Ixekizumab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Template:Shankar Kumar
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Overview
Ixekizumab is a humanized anti-interleukin-17 monoclonal antibody that is FDA approved for the treatment of of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.. Common adverse reactions include injection site reactions, upper respiratory tract infections, nausea, and tinea infections (≥1%)..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Administer by subcutaneous injection.
- 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ixekizumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ixekizumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ixekizumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ixekizumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ixekizumab in pediatric patients.
Contraindications
Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients
Warnings
- Infections
- TALTZ may increase the risk of infection. In clinical trials, the TALTZ group had a higher rate of infections than the placebo group (27% vs. 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ group than in the placebo group [see Adverse Reactions (6.1)].
Instruct patients treated with TALTZ to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TALTZ until the infection resolves.
- Pre-treatment Evaluation for Tuberculosis
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TALTZ. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering TALTZ. Consider anti-TB therapy prior to initiating TALTZ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving TALTZ should be monitored closely for signs and symptoms of active TB during and after treatment.
- Hypersensitivity
- Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the TALTZ group in clinical trials. If a serious hypersensitivity reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy [see Adverse Reactions (6.1)].
- Inflammatory Bowel Disease
- Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the TALTZ group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than the placebo group (0%) during the 12-week, placebo-controlled period. During TALTZ treatment, monitor for onset or exacerbation of inflammatory bowel disease.
- Immunizations
- Prior to initiating therapy with TALTZ, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TALTZ. No data are available on the response to live or inactive vaccines.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ixekizumab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ixekizumab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ixekizumab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ixekizumab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ixekizumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ixekizumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ixekizumab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ixekizumab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ixekizumab in geriatric settings.
Gender
There is no FDA guidance on the use of Ixekizumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ixekizumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ixekizumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ixekizumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ixekizumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ixekizumab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ixekizumab Administration in the drug label.
Monitoring
There is limited information regarding Ixekizumab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ixekizumab and IV administrations.
Overdosage
There is limited information regarding Ixekizumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ixekizumab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ixekizumab Mechanism of Action in the drug label.
Structure
There is limited information regarding Ixekizumab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ixekizumab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ixekizumab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ixekizumab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ixekizumab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ixekizumab How Supplied in the drug label.
Storage
There is limited information regarding Ixekizumab Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ixekizumab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ixekizumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ixekizumab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ixekizumab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.