efgartigimod alfa-fcab (Vyvgart)

Brand name: Vyvgart

Generic name: efgartigimod alfa-fcab

Dosage forms: injection (10 mg/kg)

Drug class: FcRn Inhibitor

Vyvgart efgartigimod alfa-fcab injection is a prescription medicine used to treat the symptoms of the autoimmune neuromuscular disease Myasthenia gravis (gMG) in adults who test positive for the antiacetylcholine receptor (AChR) antibody. Vyvgart may be used alone or with other medications.

It is not known if Vyvgart is safe and effective in children. 

Vyvgart may cause serious side effects including:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• severe dizziness, 
• fever, and 
• sore throat

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vyvgart include:

• cough, 
• sneezing, 
• stuffy or runny nose, 
• sore throat, 
• shortness of breath, 
• wheezing, 
• fever, 
• headache, 
• migraine and procedural headache, 
• pain or burning when you urinate, 
• numbness and tingling, 
• loss of sensation in the mouth, 
• decreased sense of touch or sensation, 
• increased sensitivity to stimulation, and 
• muscle pain or soreness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vyvgart. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Vaccination

• Because Vyvgart causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with Vyvgart.
• Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with Vyvgart.

Recommended Dose And Dose Schedules

• Dilute Vyvgart prior to administration. Administer via intravenous infusion only.
• The recommended dosage of Vyvgart 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 of Vyvgart is 1200 mg (3 vials) 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.
• If a scheduled infusion is missed, Vyvgart may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.

Effect Of Vyvgart On Other Drugs

• Concomitant use of Vyvgart with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications.
• Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor.
• When concomitant long-term use of such medications is essential for patient care, consider discontinuing Vyvgart and using alternative therapies.

Infections

• Patients should communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection.
• Patients should complete age-appropriate vaccines according to immunization guidelines prior to initiation of a new treatment cycle with Vyvgart. Administration of live or live-attenuated vaccines is not recommended during treatment with Vyvgart.

Hypersensitivity Reactions

• Patients should contact their healthcare provider immediately for signs or symptoms of hypersensitivity reactions.

Pregnancy

• There are no available data on the use of Vyvgart during pregnancy.

Lactation

• There is no information regarding the presence of efgartigimod alfa-fcab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vyvgart and any potential adverse effects on the breastfed infant from Vyvgart or from the underlying maternal condition.