Kesimpta (ofatumumab) is a targeted B-cell therapy used to treat relapsing forms of multiple sclerosis (RMS). While it is an effective treatment, it is not suitable for all patients and has specific contraindications and warnings. These are important considerations for healthcare providers and patients.
Absolute Contraindications for Kesimpta
There are two main reasons why a patient should not receive Kesimpta:
- Active Hepatitis B Virus (HBV) Infection: Patients with an active HBV infection should not take Kesimpta. Screening for HBV is required before starting treatment due to the risk of the virus becoming active again, which can cause severe liver problems.
- History of Hypersensitivity: Kesimpta should not be used if a patient has had a life-threatening allergic reaction to ofatumumab or any ingredient in Kesimpta.
Important Warnings and Precautions
Besides the absolute contraindications, there are other important risks and considerations when using Kesimpta.
Managing Active Infections
Kesimpta can weaken the immune system, making patients more susceptible to serious infections. Therefore, treatment should be postponed if a patient has an active infection until it is resolved. Patients should also be watchful for signs of new infections and report them to their doctor.
Hepatitis B Reactivation Risk
Even if there is no active infection, a history of HBV requires careful attention. All patients are screened for HBV before starting Kesimpta. If a patient has a history of HBV, a liver specialist should be consulted before and during treatment.
Vaccinations
Kesimpta can affect how well vaccines work. Live or live-attenuated vaccines are not recommended during treatment and should be given at least four weeks beforehand. Non-live vaccines should ideally be given at least two weeks before starting Kesimpta.
Pregnancy and Lactation
Kesimpta may harm a developing fetus. Women who can become pregnant are advised to use birth control during treatment and for six months after the last dose. Information about whether Kesimpta is present in breast milk is not available.
Immunoglobulin Reduction
Treatment with Kesimpta can lower levels of certain antibodies (immunoglobulins), particularly IgM. Immunoglobulin levels should be checked before, during, and after treatment. If a patient has low immunoglobulin levels and gets frequent or severe infections, stopping Kesimpta may be considered.
Kesimpta vs. Other MS Therapies: A Safety Comparison
It can be helpful to compare Kesimpta's safety profile with other MS treatments. Below is a table highlighting some key safety aspects based on available information.
| Feature | Kesimpta (Ofatumumab) | Teriflunomide (Aubagio) | Ocrelizumab (Ocrevus) |
|---|---|---|---|
| Primary Contraindications | Active HBV infection, life-threatening hypersensitivity to ofatumumab. | Severe hepatic impairment, pregnancy, hypersensitivity. | Active HBV infection, life-threatening hypersensitivity to ocrelizumab. |
| Route of Administration | Subcutaneous (self-injection). | Oral (pill). | Intravenous (infusion). |
| Common Infections | Upper respiratory tract infections, urinary tract infections. | Upper respiratory tract infections. | Upper respiratory tract infections, herpes. |
| HBV Risk | Reactivation risk in patients with prior infection; contraindicated with active HBV. | No significant HBV reactivation risk noted in prescribing info. | Reactivation risk in patients with prior infection; contraindicated with active HBV. |
| Pregnancy Risk | Potential fetal harm; contraception required for females of reproductive potential. | Harmful to fetus; contraindicated during pregnancy; contraception required. | Fetal harm risk; contraception required. |
| Primary Mechanism | Anti-CD20 monoclonal antibody; depletes B-cells. | Pyrimidine synthesis inhibitor; reduces lymphocyte activation. | Anti-CD20 monoclonal antibody; depletes B-cells. |
A Checklist for Patients and Healthcare Providers
Before starting Kesimpta, a thorough evaluation is necessary. The following steps should be completed:
- Screen for Hepatitis B virus.
- Address any active infections.
- Review history of allergic reactions.
- Check vaccination records and administer any needed vaccines according to guidelines.
- Discuss pregnancy plans and contraception for women of reproductive potential.
- Establish baseline immunoglobulin and liver function values.
Conclusion: Prioritizing Safety in MS Treatment
While Kesimpta is an important treatment option for RMS, it is vital to be aware of its contraindications, particularly active HBV infection and severe hypersensitivity reactions. Other significant risks, including those related to infections, HBV reactivation, vaccinations, pregnancy, and low immunoglobulins, also require careful management. A comprehensive assessment before starting treatment and ongoing monitoring are crucial to ensure Kesimpta is used safely and effectively. Always consult a healthcare professional to determine the best treatment plan for your individual needs. For more details, refer to the official FDA prescribing information.
