Kesimpta

Approved Uses for Kesimpta

Kesimpta is specifically approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This includes several specific types of the condition:

• Clinically Isolated Syndrome (CIS): This refers to a single, first episode of neurologic symptoms that lasts at least 24 hours and may be the first sign of MS.
• Relapsing-Remitting MS (RRMS): This is the most common form of MS, characterized by clearly defined attacks of new or increasing neurologic symptoms followed by periods of partial or complete recovery.
• Active Secondary Progressive MS (SPMS): This is a stage of MS that follows an initial relapsing-remitting course. It is considered active when the person continues to experience relapses or new activity on imaging scans.

Treatment Goals

The primary goals of treatment with Kesimpta are to help manage the course of the disease by:

• Decreasing the frequency of clinical relapses (flare-ups).
• Slowing the accumulation of physical disability associated with MS.
• Reducing the number of active brain lesions as seen on MRI scans.

While Kesimpta helps manage the symptoms and progression of relapsing MS, it is not a cure for the disease. It is intended for long-term use to modify the disease course and is not typically used to treat primary progressive multiple sclerosis (PPMS).

Targeting B Cells

Kesimpta works by targeting B cells, which are a type of white blood cell. In people with multiple sclerosis (MS), these cells are believed to play a role in attacking the protective sheath, known as myelin, that covers nerve fibers in the brain and spinal cord.

Mechanism of Action

The active ingredient in Kesimpta is ofatumumab, a laboratory-made protein called a monoclonal antibody. It is designed to recognize and bind to a specific protein called CD20 found on the surface of certain B cells. Once the medication attaches to these cells, it causes them to be broken down and removed from the body.

Reducing Inflammation

By reducing the number of circulating B cells, Kesimpta helps to:

• Lower the immune system's attack on the central nervous system.
• Decrease the frequency of MS relapses.
• Slow the progression of physical disability.
• Reduce the formation of new brain lesions.

While the medication significantly lowers the levels of specific B cells, it typically spares the stem cells that create new blood cells and the plasma cells that help maintain long-term immunity.

Common Side Effects

The most frequently reported side effects of Kesimpta include:

• Injection-site reactions: Localized redness, pain, itching, or swelling where the medication was injected.
• Injection-related reactions: These are most common with the first injection and may include fever, headache, muscle pain, chills, and tiredness.
• Upper respiratory tract infections: Symptoms like a sore throat, runny nose, or cough.
• Headache.

Serious Side Effects

Kesimpta can cause serious side effects that require immediate medical attention, including:

• Infections: The medication can increase the risk of developing infections, including serious ones like pneumonia or bronchitis. It may also cause a decrease in immunoglobulin (antibody) levels in the blood.
• Hepatitis B reactivation: In people who have previously had hepatitis B, the virus may become active again during or after treatment.
• Progressive Multifocal Leukoencephalopathy (PML): Although rare, this serious brain infection has been associated with drugs that affect the immune system. Symptoms include changes in thinking, balance, or vision.

Infections

Kesimpta affects the immune system, which can increase the risk of developing infections. These infections may be serious or life-threatening. Treatment is typically delayed in individuals with a current active infection until the infection has resolved.

Hepatitis B Virus Reactivation

Hepatitis B virus (HBV) reactivation has occurred with drugs that work similarly to Kesimpta. Healthcare providers perform blood tests to screen for HBV before the first dose. Kesimpta is not used in individuals with an active Hepatitis B infection.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. While it is rare, drugs that affect the immune system have been associated with this condition. Symptoms can include confusion, vision changes, or weakness on one side of the body.

Injection-Related Reactions

Systemic reactions are common, particularly with the first injection. These reactions usually occur within 24 hours of administration. Symptoms may include:

• Fever
• Headache
• Muscle pain
• Chills
• Fatigue

Immunoglobulin Levels

Treatment may lead to a decrease in blood levels of certain antibodies, known as immunoglobulins (IgM and IgG). Healthcare providers may monitor these levels during treatment, especially if a patient develops frequent infections.

Vaccinations

Live-attenuated vaccines should not be administered during treatment or until B-cell levels have recovered following the discontinuation of the drug. It is generally recommended that all necessary vaccinations be completed at least four weeks before starting Kesimpta.

Pregnancy and Fetal Risk

Based on its mechanism of action, Kesimpta may cause harm to a developing fetus by depleting B-cells. Individuals of childbearing potential are advised to use effective contraception during treatment and for at least six months after the final dose.

Pregnancy

Data on the use of Kesimpta during pregnancy is limited. Animal studies suggest that the drug may cause harm to the fetus by depleting B-cells, which are essential for the immune system. Because of these potential risks, it is important to discuss your situation with a healthcare provider if you are pregnant or planning to become pregnant.

Individuals who can become pregnant are typically advised to use effective contraception while receiving Kesimpta and for at least 6 months after the final dose.

Breastfeeding

It is not known if Kesimpta is present in human breast milk or if it affects the breastfed infant. While some antibodies are known to pass into breast milk, the impact of this specific medication is unclear. Consult with your doctor to evaluate the risks and benefits of breastfeeding while using this treatment.

Kesimpta is supplied as a clear to slightly opalescent, colorless to slightly brown solution. It is intended for subcutaneous injection, which is an injection administered into the fatty tissue just beneath the skin.

This medication is available in the following forms:

• Single-dose prefilled Sensoready pen: A disposable device designed for self-administration.
• Single-dose prefilled syringe: A disposable syringe containing a single dose of the medication.

FDA Approval Status

Kesimpta was approved by the U.S. Food and Drug Administration (FDA) in August 2020. It is a CD20-directed cytolytic antibody. While the active ingredient, ofatumumab, was previously approved for other medical conditions under a different brand name and intravenous administration route, Kesimpta is specifically approved for the treatment of multiple sclerosis via subcutaneous injection.

Approved Indications

The FDA has approved Kesimpta for use in adults to treat relapsing forms of multiple sclerosis (MS). These indications include:

• Clinically isolated syndrome
• Relapsing-remitting multiple sclerosis
• Active secondary progressive multiple sclerosis

Regulatory Safety Information

There is no boxed warning for Kesimpta, but the FDA-approved labeling includes several important safety requirements and precautions:

• Hepatitis B Screening: Healthcare providers are required to screen patients for Hepatitis B virus (HBV) infection before the first dose. Kesimpta should not be started in patients with active HBV, as the medication can cause the virus to reactivate.
• Infection Risk: Because Kesimpta depletes certain B cells, it may increase the risk of infections. The FDA labeling includes warnings about the potential for progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, which has been observed with other B-cell depleting therapies.
• Immunoglobulin Monitoring: Healthcare providers may monitor levels of immunoglobulins (antibodies) in the blood during treatment, as a decrease in these levels can further increase the risk of infection.

The FDA has also issued general safety communications for the class of drugs used in MS treatment, advising patients and providers to monitor for severe worsening of symptoms if certain MS medications are discontinued.

Insurance and Pharmacy Factors

Kesimpta is a brand-name medication with no generic version currently available. Its cost is largely determined by your health insurance plan's formulary and your specific coverage levels, such as deductibles and coinsurance. Because it is a specialty drug, it is typically dispensed through a specialty pharmacy rather than a standard retail pharmacy.

Financial Assistance

Several options may help reduce the out-of-pocket cost of Kesimpta:

• Copay Savings Cards: The manufacturer offers a copay card for eligible patients with commercial insurance, which can lower the cost of each prescription.
• Patient Assistance Programs: For individuals without insurance or those who meet certain financial requirements, programs may be available to provide the medication at a reduced cost or for free.

It is recommended to contact your insurance provider and the manufacturer's support program to get a precise estimate of your costs.