Bimzelx (Bimekizumab) – Psoriasis | HongKong DengYue Medicine

  • Generic Name/Brand Name: ​Bimekizumab/Bimzelx
  • Indications: Psoriasis
  • Dosage Form: ​Solution for injection
  • Specification: 160 mg × 1 & 320 mg × 2 syringes

Bimekizumab Application Scope

  • Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
  • Treatment of active psoriatic arthritis (PsA) in adults.
  • Treatment of active ankylosing spondylitis (AS) in adults.
  • Treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adults.
  • Treatment of moderate to severe hidradenitis suppurativa (HS) in adults.
bimekizumab
bimekizumab

Bimekizumab Characteristics

  • Ingredients: Bimekizumab

  • Properties:​ Bimekizumab is a recombinant humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17A and interleukin (IL)-17F, key cytokines involved in inflammatory processes.

  • Packaging Specification:​ Pre-filled syringe or pre-filled pen containing 160 mg/mL solution for subcutaneous injection.

  • Storage:​ Store refrigerated at 2°C–8°C. Do not freeze. Protect from light.

  • Expiry Date: As indicated on the product packaging.

  • Executive Standard: ​According to relevant pharmacopoeial and biologic product standards.

  • Approval Number: Varies by country.

  • Date of Revision: Varies by region.

  • Manufacturer: UCB Pharma S.A.

Guidelines for the Use of Bimekizumab

  • Dosage and Administration:

    • Recommended Dose:

      • Plaque Psoriasis: 320 mg (two 160 mg injections or one 320 mg injection) at Weeks 0, 4, 8, 12, 16, then every 8 weeks. For patients ≥120 kg, consider 320 mg every 4 weeks after Week 16.
      • Psoriatic Arthritis: 160 mg every 4 weeks. Use plaque psoriasis regimen if coexistent moderate to severe plaque psoriasis.
      • Non-Radiographic Axial Spondyloarthritis: 160 mg every 4 weeks.
      • Ankylosing Spondylitis: 160 mg every 4 weeks.
      • Hidradenitis Suppurativa: 320 mg at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, then every 4 weeks.
    • Administration: Administer subcutaneously in the abdomen, thigh, or upper arm. Avoid injecting into areas where the skin is tender, bruised, or damaged.

    • Missed Dose:​ If a dose is missed, administer as soon as possible. Resume the regular dosing schedule thereafter.

  • Adverse Reactions:

    • Common Adverse Reactions:

      • Upper respiratory tract infection

      • Oral candidiasis

      • Headache

      • Injection site reactions

      • Fatigue

    • Serious Adverse Reactions:

      • Serious infections (e.g., fungal infections)

      • Hypersensitivity reactions

      • Inflammatory bowel disease exacerbation (rare)

  • Contraindications:

    • Hypersensitivity to Bimekizumab or any excipients

    • Active clinically significant infections, including tuberculosis

  • Precautions:

    • Screen for tuberculosis prior to initiation.

    • Monitor for signs of infection during treatment.

    • Avoid live vaccines during therapy.

    • Use with caution in patients with a history of chronic infections or inflammatory bowel disease.

Bimekizumab Interactions

  • Live Vaccines: Avoid concurrent use (due to increased risk of infection from the vaccine).
  • CYP450 Substrates (Narrow Therapeutic Index): Bimekizumab may normalize the formation of certain CYP450 enzymes that are suppressed by chronic inflammation. This could result in lower exposure of certain co-administered drugs metabolized by CYP450 (e.g., Warfarin, Cyclosporine). Therapeutic monitoring is advised when starting Bimekizumab with these types of medications.
  • Other Immunosuppressants: Caution is generally advised with other immunosuppressive agents due to the potential for increased risk of infection.

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  •  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.
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