那他珠单抗(Natalizumab)的用法用量

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

Natalizumab usage and dosage

1. Standard dose and administration method

(1) Dosage: The recommended dose is 300mg each time.

(2) Route of administration: Administer via intravenous infusion, and the infusion time should last approximately 1 hour.

(3) Dosing frequency: Once every 4 weeks, administration must be strictly on time to maintain stable blood concentration.

2. Preparation and operation requirements before infusion

(1) Dilution method: Before use, inject 15mL of medicinal solution (300mg) into 100mL of 0.9% sodium chloride injection, mix gently by inverting, and no shaking is allowed.

(2) Stability: The infusion should be completed within 4 hours after dilution. If it cannot be used immediately, it can be stored in a refrigerator (2°C–8°C) and needs to be returned to room temperature before infusion.

(3) Infusion observation: The patient should be observed for 1 hour after the first infusion, and the observation time for subsequent infusions is determined based on clinical judgment.

3. Indications for discontinuation

(1) Patients with Crohn's disease: If no effect is seen after 12 weeks of induction therapy, the drug should be discontinued; if the patient is using glucocorticoids, they should be gradually tapered within 6 months, otherwise natalizumab needs to be discontinued.

(2) Patients with multiple sclerosis: disease progression and imaging changes need to be evaluated regularly, and the risk of PML needs to be continuously monitored for long-term medication.

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.

Contraindications of Natalizumab

1. Absolute contraindications

(1) Patients with past or existing PML: This product should not be used, as the drug may aggravate or induce PML.

(2) Those who are allergic to talizumab or its ingredients: including those who have experienced severe allergic reactions (such as anaphylactic shock, urticaria, etc.).

2. Special contraindications

(1) Combined use of immunosuppressants or TNF-α inhibitors (Crohn's disease patients): Combination use is prohibited to avoid increasing the risk of infection and PML.

(2) Patients with severely weakened immune function: such as those with active AIDS, lymphoma, and those after organ transplantation should not use it.

Natalizumab (Natalizumab) Medication for Special Populations

1. Medication for Pregnant Women

Natalizumab may cause fetal harm, and there have been reports of neonatal thrombocytopenia and anemia. Neonates exposed to natalizumab in utero require a CBC; use in pregnant women requires weighing the benefits and risks.

2. Lactating women

Natalizumab can enter human milk, and its impact on the infant and milk secretion has not yet been determined. The benefits of breastfeeding need to be weighed against the mother's treatment needs and the potential risks of the drug to the nursing infant.

3. Males and females with reproductive potential

It is not clear in the instructions.

4. Use in children

The safety and effectiveness of natalizumab in children under 18 years of age with multiple sclerosis or Crohn's disease have not been established, and natalizumab is not for use in pediatric patients.

5. Use in the elderly

The number of patients aged 65 and above in clinical studies is insufficient to determine whether their responses are different from those of younger patients. No differences have been found in other clinical experiences.

6. Renal function impairment

It is not clear in the instructions.

7. Liver function impairment

It is not clear in the instructions.