General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Bimzelx
BIMEKIZUMAB
1 INDICATIONS AND USAGE 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 ) Adults with moderate to severe hidraden...
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Brand names:Bimzelx
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BIMEKIZUMAB
- Medicine class
- General Medicine
- Brand names
- Bimzelx
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life was 23 days, with clearance independent of dose
- FDA approved
- Yes
What Is Bimzelx?
1 INDICATIONS AND USAGE 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 ) Adults with moderate to severe hidraden...
Bimzelx (BIMEKIZUMAB) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Bimzelx. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Bimzelx with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Bimzelx is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE 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 ) Adults with moderate to severe hidradenitis suppurativa (HS) .
( 1.5 ) 1.1 Plaque Psoriasis BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
1.2 Psoriatic Arthritis BIMZELX is indicated for the treatment of adults with active psoriatic arthritis.
1.3 Non-Radiographic Axial Spondyloarthritis BIMZELX is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION 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 by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, 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 ) Hidradenitis Suppurativa Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16,
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS 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 and Hidradenitis Suppurativa (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.
- 6.1 Clinical Trials Experience 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.
Serious
- 5 WARNINGS AND PRECAUTIONS 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, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at
- 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Carefully weigh risks and
How Bimzelx Works
12.1 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.
Pharmacokinetics
Absorption
Absorption The absolute bioavailability of bimekizumab-bkzx was 70% in healthy subjects
Half-Life
half-life was 23 days, with clearance independent of dose
Metabolism
Metabolism: Bimekizumab-bkzx is expected to be degraded into small peptides by catabolic pathways
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Bimzelxwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Storage and Handling Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use. Do not freeze. Do not shake. Do not use beyond expiration date. BIMZELX does not contain a preservative; discard any
Frequently Asked Questions
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Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Bimzelx
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.