Vyvgart

VYVGART is a neonatal Fc receptor blocker indicated for the  treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. 

DOSAGE AND ADMINISTRATION

Evaluate the need to administer age-appropriate vaccines according  to immunization guidelines before initiation of a new treatment cycle  with VYVGART.

  • The recommended dosage is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks. In  patients weighing 120 kg or more, the recommended dose is 1200  mg per infusion.
  • Administer subsequent treatment cycles 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.
  • Must be diluted with 0.9% Sodium Chloride Injection, USP prior to  administration.
  • Administer as an intravenous infusion over one hour via a 0.2 micron  in-line filter.

DOSAGE FORMS AND STRENGTHS

Injection: 400 mg in 20 mL (20 mg/mL) single-dose vial.

Infections

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were  urinary tract infection (10% of VYVGART-treated patients compared to 5% of placebo-treated  patients) and respiratory tract infections (33% of VYVGART-treated patients compared to 29% of  placebo-treated patients) [see Adverse Reactions (6.1) and Clinical Studies (14)]. A higher frequency  of patients who received VYVGART compared to placebo were observed to have below normal levels  for white blood cell counts (12% versus 5%, respectively), lymphocyte counts (28% versus 19%,  respectively), and neutrophil counts (13% versus 6%, respectively). The majority of infections and  hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in  patients with an active infection until the infection is resolved. During treatment with VYVGART,  monitor for clinical signs and symptoms of infections. If serious infection occurs, administer  appropriate treatment and consider withholding VYVGART until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART treatment has not been studied. The safety of  immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART causes a reduction in IgG levels, vaccination with live-attenuated  or live vaccines is not recommended during treatment with VYVGART. Evaluate the need to  administer age-appropriate vaccines according to immunization guidelines before initiation of a new  treatment cycle with VYVGART.

More Information:

Please read the full Prescribing Information for Vyvgart and discuss any questions you have with your doctor.

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CONTRAINDICATIONS

None.

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