UCB, Inc.
Bimzelx
BrandGeneric: Bimekizumab
ID: 50474078079
NaN Reviews
đ Prescription Required
FORM
Injection
STRENGTH
QUANTITY
*Final prices are shown at checkout.
Don't have a prescription?
Do you already have an Rx?
How Medmind Works
1
Search for your medication
Find your prescription or over-the-counter medication using our comprehensive database.
2
Compare prices from multiple pharmacies
View prices from various pharmacies in your area to find the best deals.
3
Get your prescription filled
Choose your preferred pharmacy and get your medication at the best price.
TL;DR â Quick Summary
Key facts from the full medication guide below
đŠēWhat it's for
BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. (1.1) Adults with active psoriatic arthritis (PsA). (1.2) Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (1.3) Adults with active ankylosing spondylitis (AS).
đHow to take it
Prior to treatment: (2.1) Evaluate patients for tuberculosis infection. Test liver enzymes, alkaline phosphatase, and bilirubin. Complete all age-appropriate vaccinations as recommended by current immunization guidelines. Plaque Psoriasis Administer 320 mg (two 160 mg injections) by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg, consider a dose of 320 mg every 4 weeks after Week 16.
âšī¸Common side effects
The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)] Inflammatory Bowel Disease [see Warnings and Precautions (5.5)] Most common adverse reactions are: Psoriasis: (incidence 1%): upper respiratory tract infections, oral candidiasis,âĻ
â ī¸Serious risks
Suicidal Ideation and Behavior (SI/B): May increase risk of SI/B. 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. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior.
Ask MedMind
Questions answered from this medication guide. Sign in to personalize with your meds & labs.
Bimekizumab (Bimzelx) Prices
Current MedMind pricing â no insurance required
BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. (1.1) Adults with active psoriatic arthritis (PsA). (1.2) Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (1.3) Adults with active ankylosing spondylitis (AS). (1.4)
BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis.
BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis.
Prior to treatment: (2.1) Evaluate patients for tuberculosis infection. Test liver enzymes, alkaline phosphatase, and bilirubin. Complete all age-appropriate vaccinations as recommended by current immunization guidelines. Plaque Psoriasis Administer 320 mg (two 160 mg injections) by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg, consider a dose of 320 mg every 4 weeks after Week 16. (2.2) Psoriatic Arthritis Administer 160 mg by subcutaneous injection every 4 weeks. (2.3) For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis (2.2) Non-Radiographic Axial Spondyloarthritis Administer 160 mg by subcutaneous injection every 4 weeks. (2.4) Ankylosing Spondylitis Administer 160 mg by subcutaneous injection every 4 weeks. (2.5)
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.3)]. Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.4)]. Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warning and Precautions (5.6)].
The recommended dosage of BIMZELX is 320 mg (given as 2 subcutaneous injections of 160 mg each) 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 [see Clinical Pharmacology (12.3)]. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis [see Dosage and Administration (2.2) ]. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Before injecting, remove the carton with BIMZELX from the refrigerator and allow BIMZELX to reach room temperature (30 to 45 minutes) without removing the prefilled syringes or autoinjectors from the carton to protect from light. Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BIMZELX injection is clear to slightly opalescent, and colorless to pale brownish- yellow. Do not use if the solution contains visible particles, is discolored or cloudy.
BIMZELX is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of BIMZELX according to the "Instructions for Use" [see Instructions for Use]. If two separate 160 mg injections are used to achieve the recommended dose, administer each injection subcutaneously at different anatomic location (such as thighs, abdomen or back of upper arm). Discard the syringes or autoinjectors after use. Do not reuse. Do not inject BIMZELX within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Administration of BIMZELX in the upper, outer arm may only be performed by a healthcare professional or caregiver. Rotate the injection site with each injection.
Injection: 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector. (3)
Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080 US License No. 1736
None. None. (4)
Suicidal Ideation and Behavior (SI/B): May increase risk of SI/B. 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. Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. (5.1) Infections: May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer BIMZELX until the infection resolves. (5.2) Tuberculosis (TB): Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment. (5.3) Liver Biochemical Abnormalities: Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin. (5.4) Inflammatory Bowel Disease (IBD): Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. (5.5)
Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials. 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). During the placebo-controlled periods of Trials Ps-1 and Ps-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX treated subjects than in placebo treated subjects. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been established.
BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX 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 BIMZELX. 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 BIMZELX until the infection resolves.
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX 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 BIMZELX for signs and symptoms of active TB during and after treatment.
Treatment with BIMZELX 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 BIMZELX [see Adverse Reactions (6.1)]. Elevated liver serum transaminases resolved after discontinuation of BIMZELX. The time to onset of these adverse reactions varied between 28 and 198 days after starting BIMZELX treatment. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue BIMZELX 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 BIMZELX in these patients.
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX [see Adverse Reactions (6.1)]. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Limited data are available regarding coadministration of BIMZELX with non-live vaccines [see Clinical Pharmacology (12.2)].
The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling: Suicidal Ideation and Behavior [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4)] Inflammatory Bowel Disease [see Warnings and Precautions (5.5)] Most common adverse reactions are: Psoriasis: (incidence 1%): upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. (6.1) Psoriatic arthritis (incidence 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection. (6.1) Non-radiographic axial spondyloarthritis (incidence 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection. (6.1) Ankylosing spondylitis (incidence 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported during post-approval use of BIMZELX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections: conjunctivitis, esophageal candidiasis
The safety and effectiveness of BIMZELX in pediatric patients have not been established.
Of the 1789 subjects with plaque psoriasis that were exposed to BIMZELX, 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 aged 65 years and over is not sufficient to determine whether they respond differently from younger adult subjects.
Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1.
Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ 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.
Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown.
Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) g/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.
The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of BIMZELX or of other bimekizumab products. Across the pivotal trials in all indications, there was no identified clinically significant effect of anti-bimekizumab-bkzx antibodies, including neutralizing anti-drug antibodies, on safety or effectiveness of BIMZELX.
Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx. No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.
Three multicenter, randomized, double-blind trials [Trial-Ps-1 (NCT03370133), Trial-Ps-2 (NCT03410992), and Trial-Ps-3 (NCT03412747)] enrolled a total of 1480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of 10%, an Investigator's Global Assessment (IGA) score of 3 ("moderate") in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score 12. In Trial-Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing 100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52. At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52. In Trial-Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period. Subjects originally randomized to BIMZELX 320 mg every 4 weeks were re-randomized to either BIMZELX 320 mg every 4 weeks or BIMZELX 320 mg every 8 weeks or placebo. Subjects originally randomized to placebo continued to receive placebo if they were PASI 90 responders. Subjects who did not achieve a PASI 90 response at week 16 entered an open-label escape arm and received BIMZELX 320 mg every 4 weeks for 12 weeks. Subjects who relapsed, defined as having a less than PASI 75 response compared to baseline, during the randomized withdrawal period also entered the 12-week escape arm. In Trial-Ps-3, 478 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks through week 56, BIMZELX 320 mg every 4 weeks through week 16 followed by BIMZELX every 8 weeks through week 56, or adalimumab (80 mg as an initial dose followed by 40 mg every other week starting 1 week after initial dose through Week 24) followed by BIMZELX 320 mg every 4 weeks through Week 56. In Trial-Ps1, Trial-Ps-2, and Trial-Ps-3, 71% of the subjects were male and 84% of the subjects were White, with a mean age of 45 years and a mean weight of 89 kg. At baseline, subjects had a median baseline PASI score of 18, median baseline for BSA of 20%, and baseline IGA score of 4 ("severe") in 33% of subjects. A total of 93% subjects had psoriasis of the scalp (Scalp IGA score of 1) and a total of 26% of subjects had a history of psoriatic arthritis. Additionally, 38% had received prior biologic therapy.
The safety and efficacy of BIMZELX were assessed in 1,112 subjects in two multicenter, randomized, double-blind, placebo-controlled studies [Trial PsA-1 (NCT 03895203) and Trial PsA-2 (NCT 03896581)] in subjects 18 years and older with active psoriatic arthritis (PsA). Subjects in these studies had a diagnosis of PsA of at least 6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of 4.6 years at baseline, and active disease with 3 tender joint count and 3 swollen joint count. Subjects with each subtype of PsA were enrolled in these studies, including polyarticular symmetric arthritis (63.5%), oligoarticular asymmetric arthritis (25.9%), distal interphalangeal joint predominant (4.4%), spondylitis predominant (4.2%), and arthritis mutilans (1.5%). At baseline, 56% of subjects had 3% Body Surface Area (BSA) with active plaque psoriasis. At baseline across both studies, 32% and 12% of subjects had enthesitis and dactylitis, respectively, 58% of subjects had psoriatic nail disease, and 53% of subjects were receiving concomitant methotrexate. The PsA-1 study evaluated 852 biologic-na ve subjects, who were treated with either BIMZELX 160 mg every 4 weeks up to Week 52, adalimumab 40 mg every 2 weeks up to Week 52 (active reference arm), or placebo. Subjects receiving placebo were switched to BIMZELX every 4 weeks at Week 16 to Week 52. In this study, 78% of subjects had received prior treatment with 1 conventional DMARDs (cDMARDs), and 22 % of subjects had no prior treatment with cDMARDs. At baseline, 58% of subjects were receiving concomitant methotrexate (MTX), 11% were receiving concomitant cDMARDs other than MTX, and 31% were receiving no cDMARDs. The PsA-2 study evaluated 400 anti-TNF experienced subjects (inadequate response or intolerance to treatment), who were treated with BIMZELX 160 mg every 4 weeks or placebo up to Week 16. In this study, 43% of subjects were receiving concomitant MTX, 8% were receiving concomitant cDMARDs other than MTX, and 50% were receiving no cDMARDs. For both studies, the primary endpoint was the proportion of subjects who achieved an America College of Rheumatology (ACR) 50 response at Week 16.
The efficacy and safety were assessed in 254 patients in one randomized, double-blind, placebo-controlled study [(Trial nr-axSpA-1 (NCT03928704)] in adult subjects 18 years of age and older with active non-radiographic axial spondyloarthritis. Subjects had to have objective signs of inflammation with elevated C-reactive protein (CRP) level and/or evidence of sacroiliitis on Magnet Resonance Imaging (MRI). Subjects met ASAS classification criteria for axial spondyloarthritis and have active disease as defined by BASDAI greater than or equal to 4, spinal pain of greater than or equal to 4 (0-10 numeric rating scale (NRS)), and no definitive radiographic evidence of structural damage in the sacroiliac joints. At baseline, 73% of subjects had enthesitis. Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 24% of subjects were on concomitant cDMARDs. Overall, 11% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents. Subjects were randomized to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.
The efficacy and safety were assessed in 332 patients in one randomized, double-blind, placebo-controlled study [Trial AS-1 (NCT03928743)] in adult subjects 18 years of age and older with active ankylosing spondylitis. Subjects had to have documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS. Subjects had active disease as defined by BASDAI 4 and spinal pain 4 on a 0 to 10 numeric rating scale (NRS)(from BASDAI Item 2). Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 20% of subjects were on concomitant cDMARDs. Overall, 16% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents. Subjects were randomized 2:1 to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
MEDICATION GUIDE BIMZELX (bim zel'ex) (bimekizumab-bkzx) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 9/2024 What is the most important information I should know about BIMZELX? BIMZELX is a medicine that affects your immune system. BIMZELX may increase your risk of having serious side effects, including: Suicidal thoughts and behavior have happened in some people treated with BIMZELX. Get medical help right away or call the National Suicide and Crisis Lifeline at 988 if you, your caregiver or your family member notice in you any of the following symptoms: new or worsening depression or anxiety thoughts of suicide, dying, or hurting yourself changes in behavior or mood acting on dangerous impulses attempt to commit suicide Infections. BIMZELX is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with BIMZELX. If your healthcare provider feels you are at risk for TB, you may be treated with medicine for TB before you begin treatment with BIMZELX and during your treatment with BIMZELX. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with BIMZELX. Do not take BIMZELX if you have an active TB infection. Before starting BIMZELX, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in your phlegm weight loss warm, red, or painful skin or sores on your body different from your psoriasis diarrhea or stomach pain burning when you urinate or urinating more often than normal After starting BIMZELX, call your healthcare provider right away if you have any of the signs of infection listed above. Do not use BIMZELX if you have any signs of infection unless you are instructed to by your healthcare provider. See " What are the possible side effects of BIMZELX ?" for more information about side effects. What is BIMZELX? BIMZELX is a prescription medicine used to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet light alone or with pills (phototherapy). adults with active psoriatic arthritis. adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. adults with active ankylosing spondylitis. It is not known if BIMZELX is safe and effective in children. Before using BIMZELX, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about BIMZELX?" have a history of depression, or suicidal thoughts or behavior have liver problems have inflammatory bowel disease (Crohn's disease or ulcerative colitis) have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with BIMZELX. Tell all your healthcare providers that you are being treated with BIMZELX before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if BIMZELX can harm your unborn baby. If you become pregnant while taking BIMZELX, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-311-8972 to enroll in this registry or visit http://mothertobaby.org/pregnancy-studies/. are breastfeeding or plan to breastfeed. It is not known if BIMZELX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with BIMZELX. Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins and herbal supplements. How should I use BIMZELX? See the detailed "Instructions for Use" that comes with your BIMZELX for information on how to prepare and inject a dose of BIMZELX, and how to properly throw away (dispose of) used BIMZELX autoinjectors and prefilled syringes. Use BIMZELX exactly as prescribed by your healthcare provider. If you miss your BIMZELX dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do. What are the possible side effects of BIMZELX? BIMZELX may cause serious side effects, including: See "What is important information I should know about BIMZELX?" Elevated liver enzyme levels. Your healthcare provider will do blood tests to check your liver enzyme levels before starting treatment and during treatment with BIMZELX. Your healthcare provider may temporarily stop or permanently stop your treatment with BIMZELX if you develop liver problems. Call your healthcare provider right away if you develop any signs or symptoms of liver problems, including: pain on the right side of your stomach-area feeling very tired loss of appetite nausea and vomiting itching dark urine light-colored stool yellowing of your skin or the whites of your eyes Inflammatory bowel disease. New cases of inflammatory bowel disease or "flare-ups" have happened with BIMZELX. If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis), tell your healthcare provider if you have worsening disease symptoms during treatment with BIMZELX or develop new symptoms of stomach pain or diarrhea. Your healthcare provider will stop treatment with BIMZELX if you develop new or worsening signs of Crohn's disease or ulcerative colitis. The most common side effects of BIMZELX in people treated for Psoriasis include: upper respiratory tract infections headache herpes simplex infections (cold sores in or around the mouth) small red bumps on your skin feeling tired fungal infections (oral thrush or infections in the mouth, throat, skin, nails, feet or genitals) pain, redness or swelling at injection site stomach flu (gastroenteritis) acne The most common side effects of BIMZELX in people treated for psoriatic arthritis include: upper respiratory tract infections headache urinary tract infection oral thrush or infections in the mouth diarrhea The most common side effects of BIMZELX in people treated for non-radiographic axial spondyloarthritis include: upper respiratory tract infections headache cough joint pain tonsilitis urinary tract infection oral thrush or infections in the mouth diarrhea feeling tired muscle aches liver enzyme increase The most common side effects of BIMZELX in people treated for ankylosing spondylitis include: upper respiratory tract infections headache pain at injection site vaginal yeast infections oral thrush or infections in the mouth diarrhea rash These are not all of the possible side effects of BIMZELX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store BIMZELX? Store BIMZELX in the refrigerator between 36 F to 46 F (2 C to 8 C). BIMZELX may be stored at room temperature up to 77 F (25 C) for up to 30 days in the original carton. Do not place BIMZELX prefilled syringes or autoinjectors back in the refrigerator after they have been stored at room temperature. Write the date removed from the refrigerator in the space provided on the carton and throw away BIMZELX if it has been kept at room temperature and not been used within 30 days. Keep BIMZELX in the original carton until ready for use to protect from light. Do not freeze BIMZELX. Do not shake BIMZELX. Do not use BIMZELX past the expiration date printed on the carton. Keep BIMZELX and all medicines out of the reach of children. General information about the safe and effective use of BIMZELX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BIMZELX for a condition for which it was not prescribed. Do not give BIMZELX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BIMZELX that is written for health professionals. What are the ingredients in BIMZELX? Active ingredient: bimekizumab-bkzx Inactive ingredients: glacial acetic acid, glycine, polysorbate 80, sodium acetate and Water for Injection, USP. Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080 US License No. 1736 For more information, go to www.BIMZELX.com or call 1-844-599-2273
This Instructions for Use contains information on how to inject BIMZELX. Read this Instructions for Use before using the BIMZELX prefilled syringe and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of BIMZELX. Important Information you Need to Know Before Injecting BIMZELX: Your healthcare provider should show you or a caregiver how to prepare and inject BIMZELX using the prefilled syringe for the first time. Do not inject yourself or someone else until you have been shown how to inject BIMZELX the right way. Call your healthcare provider if you have any questions. The BIMZELX prefilled syringe has a needle safety feature that will be activated to cover the needle after the injection is finished. The needle safety feature will help to prevent needle stick injuries to anyone who handles the prefilled syringe after injection. Do not share or reuse your BIMZELX prefilled syringe. You may give or get an infection. Do not remove the needle cap until just before you give the injection. How should I store BIMZELX prefilled syringe? Store the BIMZELX prefilled syringe in the refrigerator between 36 F to 46 F (2 C to 8 C). BIMZELX prefilled syringes may be stored at room temperature up to 77 F (25 C) in the original carton for up to 30 days. Do not place BIMZELX prefilled syringes back in the refrigerator after they have been stored at room temperature. Write the date removed from the refrigerator in the space provided on the carton and throw away if it has been kept at room temperature and not used within 30 days. Keep the BIMZELX prefilled syringe in the original carton until ready for use to protect from light. Do not freeze BIMZELX. Do not shake BIMZELX. Do not use the BIMZELX prefilled syringe past the expiration date printed on the carton. Keep BIMZELX prefilled syringes and all medicines out of the reach of children. BIMZELX prefilled syringe parts (see Figure A): Supplies Needed For each BIMZELX injection: 1 BIMZELX prefilled syringe. You may need 2 BIMZELX prefilled syringes to give the prescribed dose. Not provided in the BIMZELX prefilled syringe carton: 1 alcohol swab 1 clean cotton ball 1 sharps disposal container. See, " Step 12: Dispose of (throw away) the used BIMZELX prefilled syringe " at the end of this Instructions for Use. Setting up for your BIMZELX injection. Step 1: Take the BIMZELX prefilled syringe carton out of the refrigerator. Do not use the BIMZELX prefilled syringe(s) if the carton seal is broken. Throw it away and get a new one. Keep the BIMZELX prefilled syringe in its original carton for 30 to 45 minutes to warm to room temperature. This will help to reduce discomfort when injecting. Do not microwave the prefilled syringe, run hot water over it, or leave it in direct sunlight Do not shake the prefilled syringe. Do not take the cap off the prefilled syringe until you are ready to inject. Step 2: Find a clean, flat, and well-lit work surface, like a table. Step 3: Gather the supplies for your injection. Step 4: Wash your hands well with soap and water and dry with a clean towel. Step 5: Inspect the BIMZELX prefilled syringe (see Figure B): Remove the BIMZELX prefilled syringe from the carton. Make sure the name BIMZELX appears on the label. Check the expiration date printed on the label. Check the medicine through the viewing window. The medicine inside should be clear to slightly pearly, and colorless to pale brownish-yellow. You may see air bubble(s) in the liquid. This is normal. Do not use the BIMZELX prefilled syringe, throw it away and get a new one if: The expiration date printed on the label has passed The medicine is cloudy, discolored, or has particles It looks damaged or has been dropped Choose and prepare your injection site. Step 6: Choose and clean your injection site. The sites you may choose for your injection are: your stomach area (abdomen) or in your thigh (see Figure C). the back of your arm (see Figure D). BIMZELX may be injected into the back of your arm by a healthcare provider or caregiver only. Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis, or within 2 inches of the belly button (navel). Choose a new injection site on the body each time you use BIMZELX. Do not use the same injection site 2 times in a row. Step 7: Prepare your skin. Clean the injection site with an alcohol swab. Let the area dry completely. Do not touch the cleaned area again before injecting. Injecting BIMZELX. Step 8: Remove the BIMZELX prefilled syringe needle cap. Hold the BIMZELX prefilled syringe around the finger grip with one hand. Pull the cap straight off (away from) the BIMZELX prefilled syringe with the other hand (see Figure E). You may see a drop of liquid on the tip of the needle, this is normal. Put the cap into an FDA-cleared sharps disposal container right away. You will not need it again. Do not touch the needle or let the needle touch any surface. Do not hold the plunger rod during cap removal. If you accidentally remove the plunger rod, throw the BIMZELX prefilled syringe away and call your healthcare provider. Do not put the needle cap back on. Step 9: Gently pinch and hold a fold of skin where you cleaned the injection site with one hand. With the other hand, insert the needle into your skin at about a 45-degree angle. Push the needle all the way in to make sure that you inject your full dose. Then gently let go of your skin. Make sure the needle is in place (see Figure F). Step 10: Firmly push the plunger head all the way down until all the medicine is injected. (see Figure G). All the medicine is injected when you cannot push the plunger head any further (see Figure H). Step 11: Lift your thumb off the plunger head (see Figure I). The needle will automatically move back in and lock in place. Press a clean cotton ball or gauze pad over the injection site for a few seconds. Do not rub the injection site. You may see slight bleeding or a drop of liquid. This is normal. You may cover the injection site with a small adhesive bandage, if needed. Step 12: Dispose of (throw away) the used BIMZELX prefilled syringe (see Figure J). Put the used BIMZELX prefilled syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the BIMZELX prefilled syringe in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not recycle your used sharps disposal container. Step 13: Repeat steps 1 through 12 with a new BIMZELX prefilled syringe if you need to use 2 prefilled syringes to give the prescribed dose. Make sure to select a new injection site on the body each time you use BIMZELX. Do not use the same site that you used for your first injection. You can sign up to receive sharps containers for BIMZELX syringe disposal at no additional cost by going to www.BIMZELX.com or call 1-844-599-2273. Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080 US License No. 1736 This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 9/2024
NDC 50474-781-85 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx (bimekizumab-bkzx) Injection 160 mg/mL per autoinjector FOR SUBCUTANEOUS USE ONLY Two single-dose autoinjectors. Each autoinjector delivers 160 mg in 1 mL of bimekizumab-bkzx. For a 320 mg dose, two 160 mg autoinjectors are required.
NDC 50474-780-79 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx (bimekizumab-bkzx) Injection 160 mg/mL per syringe FOR SUBCUTANEOUS USE ONLY Two single-dose prefilled syringes. Each syringe delivers 160 mg in 1 mL of bimekizumab-bkzx. For a 320 mg dose, two 160 mg prefilled syringes are required.