那他珠单抗(Natalizumab)的副作用如何缓解

Natalizumab is an integrin receptor antagonist that exerts anti-inflammatory effects by inhibiting α4-integrin-mediated leukocyte adhesion and migration.

Side effects of Natalizumab

1. Common side effects

(1) Patients with multiple sclerosis: headache, fatigue, joint pain, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, limb pain, abdominal discomfort, non-specific diarrhea and rash.

(2) Crohn's disease patients: headache, upper respiratory tract infection, nausea, fatigue.

2. Serious side effects

(1) Progressive multifocal leukoencephalopathy (PML): an opportunistic brain infection caused by JC virus with a high fatality rate and is the most serious risk of natalizumab.

(2) Herpes infection: including encephalitis, meningitis and acute retinal necrosis (can cause blindness).

(3) Hepatotoxicity: It may cause acute liver failure and require transplantation.

(4) Allergic reactions: such as urticaria, dyspnea, hypotension, and in severe cases, anaphylactic shock.

(5). Thrombocytopenia: may lead to bleeding tendencies, such as ecchymoses, nosebleeds, menorrhagia, etc.

(6) Infections related to immunosuppression: such as pneumonia, urinary tract infections, and other opportunistic infections.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

How to alleviate the side effects of Natalizumab

1. Monitoring and response to progressive multifocal leukoencephalopathy (PML)

JC virus antibody testing and MRI examinations should be performed regularly before and during medication.

If neurological symptoms such as cognitive impairment, limb weakness, and vision changes occur, you should stop taking the drug immediately and seek medical treatment.

Even if the drug is discontinued, monitoring still needs to be continued for 6 months. Progressive multifocal leukoencephalopathy may occur after discontinuation of the drug.

2. Treatment of allergic reactions

If symptoms such as urticaria, dyspnea, and chest pain occur during the infusion, the infusion should be stopped immediately and treated with antihistamines, corticosteroids, or epinephrine.

Patients who have experienced severe allergic reactions should not use natalizumab again.

3. Liver function and platelet monitoring

Liver function and platelet count should be checked regularly during medication. If symptoms such as jaundice, nausea, vomiting, abnormal bleeding, etc. occur, the medication must be stopped immediately and seek medical attention.

Dosage and medication information of Natalizumab

1. Standard dose

300 mg each time, once every 4 weeks, administered by intravenous infusion, and the infusion time is about 1 hour.

No bolus injection: intravenous bolus injection or rapid infusion is strictly prohibited.

2. Medication conditions

(1) Limited to registered medical centers: Due to the risk of PML, natalizumab must be prescribed and used through the "TYRUKOREMS" restricted distribution program.

(2) Pre-medication assessment: Doctors need to assess whether the patient is suitable for medication, especially the JC virus antibody status and previous use of immunosuppressants.

3. Medication for special groups

(1) Pregnant women: It may cause neonatal thrombocytopenia and should be used with caution.

(2) Breastfeeding women: The drug can enter breast milk, and breastfeeding is not recommended.

(3) Elderly people and children: The safety and effectiveness are not yet clear and use is not recommended.

4. Indications for discontinuation of medication

(1) Patients with Crohn's disease: If there is no effect within 12 weeks, or corticosteroids cannot be discontinued within 6 months, the medication should be discontinued.

(2) If serious side effects occur: such as PML, serious infection, liver damage, allergic reaction, etc., the drug needs to be stopped immediately.