By specifically targeting the neonatal Fc receptor, the clinical application of Nicalimab (Imaavy) has initially explored a novel therapeutic approach and strategy for generalized myasthenia gravis caused by antibodies against the acetylcholine receptor or anti-muscle-specific tyrosine kinase.

Common Side Effects of Nicalimab

1. Increased risk of infection

(1) The risk of infection is significantly increased during treatment. Common infections include respiratory tract infection, urinary tract infection, oral infection, and herpesvirus infection (e.g., herpes zoster).

(2) Severe infection may lead to treatment interruption.

2. Hypersensitivity reactions

Some patients may develop angioedema, anaphylactic reactions, rash, urticaria, or eczema. These reactions usually occur from within 1 hour up to 2 weeks after administration. Severe cases require immediate discontinuation and appropriate management.

3. Infusion-related reactions

Headache, influenza-like symptoms, rash, nausea, fatigue, dizziness, chills, or erythema may occur during or after infusion. Most are mild to moderate in severity.

4. Other common reactions

Including peripheral edema, muscle spasm, abdominal pain, back pain, pyrexia, diarrhea, cough, anemia, dizziness, nausea, hypertension, and insomnia.

Methods to Alleviate Side Effects

1. Prevention and management of infection

(1) Complete all age-appropriate vaccinations before treatment (avoid live vaccines).

(2) Closely monitor for signs of infection during treatment, such as fever, cough, chills, etc.

(3) Seek medical attention promptly if infection occurs. For severe infection, temporarily discontinue the drug until the infection is controlled.

2. Management of hypersensitivity and infusion reactions

(1) Monitor for 30 minutes during and after infusion for hypersensitivity symptoms.

(2) If severe hypersensitivity or infusion reaction occurs, discontinue the infusion immediately and administer appropriate treatment.

(3) For mild to moderate reactions, consider slowing the infusion rate and readministering after premedication.

3. Laboratory monitoring

(1) Regularly monitor blood lipid levels, as this product may increase total cholesterol and low-density lipoprotein.

(2) Intervention and management should be performed if necessary.

4. Individualized dosage adjustment

For patients with a history of infection, allergic constitution, or hepatic/renal impairment, use cautiously under medical evaluation and adjust the treatment regimen if necessary.

Key Points for Drug Storage

1. Storage of unopened product

(1) Store the original vials refrigerated at 2°C–8°C, protected from light. Do not freeze or shake.

(2) Keep the original packaging intact before use.

2. Storage of reconstituted solution

(1) Use the reconstituted solution immediately. If not used immediately, store protected from light under refrigeration for no more than 24 hours.

(2) After removal from the refrigerator, use within 12 hours (including infusion time), during which it may be kept at room temperature 15°C–30°C.

3. Precautions during infusion

(1) A 0.2‑micron filter must be used for infusion. Do not share the same infusion line with other medications.

(2) Allow the solution to reach room temperature before infusion. Do not heat externally.