Bimzelx 160 mg/mL
bimekizumab · INJECTION, SOLUTION · UCB, Inc.
Bimzelx is a injection, solution containing bimekizumab at 160 mg/mL, taken subcutaneous. Manufactured by UCB, Inc..
Key Facts
- Brand Name
- Bimzelx
- Generic Name
- bimekizumab
- NDC Code (Product)
50474-780- Manufacturer
- UCB, Inc.
- Strength
- 160 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761151
- Marketing Start
- 10/17/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. 1.4 Ankylosing Spondylitis BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis. 1.5 Hidradenitis Suppurativa BIMZELX is indicated for the treatment of adults with moderate to seve…
Dosage & Administration
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, then every 4 weeks thereafter. ( 2.6 ) See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. ( 2.7 , 2.8 , 2.9 ) 2.1 Recommended Ev…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with BIMZELX may modulate serum levels of some cytokines. Therefore, upon initiation or discontinuation of BIMZELX in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate. Population pharmacokinetic (PK) data analyses indicated that the clearance of BIMZELX was not impacted by concomitant administration of cDMARDs including methotrexate, or by prior exposure to biologics.
Adverse Reactions
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, ora…
Frequently Asked Questions
What is Bimzelx used for?
Bimzelx contains bimekizumab. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Bimzelx a controlled substance?
Bimzelx is not classified as a controlled substance by the DEA.
What is the generic name for Bimzelx?
The generic name for Bimzelx is bimekizumab. There are no other listed brand versions of bimekizumab.
What is the NDC code for Bimzelx 160 mg/mL?
The NDC (National Drug Code) for Bimzelx 160 mg/mL is 50474-780, listed by UCB, Inc..
Other Bimzelx Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)