Europe — EMA
Kesimpta
GNH USA supplies Kesimpta (ofatumumab), a monoclonal antibody for relapsing forms of multiple sclerosis. Request a quote for global supply to clinics.
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What is 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 USA 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.
What is Ofatumumab used for?
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.
What are the side effects of Ofatumumab?
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.
What precautions apply to Ofatumumab?
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.
What does Ofatumumab interact with?
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
What is Kesimpta used for?+
How does ofatumumab work?+
What is the usual dose of Kesimpta?+
Is Kesimpta safe during pregnancy or breastfeeding?+
How do I order Kesimpta from GNH USA?+
How does Kesimpta compare with the main alternative drug or class?+
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Who should not use Kesimpta?+
Product details
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