( 1.3 ) adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. ( 1.4 ) 1.1 Plaque Psoriasis TALTZ ® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis. 1.3 Ankylosing Spondylitis TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Non-radiographic Axial Spondyloarthritis TALTZ is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection. Adult Plaque Psoriasis ( 2.2 ) 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 ( 2.3 ) 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 ( 2.4 ) 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. ( 2.2 ) TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate). Ankylosing Spondylitis ( 2.5 ) 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 Spondy…
Contraindications
4 CONTRAINDICATIONS TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: Infections [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Eczematous Eruptions [see Warnings and Precautions ( 5.4 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.5 )] 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Plaque Psoriasis Weeks 0 to 12 : Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of TALTZ compared to placebo f…
Frequently Asked Questions
What is TALTZ used for?
Taltz (ixekizumab) is an injectable medication that blocks a protein called interleukin-17A to treat inflammatory conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis. It is given as a subcutaneous injection and works by reducing the immune system's inflammatory response.
Is TALTZ a controlled substance?
TALTZ is not classified as a controlled substance by the DEA.
What is the generic name for TALTZ?
The generic name for TALTZ is ixekizumab. There are no other listed brand versions of ixekizumab.
What is the NDC code for TALTZ 20 mg/.25mL?
The NDC (National Drug Code) for TALTZ 20 mg/.25mL is 0002-8900, listed by Eli Lilly and Company.
Other TALTZ Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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