What are the precautions for satlizumab (Anshiping)?

During clinical studies of Satralizumab (Satralizumab), warnings and precautions such as infection, elevated liver enzymes, reduced neutrophil count, and allergic reactions have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Infection: An increased risk of infection, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including satelizumab. The most common infections were nasopharyngitis and cellulitis, and the most common infections in patients receiving additional combination immunosuppressive therapy were nasopharyngitis, upper respiratory tract infection, and pharyngitis. In patients with active infection, including localized infection, dosing of satelizumab should be delayed until the infection resolves.

(1) Hepatitis B virus (HBV): Other immunosuppressive therapies carry the risk of HBV reactivation. Patients with chronic HBV infection were excluded from clinical trials. All patients are screened for HBV before starting treatment. Do not give satelizumab to patients with active hepatitis. 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: Before starting treatment, evaluate 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) Vaccination: Because clinical safety has not been established, therefore administer all immunizations (for live or live-attenuated vaccines) according to immunization guidelines at least 4 weeks before initiating use and, where possible, non-live vaccines at least 2 weeks before initiating use.

2. Liver enzyme elevations: A higher incidence of mild and moderate liver enzyme elevations was observed in patients treated with satelizumab than in patients treated with placebo. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels should be monitored every 4 weeks for the first 3 months of treatment, then every 3 months for 1 year, and as clinically indicated thereafter.

3. Decreased neutrophil count: Decreased neutrophil count was observed in patients treated with satelizumab. Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy and periodically thereafter at clinically determined intervals.

4. Allergic reactions: Allergic reactions have occurred with other interleukin-6 receptor antagonists, including rash, urticaria and fatal anaphylaxis.

The original drug satlizumab 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 areThe 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.