那他珠单抗(Natalizumab)如何用药

Natalizumab is a recombinant humanized monoclonal antibody that must be administered in strict compliance with guidelines and under professional medical supervision.

How to use Natalizumab

1. Standard dose and administration method

The recommended dose is 300 mg each time, once every four weeks, administered by intravenous infusion. The infusion time should last about one hour, and the infusion rate should be controlled at about 5 mg/minute. Intravenous bolus or rapid infusion is strictly prohibited.

2. Preparation and observation before infusion

(1) Preparation requirements: It needs to be operated under sterile conditions. The prepared solution should be used within 4 hours. It can be refrigerated but cannot be frozen.

(2) Patient monitoring: All infusion processes require close observation of patient response. After the first 12 infusions, observation should be continued for one hour; thereafter, the observation time can be shortened appropriately based on clinical judgment.

(3) Treatment of allergic reactions: If allergic symptoms such as urticaria, difficulty breathing, hypotension, etc. occur, the infusion should be stopped immediately and corresponding treatment should be taken.

3. Medication for special groups

(1) Pregnant women: It may cause neonatal thrombocytopenia, and the pros and cons need to be carefully evaluated.

(2) Lactating women: The drug can enter the breast milk. It is recommended to suspend breastfeeding during the medication.

(3) Elderly people and children: There is currently insufficient data to support its safety and effectiveness in people under 18 years old or over 65 years old.

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Principles for dose adjustment of Natalizumab

1. No routine adjustment is required

There is no need to adjust the dose of Natalizumab in patients with hepatic and renal insufficiency because the relevant pharmacokinetic studies are insufficient.

2. Indications for discontinuation of treatment

Patients with Crohn's disease:

(1). No clinical response after 12 weeks of induction therapy.

(2) Chronic systemic corticosteroids cannot be stopped within 6 months of starting treatment.

(3) Severe adverse reactions occur, such as PML, severe liver damage, sustained thrombocytopenia, severe infection or allergic reaction.

(4) If persistent antibody positivity is detected and is accompanied by decreased efficacy or infusion reaction, discontinuation of the drug should be considered.

Contraindications of Natalizumab

1. Absolute contraindications

(1) Patients with current or past progressive multifocal leukoencephalopathy (PML).

(2) Patients with a history of allergy to natalizumab or any of its components, including reactions such as severe anaphylactic shock or urticaria.

2. Relative contraindications and caution in use

(1) Combined immunosuppressive therapy: Patients with Crohn's disease are prohibited from using it in combination with immunosuppressants such as tacrolimus, azathioprine, methotrexate, or TNF-α inhibitors.

(2). Active serious infections: such as active tuberculosis, severe hepatitis, uncontrolled fungal or bacterial infections.

(3). History of malignant tumors: especially lymphoproliferative diseases.

(4) Not included in the REMS project: Natalizumab needs to be used under the strict Risk Assessment and Mitigation Strategy (REMS) project, and is not allowed to be used by unregistered medical institutions or patients.