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Brand Name
TALTZ
Generic Name
Ixekizumab
View Brand Information FDA approval date: March 22, 2016
Classification: Interleukin-17A Antagonist
Form: Injection
What is TALTZ (Ixekizumab)?
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.
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Brand Information
TALTZ (ixekizumab)
1DOSAGE FORMS AND STRENGTHS
TALTZ is a clear and colorless to slightly yellow solution available as:
- Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled autoinjector
- Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled syringe
- Injection: 40 mg/0.5 mL solution of TALTZ in a single-dose prefilled syringe
- Injection: 20 mg/0.25 mL solution of TALTZ in a single-dose prefilled syringe
2CONTRAINDICATIONS
TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients
3ADVERSE REACTIONS
The following adverse drug reactions are discussed in greater detail in other sections of the label:
- Infections
- Hypersensitivity Reactions
- Eczematous Eruptions
- Inflammatory Bowel Disease
3.1Clinical 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.
3.2Immunogenicity
As with all therapeutic proteins there is the potential for immunogenicity with TALTZ. The assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of ixekizumab; therefore, the incidence of neutralizing antibodies development could be underestimated.
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of TALTZ. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to TALTZ exposure.
Immune system disorders: anaphylaxis [see Contraindications (.
Infections: bacterial, viral, and fungal opportunistic infections, including cryptococcal meningoencephalitis, esophageal and disseminated mucocutaneous candidiasis, pulmonary tuberculosis, toxoplasmosis, varicella zoster virus reactivation, cytomegalovirus colitis, pulmonary aspergillosis.
Skin and subcutaneous tissue disorders: Eczematous eruptions (erythroderma, atopic dermatitis-like eruptions, and dyshidrotic eczema).
4DESCRIPTION
Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule.
TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab.
Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.
Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.
Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.
5PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling
Instructions on Self-Administration: Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly [see Instructions for Use].
Infection: Inform patients that TALTZ may lower the ability of their immune system to fight infections, and that serious infections, including opportunistic infections, may occur with the use of TALTZ. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection [see Warnings and Precautions (.
Allergic Reactions: Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (.
Eczematous Eruptions: Inform patients that skin reactions resembling eczema may occur with the use of TALTZ. Instruct patients to seek medical advice if they develop signs or symptoms of eczema [see Warnings and Precautions (.
Pregnancy: Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy. Advise patients to contact the registry at 1-800-284-1695 to enroll [see Use in Specific Populations (.
Eli Lilly and Company, Indianapolis, IN 46285, USA
Copyright © 2016, 2024, Eli Lilly and Company. All rights reserved.
TAL-0016-USPI-20240820
6PACKAGE CARTON – Taltz Autoinjector 80 mg
taltz
(ixekizumab)
80 mg/mL
For Subcutaneous Use Only
1 Single-Dose prefilled autoinjector
Discard any unused product.
NDC 0002-1445-11
1 x 1 mL Single-Dose prefilled autoinjector
Rx Only
Dispense enclosed Medication Guide to each patient.
Lilly
7PACKAGE CARTON – Taltz Prefilled Syringe 80 mg
taltz
(ixekizumab)
80 mg/mL
For Subcutaneous Use Only
1 Single-Dose prefilled syringe
Discard any unused product.
NDC 0002-7724-11
1 x 1 mL Single-Dose prefilled syringe
Rx Only
Dispense enclosed Medication Guide to each patient.
Lilly
8PACKAGE CARTON – Taltz Prefilled Syringe 40 mg
taltz
(ixekizumab)
40 mg/0.5 mL
For Subcutaneous Use Only
1 Single-Dose prefilled syringe
Discard any unused product.
NDC 0002-8905-11
1 x 0.5 mL Single-Dose prefilled syringe
Rx Only
Dispense enclosed Medication Guide to each patient.
Lilly
9PACKAGE CARTON – Taltz Prefilled Syringe 20 mg
taltz
(ixekizumab)
20 mg/0.25 mL
For Subcutaneous Use Only
1 Single-Dose prefilled syringe
Discard any unused product.
NDC 0002-8900-11
1 x 0.25 mL Single-Dose prefilled syringe
Rx Only
Dispense enclosed Medication Guide to each patient.
Lilly
