Efgartigimod Alfa / Hyaluronidase Dosage

Medically reviewed by Drugs.com. Last updated on Dec 4, 2023.

Usual Adult Dose for Myasthenia Gravis

Usual dose: 1,008 mg / 11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) subcutaneously over approximately 30 to 90 seconds once weekly for 4 weeks.

Duration of therapy: 4 weeks

Comments:

• The decision to proceed with additional 4 week treatment cycles should be based on clinical assessment.
• The safety of initiating subsequent cycles within a period shorter than 50 days from the beginning of the previous treatment cycle has not been confirmed.
• Due to the transient decrease in IgG levels caused by this drug product, immunization with live-attenuated or live vaccines is not recommended during the treatment. Before starting a new treatment cycle with this drug product, it is important to assess the necessity of administering age-appropriate immunizations based on immunization guidelines.

Use: For the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

Renal Dose Adjustments

Mild renal impairment: No adjustment recommended.
Moderate and severe renal impairment: Insufficient data to evaluate.

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

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:

• This drug product should only be administered by a healthcare professional.
• It is intended for subcutaneous use and should be administered using a winged infusion set.
• Intravenous administration should be avoided.
• Do not dilute this drug product.

Storage requirements:

• Refrigerate at 2C to 8C (36F to 46F) in the original carton to protect from light until time of use.
• Do not freeze. Do not shake.
• If needed, unopened vials can be stored in their original carton at room temperature (20C to 25C or 68F to 77F) for a single period of up to 3 days before administration, or they can be returned to refrigeration.
• It is important not to store the vial at room temperature more than once. Remember to record the date the vial was removed from and returned to the refrigerator on the carton.

Reconstitution/preparation techniques:

• When preparing and administering this drug product, maintain aseptic technique.
• Do not shake the vial, and use each vial only once.
• Avoid direct exposure to sunlight.
• Refer to manufacturer product information for detailed information on preparation and administration techniques.

Patient advice:

• Patients should inform their healthcare provider about any history of infections and promptly seek medical attention if they experience any symptoms of an infection.
• Prior to initiating a new treatment cycle with this drug product, patients should ensure they have completed age-appropriate vaccines following immunization guidelines.
• It is not recommended to administer live or live-attenuated vaccines while undergoing treatment with this drug product.
• Patients should be educated about the signs and symptoms associated with hypersensitivity reactions.
• If patients notice any indications or symptoms of hypersensitivity reactions, they should immediately contact their healthcare provider.

Further information

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

Medical Disclaimer