Question 1

What is Kesimpta?

Accepted Answer

Kesimpta is a monoclonal antibody that belongs to a class of medications known as CD20-directed cytolytic antibodies . It is designed to identify and bind to a specific protein called CD20 located on the surface of B cells, which are components of the immune system.

By targeting these cells, the medication helps to lower the number of circulating B cells in the body. This action is intended to limit the immune system's inflammatory activity.

Question 2

What is Kesimpta used for?

Accepted Answer

Kesimpta is used to treat relapsing forms of multiple sclerosis.

Question 3

How does Kesimpta work?

Accepted Answer

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.

Question 4

What are the active ingredients in Kesimpta?

Accepted Answer

The active ingredient in Kesimpta is ofatumumab .

Question 5

What are the side effects of Kesimpta?

Accepted Answer

Common side effects of Kesimpta may include:

Upper respiratory tract infection

Headache

Injection site reactions

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Kesimpta?

Accepted Answer

Kesimpta belongs to the anti-CD20 monoclonal antibody drug class.

Question 7

What is the dosage of Kesimpta and how do I take it?

Accepted Answer

How it is given

Kesimpta is administered as a subcutaneous injection, which is an injection into the fatty tissue just under the skin. It is provided in a single-use prefilled pen or syringe designed for self-injection at home after you have been trained by a healthcare professional.

Dosing schedule

The typical treatment plan involves a loading phase followed by a maintenance phase. During the first few weeks, the medication is usually injected once a week. After these initial doses, the medication is then administered once every month.

Administration tips

Common injection sites include the abdomen, the front of the thighs, or the outer upper arms. It is important to use a different site for each injection. Avoid areas where the skin is tender, bruised, red, or has scars or stretch marks.

Remove the medication from the refrigerator and let it reach room temperature before use.

Do not shake the medication.

Check the liquid in the viewing window to ensure it is clear to slightly cloudy and does not contain large particles.

Missed doses

If a dose is missed, it should be taken as soon as it is remembered. You should not skip the dose or wait until the next scheduled date. Once the missed dose is taken, the next dose should be scheduled based on that new date to maintain the proper monthly interval between injections.

Question 8

Is Kesimpta safe during pregnancy and breastfeeding?

Accepted Answer

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.

Question 9

What forms and strengths does Kesimpta come in?

Accepted Answer

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.

Question 10

What is the FDA approval status of Kesimpta?

Accepted Answer

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.

Question 11

What should I know about Kesimpta and cost?

Accepted Answer

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.

Kesimpta

Medication Quick Facts

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What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

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