Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
efgartigimod alfa, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (0)
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)
Adverse Effects
>10%
Respiratory tract infection (33%)
Headache (32%)
1-10%
Urinary tract infection (10%)
Paresthesia (7%)
Myalgia (6%)
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.
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.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 FcRn 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
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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Formulary
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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.
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