Kesimpta (Ofatumumab) – Multiple Sclerosis | DengYueMed

Kesimpta Application Scope

Kesimpta is a fully human anti-CD20 monoclonal antibody administered via subcutaneous injection for the treatment of relapsing forms of multiple sclerosis (MS).

 

Characteristics

• Ingredients: Ofatumumab

• Properties:

  • Monoclonal antibody targeting CD20 on B lymphocytes

  • Solution is clear to slightly opalescent, colorless to slightly brownish‑yellow

• Packaging Specification: Pre‑filled syringe or Sensoready pen, single‑dose, 20 mg/0.4 mL

• Storage:

  • Refrigerate at 2–8 °C (36–46 °F)

  • Protect from light; allow to reach room temperature before use

• Expiry Date: As stated on the package, typically 24 months from manufacture (see carton)

• Executive Standard: Fulfills FDA-approved Prescribing Information and EMA SmPC standards

• Approval Number: FDA BLA 125326 for Kesimpta (ofatumumab)

• Date of Revision:

  • U.S. label revised June 18, 2025

  • EMA SmPC revised ~5 months ago

• Manufacturer: Novartis Pharmaceuticals Corp.

Guidelines for the Use of Kesimpta

• Dosage and Administration:

  • Initial: 20 mg SC at Weeks 0, 1, and 2

  • Maintenance: 20 mg monthly starting Week 4

  • First injection under professional supervision

  • If a dose is missed, administer as soon as possible and resume the monthly schedule

• Adverse Reactions:

  • Very common (>10%):

    • upper respiratory infections, headache

    • systemic and local injection‑site reactions

  • Common:

    • urinary tract infection, back pain, reduced IgM, anxiety

    • pyrexia, constipation, muscular weakness

  • Injection reactions:

    • fever, myalgia, chills, fatigue; usually mild/moderate; serious, rare

  • Laboratory: decreased IgM (14%); IgG dip by 4.3% at 48 weeks

• Contraindications:

  • Hypersensitivity to ofatumumab or excipients

  • Active hepatitis B infection

  • Severe immunocompromise

  • Active malignancy (EMA)

• Precautions:

  • Screen for hepatitis B and quantitative immunoglobulins pre‑treatment

  • Monitor for infections, immunoglobulin levels

  • Delay or stop if serious infections or hypogammaglobulinemia

  • PML risk—monitor new neurological symptoms

  • Advise contraception during

  • For 6 months after therapy in women of childbearing potential

  • Do not administer live vaccines during and until B-cell recovery

Kesimpta Interactions

• Drug Interactions:

  • Live or live‑attenuated vaccines: contraindicated until immune reconstitution

  • Inactivated vaccines: less effective; vaccinate at least 2 weeks pre‑treatment

  • Concomitant immunosuppressants (e.g., steroids) may increase infection risk

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.