Nipocalimab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 21, 2026🚩 Report this page

Nipocalimab

Neonatal Fragment Crystallizable Receptor (Fcrn) Inhibitors

Sold as Imaavy

EU EMACA Health Canada

Drug class: Neonatal Fragment Crystallizable Receptor (Fcrn) Inhibitors
Availability: See label
Routes: Intravenous
Markets covered: 2
Products on record: 3

L04ALNeonatal Fragment Crystallizable Receptor (Fcrn) Inhibitors

Overview

Nipocalimab is an active pharmaceutical ingredient in the Neonatal Fragment Crystallizable Receptor (Fcrn) Inhibitors group (L04AL). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	December 12, 2025
CA Canada	Health Canada	2	April 21, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 12, 2025[1]

Imaavy is indicated as an add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

How to take

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Brands in Canada (1)

IMAAVYJANSSEN INC

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006379 · revised December 12, 2025
[2]Health Canada (DPD) · 02563509 · revised April 21, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 12, 2025[1]

Summary of the safety profile The most commonly reported adverse reactions were muscle spasms (12%) and peripheral oedema (12%). Tabulated list of adverse reactions A total of 250 adult gMG patients were treated with nipocalimab in Phase 2 and Phase 3 studies.
Of these, 205 patients were treated in the Phase 3 study, including 98 in the double-blind phase. 2) for at least 6 months, and 132 were exposed for at least 12 months. Adverse reactions are listed in Table 2 below, classified by MedDRA System Organ Class (SOC).
Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) or rare (≥ 1/10 000 to < 1/1 000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 2:
Adverse reactions System organ class Adverse reaction Frequency category Infections and infestations Herpes zoster1 Common Urinary tract infection* Common Lower respiratory tract infection*2 Common Metabolism and nutrition disorders Lipids increased*3 Very common Decreased serum albumin* Very common Psychiatric disorders Insomnia Common Nervous system disorders Dizziness Common Gastrointestinal disorders Diarrhoea Common Abdominal pain4 Common Nausea Common Musculoskeletal and connective tissue disorders Muscle spasms Very Common General disorders and administration site conditions Peripheral oedema5 Very Common Pyrexia Common * See paragraph Description of selected adverse reactions 1 Includes Herpes zoster and Herpes zoster oticus; evaluation and frequency based on completed placebo-controlled Phase 2 and Phase 3 studies across several indications under study 2 Includes pneumonia and bronchitis 3 Includes hypercholesterolaemia, low density lipoproteins increased, blood cholesterol increased and hyperlipidaemia.
9%] in each group). Most cases were mild to moderate in severity and did not lead to discontinuation of nipocalimab treatment. 1%) in the nipocalimab group compared to 0 patients (0%) in the placebo group. 0%]) in severity. 0%) in the placebo group.
Lipids increased In adult and adolescent patients with gMG who received nipocalimab, increases in lipids were observed in most patients. 2 mmol/L), compared to 4% in the placebo group. 19 mmol/L, respectively. 6% of patients on placebo.
4. 08%) at Week 24 in patients on placebo. No patients had serum albumin levels below the laboratory lower limit of normal (LLN=33 g/L) in the double-blind phase or markedly low serum albumin levels (≤ 20 g/L) in the double-blind or open-label phase.
1). No major differences in the safety profile were identified between adult and adolescent patients. Increased lipid levels in adolescents followed a similar trend to that observed in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised December 12, 2025[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. , myasthenic crisis), defined as intubation with or without mechanical ventilation except in the setting of routine postoperative care, has not been studied.
5). Infusion-related and hypersensitivity reactions Administration of nipocalimab may result in infusion-related and hypersensitivity reactions. The most commonly reported infusion-related reactions were headache, rash, nausea, fatigue, dizziness, chills, and erythema.
The most commonly reported hypersensitivity reactions were rash, urticaria and eczema. Most infusion-related and hypersensitivity reactions were non-serious, mild or moderate and did not lead to treatment discontinuation. A case of anaphylaxis has been reported that led to the discontinuation of treatment.
The patient should be monitored for 30 minutes after each infusion for clinical signs and symptoms of infusion-related or hypersensitivity reactions. If a serious infusion-related or hypersensitivity reaction occurs during administration, the infusion should be discontinued and appropriate supportive measures should be instituted, if needed.
2). 8). Plasma lipid levels should therefore be measured approximately 12 weeks following treatment initiation. g. ≥125 kg or BMI >35 kg/m²), consider closer periodic monitoring thereafter. The evaluation whether to continue treatment with Imaavy should consider the potential negative impact on long-term cardiovascular risk, considering also other risk factors, and weigh this against the expected gMG treatment benefit.
Continued monitoring of plasma lipid levels and alternative treatment options should be considered. 8). Initiation of treatment administration should be delayed in patients with an active infection until the infection is resolved. During treatment, patients should be monitored for clinical signs and symptoms of infection.
In patients with a clinically important active infection, appropriate treatment should be administered and nipocalimab treatment should be withheld until the infection has resolved. Immunisations The safety of immunisation with live or live-attenuated vaccines and the response to immunisation with these vaccines during treatment are unknown.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

CACanada· Health Canada

Drugs in the same class

Sources & citations