那他珠单抗(Natalizumab)的用法用量:用药指南,特殊人群用药

Natalizumab is an integrin receptor antagonist and was approved for marketing by the US FDA under accelerated review in 2004.

Natalizumab usage and dosage

1. Multiple sclerosis (MS)

Only prescribers registered to participate in the MSTOUCH prescription project can prescribe it for multiple sclerosis. The recommended dose of natalizumab for multiple sclerosis is 300 mg as an intravenous infusion over one hour every four weeks.

2. Crohn's disease (CD)

The recommended dose of natalizumab for Crohn's disease is 300 mg once every four weeks as an intravenous infusion for one hour. Natalizumab should not be used in combination with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or concomitant TNF-α inhibitors. Aminosalicylates may be continued during natalizumab treatment.

3. Treatment with discontinuation

If patients with Crohn's disease do not experience therapeutic benefit after 12 weeks of induction therapy, natalizumab should be discontinued. For patients with Crohn's disease who are receiving chronic oral corticosteroid therapy when initiating natalizumab, a tapering of the steroid dose should be initiated as soon as a benefit from natalizumab treatment occurs.

If a patient with Crohn's disease cannot discontinue oral corticosteroids within six months of starting natalizumab, natalizumab should be discontinued. In addition to the initial six-month tapering period, prescribers should consider discontinuing natalizumab in patients who require additional steroid use for more than three months in the calendar year to control their Crohn's disease.

4. Dilution instructions

Aseptic techniques must be used when preparing natalizumab solutions for intravenous infusion. Each vial is for single use only, discard any unused portion.

Natalizumab is a colorless, clear to slightly opalescent solution. Natalizumab vials should be inspected for particulate matter and discoloration prior to dilution and administration. If visible particulates and/or discoloration of the liquid in the vial is observed, the vial should not be used.

To prepare the dilute solution, use a sterile needle and syringe to withdraw 15 mL of natalizumab from the vial. Inject natalizumab into 100 mL of 0.9% sodium chloride injection (USP). No other intravenous diluents should be used to prepare dilute solutions of natalizumab.

Gently invert the natalizumab diluted solution to mix thoroughly without shaking. Visually inspect the solution for particulate matter before dosing. The final dose of the diluted solution should be 2.6 mg/mL.

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.

5. Dosing Instructions

Complete the infusion of natalizumab 300 mg in 100 mL 0.9% sodium chloride injection (USP) within approximately one hour (infusion rate is approximately 5 mg per minute). Do not give natalizumab as an intravenous push or bolus injection. After the infusion is completed, flush the line with 0.9% sodium chloride injection (USP).

Observe the patient during all infusions. Stop the infusion immediately if any signs or symptoms consistent with a type of hypersensitivity reaction are observed.

After infusion, for the first 12 infusions, observe the patient for one hour after the infusion is completed. For patients who have received 12 infusions without evidence of hypersensitivity, observation after the 13th and subsequent infusions should be based on clinical judgment.

The use of filter devices during administration has not been evaluated and other drugs should not be injected into the side port of the infusion device or mixed with natalizumab.

6. Dosage forms and specifications

Injection: 300mg/15mL (20mg/mL), a colorless, transparent to slightly opalescent solution, packed in a single-dose vial, which needs to be diluted before infusion.

Natalizumab (Natalizumab) Use in Special Populations

1. Pregnancy

There are insufficient data on the risk of major birth defects, miscarriage or other adverse maternal outcomes in pregnant women taking natalizumab. Adverse fetal outcomes have been reported including neonatal thrombocytopenia and anemia (see Clinical Considerations).

2. Lactation

Natalizumab has been detected in human milk. There are no data on the effects of this exposure on breastfed infants, nor on the effects of this drug on milk.

The developmental and health benefits of breastfeeding should be considered, taking into account the mother's clinical need for natalizumab and any potential adverse effects of natalizumab or the underlying maternal condition on the breastfed infant.

3. Pediatric use

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

4. Elderly use

Clinical studies of natalizumab did not include a sufficient number of patients aged 65 and above to determine whether their responses were different from those of younger patients. Other reported clinical experience has not found a difference in response between older and younger patients.