Ixekizumab

Ixekizumab
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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.