Molecule
Ofatumumab is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Ofatumumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. KESIMPTA is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Source: US FDA prescribing information
The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
Source: US FDA prescribing information
Before initiating KESIMPTA, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. Administer KESIMPTA by subcutaneous injection only. Initial Dosing: 20 mg administered at Weeks 0, 1, and 2. Subsequent Dosing: 20 mg administered monthly starting at Week 4.
Source: US FDA prescribing information
KESIMPTA is contraindicated in patients with: Active HBV infection. History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema. Active HBV infection.
Source: US FDA prescribing information
Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with anti-CD20 therapies. Delay KESIMPTA administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with KESIMPTA and after discontinuation, until B-cell repletion. Injection-Related Reactions and Hypersensitivity Reactions: Management for injection-related reactions and hypersensitivity reactions depends on the type and severity of the reaction. Reduction in Immunoglobulins: Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with KESIMPTA until B-cell repletion. Consider discontinuing KESIMPTA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling: Infections Injection-Related Reactions and Hypersensitivity Reactions Reduction in Immunoglobulins Liver Injury Most common adverse reactions (incidence greater than 10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.
Source: US FDA prescribing information
Immunosuppressive or Immune-Modulating Therapies Concomitant usage of KESIMPTA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with KESIMPTA. When switching from therapies with immune effects, the duration and mechanism of action of these therapies should be taken into account because of potential additive immunosuppressive effects when initiating KESIMPTA.
Source: US FDA prescribing information
KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F). Write the date removed from the refrigerator in the space provided on the carton labeling. If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days. Keep the product in the original carton to protect from light until the time of use. To avoid foaming, do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ofatumumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Kesimpta 20 mg/0.4 mL injectionSubcutaneous Cold chain | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Ofatumumab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Ofatumumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ofatumumab, including Kesimpta.
Yes. The US FDA first approved Ofatumumab on 26 October 2009, according to Drugs@FDA.
Yes. Ofatumumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Ofatumumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Ofatumumab is classified under ATC code L01FA02 (Ofatumumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.