efgartigimod alfa (Rx)

Brand and Other Names:Vyvgart, efgartigimod alfa-fcab
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 400mg/20mL

Myasthenia Gravis

Indicated for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive

Weight <120 kg: 10 mg/kg IV qWeek x 4 weeks  

Weight ≥120 kg: 1200 mg IV qWeek x 4 weeks

Administer subsequent treatment cycles based on clinical evaluation

Safety of initiating subsequent cycles sooner than 50 days from start of the previous treatment cycle has not been established

Dosage Modifications

Renal impairment

  • No dedicated pharmacokinetic study has been performed
  • Mild (eGRF 60-89 mL/min/1.72 m2): No dosage adjustment necessary, patients had 22% increase in exposure relative to the exposure in patients with normal renal function
  • Moderate-to-severe (eGFR <59 mL/min/1.73 m2): Insufficient data are available

Hepatic impairment

  • No dedicated pharmacokinetic study has been performed
  • Hepatic impairment is not expected to affect efgartigimod pharmacokinetics

Dosing Considerations

Owing to the fact that efgartigimod may cause transient reduction in immunoglobulin G (IgG) levels, immunization with live-attenuated or live vaccines is not recommended during treatment

Evaluate need to administer age-appropriate immunizations according to immunization guidelines before initiating new treatment cycle

Safety and efficacy not established

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Interactions

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                Monitor Closely (71)

                • adalimumab

                  efgartigimod alfa will decrease the level or effect of adalimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ado-trastuzumab emtansine

                  efgartigimod alfa will decrease the level or effect of ado-trastuzumab emtansine by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • alefacept

                  efgartigimod alfa will decrease the level or effect of alefacept by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • alemtuzumab

                  efgartigimod alfa will decrease the level or effect of alemtuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ansuvimab

                  efgartigimod alfa will decrease the level or effect of ansuvimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • antithymocyte globulin rabbit

                  efgartigimod alfa will decrease the level or effect of antithymocyte globulin rabbit by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • atoltivimab/maftivimab/odesivimab

                  efgartigimod alfa will decrease the level or effect of atoltivimab/maftivimab/odesivimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • balstilimab

                  efgartigimod alfa will decrease the level or effect of balstilimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • basiliximab

                  efgartigimod alfa will decrease the level or effect of basiliximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • bevacizumab

                  efgartigimod alfa will decrease the level or effect of bevacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • bezlotoxumab

                  efgartigimod alfa will decrease the level or effect of bezlotoxumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • botulism immune globulin iv

                  efgartigimod alfa will decrease the level or effect of botulism immune globulin iv by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • brentuximab vedotin

                  efgartigimod alfa will decrease the level or effect of brentuximab vedotin by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • brodalumab

                  efgartigimod alfa will decrease the level or effect of brodalumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • canakinumab

                  efgartigimod alfa will decrease the level or effect of canakinumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • caplacizumab

                  efgartigimod alfa will decrease the level or effect of caplacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • cetuximab

                  efgartigimod alfa will decrease the level or effect of cetuximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • cytomegalovirus immune globulin (CMV IG)

                  efgartigimod alfa will decrease the level or effect of cytomegalovirus immune globulin (CMV IG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • daclizumab

                  efgartigimod alfa will decrease the level or effect of daclizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • daratumumab

                  efgartigimod alfa will decrease the level or effect of daratumumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • denosumab

                  efgartigimod alfa will decrease the level or effect of denosumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • dinutuximab

                  efgartigimod alfa will decrease the level or effect of dinutuximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • eculizumab

                  efgartigimod alfa will decrease the level or effect of eculizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • elotuzumab

                  efgartigimod alfa will decrease the level or effect of elotuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • emicizumab

                  efgartigimod alfa will decrease the level or effect of emicizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • gemtuzumab

                  efgartigimod alfa will decrease the level or effect of gemtuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • golimumab

                  efgartigimod alfa will decrease the level or effect of golimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • guselkumab

                  efgartigimod alfa will decrease the level or effect of guselkumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • hepatitis B immune globulin (HBIG)

                  efgartigimod alfa will decrease the level or effect of hepatitis B immune globulin (HBIG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ibritumomab tiuxetan

                  efgartigimod alfa will decrease the level or effect of ibritumomab tiuxetan by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • immune globulin IM (IGIM)

                  efgartigimod alfa will decrease the level or effect of immune globulin IM (IGIM) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • immune globulin IV (IGIV)

                  efgartigimod alfa will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • immune globulin SC

                  efgartigimod alfa will decrease the level or effect of immune globulin SC by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • inebilizumab

                  efgartigimod alfa will decrease the level or effect of inebilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • infliximab

                  efgartigimod alfa will decrease the level or effect of infliximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ipilimumab

                  efgartigimod alfa will decrease the level or effect of ipilimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • loncastuximab tesirine

                  efgartigimod alfa will decrease the level or effect of loncastuximab tesirine by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • mogamulizumab

                  efgartigimod alfa will decrease the level or effect of mogamulizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • moxetumomab pasudotox

                  efgartigimod alfa will decrease the level or effect of moxetumomab pasudotox by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • narsoplimab

                  efgartigimod alfa will decrease the level or effect of narsoplimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • nivolumab

                  efgartigimod alfa will decrease the level or effect of nivolumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • obinutuzumab

                  efgartigimod alfa will decrease the level or effect of obinutuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ocrelizumab

                  efgartigimod alfa will decrease the level or effect of ocrelizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ofatumumab

                  efgartigimod alfa will decrease the level or effect of ofatumumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • olaratumab

                  efgartigimod alfa will decrease the level or effect of olaratumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • oportuzumab monatox

                  efgartigimod alfa will decrease the level or effect of oportuzumab monatox by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • panitumumab

                  efgartigimod alfa will decrease the level or effect of panitumumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • pembrolizumab

                  efgartigimod alfa will decrease the level or effect of pembrolizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • rabies immune globulin, human (RIG)

                  efgartigimod alfa will decrease the level or effect of rabies immune globulin, human (RIG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ravulizumab

                  efgartigimod alfa will decrease the level or effect of ravulizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • raxibacumab

                  efgartigimod alfa will decrease the level or effect of raxibacumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • Rho(D) immune globulin

                  efgartigimod alfa will decrease the level or effect of Rho(D) immune globulin by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • risankizumab

                  efgartigimod alfa will decrease the level or effect of risankizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • rituximab

                  efgartigimod alfa will decrease the level or effect of rituximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • rituximab-hyaluronidase

                  efgartigimod alfa will decrease the level or effect of rituximab-hyaluronidase by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • sarilumab

                  efgartigimod alfa will decrease the level or effect of sarilumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • secukinumab

                  efgartigimod alfa will decrease the level or effect of secukinumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • siltuximab

                  efgartigimod alfa will decrease the level or effect of siltuximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • sintilimab

                  efgartigimod alfa will decrease the level or effect of sintilimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • sutimlimab

                  efgartigimod alfa will decrease the level or effect of sutimlimab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • tafasitamab

                  efgartigimod alfa will decrease the level or effect of tafasitamab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • teplizumab

                  efgartigimod alfa will decrease the level or effect of teplizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • tetanus immune globulin (TIG)

                  efgartigimod alfa will decrease the level or effect of tetanus immune globulin (TIG) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • tocilizumab

                  efgartigimod alfa will decrease the level or effect of tocilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • tositumomab

                  efgartigimod alfa will decrease the level or effect of tositumomab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • trastuzumab

                  efgartigimod alfa will decrease the level or effect of trastuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • trastuzumab deruxtecan

                  efgartigimod alfa will decrease the level or effect of trastuzumab deruxtecan by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ublituximab

                  efgartigimod alfa will decrease the level or effect of ublituximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • ustekinumab

                  efgartigimod alfa will decrease the level or effect of ustekinumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • vaccinia immune globulin intravenous

                  efgartigimod alfa will decrease the level or effect of vaccinia immune globulin intravenous by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • varicella zoster immune globulin, human

                  efgartigimod alfa will decrease the level or effect of varicella zoster immune globulin, human by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Respiratory tract infection (33%)

                  Headache (32%)

                  1-10%

                  Urinary tract infection (10%)

                  Paresthesia (7%)

                  Myalgia (6%)

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                  Warnings

                  Contraindications

                  None

                  Cautions

                  Hypersensitivity reactions, including rash, angioedema, and dyspnea, observed; monitor patients during administration and for 1 hr after infusion for clinical signs and symptoms of hypersensitivity reactions; if reaction occurs during administration, discontinue infusion and institute appropriate supportive measures if needed

                  Immunization

                  • Immunization with vaccines during treatment has not been studied; safety of immunization with live or live, attenuated vaccines and the response to immunization with any vaccine are unknown
                  • Vaccination with live, attenuated or live vaccines is not recommended during treatment
                  • Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle

                  Infections

                  • May increase the risk of infection
                  • Majority of infections and hematologic abnormalities were mild to moderate in severity
                  • Delay administration in patients with an active infection until infection is resolved
                  • During treatment, monitor for clinical signs and symptoms of infections
                  • If serious infection occurs, administer appropriate treatment, and consider withholding therapy until infection resolved

                  Drug interactions overview

                  • Fc receptor antagonists
                    • Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor (FcRn)
                    • Medications that bind to the human FcRn (eg, immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the immunoglobulin G [IgG] subclass) may lower systemic exposures and reduce effectiveness of such medications
                    • When concomitant, long-term use of such medications is essential for patient care, consider discontinuing therapy and using alternative therapies.
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                  Pregnancy & Lactation

                  Pregnancy

                  No data are available on the use during pregnancy

                  There is no evidence of adverse developmental outcomes following the administration of up to 100 mg/kg/day in rats and rabbits

                  Fetal or neonatal adverse reactions

                  • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
                  • Efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus
                  • May reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated.
                  • Consider risks and benefits before administering live or live-attenuated vaccines to infants exposed in utero

                  Lactation

                  There is no information regarding the presence of efgartigimod alfa-fcab in human milk, effects on the breastfed infants, or effects on milk production

                  Maternal IgG is known to be present in human milk

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Antibody fragment that targets the neonatal Fc receptor (FcRn), thereby reducing circulating IgG

                  Myasthenia gravis is an autoimmune disease in which IgG autoantibodies are formed against the nicotinic acetylcholine receptor (AChR) or other components of the neuromuscular junction

                  FcRn prolongs IgG half-life; antagonizing FcRc causes IgG catabolism, resulting in reduced overall IgG and pathogenic autoantibody levels, while avoiding widespread immunosuppression

                  Distribution

                  Vd: 15-20 L

                  Metabolism

                  Expected to be degraded by proteolytic enzymes into small peptides and amino acids

                  Elimination

                  Half-life: 80-120 hr

                  After a single IV dose of 10 mg/kg in healthy subjects, <0.1% of administered dose was recovered in urine

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                  Administration

                  IV Compatibilities

                  0.9% NaCl

                  IV Preparation

                  Visually inspect for particulate matter and discoloration before administration; solution is clear to slightly opalescent and colorless to slightly yellow; discard if opaque particles, discoloration, or other foreign particles are present

                  Calculate dose (mg), total drug volume (mL) solution required, and number of vials needed based on dose according to patient’s body weight

                  Gently withdraw calculated dose from the vial(s) with a sterile syringe and needle; discard any unused portion remaining in vials

                  Dilute withdrawn drug with 0.9% NaCl to make a total volume of 125 mL for IV infusion; gently invert the infusion bag containing the diluted solution without shaking to ensure thorough mixing of the product and the diluent

                  Administer diluted solution using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefin bags) and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines

                  IV Administration

                  Infuse 1 hr

                  If diluted solution was refrigerated, allow diluted solution to reach room temperature

                  Missed infusion: Administer up to 3 days after the scheduled time; resume original dosing schedule until treatment cycle is completed

                  Administer immediately after dilution, and complete the infusion within 4 hr of dilution

                  Missed infusion: Administer up to 3 days after the scheduled time; resume original dosing schedule until treatment cycle completed

                  Administer immediately after dilution and complete infusion within 4 hr of dilution (or refrigerate if not used immediately)

                  Storage

                  Unused vials

                  • Does not contain preservatives
                  • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light until time of use
                  • Do not freeze
                  • Do not shake

                  Diluted solutions

                  • Does not contain preservatives
                  • If not used immediately, refrigerate at 2-8ºC (36-46ºF) for up to 8 hr
                  • Do not freeze
                  • Protect from light
                  • Allow diluted drug to reach room temperature before administration; do not heat diluted drug in any manner other than via ambient air
                  • Complete infusion within 4 hr of removal from refrigeration
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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.