Instructions for satlizumab (Anshiping)

1. Name: Satralizumab, Satralizumab

Product name:ENSPRYNG, An Shiping

2. Indications:

Satralizumab (Satralizumab) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQ P4) antibody-positive.

3. Usage and dosage:

1. Assessment before injecting the first dose of satelizumab:

(1) Hepatitis B virus screening: Before starting treatment, perform a hepatitis B virus (HBV) screening. Satelizumab is contraindicated in patients with active HBV confirmed by positive surface antigen [HBsAg] and anti-HBV test results. For people who are HBsAg negative, HB core antibody [HBcAb+] positive, or HBV [HBsAg+] carriers, please consult your doctor before starting treatment and during treatment.

(2) Tuberculosis screening: Before starting treatment, assess for active tuberculosis and test for latent infection. In patients with active TB or a positive TB screen who do not have a history of appropriate treatment, consult a physician before initiating treatment with satelizumab.

(3) Liver transaminases screening: Hepatic transaminases and serum bilirubin should be assessed before initiating treatment with satelizumab. Caution should be exercised when considering prescribing satlizumab for patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 1.5 times the upper limit of normal (ULN).

(4) Infection: Prior to each use, patients are advised to consult their physician when they suspect an active infection, including localized infection. In the case of active infection, delay the use of satelizumab until the infection has resolved.

(5) Vaccination: Because administration of live-attenuated or live-attenuated vaccines is not recommended during treatment with satlizumab, conduct all immunizations (for live or live-attenuated vaccines) according to immunization guidelines at least 4 weeks before initiating use and, if possible, administer non-live vaccines at least 2 weeks before initiating use.

2. Recommended dosage: Satelizumab is for subcutaneous use only. The recommended loading dose of satelizumab for the first three doses is 120 mg subcutaneously at weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks.

If a dose of satelizumab is missed for any reason other than elevated liver enzymes, the dose may need to be adjusted under the direction of your doctor. If a patient develops symptoms of a severe allergic reaction, the patient or caregiver should seek immediate medical attention and no further medications should be administered until self-administration has been evaluated.

3. Medication management:

Satlizumab is for patient self-administration by subcutaneous injection under the guidance of a healthcare professional (HCP). After appropriate training in subcutaneous injection technique, the patient may self-inject or the patient's caregiver may inject if the HCP deems it appropriate. Before use, remove the prefilled syringe from the refrigerator and leave it at room temperature outside the carton for 30 minutes. Instruct patients to inject the entire amount (1 mL) into a syringe that provides 120 mg of satelizumab, according to instructions. It is given by injection under the skin in the abdomen or thigh. Rotate injection sites with each dose. Do not inject into moles, scars, or areas of skin that are tender, bruised, red, hard, or incomplete.

4. Adverse reactions:

In clinical studies of satelizumab, the most common adverse reactions (15% or more associated with any one adverse reaction) were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, and nausea.

5. Storage:

Store refrigerated in the original carton to 2°C to 8°C (36°F to 46°F) to protect from light. Do not freeze. Don't shake. Before administration, if satlizumab is unopened, it can be removed from the refrigerator and returned to the refrigerator if necessary. The total refrigeration time should not exceed 8 days at temperatures not exceeding 30°C (86°F).

6. Taboo:

Satlizumab is contraindicated in the following patients:

1. Known allergy tosatralizumab or any inactive ingredients;

2. Active hepatitis B infection;

3. Active or untreated latent tuberculosis.

7. Mechanism of action:

The exact mechanism by which satelizumab exerts its therapeutic effect inNMOSD is unknown, but it is speculated that it may involve inhibition of IL-6-mediated signaling by binding to soluble and membrane-bound IL-6 receptors.

The patent drug Saterizumab has been launched in China, sold under the brand name Anshiping, and is included in medical insurance. Only patients who meet the indications can be reimbursed. The specifications are:The price of each box of 120mg (1ml) may be more than RMB 10,000, which is still relatively expensive; the price of each box of the original drug Saterizumab sold overseas is more than $10,000 (the price may fluctuate due to the exchange rate). The ingredients of the original drug sold domestically and abroad are basically the same. There are currently no generic versions of satlizumab available on the market.