General Information
Manufacturer: Novartis
Medical Name: Ofatumumab
Purpose: Kesimpta is a prescription disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and clinically isolated syndrome (CIS) in adults.
Side Effects
| Side-Effect | Percent Affected |
|---|---|
| Upper respiratory tract infections (common cold, etc.) | 39% |
| Injection-related reactions (systemic) | 21% |
| Headache | 13% |
| Injection-site reactions (local) | 11% |
| Urinary tract infection | 10% |
| Back pain | 8% |
| Decreased blood immunoglobulin M (IgM) levels | 6% |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Serious Infections | The overall rate of serious infections in clinical trials was low (~2.5%) and similar to other MS treatments. Symptoms can vary and may include persistent fever or cough, or painful/frequent urination. |
| Progressive Multifocal Leukoencephalopathy (PML) | This is a rare, serious brain infection that is often fatal. No cases of PML were reported in the Kesimpta MS clinical trials, but it has occurred with a higher intravenous dose of the same active ingredient (ofatumumab) used for other conditions. Symptoms may include new or worsening weakness, vision problems, clumsiness, confusion, or personality changes. |
| Hepatitis B Virus (HBV) Reactivation | Patients will be screened for HBV before starting treatment. If you have had a previous HBV infection, it could become active again, leading to severe liver problems. |
| Low Immunoglobulins | Kesimpta can decrease certain antibodies, which may increase the risk of infection. Your healthcare provider will monitor your blood immunoglobulin levels. |
| Allergic Reactions | Severe allergic reactions are possible, with symptoms such as difficulty breathing, swelling of the face/throat, or hives. |
Preclusions To Starting Treatment
- An active hepatitis B virus (HBV) infection
- A history of a life-threatening allergic reaction to ofatumumab (the active ingredient in Kesimpta)
Preconditions That Should Be Discussed Before Starting Treatment
| Preclusion | Description |
|---|---|
| Active Infection | Kesimpta treatment should be delayed if a patient has any active infection until the infection has resolved. |
| Low Immunoglobulin Levels | Patients with low serum immunoglobulin levels, which indicate potential immune compromise, may require consultation with an immunology expert before starting treatment. Discontinuation may be necessary if a serious opportunistic or recurrent infection develops. |
| Recent Vaccinations | Vaccination with live-attenuated or live vaccines is not recommended during treatment with Kesimpta and until B-cell levels recover. These vaccines should be administered at least four weeks before initiating therapy, and inactivated vaccines at least two weeks prior, if possible. |
| Pregnancy/Breastfeeding | Based on animal data, Kesimpta may cause fetal harm. Females of childbearing potential are advised to use effective contraception during treatment and for six months after the last dose. It is unknown if Kesimpta passes into breast milk, so consultation with a doctor is necessary. |
| Concurrent Immunosuppressive Therapies | Use of Kesimpta in combination with other disease-modifying therapies for multiple sclerosis or other immunosuppressant medications is not recommended due to the potential for an increased risk of infection. |