那他珠单抗(Natalizumab)是治疗什么疾病的？

Natalizumab is a biological agent used to treat specific autoimmune diseases and will be approved for marketing in the United States in 2024.

What diseases does Natalizumab treat?

It is mainly used to treat the following two diseases:

1. Multiple sclerosis (MS)

Natalizumab is used as a monotherapy for adults with relapsing forms of multiple sclerosis, including:

Clinically isolated syndrome.

Relapsing-remitting multiple sclerosis.

Active secondary progressive multiple sclerosis.

Before use, it is necessary to evaluate whether the patient is qualified to use this drug, especially the risk of progressive multifocal leukoencephalopathy (PML) that it may cause.

2. Crohn's disease (CD)

Natalizumab is suitable for adult patients with moderately to severely active Crohn's disease to induce and maintain clinical response and remission, especially for patients with insufficient response or intolerance to traditional treatments or TNF-α inhibitors. It should be noted that patients with Crohn's disease should not use immunosuppressants or TNF-α inhibitors in combination with this product.

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.

Natalizumab usage and dosage

1. Administration method and dosage

(1), dosage: 300mg each time.

(2) Route of administration: intravenous infusion, lasting about 1 hour.

(3) Frequency: once every 4 weeks.

(4) Contraindications: Intravenous injection or rapid injection is prohibited.

2. Preparation and storage

(1) Before use, 15 mL of medicinal solution must be injected into 100 mL of 0.9% sodium chloride injection for dilution.

(2). It should be used within 4 hours after dilution. It can be stored in a refrigerator (2°C–8°C) and avoid freezing and shaking.

(3). The pipeline needs to be flushed with physiological saline after infusion.

3. Medication monitoring and discontinuation indications

(1) Infusion observation: 1 hour of observation is required after the first 12 infusions; the observation time for subsequent infusions is determined based on clinical judgment.

(2) Indications for discontinuation of Crohn's disease:

Individuals who fail to respond to induction therapy for 12 weeks.

Patients who cannot stop taking glucocorticoids within 6 months of starting treatment.

Natalizumab adverse reactions

Natalizumab may cause a variety of adverse reactions, some of which are serious and require close monitoring.

1. Serious adverse reactions

(1) Progressive multifocal leukoencephalopathy (PML): caused by JC virus, common in immunosuppressed patients, with high fatality or disability rate. Risk factors include positive anti-JCV antibodies, long-term medication use (especially more than 2 years), and previous use of immunosuppressants.

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

(3) Hepatotoxicity: It may cause acute liver failure, and liver function indicators need to be monitored.

(4) Hypersensitivity reactions: such as urticaria and anaphylactic shock, mostly occur within 2 hours of infusion.

(5) Thrombocytopenia: It may increase the risk of bleeding and platelet count needs to be monitored.

2. Common adverse reactions (incidence ≥10%)

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

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