Efgartigimod Access Program for Generalized Myasthenia Gravis

Inclusion Criteria

• Must be 18 years or older.
• Diagnosed with myasthenia gravis (MG) with generalized muscle weakness, whether or not specific antibodies are present.
• Must have been vaccinated against COVID-19 or tested negative for COVID-19 within two weeks before joining.
• Must have a documented IgG level greater than 6 g/L within one month before joining.
• Must agree to use contraception as per local guidelines:
  • Men must use contraception and not donate sperm during the program.
  • Women of childbearing age must use effective contraception and have a negative pregnancy test before starting.
• Must sign a consent form agreeing to follow the program's rules.
• If there's a history of hepatitis B, C, or HIV, must have a negative test for active infection.

Exclusion Criteria

• Have an uncontrolled or active infection at the time of joining.
• Have another autoimmune disease that could affect the assessment of gMG symptoms or increase risk.
• Have had cancer unless it was treated and has not returned for at least 3 years, except for certain skin cancers or early-stage prostate cancer.
• Have other serious health conditions, recent major surgery, or any condition that could increase risk.
• Have received a live vaccine in the month before joining.
• Are pregnant, breastfeeding, or planning to become pregnant during or shortly after the program.
• Are a sexually active male not using contraception during the program and for 90 days after, or planning to donate sperm during this time.
• Have received rituximab within 6 months before starting efgartigimod.