Bimekizumab-bkzx (Monograph)

Brand name: Bimzelx
Drug class:

Medically reviewed by Drugs.com on Mar 10, 2024. Written by ASHP.

Introduction

Bimekizumab-bkzx is a humanized interleukin-17A and F antagonist.

Uses for Bimekizumab-bkzx

Bimekizumab-bkzx has the following uses:

Bimekizumab-bkzx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Bimekizumab-bkzx Dosage and Administration

General

Bimekizumab-bkzx is available in the following dosage form(s) and strength(s):

Injection: 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• Bimekizumab-bkzx is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique.

• Prior to treatment, evaluate patients for tuberculosis infection, perform appropriate tests (i.e., liver enzymes, alkaline phosphatase, bilirubin), and complete all age-appropriate vaccinations as recommended by current immunization guidelines.

• 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.

Related/similar drugs

Otezla, Sotyktu, Humira, Taltz, Enbrel, Stelara, Remicade

Cautions for Bimekizumab-bkzx

Contraindications

None.

Warnings/Precautions

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. 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. 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.

Specific Populations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bimekizumab-bkzx during pregnancy. For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/.

Available data from case reports on bimekizumab-bkzx use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, bimekizumab-bkzx may be transmitted from the mother to the developing fetus. In an enhanced pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of bimekizumab-bkzx during the period of organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Fetal/Neonatal Adverse Reactions: Because bimekizumab-bkzx may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to bimekizumab-bkzx in utero. There are no data regarding infant serum levels of bimekizumab-bkzx at birth and the duration of persistence of bimekizumab-bkzx in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 4 months after birth may be considered because of the half-life of the product.

Lactation

There are no data on the presence of bimekizumab-bkzx in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Endogenous IgG and monoclonal antibodies are transferred in human milk. The effects of local GI exposure and limited systemic exposure in the breastfed infant to bimekizumab-bkzx are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bimekizumab-bkzx and any potential adverse effects on the breastfed infant from bimekizumab-bkzx or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of bimekizumab-bkzx in pediatric patients have not been established.

Geriatric Use

Of the 1789 subjects with plaque psoriasis that were exposed to bimekizumab-bkzx, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the number of subjects 65 years of age and over is not sufficient to determine whether they respond differently from younger adult subjects.

Common Adverse Effects

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.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Bimekizumab-bkzx 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. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.

Advice to Patients

• Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

• Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique.

• Instruct patients or caregivers to administer two 160 mg single-dose syringes or two 160 mg single-dose autoinjectors to achieve the 320 mg dose of bimekizumab-bkzx.

• Instruct patients or caregivers in the technique of needle and syringe disposal.

• Advise patients if they forget to take their dose of bimekizumab-bkzx to inject their dose as soon as they remember. Instruct patients to then take their next dose at the appropriate scheduled time.

• Instruct patients and their caregivers to monitor for the emergence of suicidal ideation and behavior and promptly seek medical attention if the patient experiences suicidal ideation or behavior; or new onset or worsening depression, anxiety, or other mood changes. Instruct patients to call the National Suicide and Crisis Lifeline at 988 if they experience suicidal ideation or behavior.

• Inform patients that bimekizumab-bkzx may lower the ability of their immune system to fight infections. 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 an infection.

• Inform patients that bimekizumab-bkzx may increase the risk of elevated liver enzymes. Acute liver disease or cirrhosis may increase this risk. Advise patients that laboratory evaluation is needed prior to and periodically during treatment. Advise patients to hold the next dose of bimekizumab-bkzx and call their healthcare provider right away, if signs or symptoms of liver dysfunction occur.

• Instruct patients to seek medical advice if they develop signs and symptoms of Crohn's disease or ulcerative colitis.

• Advise patients that vaccination with live vaccines is not recommended during bimekizumab-bkzx treatment. Instruct patients to inform their healthcare practitioner that they are taking bimekizumab-bkzx prior to a potential vaccination.

• Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to bimekizumab-bkzx during pregnancy.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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