From the Guidelines
Kesimpta (ofatumumab) can cause several side effects, including injection site reactions, upper respiratory tract infections, headache, and urinary tract infections, as well as more serious infections and a decrease in immunoglobulins, potentially increasing infection risk. Common side effects include injection site reactions such as redness, pain, itching, or swelling at the injection site, as reported in studies such as 1. Many patients experience upper respiratory tract infections, headache, and urinary tract infections. More concerning side effects include serious infections, as Kesimpta suppresses part of the immune system by targeting B cells. Progressive Multifocal Leukoencephalopathy (PML), a rare but serious brain infection, has been associated with similar medications. Kesimpta may also cause a decrease in immunoglobulins, potentially increasing infection risk. Injection-related reactions like fever, headache, muscle pain, chills, and fatigue can occur, especially with the first injection, as seen in studies like 1. Liver enzyme elevations have been reported in some patients. Before starting Kesimpta, patients should be screened for hepatitis B, as the medication can reactivate the virus. Vaccination status should be updated before beginning treatment, as live vaccines should be avoided during therapy. Patients should promptly report any signs of infection, unusual bruising or bleeding, or neurological symptoms to their healthcare provider.
Some key points to consider when prescribing Kesimpta include:
- Monitoring for signs of infection, such as fever or chills
- Regular liver function tests to monitor for liver enzyme elevations
- Screening for hepatitis B before starting treatment
- Updating vaccination status before beginning treatment
- Avoiding live vaccines during therapy
- Promptly reporting any signs of infection, unusual bruising or bleeding, or neurological symptoms to the healthcare provider, as recommended in studies such as 1 and 1.
It is essential to weigh the benefits and risks of Kesimpta treatment, considering the potential for serious infections and other side effects, as discussed in studies like 1 and 1. However, for many patients, the benefits of Kesimpta treatment may outweigh the risks, particularly when carefully monitored and managed by a healthcare provider.
From the FDA Drug Label
KESIMPTA may cause serious side effects, including: Infections. Serious infections, which can be life-threatening or cause death, can happen during treatment with KESIMPTA. Hepatitis B virus (HBV) reactivation Progressive Multifocal Leukoencephalopathy (PML) Weakened immune system. Injection-related reactions. Low immunoglobulins. The most common side effects of KESIMPTA include: upper respiratory tract infection, with symptoms, such as sore throat and runny nose, and headache.
The side effects of Kesimpta include infections, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy (PML), weakened immune system, injection-related reactions, and low immunoglobulins. Common side effects are upper respiratory tract infection and headache 2.
From the Research
Side Effects of Kesimpta
- The most common adverse events (AEs) associated with Kesimpta (ofatumumab) include:
- Nasopharyngitis
- Headache
- Upper respiratory tract infections
- Urinary tract infections 3
- Adverse events of special interest (AESIs) include:
- Infections
- Injection-related reactions, which were generally manageable 3
- There is no apparent association between changes in immunoglobulin G or M levels and the risk of serious infections after 3.5 years of ofatumumab treatment 3
Comparison with Other Treatments
- Kesimpta has been compared to other disease-modifying therapies (DMTs) such as interferons-beta and glatiramer acetate in terms of efficacy and safety 4, 5, 6
- The choice of a specific DMT should reflect the risk/benefit profile, as well as the impact on quality of life 4
- Head-to-head trials are considered the best approach for gaining objective reliable data when two different drugs are compared 5
Safety and Efficacy
- Kesimpta has a generally manageable tolerability profile, with a low risk of serious infections 3
- The effects of Kesimpta on disease course, including clinical and MRI outcomes, have been evaluated in several studies 3, 5, 6
- The quality of evidence for primary outcomes was judged as moderate for clinical end points, but for safety and some MRI outcomes, quality was judged as low 5