Kesimpta: одобренное FDA решение для лечения рассеянного склероза

Kesimpta is an FDA-approved prescription medication that is given to treat certain types of multiple sclerosis (MS) in adults. It contains the active ingredient, ofatumumab. Kesimpta comes as a liquid solution that is injected under the skin subcutaneously, using pens or single-dose syringes. 

Before taking Kesimpta, it is crucial to inform your doctor or pharmacist: 

• About any allergies, including drug allergies.
• If you are taking any prescription medications, herbal products, vitamins, supplements, or over-the-counter medicines.
• About your medical condition and disease history. If you had any disorder or are currently suffering from any chronic or long-term disease, make sure you share this information. For example, tell your doctor about your past or current infections, immune problems, or liver diseases, like hepatitis B.
• If you are breastfeeding, pregnant, or planning to become pregnant. Kesimpta should not be used in pregnancy as it can harm your unborn baby.

What Is Kesimpta?

Kesimpta is a monoclonal antibody that is used to treat relapsing multiple sclerosis (MS), including clinically isolated syndrome (CIS), active secondary progressive disease, and relapsing-remitting disease.

What Is Kesimpta Used To Treat?

Kesimpta belongs to the class of drugs known as monoclonal antibodies. It is used to slow the risk and progression of relapsing multiple sclerosis.

Kesimpta is used to treat the following forms of relapsing multiple sclerosis:

• Clinically isolated syndrome
• Active secondary progression disease
• Relapsing-remitting multiple sclerosis (MS)

Multiple sclerosis is a disease of the central nervous system that causes inflammation and damage to the nerves, spinal cord, and brain. It causes the immune system to destroy myelin, a coating that covers the nerves.

How Does Kesimpta Work?

Kesimpta does not cure multiple sclerosis; however, it is used to slow down the progression of the disease and reduce its relapse rate. The medication works by targeting and binding to B-cell antigens and reducing B-cells. This slows the immune system from attacking the nerves and decreases inflammation.

How Is Kesimpta Administered?

• This medication should be used exactly as recommended by your doctor.
• Kesimpta is given by injection under the skin (subcutaneously) in a fatty body part, like the abdomen or thighs.
• It is commonly injected using pens or prefilled syringes.
• Kesimpta is administered by a medical professional, usually in a medical setting. The drug can be self-administered by the patient, but it is necessary to learn and practice with a healthcare professional how to inject the drug subcutaneously.
• Do not inject Kesimpta into damaged skin, such as skin that is red, swollen, tender, bruised, hard, or scaly. 
• If you miss a dose of Kesimpta, talk to your healthcare provider as soon as you remember to administer the drug without waiting for the next dose.
• Kesimpta is approved for use in adults only. It is unknown if the medication is safe and effective to be used in children with multiple sclerosis.

Kesimpta Side Effects

Mild side effects include:

• Головная боль
• Боль в мышцах
• Усталость
• Fever and chills
• Upper respiratory tract infection 
• Urinary tract infection 

Serious side effects of include:

• Redness, swelling, bleeding, itching, or pain at the injection site
• Одышка
• Sudden dizziness
• Irregular or fast heartbeat
• Loss of coordination
• Severe headache
• Fluttering in chest 
• Tremors
• Profuse sweating
• High fever 
• Blurred vision 

The minor side effects of Kesimpta go away on their own as your body gets used to the drug. But if you face serious side effects or if mild side effects become intolerable, persistent, or severe, consult your doctor or pharmacist immediately.

Strength

Kesimpta is available in the following strength: 20 mg/0.4 ml (20 mg per 0.4 ml).

Dose

The doses of Kesimpta can vary according to the patient’s conditions and can depend on some factors, such as:

• The type and severity of multiple sclerosis
• Other health conditions of the patient
• Vaccinations of the patient

The usual recommended dosages are given below:

• The starting dose of Kesimpta is 20 mg given by subcutaneous injection on weeks 0, 1, and 2.
• A subsequent dose of 20 mg by subcutaneous injection is given once a month from week 4.

Storage and Handling Guidelines

The following storage and handling guidelines should be followed while using Kesimpta:

• The medication should be stored in the refrigerator between 2°C to 8°C.
• Do not shake or freeze Kesimpta.
• Protect the medication from light by storing it in its original carton until use.
• Keep Kesimpta away from the reach of children.

Kesimpta Drug Interactions

Kesimpta has various drug interactions; therefore, it is crucial to inform your doctor and your pharmacist about all your medicines and supplements used before starting Kesimpta.

Kesimpta may interact with drugs that weaken your immune system, such as:

• Иммунодепрессанты (drugs that are used to prevent organ transplant rejections)
• Steroids
• Cancer medications
• Certain vitamins, herbal products, supplements, OTC medicines, and prescription-based medications

Расходы

The cost of Kesimpta depends on several factors, including:

• The location and type of pharmacy you visit
• Your health condition and disease history
• The number of doses prescribed by your doctor
• Whether or not your insurance covers the cost of Kesimpta drug treatment

The average cost of a subcutaneous injection of 20 mg/0.4 ml is around $8,606 for a supply of 0.4 ml. Contact us if you are interested in financial or copay assistance. 

Часто задаваемые вопросы

How long is treatment?

Kesimpta is a long-term drug treatment. Initially, it is given once a week for 3 weeks, then switched to once per month until disease progression or recommended by the doctor.

Is Kesimpta a chemo drug?

Yes. In 2009, Kesimpta was first approved by the FDA as an intravenous injection for the treatment of chronic lymphocytic leukemia. Later, the U.S. FDA also approved Kesimpta subcutaneous injection for the treatment of relapsing forms of multiple sclerosis in adults.

Is Kesimpta a safe drug?

The FDA has approved Kesimpta as a safe drug to treat multiple sclerosis in adults. It may be safe when used exactly as recommended by your doctor. The drug may weaken your immune system and increase the risk of mild infections or side effects. It is recommended to consult your doctor if you face any injection-related, severe, or intolerable side effects.

Заключение

Kesimpta is an FDA-approved prescription medication used to treat a central nervous system disorder in adults, known as multiple sclerosis. It is administered once a month by subcutaneous injection for a few months or more, depending on the patient’s health progress. Kesimpta works by decreasing В-клетки, slowing the immune system from attacking the nerves, and reducing inflammation.