Instructions for Imaavy (nipocalimab-aahu)

1. Common names:Imaavy, nipocalimab-aahu

2. Indications:

Imaavy (nipocalimab-aahu) is indicated for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies.

3. Usage and dosage:

1. Recommended vaccinations: Before starting immunization, evaluate whether age-appropriate vaccinations are needed according to the immunization guidelines. Because Imaavy causes a transient decrease in IgG levels, live vaccination is not recommended during treatment with Imaavy.

2. Recommended dosage: Dilute this product before administration. Administered by intravenous infusion only. The recommended initial dose of Imaavy is 30 mg/kg administered by intravenous infusion over at least 30 minutes. Two weeks after the initial dose, give a maintenance dose of 15 mg/kg by intravenous infusion over at least 15 minutes. Maintenance doses are continued every two weeks thereafter. If a scheduled infusion appointment is missed, the maintenance dose of Imaavy should be administered as soon as possible. Dosing resumes every two weeks thereafter.

3. Preparation and Administration Instructions: Prior to administration, dilute Imaavy single-dose vials with 0.9% Sodium Chloride Injection as directed below. For patients weighing 40 kg or more, the total dose is 250 mL; for patients 12 years or older and weighing less than 40 kg, the total dose is 100 mL.

4. Adverse reactions:

InImaavy's clinical studies, common adverse reactions may include respiratory tract infection, peripheral edema and muscle spasm.

5. Supply and storage:

Imaavy injection is a sterile, preservative-free, colorless to slightly brown, clear to slightly opalescent solution that can be used for intravenous injection after dilution. Imaavy is packaged in cartons, each containing one single-dose vial of 300 mg/1.62 mL (185 mg/mL) or 1200 mg/6.5 mL (185 mg/mL); keep vials refrigerated in the original carton at 2°C to 8°C (36°F to 46°F) to protect from light until use. Do not freeze. Don't shake.

6. Taboo:

Imaavy is contraindicated in patients with a history of severe allergic reactions to nipocalimab or any of the excipients in Imaavy, including anaphylaxis and angioedema.

7. Mechanism of action:

Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in reduced circulating IgG levels. Imaavy improves myasthenia gravis symptoms and daily functioning by reducing harmful levels of immunoglobulin G (IgG) antibodies. Imaavy works by blocking the receptor FcRn, which increases the breakdown of IgG antibodies, so there are fewer IgG antibodies that cause damage to the nervous system.

8. Drug interactions:

Concomitant use of Imaavy with drugs that bind the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivatives containing human Fc domains of the IgG subclass) may decrease systemic exposure and reduce the efficacy of such drugs. Monitor closely for reduced effectiveness of drugs that bind to Fc receptors in human neonates. When concurrent long-term use of such drugs is critical to patient care, discontinuation of Imaavy and use of alternative therapies should be considered.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8886274c-f2b2-48af-85c1-2f90bfe304b8