Nipocalimab Dosage

Medically reviewed by Drugs.com. Last updated on Jun 2, 2025.

Usual Adult Dose for Myasthenia Gravis

Initial dose: 30 mg/kg IV once; infuse over at least 30 minutes
Maintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeks

Comments:

• Determine the need to administer age-appropriate vaccines before administering this drug.

Use: For the treatment of generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive

Usual Pediatric Dose for Myasthenia Gravis

Initial dose: 30 mg/kg IV once; infuse over at least 30 minutes
Maintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeks

Comments:

• Determine the need to administer age-appropriate vaccines before administering this drug.

Use: For the treatment of generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive

Renal Dose Adjustments

Mild to moderate renal dysfunction (estimated glomerular filtration rate [eGFR] 30-89 mL/min/1.73 m2): No adjustment recommended
Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2): Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Data not available

Precautions

CONTRAINDICATIONS:

• History of serious hypersensitivity to the active component or any of the excipients (such as anaphylaxis and angioedema)

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Dilute the drug before administration.
• Before administration inspect visually for particulate matter. Ensure that the solution in each vial is colorless to slightly brownish, clear to slightly opalescent, and free of visible particles.
• Do not use if visible particles are present or if the solution is discolored (other than colorless to slightly brownish).
• Only use infusion containers made of polyolefin, polypropylene, or polyvinylchloride.
• Administer the diluted solution immediately after preparation.
• If diluted solution is refrigerated before administration, allow to warm to room temperature; do not use external heat sources to warm.
• Administer IV using infusion set with in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometer or less).
• Do not administer another drug through the same IV line.
• This drug causes transient reduction in immunoglobulin G levels.
• Vaccination with live vaccines is not recommended during treatment.
• If a dose is missed, administer the missed dose as soon as possible and resume dosing every two weeks thereafter.

Storage requirements:
Diluted Solution:

• Refrigerate at 2C to 8C (36F to 46F) for no more than 24 hours.
• Do not freeze.
• Protect from light.
• After preparation or removal from refrigerator, use or discard diluted solution within 12 hours, including infusion time.
• During these 12 hours, store under ambient light at 15C to 30C (59F to 86F).

Unopened vials:

• Refrigerate at 2C to 8C (36F to 46F) in the original carton to protect from light.
• Do not freeze or shake.

Reconstitution/preparation techniques:

• Calculate dosage (mg), total drug volume (mL) of drug solution needed, and number vials needed, based on patient's current weight.
• Dilute the required volume of drug solution by adding to an infusion container containing 0.9% sodium chloride injection to the required volume.
• The manufacturer product information should be consulted.

IV compatibility:

• 0.9% sodium chloride injection.

Monitoring:

• Hypersensitivity: Signs and symptoms of infection (during treatment and 30 minutes after the infusion)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Inform your healthcare provider that you are being treated with this drug before receiving any vaccinations.
• Complete all age-appropriate vaccines according to immunization guidelines before starting treatment with this drug.
• This drug may cause infusion-related reactions.
• Inform your healthcare provider of any history of infections and contact them if you develop any signs or symptoms of infection.
• Immediately contact your healthcare provider if signs and symptoms of hypersensitivity reactions develop.
• If you were exposed to this drug during pregnancy, you can join a safety study that monitors pregnancy outcomes by calling 1-800-526-7736 or visiting www.IMAAVY.com

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer