Bimzelx (Bimekizumab)

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 Plaque Psoriasis

  BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
  )
  
• Adults with active
  
  
  psoriatic arthritis (PsA)
  . (
  
  
  1.2 Psoriatic Arthritis

  BIMZELX is indicated for the treatment of adults with active psoriatic arthritis.
  )
  
• Adults with active
  
  
  non-radiographic axial spondyloarthritis
  (
  
  
  nr-axSpA
  ) with objective signs of inflammation. (
  
  
  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.
  )
  
• Adults with active
  
  
  ankylosing spondylitis
  (
  
  
  AS
  ). (
  
  
  1.4 Ankylosing Spondylitis

  BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis.
  )
  
• Adults with moderate to severe
  
  
  hidradenitis suppurativa (HS)
  . (
  
  
  1.5 Hidradenitis Suppurativa

  BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.
  )
  

• Prior to treatment: (
  
  2.1 Recommended Evaluations and Immunization Prior to Treatment Initiation

  • 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)]
    .
  )
  
  
  • 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 Recommended Dosage for Plaque Psoriasis

    The recommended dosage is 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 dosage of 320 mg every 4 weeks after Week 16

    [see Clinical Pharmacology (12.3)]

    .
    )
    
• Psoriatic Arthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. (
    
    2.3 Recommended Dosage for Psoriatic Arthritis

    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)]

    .
    )
    
  • For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. (
    
    2.2 Recommended Dosage for Plaque Psoriasis

    The recommended dosage is 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 dosage of 320 mg every 4 weeks after Week 16

    [see Clinical Pharmacology (12.3)]

    .
    )
    
• Non-Radiographic Axial Spondyloarthritis
  • Administer 160 mg by subcutaneous injection every 4 weeks. (
    
    2.4 Recommended Dosage for Non-Radiographic Axial Spondyloarthritis

    The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
    )
    
• Ankylosing Spondylitis
  • Administer 160 mg by subcutaneous injection every 4 weeks. (
    
    2.5 Recommended Dosage for Ankylosing Spondylitis

    The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
    )
    
• 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 Recommended Dosage for Hidradenitis Suppurativa

    The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
    )
    
• See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. (
  
  2.7 Missed Doses

  If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.
  ,
  
  2.8 Preparation Instructions

  • 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.
  ,
  
  2.9 Administration Instructions

  • 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 a 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 DOSAGE FORMS AND STRENGTHS

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

  • Injection (1 mL): 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
  • Injection (2 mL): 320 mg/2 mL (160 mg/mL) clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
  )
  
• Injection
  : 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector. (
  
  
  3 DOSAGE FORMS AND STRENGTHS

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

  • Injection (1 mL): 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
  • Injection (2 mL): 320 mg/2 mL (160 mg/mL) clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
  )
  

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/.