Product image of Kesimpta (Ofatumumab) supplied by GNH India

Kesimpta

Active Ingredient:
Ofatumumab
Origin:
EU

Kesimpta (Ofatumumab)

Ofatumumab, the active ingredient in Kesimpta, is a monoclonal antibody presented as a subcutaneous formulation for injection use. It is indicated for the treatment of relapsing forms of multiple sclerosis in adult patients.

GNH India supplies Kesimpta as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Kesimpta is a disease‑modifying therapy that targets B‑cell activity in multiple sclerosis.

  • Relapsing‑remitting multiple sclerosis: reduces annual relapse rate and slows disability progression.
  • Active secondary progressive multiple sclerosis: delays confirmed disability worsening.
  • Clinically isolated syndrome at high risk of conversion: may lower the likelihood of developing clinically definite MS.

How It Works

  • Ofatumumab binds with high affinity to the CD20 antigen expressed on B‑lymphocytes. This binding triggers complement‑dependent cytotoxicity and antibody‑dependent cellular cytotoxicity, leading to rapid and sustained depletion of circulating CD20‑positive B cells, thereby modulating the autoimmune response implicated in multiple sclerosis.

Side Effects

Kesimpta may cause a range of adverse reactions, most of which are mild to moderate.

Common Side Effects

  • Injection site reactions: redness, swelling, or pain at the injection site.
  • Upper respiratory tract infections: nasopharyngitis, sinusitis.
  • Headache.
  • Fatigue.
  • Mild lymphopenia.
  • Transient fever.

Serious or Rare Side Effects

  • Severe infections: opportunistic or serious bacterial infections.
  • Progressive multifocal leukoencephalopathy (PML).
  • Hepatitis B reactivation.
  • Severe neutropenia.
  • Anaphylaxis or severe hypersensitivity reactions.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient history and monitor for potential risks.

  • Infection screening: assess for active or latent infections, especially hepatitis B.
  • Immunization: administer required vaccines before starting treatment.
  • Monitoring: perform regular blood counts and liver function tests.
  • Pregnancy and lactation: discuss potential risks; use only if clearly needed.
  • Contraindications: avoid in patients with known hypersensitivity to ofatumumab.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ofatumumab may interact with other agents that affect immune function or infection risk.

Major Interactions (Avoid)

  • Live vaccines: concurrent use can cause uncontrolled infection.
  • Immunosuppressive chemotherapy: may exacerbate immunosuppression.

Moderate Interactions (Monitor Closely)

  • Antiviral agents for hepatitis B: monitor viral load.
  • Other disease‑modifying therapies for MS: assess additive immunosuppression.
  • Corticosteroids: may increase infection susceptibility.

Frequently Asked Questions

Kesimpta is prescribed to treat relapsing forms of multiple sclerosis, including relapsing‑remitting, active secondary progressive, and clinically isolated syndrome at high risk of conversion. It works as a disease‑modifying therapy to reduce relapse frequency and slow disability progression.

Ofatumumab targets the CD20 protein on B‑lymphocytes. By binding to CD20, it activates complement and cellular immune mechanisms that destroy these B cells, reducing their contribution to the autoimmune inflammation that drives multiple sclerosis activity.

The dosing regimen for Kesimpta is determined by the prescribing clinician based on the patient’s condition, weight, and clinical response. Healthcare professionals follow the approved label and adjust the schedule as needed for individual patients.

Safety data for ofatumumab in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made in consultation with a specialist.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details—including cold‑chain handling—and necessary import documentation.

Kesimpta is a fully human anti‑CD20 monoclonal antibody administered subcutaneously, offering a convenient at‑home dosing schedule. Compared with intravenous anti‑CD20 agents, it reduces infusion‑related reactions and clinic visits, while providing comparable efficacy in reducing relapses.

Kesimpta must be stored refrigerated between 2 °C and 8 °C. Keep the product in its original packaging, protect it from light, and avoid freezing or shaking the vial to maintain stability and potency.

Kesimpta is given as a subcutaneous injection. After an initial loading phase, patients typically self‑administer the medication at home using a pre‑filled syringe or autoinjector, following the training and schedule provided by their healthcare professional.

Serious risks include severe infections such as opportunistic or bacterial infections, reactivation of hepatitis B, progressive multifocal leukoencephalopathy (PML), and severe hypersensitivity reactions including anaphylaxis. Patients should be monitored closely for signs of infection or immune‑related complications.

Kesimpta is contraindicated in individuals with known hypersensitivity to ofatumumab or any of its excipients. It should also be avoided in patients with active severe infections or those who cannot receive required vaccinations before therapy initiation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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