Nipocalimab is a prescription medicine indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. MedsAcross supplies Nipocalimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
Source: US FDA prescribing information
Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.
Source: US FDA prescribing information
See Full Prescribing Information for instructions on dosage, preparation, and administration. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Administer via intravenous infusion only. gMG: The recommended initial dosage is 30 mg/kg once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage, administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes, and continue every two weeks thereafter. wAIHA: The recommended initial dosage is 30 mg/kg once via intravenous infusion over at least 30 minutes. Four weeks after the initial dosage, administer a subsequent dosage of 30 mg/kg via intravenous infusion over at least 15 minutes, and continue every four weeks thereafter. Must be diluted with 0.9% Sodium Chloride Injection prior to administration.
Source: US FDA prescribing information
IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema. IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or to any of the excipients in IMAAVY.
Source: US FDA prescribing information
Infections: Delay administration of IMAAVY to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with IMAAVY. If serious infection occurs, administer appropriate treatment and consider withholding IMAAVY until the infection has resolved. Hypersensitivity Reactions: Angioedema, anaphylaxis, rash, urticaria, and eczema have occurred in patients treated with IMAAVY. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. Infusion-Related Reactions: If a severe infusion-related reaction occurs, discontinue the infusion and initiate appropriate therapy, consider the risks and benefits of readministering. If a mild to moderate infusion-related reaction occurs, may rechallenge with close clinical observation, slower infusion rates, and pre-medication.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling Infections Hypersensitivity Reactions Infusion-related Reactions The most common adverse reactions (≥10%) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms. The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and pyrexia.
Source: US FDA prescribing information
Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY and using alternative therapies.
Source: US FDA prescribing information
Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Diluted Solution For storage of the diluted IMAAVY solution, see Dosage and Administration.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Nipocalimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Imaavy 1202.5 mg/6.5 mL injectionIntravenous Cold chain | Janssen Biotech | US FDA | Available on request |
| Imaavy 299.7 mg/1.62 mL injectionIntravenous Cold chain | Janssen Biotech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Nipocalimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Nipocalimab, including Imaavy.
Yes. The US FDA first approved Nipocalimab on 29 April 2025, according to Drugs@FDA.
Yes. Nipocalimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Nipocalimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Nipocalimab is classified under ATC code L04AL03 (Nipocalimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.