Ofatumumab Application Scope

KESIMPTA® (ofatumumab, SC): Indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in adults — to reduce the frequency of clinical relapse and inflammatory disease activity.
ARZERRA® (ofatumumab, IV): Indicated for treatment of chronic lymphocytic leukemia (CLL) in specific patient populations as described in the full prescribing information (e.g., in combination with chlorambucil for previously untreated CLL when fludarabine-based therapy is inappropriate; also for refractory/extended treatment situations per label).

Ofatumumab Characteristics

Ingredients:
- Active ingredient: Ofatumumab (recombinant fully human monoclonal anti-CD20 antibody).
- Excipients: See local product label for full excipient list (formulation differs between SC and IV products).
Properties:
- KESIMPTA (SC): Clear to slightly opalescent, colorless to pale-yellow solution supplied in prefilled syringe or Sensoready® pen for subcutaneous injection (20 mg/0.4 mL).
- ARZERRA (IV): Sterile concentrate/diluent for intravenous infusion; follow IV preparation instructions in prescribing information.
Packaging Specification:
- KESIMPTA: 20 mg / 0.4 mL prefilled syringe or Sensoready pen (single-use). Typical pack configurations vary by market — check outer carton.
- ARZERRA: Intravenous vials of specified mg/vial per product label.
Storage: Refrigerate at 2 °C – 8 °C (36–46 °F). Do not freeze. Protect from light. Keep in original carton until use. (Refer to local label for any permitted short-term room-temperature excursions.)
Expiry Date: Refer to the vial/carton for the expiry date. Typical labeled shelf life is up to 36 months from manufacture for many biologic presentations — confirm on product packaging.
Executive Standard: Manufactured and released according to applicable regulatory and GMP standards for therapeutic biological products (refer to local regulatory/label information).
Approval Number: Approval/registration numbers vary by market and formulation. Please refer to the product carton/label or national regulatory database for the exact approval number in your country/market (e.g., KESIMPTA approved by FDA and EMA; launched in China/other markets under local arrangements).
Date of Revision: See the revision date printed on the local package insert. (Different local labels may have different revision dates.)
Manufacturer:
- KESIMPTA (SC) — marketed by Novartis/Genmab/partner depending on territory (Kesimpta is commercially distributed by Novartis in many markets).
- ARZERRA (IV) — Novartis/Glaxo/previous licensors depending on region historically; see local label for the manufacturing site and marketing authorization holder.

Guidelines for the Use of xxx

Dosage and Administration:
- Recommended Dose:
  - Initial (loading): 20 mg subcutaneously at Week 0, Week 1 and Week 2 (three weekly 20 mg doses).
  - Maintenance: 20 mg subcutaneously once monthly starting at Week 4 (i.e., monthly thereafter).
- Administration: Route: For subcutaneous (SC) injection only (Kesimpta). Use the prefilled syringe or Sensoready pen as instructed. First injection(s) should be performed under healthcare provider supervision with appropriate training for self-administration thereafter where allowed.
- Missed Dose: If an injection is missed, give the missed dose as soon as possible and then continue with the regular monthly schedule. Do not double doses to make up for missed injections; follow the local prescribing information for specific guidance.
Adverse Reactions:
- Common Adverse Reactions: Injection site reactions (erythema, pain, pruritus), upper respiratory tract infections, headache, fatigue. Frequency and severity vary by study and formulation.
- Serious Adverse Reactions:
  - Infections due to immunosuppression/B-cell depletion (including serious and opportunistic infections) — monitor patients.
  - Infusion-related or injection-related reactions (for IV formulations infusions may provoke reactions; monitor during and after administration).
  - Hepatitis B virus reactivation has been reported with anti-CD20 antibodies — screen and manage per label.
  - For oncology IV formulations (Arzerra) there are additional serious event profiles (neutropenia, cytopenias, etc.). See full prescribing information.
Contraindications: Known hypersensitivity to ofatumumab or any excipient in the formulation. Specific contraindications (if any) appear on the local label and should be followed.
Precautions:
- Screen for active infections prior to initiation; evaluate for chronic infection risks (e.g., HBV).
- Vaccination: live vaccines should generally be avoided during and after treatment until immune recovery; inactivated vaccine responses may be attenuated — follow label guidance for timing of vaccines.
- Monitor for hypogammaglobulinemia and consider immunoglobulin replacement if clinically indicated (oncology indications have more intensive monitoring).

Ofatumumab Interactions

No specific small-molecule pharmacokinetic interactions are established; however, concomitant immunosuppressive therapies increase infection risk. Check full prescribing information and local formularies for detailed interaction guidance.

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.