Description
Indication & Scope
Imaavy (Nipocalimab aahu) contains nipocalimab, a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). It is indicated for the treatment of adults and adolescents aged 12 years and older with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific tyrosine kinase (MuSK) antibodies.
- Mechanism: Nipocalimab aahu binds to the neonatal Fc receptor (FcRn), blocking IgG recycling and increasing IgG degradation, thereby reducing circulating pathogenic IgG autoantibody levels involved in autoimmune diseases.
- Drug class: Fully human anti-FcRn monoclonal antibody.
- Clinical use: Treatment of AChR antibody-positive or MuSK antibody-positive generalized myasthenia gravis (gMG) in adults and adolescents aged 12 years and older, in combination with standard therapy.
| Generic Name | Nipocalimab aahu |
| Brand Name | Imaavy® |
| Ingredient | Each single-dose vial contains nipocalimab-aahu at a concentration of 185 mg/mL. Available strengths: 300 mg/1.62 mL and 1200 mg/6.5 mL. |
| Dosage Form | Solution for Injection. |
| Package | One single-dose vial |
| Conditions Treated | Treatment of adults and adolescents aged 12 years and older with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific tyrosine kinase (MuSK) antibodies. |
| Taboos | Hypersensitivity to nipocalimab-aahu or any component of the product. |
| Place of origin | United States |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store refrigerated at 2°C–8°C (36°F–46°F). Keep in the original carton to protect from light. Do not freeze. Do not shake. |
| Manufacturer | Johnson & Johnson (Janssen Pharmaceutical Companies) |
| Registration Authority | U.S. Food and Drug Administration (FDA) |
| Approval number | BLA 761420 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: The recommended dosage of Imaavy® is 30 mg/kg administered by intravenous infusion as an initial dose, followed by 15 mg/kg administered by intravenous infusion every 2 weeks.
Time: Administer by intravenous infusion according to the approved dosing schedule.
Instructions for use: Administer Imaavy® by intravenous infusion under the supervision of a healthcare professional. The product must be diluted with 0.9% sodium chloride injection before administration. The initial dose should be infused over at least 30 minutes, and subsequent maintenance doses should be infused over at least 15 minutes.
Interaction: Nipocalimab may reduce the systemic exposure and effectiveness of medicines that bind to the neonatal Fc receptor (FcRn), including immunoglobulin products, monoclonal antibodies, or antibody derivatives containing a human IgG Fc domain. Monitor the effectiveness of such therapies when used concomitantly.
Side effects: The most common adverse reactions (≥10%) include respiratory tract infections, peripheral edema, and muscle spasms. Other important risks include infections, hypersensitivity reactions, and infusion-related reactions.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is Imaavy used for?
Imaavy is used for the treatment of generalized myasthenia gravis (gMG) in adults and adolescents aged 12 years and older who are positive for anti-AChR or anti-MuSK antibodies.
What are the common side effects of Nipocalimab aahu?
Common adverse reactions include respiratory tract infections, peripheral edema, and muscle spasms.
Is Nipocalimab aahu an immunosuppressant?
Nipocalimab aahu is an FcRn blocker that selectively reduces IgG antibody levels rather than broadly suppressing the immune system.
What type of molecule is nipocalimab aahu?
Nipocalimab aahu is a recombinant fully human monoclonal antibody designed to block FcRn and reduce circulating IgG antibody levels.
Imaavy® Nipocalimab Aahu | Generalized Myasthenia Gravis (gMG) | DengYueRX
INN: Nipocalimab aahu
Indications: Treatment of antibody-positive generalized myasthenia gravis (gMG).
Dosage Form: Solution for Injection
Strength: 300 mg/1.62 mL per vial; 1200 mg/6.5 mL per vial
