What is Natalizumab?
Natalizumab is a kind of biologic medication known as a monoclonal antibody. It is utilized to treat a disorder in the brain known as MS as well as an intestinal inflammation condition called Crohn's disease.
Natalizumab, an immunosuppressant, is able to attach itself to the leukocytes' surface; they are white blood cells that move through your blood. They can help in the event of injury or illness. Leukocytes form part of the immune system, and their levels are higher in those suffering from diseases like multiple sclerosis and Crohn's disease.
Natalizumab is an antagonist of the integrin receptor that binds specifically to integrins, which are a kind of protein that is found at the top of blood vessels. This stops the white blood cells from moving from the bloodstream to areas of tissue that are inflamed.
It's unclear precisely how this can help patients suffering from multiple sclerosis and Crohn's disease. It is believed that by halting the growth of white blood cells, the drug natalizumab helps stop nerve inflammation and injury.
Natalizumab was approved by the US Food and Drug Administration (FDA) in 2004. It has not yet been approved as a biosimilar. been accepted by the FDA. Biosimilars are very similar to the original drug and are created to exert the same effects on a person, but they are not like the original version.
What are the uses of Natalizumab?
Natalizumab is an approved medicine for adults suffering from:
- Relapsing forms of MS, including an isolated clinical manifestation Relapsing-remitting disease, active secondary progressive diseases The use of natalizumab can increase the risk of PML. When you begin and continue treatment with natalizumab, it is essential to discuss with your doctor if the anticipated benefit of natalizumab outweighs the risk. Refer to "Important Information" below.
- moderate to severe Crohn's disease that is moderate to severe Natalizumab is used to treat:
- to minimize the symptoms and signs of Crohn's disease.
- for those who haven't been adequately helped by or are unable to use the typical Crohn's disease drugs and medications known as TNF (TNF) inhibitors.
- It isn't known whether natalizumab is safe or efficient for children who aren't yet 18 years old.
- Natalizumab increases the chance (or risk) of contracting a rare brain disease that can cause death or severe impairment. This type of infection is known as progressive multifocal leukoencephalopathy (PML). If PML occurs, it typically occurs in people with weak immune systems.
- There is currently no treatment, cure, or preventative for PML.
- The chance of developing PML is higher when you're also treated with other drugs that could weaken the immune system, for example, other treatments for MS as well as Crohn's disease. It is not recommended to take medications that weaken your immune system while you're taking natalizumab. If you are using only natalizumab to treat your Crohn's disease or multiple sclerosis, it is possible to develop PML.
- The risk of developing PML is greater if:
- are infected with people infected by the John Cunningham Virus (JCV). JCV is a widespread virus that is not harmful to many people, but it can cause PML in those with compromised immune systems, for instance, people who are taking Natalizumab. The majority of people affected by JCV are unaware that they are suffering from it or don't have any symptoms. The infection is usually seen in the early years of childhood. Prior to receiving natalizumab treatment, your doctor might perform a blood test in order to determine if you've been affected by JCV.
- Have received natalizumab over an extended period of time, particularly one that lasts longer than 2 years.
- You have been exposed to certain medicines that could reduce your immune system's strength before you can begin receiving natalizumab.The risk of developing PML is highest if you are a victim of all three risk factors mentioned above. There could be additional risk factors that increase the chance of getting PML when you receive natalizumab treatment that we don't know about as of yet. Your physician should go over the risks and advantages of natalizumab therapy with you prior to your deciding to take the drug. Read "What are the side effects of natalizumab?" below.
- If you get natalizumab and, for a period of 6 months following, stop receiving the drug, it is crucial to contact your physician right away in case you experience any new or deteriorating health issues that last for more than a few days.These could be completely unexpected or new and may include issues with:
- an area of weakness on one aspect of your body
- using your legs and armsInform your doctor that you're taking natalizumab.
- Due to the risk of developing PML when you are receiving the drug natalizumab only through a limited distribution program known as the TOUCH Prescribing Program, To be eligible for natalizumab treatment, you must consult your physician and be aware of the risks and advantages of natalizumab. Then, you must accept the directions provided in the TOUCH Prescribing Program.
- Natalizumab is just:
- that are prescribed by doctors who are part of the TOUCH Prescribing Program.
- provided at an infusion center that is enrolled in the TOUCH Prescribing program.
- The drug is provided to patients who are members of the TOUCH Prescribing Program.
- Before you receive natalizumab, your doctor will:
- Define the TOUCH Prescribing Program for you.
- must you sign the TOUCH Prescriber and the Patient Registration Form.
What should be avoided?
Do not take natalizumab if you are:
- Are PML holders.
- You may be allergic to natalizumab as well as any other ingredients in the drug. Look below for a full list of the ingredients in natalizumab.
Speak to your doctor prior to getting natalizumab if you suffer from any of the following health conditions:
Before you take this drug
Before you receive natalizumab, tell your doctor if you:
- Medical conditions that could affect your immune system are:
- HIV disease, or AIDS
- leukemia, lymphoma, or other blood cancers
- an organ transplant
- other medical conditions that may cause a decline in your immune system.
- Have any recent or more serious health issues that last more than a few days. They could be recent or sudden and could include problems with:
- an area of weakness on one aspect of your body
- by using your legs and arms
- Some patients have experienced itching, hives, or difficulty breathing following a dose of natalizumab.
- are suffering from an infection or fever (including shingles or any other unusually persistent illness that lasts for a long time).
How to Take Natalizumab?
Natalizumab is administered once every 4 weeks via an injection into the vein (IV infusion).
Prior to each dose of natalizumab, it is possible to ask questions to ensure that natalizumab is the right medication for you.
Details on dosage
- The dosage recommended for the drug is 300 mg infusion intravenously for 1 hour every 4 weeks. Natalizumab is not to be administered as an intravenous push or bolus.
- Find the complete prescribing instructions for additional information about dosing natalizumab.
Side effects of Natalizumab
Natalizumab may cause serious side effects, including:
- Read "Important information" above.
- Herpes Infections. Natalizumab can increase the chance of contracting an infection of either the brain area or skin of the spinal cord (encephalitis or meningitis) that is caused by herpes viruses, which can cause death. Contact your physician immediately in the event of a sudden fever, severe headache, or confusion following the administration of Natalizumab. Eye infections caused by herpes that cause blindness in a few patients have also occurred. Consult your physician immediately. If you notice any changes in your vision as well as eye redness or eye discomfort,
- Liver damage. The symptoms of liver damage are:
- Skin in the eyes and skin (jaundice)
- an unusual darkening of the urine
- Feeling tired or weak
Get in touch with your doctor as soon as possible. If you notice signs that suggest liver problems, Doctors can conduct blood tests to determine if you have liver damage.
- Allergic reactions can include severe reactions. Signs that indicate an allergy could be:
- the skin flush
- Trouble breathing
- Low blood pressure
- chest pain
The most severe allergic reactions typically occur within two hours after the beginning of your treatment, but they can occur anytime following the infusion of natalizumab.
Contact your doctor immediately if you experience any symptoms or a reaction, even if it occurs after leaving the infusion center. It is possible to require treatment if you're suffering from any type of allergic reaction.
- Natalizumab could increase the risk of developing an uncommon or serious infection because the drug may affect the immune system. There is a greater chance of contracting infections if you are also taking other medications that affect your immune system.
- The platelet count is low. Natalizumab could cause the number of platelets in the blood of your patients to decrease. Consult your physician if you experience some of the symptoms listed below:
- Easy bruises
- Menstrual cycles with more force than normal
- the gums, the nose is brand new, or it requires more time to stop
- Bleeding from a cut is difficult to stop.
- small red spots scattered on your skin, which are pink, red, or purple.
The most frequent adverse effects of natalizumab are:
- Lung infection
- Stomach area pain
- Feeling tired
- It is a rash.
- Urinary tract infection
- The arm or legs
- Throat and nose infection
- Joint pain
Inform your doctor of any side effect that is bothering you or does not disappear.This is not the only possible side effect that natalizumab can cause. Ask your doctor for more information.
Contact your doctor for advice from a medical professional regarding possible side effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.