Prescription medicine
Ofatumumab Brand names: Kesimpta
Ofatumumab (Kesimpta) is a prescription medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $24,369.37 per mL (Kesimpta 20 mg/0.4 mL pen) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ofatumumab FDA label on DailyMed (effective April 1, 2026, Novartis Pharmaceuticals Corporation); the BLA 125326 record on Drugs@FDA; every ofatumumab label on DailyMed.
Highlights of the record
FDA label of April 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageKESIMPTA 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.
Forms and strengths
- 20 mg/.4ml
Injection (solution).
On the market
- Earliest approval on file
- October 26, 2009 Kesimpta, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $24,369.37 per mL Kesimpta 20 mg/0.4 mL pen
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 33,037 through July 30, 2026
What is ofatumumab used for?
From the label: indications and usageKESIMPTA 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.
Conditions named in the indications of ofatumumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD20-directed Cytolytic Antibody.
Source: FDA drug label (KESIMPTA), Novartis Pharmaceuticals Corporation, effective April 1, 2026 (SPL set 6a8a3f53-2062-48ff-9dbe-b939df133ca3), via openFDA; the full label on DailyMed
What does the patient leaflet for ofatumumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KESIMPTA?KESIMPTA can cause serious side effects, including: Infections. Serious infections, which can be life-threatening or cause death, can happen during treatment with KESIMPTA. If you have an active infection, your healthcare provider should delay your treatment with KESIMPTA until your infection is gone. KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches. Hepatitis B virus (HBV) reactivation. Before starting treatment with KESIMPTA, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV infection, the HBV may become active again during or after treatment with KESIMPTA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. You should not receive KESIMPTA if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using KESIMPTA. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment with KESIMPTA. Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. […]
From the patient leaflet: How should I store KESIMPTA?Store KESIMPTA in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep KESIMPTA in the original carton until ready for use to protect from light. If needed, KESIMPTA may be stored for up to 7 days at room temperature, up to 86°F (30°C). Write the date taken out of the refrigerator in the space provided on the carton. If stored below 86°F (30°C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days. If this KESIMPTA is not used within those 7 days, then discard the medicine. Do not freeze KESIMPTA. Do not shake KESIMPTA. Keep KESIMPTA and all medicines out of the reach of children.
Source: FDA drug label (KESIMPTA), Novartis Pharmaceuticals Corporation, effective April 1, 2026 (SPL set 6a8a3f53-2062-48ff-9dbe-b939df133ca3), via openFDA; the full label on DailyMed
Is there a generic for ofatumumab (Kesimpta)?
No generic ofatumumab is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ofatumumab (Kesimpta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $24,369.37 per mL (Kesimpta 20 mg/0.4 mL pen), up 8% from $22,578.60 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Kesimpta 20 mg/0.4 mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Kesimpta 20 mg/0.4 mL pen | Brand | $24,369.37 per mL | $9,747.75 per single-dose pen | +8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ofatumumab label say about other medicines?
The ofatumumab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Only limited benefit of premedication with corticosteroids, antihistamines, or acetaminophen was observed in RMS clinical studies. |
| Teriflunomide | warnings and precautions | Decrease in immunoglobulin M (IgM) was reported in 7.7% of patients treated with KESIMPTA compared to 3.1% of patients treated with teriflunomide in RMS clinical trials [see Adverse Reactions (6.1)]. |
Source: FDA drug label (KESIMPTA), Novartis Pharmaceuticals Corporation, effective April 1, 2026 (SPL set 6a8a3f53-2062-48ff-9dbe-b939df133ca3), via openFDA; the full label on DailyMed
What do FAERS reports show for ofatumumab?
The FDA Adverse Event Reporting System holds 33,037 reports that list ofatumumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 762 are coded as a death and 4,565 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (8,729, against a median of 680 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ofatumumab?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as ofatumumab or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glatiramer | Multiple sclerosis | 8 labelers | $86.10 per mL 40 mg/mL syringe | No current entry |
| Interferon beta 1a | Multiple sclerosis | none listed | $1,848.67 per mL 44 mcg/0.5 mL | No current entry |
| Peginterferon beta 1a | Multiple sclerosis | none listed | n/a | No current entry |
| Corticotropin | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ofatumumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ofatumumab
- 4 medicines for the same use
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Ofatumumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other