Efgartigimod Alfa Dosage

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

Usual Adult Dose for Myasthenia Gravis

10 mg/kg IV once weekly for 4 weeks

• Weight 120 kg or greater: 1200 mg IV once weekly for 4 weeks
• Maximum dose: 1200 mg/dose

Comments:

• Administer as an intravenous infusion over one hour via a 0.2 micron in-line filter.
• Subsequent treatment cycles should be based on clinical evaluation.
• The safety of initiating a cycle sooner than 50 days from the start of the prior cycle has not been established.
• Evaluate the need for age-appropriate immunizations (per guidelines) prior to initiation of a new treatment cycle; do not use live vaccines during therapy.

Use: For the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive.

Renal Dose Adjustments

Mild renal dysfunction (estimated GFR [eGFR] 60 to 89 mL/min/1.73 m2): No adjustment recommended
Moderate to severe renal dysfunction (eGFR less than 60 mL/min/1.73 m2): Data not available

Liver Dose Adjustments

Data not available

Comment:

• The manufacturer has not provided recommendations, however it is stated that liver dysfunction is not expected to affect the pharmacokinetics of this drug.

Precautions

CONTRAINDICATIONS:

• Serious hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer as an IV infusion over 1 hour; use a 0.2 micron in-line filter and flush line after administration.
• The diluted solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefins bags), and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines.
• Administration should be performed by a healthcare professional.
• If a hypersensitivity reaction occurs during administration, discontinue infusion and institute appropriate supportive measures.
• If a scheduled infusion is missed, it may be administered up to 3 days after scheduled; thereafter, the original dosing schedule should be resumed until the treatment cycle is complete.

Storage requirements:

• Prior to use: Store vials in refrigerator (2C to 8C [36F to 46F]) in the original carton to protect from light; do not freeze; do not shake.
• Once diluted, complete infusion within 4 hours.
• If immediate use is not possible, may store diluted solution in refrigerator for up to 8 hours; do not freeze, protect from light.
• Once diluted solution has been refrigerated, allow to reach room temperature via ambient air (do not heat in any other manner); complete infusion within 4 hours of removing from the refrigerator.

Reconstitution/preparation techniques:

• Prescribed dose should be gently withdrawn from vials and diluted with 0.9% Sodium Chloride Injection, USP to make a total volume of 125 mL for IV infusion.
• The diluted solution should be gently inverted without shaking to ensure thorough mixing.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP
• Should not be mixed with other drugs

General:

• Subsequent treatment cycles should be based on clinical evaluation; the safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy. Health care providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry.
• Health care providers can report suspected adverse reactions to Argenx at 1-833-argx411 or US FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• Hypersensitivity: For hypersensitivity reactions (during administration and for 1 hour after)
• Infections/Infestations: For signs and symptoms of infection

Patient advice:

• Patients should be instructed to contact their healthcare provider if they develop an infection or any signs or symptoms of a hypersensitivity reaction.
• Patients are advised to discuss vaccination status with their healthcare provider.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy.

See also:

Further information

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

Medical Disclaimer