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 20 mg/mL solution for injection for subcutaneous use. It targets CD20‑positive B cells and is approved in the European Union 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. The company adheres to stringent quality standards and provides cold‑chain logistics for biologic products.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Kesimpta (ofatumumab) is an anti‑CD20 disease‑modifying therapy used in the multiple sclerosis therapeutic area.

  • Relapsing‑remitting multiple sclerosis: reduces annualized relapse rate and delays disability progression.
  • Clinically isolated syndrome: lowers risk of conversion to clinically definite multiple sclerosis.
  • Active secondary progressive multiple sclerosis: decreases relapse activity and may slow disease worsening.

How It Works

  • Ofatumumab binds with high affinity to the CD20 antigen on mature B lymphocytes. This interaction triggers complement‑dependent cytotoxicity and antibody‑dependent cellular cytotoxicity, leading to rapid and sustained depletion of CD20‑positive B cells, thereby modulating the autoimmune processes that drive multiple sclerosis.

Side Effects

The safety profile of Kesimpta includes a range of adverse reactions observed in clinical use.

Common Side Effects

  • Injection site reactions: erythema, pain, or swelling at the injection site.
  • Upper respiratory tract infection: mild to moderate symptoms such as cough or sore throat.
  • Headache: transient headache episodes.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Progressive multifocal leukoencephalopathy (PML): rare but potentially fatal brain infection.
  • Serious infections: bacterial, viral, or fungal infections requiring hospitalization.
  • Hepatitis B reactivation: may occur in patients with prior hepatitis B infection.

Precautions & Warnings

When prescribing Kesimpta, clinicians should consider several precautionary measures to ensure patient safety.

  • Screening: test for hepatitis B virus infection before initiating therapy.
  • Monitoring: observe for signs of infection during treatment.
  • Vaccination: avoid live vaccines while receiving Kesimpta.
  • Pregnancy: avoid use during pregnancy unless benefit outweighs risk; data are limited.
  • Immunization: assess immune status and consider prophylactic measures for opportunistic infections.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Kesimpta may interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Live vaccines: concurrent use can cause severe infection.
  • Immunosuppressive agents: combined use may increase infection risk.

Moderate Interactions (Monitor Closely)

  • Antiviral prophylaxis for hepatitis B: may be needed when co‑administered.
  • Concomitant monoclonal antibodies: may augment B‑cell depletion and infection risk.
  • CYP450 substrates: ofatumumab does not significantly affect CYP enzymes, but monitor drugs with narrow therapeutic windows if infection alters metabolism.

Frequently Asked Questions

Kesimpta is indicated for the treatment of relapsing forms of multiple sclerosis in adult patients. This includes relapsing‑remitting disease, clinically isolated syndrome, and active secondary progressive multiple sclerosis, where it helps reduce relapse frequency and may slow disability progression.

Ofatumumab is a fully human monoclonal antibody that binds specifically to the CD20 antigen on mature B cells. The binding activates complement‑dependent cytotoxicity and antibody‑dependent cellular cytotoxicity, leading to rapid depletion of CD20‑positive B cells and modulation of the autoimmune response that drives multiple sclerosis.

The dosage regimen for Kesimpta is determined by the prescribing clinician based on the approved label and individual patient factors. Healthcare professionals set the dose, frequency, and any titration steps, and patients should follow the prescriber’s instructions without deviation.

Data on the use of Kesimpta in pregnancy and lactation are limited. The product is generally not recommended for pregnant or nursing women unless the potential benefit justifies the potential risk. Physicians should discuss possible risks and alternatives with patients who are or may become pregnant.

To order Kesimpta, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. The sales team then provides pricing, availability, shipping details—including cold‑chain handling where required—and assists with import documentation.

The primary alternative in the anti‑CD20 class is ocrelizumab, another monoclonal antibody that depletes CD20‑positive B cells. Both agents share a similar mechanism, but they differ in dosing frequency, administration route (intravenous for ocrelizumab versus subcutaneous for Kesimpta), and specific safety profiles. Choice of therapy depends on clinical judgment, patient preference, and individual risk considerations.

Kesimpta must be stored refrigerated at 2 °C to 8 °C. It should be kept in its original packaging to protect from light, and it must never be frozen or shaken. If temporary temperature excursions occur, the product should be inspected for visual changes before use.

Kesimpta is supplied as a 20 mg/mL solution for subcutaneous injection. The injection is typically performed by a healthcare professional or, after appropriate training, by the patient themselves using the pre‑filled device provided in the kit. The injection site is usually the abdomen or thigh, and rotating sites is recommended.

The most serious adverse events include progressive multifocal leukoencephalopathy (PML), severe or opportunistic infections, and reactivation of hepatitis B infection. Patients should be monitored closely for signs of infection, and hepatitis B screening is required before initiating therapy.

Kesimpta is contraindicated in individuals with known hypersensitivity to ofatumumab or any of the excipients, active severe infections, and in patients with active hepatitis B infection. Caution is also advised for those with compromised immune systems or a history of PML.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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