Prescription medicine
Nipocalimab Brand names: Imaavy
Nipocalimab (Imaavy) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nipocalimab FDA label on DailyMed (effective August 21, 2026); every nipocalimab label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMAAVY 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.
Forms and strengths
- 185 mg/ml
Injection (solution) (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 227 through July 30, 2026
What is nipocalimab used for?
From the label: indications and usageIMAAVY 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. ( 1.1 ) warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. […]
Conditions named in the indications of nipocalimab's FDA labels, with every medicine labeled for each:
From other nipocalimab labelsAnemia: Anemia (wAIHA) IMAAVY is indicated for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
Source: FDA drug label (IMAAVY), Janssen Biotech, Inc., effective August 21, 2026 (SPL set 8886274c-f2b2-48af-85c1-2f90bfe304b8), via openFDA; the full label on DailyMed
What does the patient leaflet for nipocalimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while receiving IMAAVY?You should not receive live vaccines during treatment with IMAAVY.
Source: FDA drug label (IMAAVY), Janssen Biotech, Inc., effective August 21, 2026 (SPL set 8886274c-f2b2-48af-85c1-2f90bfe304b8), via openFDA; the full label on DailyMed
Is there a generic for nipocalimab (Imaavy)?
No generic nipocalimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nipocalimab?
The FDA Adverse Event Reporting System holds 227 reports that list nipocalimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 41 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nipocalimab?
8 other medicines are given the same way (intravenous) and in the same FDA class as nipocalimab or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Iron sucrose | Anemia | 3 labelers | n/a | A presentation being discontinued |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferumoxytol | Anemia | 1 labeler | n/a | No current entry |
| Sodium ferric gluconate complex | Anemia | 1 labeler | n/a | No current entry |
| Ferric derisomaltose | Anemia | none listed | n/a | No current entry |
| Imetelstat | Anemia | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Nipocalimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other