Bimekizumab-bkzx (Monograph)

Brand name: Bimzelx
Drug class: Immunomodulatory Agents

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

Introduction

Recombinant humanized IgG₁ monoclonal antibody that binds specifically to interleukin-17A (IL-17A) and interleukin-17F (IL-17F).

Uses for Bimekizumab-bkzx

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.

Place in therapy for bimekizumab-bkzx relative to other biologic agents remains unclear; however, experts state that bimekizumab-bkzx may be used as first-line therapy for moderate to severe psoriasis.

Bimekizumab-bkzx Dosage and Administration

General

Pretreatment Screening

Do not initiate in patients with clinically important active infection until infection is resolved or adequately treated.
Evaluate for active or latent tuberculosis infection prior to starting bimekizumab-bkzx; start antimycobacterial therapy if indicated. Avoid use of bimekizumab in patients with active tuberculosis infection.
Assess serum liver enzymes, alkaline phosphatase, and bilirubin levels prior to initiating bimekizumab-bkzx.
Administer all age-appropriate vaccines prior to starting bimekizumab-bkzx.

Patient Monitoring

Monitor for emergence or worsening of depression, suicidal ideation, or other mood changes.
Monitor closely for signs or symptoms of infection or active tuberculosis during and after treatment.
Assess serum liver enzymes, alkaline phosphatase, and bilirubin levels periodically during treatment and according to routine patient management.
Monitor for signs and symptoms of inflammatory bowel disease during treatment.

Administration

Sub-Q Administration

Administer via sub-Q injection. May be self-administered if clinician determines the patient and/or caregiver is competent to safely administer the drug after appropriate training.

Commercially available as a 160 mg/mL solution in single-use autoinjectors or prefilled syringes.

Each prefilled syringe or autoinjector contains 160 mg of bimekizumab-bkzx; 2 separate prefilled syringes or autoinjectors required to administer a full dose.

Once removed from refrigerator, allow autoinjectors or prefilled syringes to sit at room temperature in unopened carton for 30–45 minutes prior to sub-Q injection.

Administer each sub-Q injection at a different anatomic site (i.e., thighs, abdomen, or back of upper arm); avoid injections within 2 inches of the navel. Rotate injection sites. Administration in upper outer arm may only be performed by caregiver or healthcare professional. Do not administer into areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

If dose is missed, administer as soon as possible and resume dosing at the regular scheduled time.

Dosage

Adults

Plaque Psoriasis

Sub-Q

320 mg (two 160-mg prefilled syringes or autoinjectors) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.

Patients weighing ≥120 kg: May consider 320 mg every 4 weeks after week 16.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Cautions for Bimekizumab-bkzx

Contraindications

None.

Warnings/Precautions

Suicidal Ideation and Behavior

Suicidal ideation and behavior, including a completed suicide, reported. Causal relationship not established.

Weigh risks and benefits of bimekizumab-bkzx in patients with a history of severe depression or suicidal ideation or behavior. Advise patients and caregivers to monitor for emergence or worsening of depression, suicidal ideation, or other mood changes; advise them to promptly seek medical attention if such changes occur. Refer patients with new or worsening symptoms of depression or suicidal ideation/behavior to a mental health professional, as appropriate. Reassess risks and benefits of continuing bimekizumab-bkzx therapy if such adverse effects occur.

Infections

Increased risk of infections. Increased rates of upper respiratory tract infections, Candida infections, tinea infections, gastroenteritis, and herpes simplex infections reported.

Do not start bimekizumab-bkzx in patients with any clinically important active infection until it is resolved or adequately treated.

Consider risks and benefits prior to prescribing in patients with a chronic infection or history of recurrent infections.

Advise patients to seek medical attention if signs or symptoms of clinically important infection occur. If patient develops such an infection or is not responding to standard therapy, closely monitor patient and discontinue bimekizumab-bkzx until infection resolves.

Tuberculosis

Evaluate patients for active or latent tuberculosis before initiating bimekizumab-bkzx. Do not administer to patients with active tuberculosis. When indicated, initiate an appropriate antimycobacterial regimen for treatment of latent tuberculosis infection before initiating bimekizumab-bkzx. Consider antimycobacterial therapy for patients with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed. Closely monitor patients for active tuberculosis during and after bimekizumab-bkzx treatment.

Liver Biochemical Abnormalities

Increases in serum liver enzymes reported, including elevations >3 times ULN. Elevations occurred 28–198 days after initiating treatment with bimekizumab-bkzx and resolved after discontinuation.

Monitor serum liver enzyme concentrations, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with bimekizumab-bkzx, and according to routine patient management. Interrupt therapy if increases in liver enzymes occur and drug-induced liver injury is suspected. Discontinue permanently in patients with causally associated combined elevations of transaminases and bilirubin.

Avoid use of bimekizumab-bkzx in patients with acute liver disease or cirrhosis (increased risk of severe hepatic injury).

Inflammatory Bowel Disease

Cases of inflammatory bowel disease reported.

Do not use in patients with active inflammatory bowel disease.

Monitor for signs and symptoms of inflammatory bowel disease and discontinue treatment if new onset or worsening inflammatory bowel disease occurs.

Immunizations

Administer all age-appropriate vaccines recommended by current immunization guidelines prior to initiation of therapy.

Avoid live vaccines during therapy.

Immunogenicity

Formation of anti-bimekizumab antibodies, including neutralizing antibodies, reported. No clinically significant effects of such antibodies identified.

Specific Populations

Pregnancy

Insufficient data in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Human IgG known to cross placenta; therefore, potential for fetal exposure exists. Reproductive and developmental toxicity studies in monkeys revealed no evidence of adverse developmental effects.

Bimekizumab-bkzx may interfere with immune responses to infections; consider risks and benefits prior to administering live vaccines to infants exposed to the drug in utero. Specific time frame to delay live virus immunizations in infants exposed in utero not established; minimum of 4 months after birth may be considered based on drug half-life.

Pregnancy registry at 1-877-311-8972.

Lactation

Not known whether distributed into human milk; effects on the breast-fed infant or on milk production unknown. Endogenous maternal IgG and monoclonal antibodies transferred in human milk; effects of local GI and limited systemic exposure unknown.

Consider developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

No apparent differences in safety or efficacy between geriatric patients and younger adults with plaque psoriasis; however, insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.

Hepatic Impairment

No formal studies to date.

Renal Impairment

No formal studies to date.

Common Adverse Effects

Adverse effects (≥1%) include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, fatigue.

Drug Interactions

No formal drug interaction studies performed to date.

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP substrates: Increased concentrations of cytokines (e.g., interleukin-17) during chronic inflammation may modulate formation of CYP isoenzymes. Treatment with bimekizumab-bkzx may modulate serum levels of some cytokines.

Upon initiation or discontinuance of bimekizumab-bkzx, consider monitoring therapeutic effect or drug concentration of CYP substrates and consider dosage adjustment of CYP substrates as necessary, especially for drugs with a narrow therapeutic index.

Vaccines

Avoid live vaccines.

Clinical effectiveness of inactivated vaccines in patients receiving bimekizumab-bkzx not established; in healthy individuals, antibody responses to inactivated seasonal influenza virus vaccine were similar regardless of bimekizumab-bkzx administration 2 weeks prior to vaccination.

Bimekizumab-bkzx Pharmacokinetics

Absorption

Bioavailability

70% following sub-Q administration.

Peak serum concentrations achieved within 3–4 days.

Dose-proportional pharmacokinetics over sub-Q dose range of 64–480 mg.

Special Populations

Mean serum concentration predicted to be at least 30% lower in adults weighing ≥120 kg.

Distribution

Extent

Not known whether distributed into human milk.

Elimination

Metabolism

Expected to occur via degradation into small peptides via catabolic pathways.

Half-life

23 days.

Special Populations

Age does not substantially alter pharmacokinetics.

Stability

Storage

Parenteral

Injection for Sub-Q Use

2–8ºC. Keep in original carton; protect from light. Do not freeze or shake.

If removed from refrigeration, may store at room temperature (not to exceed 25ºC) for up to 30 days. Once at room temperature, do not return to refrigeration. Discard if not used within a 30-day period.

Actions

Recombinant humanized IgG₁ monoclonal antibody.
Binds selectively to interleukin-17A (IL-17A), interleukin-17F (IL-17F), and interleukin-17AF (IL-17AF) cytokines.
Elevated levels of IL-17A and IL-17F found in psoriatic skin lesions.
Inhibits interaction of IL-17A and IL-17F with the IL-17 receptor complex, preventing release of proinflammatory cytokines and chemokines.

Advice to Patients

Advise patients to read the FDA-approved patient labeling.
Instruct patients and/or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training and injection technique. Instruct patients and/or caregivers on proper needle and syringe disposal.
Instruct patients and/or caregivers to administer two 160-mg single-dose syringes or autoinjectors to achieve a 320 mg dose of bimekizumab-bkzx.
If a dose is missed, advise patients to inject the dose as soon as they remember; instruct patients to then take their next dose at the appropriate scheduled time.
Advise patients and their caregivers to monitor for the emergence of suicidal ideation and/or behavior. Advise patients to promptly seek medical attention if they experience suicidal ideation or behavior, new or worsening depression or anxiety, or other changes in mood or behavior. Advise patients to call the National Suicide Prevention Lifeline at 988 if they experience suicidal thoughts or behaviors.
Advise patients that bimekizumab-bkzx may increase susceptibility to infection. Advise patients to promptly inform their clinician if any signs or symptoms of infection (e.g., fever, sweats, or chills; muscle aches; cough or shortness of breath; blood in phlegm; weight loss; warm, red or painful sores on the body; diarrhea or stomach pain; burning upon urination or increased urination) occur.
Advise patients that bimekizumab-bkzx may increase the risk of elevated liver enzymes, particularly in patients with acute liver disease or cirrhosis. Instruct patients to undergo laboratory screening both prior to and periodically throughout treatment. Instruct patients to promptly inform their clinician and hold their next dose of bimekizumab-bkzx if any signs or symptoms of liver dysfunction (e.g., pain on right side of stomach area; feeling very tired; loss of appetite; nausea and vomiting; itching; dark urine; light-colored stool; yellowing of skin and whites of eyes) occur.
Advise patients to inform their clinician if they develop new or worsening symptoms of Crohn disease or ulcerative colitis (e.g., stomach pain, diarrhea) during bimekizumab-bkzx therapy.
Advise patients that vaccination with live vaccines is not recommended during bimekizumab-bkzx therapy. Instruct patients to inform their clinician that they are taking bimekizumab-bkzx prior to a potential vaccination.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.
Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in patients exposed to bimekizumab-bkzx during pregnancy.
Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

Bimekizumab-bkzx is obtained through specialty pharmacies. Contact manufacturer or consult the Bimzelx website ([Web]) for specific availability information.