Dosing & Uses
Dosage Forms & Strengths
efgartigimod/hyaluronidase
injection, solution for SC
- 1,008mg/11,200 units/5.6mL (180mg/2,000 units/mL)
Myasthenia Gravis
Indicated for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive
1,008 mg/11,200 units (5.6 mL) SC qWeek x 4 weeks
Administer subsequent treatment cycles according to clinical evaluation
Safety of initiating subsequent cycles sooner than 50 days from the start of previous treatment cycle not 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/hyaluronidase SC, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (1)
- pozelimab
efgartigimod/hyaluronidase SC will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. Coadministration of Fc receptor antagonists 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.
Monitor Closely (74)
- adalimumab
efgartigimod/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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.
- erenumab
efgartigimod/hyaluronidase SC will decrease the level or effect of erenumab 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.
- galcanezumab
efgartigimod/hyaluronidase SC will decrease the level or effect of galcanezumab 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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.
- rozanolixizumab
efgartigimod/hyaluronidase SC will decrease the level or effect of rozanolixizumab by plasma protein binding competition. Use Caution/Monitor. Rozanolixizumab may lower systemic exposures and reduce effectiveness of medications that bind to the human neonatal Fc receptor (FcRn). Closely monitor for decreased efficacy of such medications. When long-term use of such medications is required, consider discontinuing rozanolixizumab and using alternative therapies.
- sarilumab
efgartigimod/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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/hyaluronidase SC 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%
Injection site reactions (38%)
Respiratory tract infection (33%)
Headache (32%)
1-10%
Urinary tract infection (10%)
Paresthesia (7%)
Myalgia (6%)
Warnings
Contraindications
None
Cautions
Hypersensitivity reactions
- Hypersensitivity reactions, including rash, angioedema, urticaria, and dyspnea, observed
- Monitor patients during administration and for at least 30 min after administration for clinical signs and symptoms of hypersensitivity reactions
- If reaction occurs, 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 response to immunization with any vaccine are unknown
- Vaccination with live, attenuated or live vaccines is not recommended during treatment
- Evaluate need to administer age-appropriate vaccines according to immunization guidelines before initiating a new treatment cycle
Infections
- May increase risk of infection
- Most common infections were urinary tract infection and respiratory infections
- 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 interaction overview
-
Fc receptor antagonists
- Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor (FcRn)
- Efgartigimod may decrease concentrations of drugs that bind to human FcRn (eg, immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the immunoglobulin G [IgG] subclass)
- 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 use during pregnancy
There is no evidence of adverse developmental outcomes following 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 may be transmitted from 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
Efgartigimod
- 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
Hyaluronidase
- Increases permeability of subcutaneous tissue by depolymerizing hyaluronan
- Effect is transient and permeability of subcutaneous tissue is restored within 24-48 hr
Absorption
Efgartigimod alfa exposures were approximately dose-proportional up to the highest SC tested dose of efgartigimod/hyaluronidase (1750 mg, 1.75 x recommended dosage)
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 (3-5 days)
Excretion: Urine <0.1% (single dose)
Administration
SC Preparation
Remove from refrigerator at least 15 min before injection to allow it to reach room temperature; do not use external heat sources
Do NOT dilute
Do not shake vial
Each vial is for 1 time use only
Avoid exposure to direct sunlight
Check that solution is yellowish, clear to opalescent
Inspect visually for particulate matter; discard if opaque particles or other foreign particles are present
Withdraw entire vial content using a polypropylene syringe and an 18G stainless steel transfer needle
Remove large air bubbles, if present
Each vial contains overfill to compensate for liquid loss during preparation and to compensate for priming volume of the winged infusion set
Does not contain preservatives; administer immediately after preparation
SC Administration
For SC use only
Administered by healthcare professional using a winged infusion set made of polyvinyl chloride (PVC), 25G, 12 inches tubing, maximum priming volume of 0.4 mL
Remove transfer needle from syringe and connect syringe to winged infusion set
Before administration, fill tubing of winged infusion set by gently pressing syringe plunger until plunger is at 5.6 mL; there should be solution at the end of the winged infusion set needle
Choose an injection site on abdomen (at least 2-3 inches away from navel)
Do not inject on areas where skin is red, bruised, tender, hard, or into areas where there are moles or scars
Rotate injection sites for subsequent administrations
Inject SC into a pinched skin area at an angle of about 45 degrees over 30-90 seconds
Localized injection site reactions may occur
Discard any unused portions of medicine remaining in vial, the syringe and the winged infusion set
Monitor for hypersensitivity reactions for at least 30 minutes after administration; if a hypersensitivity reaction occurs, institute appropriate measures if needed
Missed dose
- May be administered up to 3 days after the scheduled time point
- Thereafter, resume original dosing schedule until treatment cycle completed
Storage
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
- If needed, may store in original carton for up to 3 days at room temperature at 20-25ºC (68-77ºF) for a single period before administration or returned to refrigeration; do not store vial at room temperature more than 1 time; record date removed from and the date returned to refrigerator on carton
- Do not freeze
- Do not shake
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Formulary
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.
