GNH USA

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.

Ofatumumab

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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?+
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.
How does ofatumumab work?+
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.
What is the usual dose of Kesimpta?+
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.
Is Kesimpta safe during pregnancy or breastfeeding?+
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.
How do I order Kesimpta from GNH USA?+
To order Kesimpta, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Kesimpta compare with the main alternative drug or class?+
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.
What are the storage and handling requirements for Kesimpta?+
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.
How is Kesimpta administered?+
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.
What are the most serious risks associated with Kesimpta?+
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.
Who should not use Kesimpta?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ofatumumab
Route
Subcutaneous Use
Manufacturer
Novartis Europharm Limited
Origin
EU

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