Medical Information

Saphnelo is an FDA approved type I interferon receptor antagonist for moderate to severe systemic lupus erythematosus (SLE), with a standard dose of 300mg administered intravenously every 4 weeks. Attention should be paid to infection risk control and medication adjustment for special populations. The following provides detailed explanations from three aspects: approved indications, standard usage, and recommendations for special populations.

1 Approved indication

(1) Suitable for adult active SLE with poor response to standard treatments such as glucocorticoids/immunosuppressants.

(2) Specially targeting the population of moderate to severe patients with positive anti nuclear antibodies or high interferon gene characteristics.

(3) Not recommended for initial treatment of severe active lupus nephritis or central nervous system lupus.

2 Usage and Dosage

(1) Dosage regimen: 300mg intravenous infusion, once every 4 weeks, with each infusion lasting ≥ 30 minutes.

(2) Dose adjustment: Suspend administration during active infection and resume treatment after infection control.

(3) Preoperative medication: It is recommended to use antihistamines for the first infusion to prevent allergic reactions.

3. Medication for special populations

(1) Pregnancy period: Animal studies have shown embryonic toxicity, and human data is limited, requiring strict evaluation of the benefit risk ratio.

(2) Breastfeeding period: IgG1 antibodies may be secreted into breast milk. It is recommended to suspend breastfeeding during treatment and for 3 months after the last dose.

(3) Elderly people: increased risk of infection, need to strengthen monitoring but do not need to adjust dosage.

(4) Liver and kidney dysfunction: Mild to moderate without adjustment, severe lack of data should be used with caution.

4 Additional precautions

(1) Complete all age appropriate vaccinations before medication and avoid using live vaccines.

(2) Regularly monitor signs of infection, mental symptoms, and abnormal laboratory indicators during treatment.

(3) Combined use with immunosuppressants may increase the risk of infection and requires individualized evaluation.