Bimzelx

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)
  

• 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)
  

• Injection
  : 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector. (
  
  3)
  
• Injection
  : 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector. (
  
  3)
  

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BIMZELX 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/.