Bimekizumab

Bimekizumab
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: Rithish Nimmagadda,MBBS.[2]

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Overview

Bimekizumab is a humanized immunoglobulin IgG1/κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. that is FDA approved for the {{{indicationType}}} of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Common adverse reactions include Most common adverse reactions (≥ 1%) are upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Administer 320 mg (two 160 mg injections at different anatomic locations) by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Bimekizumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

none

Warnings

-Suicidal Ideation and Behavior

During the 16-week, placebo-controlled period of Trials Ps-1 and Ps-2, higher rates of suicidal ideation were reported in bimekizumab-bkzx-treated subjects than in placebo-treated subjects.

Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials of psoriasis. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from "none" to "active suicidal ideation with specific plan and intent") and behaviors (rating the injury and potential lethality of self-injury, if present). Pooled analysis of C-SSRS data from two 16-week, placebo-controlled clinical trials indicated that 12/670 (1.8%) bimekizumab-bkzx-treated subjects and 1/169 (0.6%) placebo-treated subjects reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74). Subjects without a prior history of suicidal ideation and behavior treated with bimekizumab-bkzx also reported a higher rate of new-onset suicidal ideation on the C-SSRS than subjects treated with placebo (1.3% vs. 0.6%). During the open-label extension trial, one completed suicide was reported in a bimekizumab-bkzx-treated subject. [ref] A causal association between treatment with bimekizumab-bkzx and increased risk of suicidal ideation and behavior has not been established.

Prescribers should weigh the potential risks and benefits before using bimekizumab-bkzx in patients with a history of severe depression or suicidal ideation or behavior. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise them to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Bimekizumab-bkzx-treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior should be referred to a mental health professional, as appropriate. [ref] Prescribers should also re-evaluate the risks and benefits of continuing treatment with bimekizumab-bkzx if such events occur. -Infections

Bimekizumab-bkzx may increase the risk of infections. In clinical trials in subjects with plaque psoriasis, infections occurred in 36% of the bimekizumab-bkzx group compared to 23% of the placebo group through 16 weeks of treatment. Upper respiratory tract infections, Candida infections, tinea infections, gastroenteritis, and Herpes Simplex infections occurred more frequently in the bimekizumab-bkzx group than in the placebo group.

Serious infections occurred in 0.3% of subjects treated with bimekizumab-bkzx and 0% treated with placebo.

Do not initiate treatment with bimekizumab-bkzx in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing bimekizumab-bkzx. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and discontinue bimekizumab-bkzx until the infection resolves.

-Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with bimekizumab-bkzx. Avoid the use of bimekizumab-bkzx in patients with active TB infection. Initiate treatment of latent TB prior to administering bimekizumab-bkzx. Consider anti-TB therapy prior to initiation of bimekizumab-bkzx in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients treated with bimekizumab-bkzx for signs and symptoms of active TB during and after treatment.

-Liver Biochemical Abnormalities

Treatment with bimekizumab-bkzx was associated with increased incidence of liver enzyme elevations compared to treatment with placebo in randomized clinical trials. Liver serum transaminase elevations >3 times the upper limit of normal were reported in subjects treated with bimekizumab-bkzx. Elevated liver serum transaminases resolved after discontinuation of bimekizumab-bkzx. The time to onset of these adverse reactions varied between 28 and 198 days after starting bimekizumab-bkzx treatment.

Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with bimekizumab-bkzx and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt bimekizumab-bkzx until a diagnosis of liver injury is excluded. Permanently discontinue bimekizumab-bkzx in patients with causally associated combined elevations of transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury; avoid use of bimekizumab-bkzx in these patients.

-Inflammatory Bowel Disease

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including bimekizumab-bkzx. Avoid use of bimekizumab-bkzx in patients with active IBD. During bimekizumab-bkzx treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations

Prior to initiating therapy with bimekizumab-bkzx, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with bimekizumab-bkzx. Limited data are available regarding coadministration of bimekizumab-bkzx with non-live vaccines.

Adverse Reactions

Clinical Trials Experience

Most common adverse reactions (≥ 1%) are upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue

Postmarketing Experience

There is limited information regarding Bimekizumab Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Bimekizumab Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Bimekizumab in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bimekizumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bimekizumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bimekizumab in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Bimekizumab in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Bimekizumab in geriatric settings.

Gender

There is no FDA guidance on the use of Bimekizumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bimekizumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bimekizumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bimekizumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bimekizumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bimekizumab in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Bimekizumab Administration in the drug label.

Monitoring

There is limited information regarding Bimekizumab Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Bimekizumab and IV administrations.

Overdosage

There is limited information regarding Bimekizumab 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 Bimekizumab Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Bimekizumab Mechanism of Action in the drug label.

Structure

There is limited information regarding Bimekizumab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Bimekizumab Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Bimekizumab Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Bimekizumab Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Bimekizumab Clinical Studies in the drug label.

How Supplied

There is limited information regarding Bimekizumab How Supplied in the drug label.

Storage

There is limited information regarding Bimekizumab 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 Bimekizumab Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Bimekizumab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Bimekizumab Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Bimekizumab 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.