rozanolixizumab (Rx)

Brand and Other Names:Rystiggo, rozanolixizumab-noli

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 140mg/mL (2-mL single-dose vial)

Myasthenia Gravis

Indicated for treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive

<50 kg: 420 mg SC infusion qWeek x 6 weeks

50 kg to <100 kg: 560 mg SC infusion qWeek x 6 weeks

≥100 kg: 840 mg SC infusion qWeek x 6 weeks

Administer subsequent treatment cycles based on clinical evaluation

Safety of initiating subsequent cycles sooner than 63 days from the start of previous treatment cycle not established

See Administration

Dosage Modifications

Renal or hepatic impairment

  • No dosage adjustment required
  • No dedicated pharmacokinetic study conducted
  • Not expected to affect pharmacokinetics of rozanolixizumab

Dosing Considerations

Vaccinations

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

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and rozanolixizumab

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • upadacitinib

              rozanolixizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.

            Serious - Use Alternative (1)

            • pozelimab

              rozanolixizumab 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 (80)

            • abatacept

              abatacept 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.

            • adalimumab

              rozanolixizumab will decrease the level or effect of adalimumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ado-trastuzumab emtansine

              rozanolixizumab will decrease the level or effect of ado-trastuzumab emtansine by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • alefacept

              rozanolixizumab will decrease the level or effect of alefacept by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

              alefacept 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.

            • alemtuzumab

              rozanolixizumab will decrease the level or effect of alemtuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ansuvimab

              rozanolixizumab will decrease the level or effect of ansuvimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • antithymocyte globulin rabbit

              rozanolixizumab will decrease the level or effect of antithymocyte globulin rabbit by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • atoltivimab/maftivimab/odesivimab

              rozanolixizumab will decrease the level or effect of atoltivimab/maftivimab/odesivimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • balstilimab

              rozanolixizumab will decrease the level or effect of balstilimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • basiliximab

              rozanolixizumab will decrease the level or effect of basiliximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • belatacept

              belatacept 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.

            • bevacizumab

              rozanolixizumab will decrease the level or effect of bevacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • bezlotoxumab

              rozanolixizumab will decrease the level or effect of bezlotoxumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • botulism immune globulin IV

              rozanolixizumab will decrease the level or effect of botulism immune globulin IV by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • brentuximab vedotin

              rozanolixizumab will decrease the level or effect of brentuximab vedotin by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • brodalumab

              rozanolixizumab will decrease the level or effect of brodalumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • canakinumab

              rozanolixizumab will decrease the level or effect of canakinumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • caplacizumab

              rozanolixizumab will decrease the level or effect of caplacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • cetuximab

              rozanolixizumab will decrease the level or effect of cetuximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • cytomegalovirus immune globulin (CMV IG)

              rozanolixizumab will decrease the level or effect of cytomegalovirus immune globulin (CMV IG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • daclizumab

              rozanolixizumab will decrease the level or effect of daclizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • daratumumab

              rozanolixizumab will decrease the level or effect of daratumumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • denosumab

              rozanolixizumab will decrease the level or effect of denosumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • dinutuximab

              rozanolixizumab will decrease the level or effect of dinutuximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • eculizumab

              rozanolixizumab will decrease the level or effect of eculizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • efgartigimod alfa

              efgartigimod alfa 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.

            • efgartigimod/hyaluronidase SC

              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.

            • elotuzumab

              rozanolixizumab will decrease the level or effect of elotuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • emicizumab

              rozanolixizumab will decrease the level or effect of emicizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • erenumab

              rozanolixizumab will decrease the level or effect of erenumab by receptor 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.

            • etanercept

              etanercept 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.

            • galcanezumab

              rozanolixizumab will decrease the level or effect of galcanezumab by receptor 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.

            • gemtuzumab

              rozanolixizumab will decrease the level or effect of gemtuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • golimumab

              rozanolixizumab will decrease the level or effect of golimumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • guselkumab

              rozanolixizumab will decrease the level or effect of guselkumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • hepatitis B immune globulin (HBIG)

              rozanolixizumab will decrease the level or effect of hepatitis B immune globulin (HBIG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ibritumomab tiuxetan

              rozanolixizumab will decrease the level or effect of ibritumomab tiuxetan by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • immune globulin IM (IGIM)

              rozanolixizumab will decrease the level or effect of immune globulin IM (IGIM) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • immune globulin IV (IGIV)

              rozanolixizumab will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • immune globulin SC

              rozanolixizumab will decrease the level or effect of immune globulin SC by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • inebilizumab

              rozanolixizumab will decrease the level or effect of inebilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • infliximab

              rozanolixizumab will decrease the level or effect of infliximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ipilimumab

              rozanolixizumab will decrease the level or effect of ipilimumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • loncastuximab tesirine

              rozanolixizumab will decrease the level or effect of loncastuximab tesirine by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • mogamulizumab

              rozanolixizumab will decrease the level or effect of mogamulizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • moxetumomab pasudotox

              rozanolixizumab will decrease the level or effect of moxetumomab pasudotox by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • narsoplimab

              rozanolixizumab will decrease the level or effect of narsoplimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • nivolumab

              rozanolixizumab will decrease the level or effect of nivolumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • obinutuzumab

              rozanolixizumab will decrease the level or effect of obinutuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ocrelizumab

              rozanolixizumab will decrease the level or effect of ocrelizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ofatumumab

              rozanolixizumab will decrease the level or effect of ofatumumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • olaratumab

              rozanolixizumab will decrease the level or effect of olaratumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • oportuzumab monatox

              rozanolixizumab will decrease the level or effect of oportuzumab monatox by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • panitumumab

              rozanolixizumab will decrease the level or effect of panitumumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • pembrolizumab

              rozanolixizumab will decrease the level or effect of pembrolizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • rabies immune globulin, human (RIG)

              rozanolixizumab will decrease the level or effect of rabies immune globulin, human (RIG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ravulizumab

              rozanolixizumab will decrease the level or effect of ravulizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • raxibacumab

              rozanolixizumab will decrease the level or effect of raxibacumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • Rho(D) immune globulin

              rozanolixizumab will decrease the level or effect of Rho(D) immune globulin by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • rilonacept

              rilonacept 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.

            • risankizumab

              rozanolixizumab will decrease the level or effect of risankizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • rituximab

              rozanolixizumab will decrease the level or effect of rituximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • rituximab-hyaluronidase

              rozanolixizumab will decrease the level or effect of rituximab-hyaluronidase by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • romiplostim

              romiplostim 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

              rozanolixizumab will decrease the level or effect of sarilumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • secukinumab

              rozanolixizumab will decrease the level or effect of secukinumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • siltuximab

              rozanolixizumab will decrease the level or effect of siltuximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • sintilimab

              rozanolixizumab will decrease the level or effect of sintilimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • sutimlimab

              rozanolixizumab will decrease the level or effect of sutimlimab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • tafasitamab

              rozanolixizumab will decrease the level or effect of tafasitamab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • teplizumab

              rozanolixizumab will decrease the level or effect of teplizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • tetanus immune globulin (TIG)

              rozanolixizumab will decrease the level or effect of tetanus immune globulin (TIG) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • tocilizumab

              rozanolixizumab will decrease the level or effect of tocilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • tositumomab

              rozanolixizumab will decrease the level or effect of tositumomab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • trastuzumab

              rozanolixizumab will decrease the level or effect of trastuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • trastuzumab deruxtecan

              rozanolixizumab will decrease the level or effect of trastuzumab deruxtecan by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ublituximab

              rozanolixizumab will decrease the level or effect of ublituximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • ustekinumab

              rozanolixizumab will decrease the level or effect of ustekinumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • vaccinia immune globulin intravenous

              rozanolixizumab will decrease the level or effect of vaccinia immune globulin intravenous by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            • varicella zoster immune globulin, human

              rozanolixizumab will decrease the level or effect of varicella zoster immune globulin, human by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.

            Minor (0)

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              Adverse Effects

              >10%

              Headache (44%)

              Any infection (23%)

              Diarrhea (20%)

              Upper respiratory tract infection (8-17%)

              Pyrexia (17%)

              Hypersensitivity reactions (11%)

              1-10%

              Nausea (10%)

              Urinary tract infections (9%)

              Administration site reactions (8%)

              Abdominal pain (8%)

              Arthralgia (7%)

              Herpes simplex infection (6%)

              Serious infections (4%)

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              Warnings

              Contraindications

              None

              Cautions

              Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) reported

              Infections

              • May increase risk of infection
              • Delay administration in patients with an active infection until infection is resolved
              • During treatment, monitor for clinical signs and symptoms of infection
              • If serious infection occurs, administer appropriate treatment and consider withholding therapy until infection has resolved

              Hypersensitivity reactions

              • Hypersensitivity reactions (eg, angioedema, rash) observed
              • Manage of hypersensitivity reactions depending on type and severity of reaction
              • Monitor during treatment and for 15 minutes after administration is complete for clinical signs and symptoms of hypersensitivity reactions
              • If a hypersensitivity reaction occurs, institute appropriate measures if needed or patient should seek medical attention

              Drug interaction overview

              • Immunization
                • Vaccinations of live-attenuated or live vaccines are not recommended
                • Immunization with vaccines during treatment not studied
                • Safety of immunization with live or live-attenuated vaccines and response to immunization with any vaccine are unknown
                • Evaluate need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle
              • Drugs that bind to Fc receptor
                • Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor (FcRn)
                • When concomitant long-term use of such medications is essential for patient care, consider discontinuing therapy and using alternative therapies
                • Rozanolixizumab may lower systemic exposures and reduce effectiveness of with medications that bind to FcRn (eg, immunoglobulin products, monoclonal antibodies, antibody derivatives containing the human Fc domain of the IgG subclass)
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              Pregnancy & Lactation

              Pregnancy

              There are limited data on use in pregnant females to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

              Animal data

              • Following administration of rozanolixizumab to pregnant monkeys at doses greater than those used clinically, increases in embryonic death, reduced body weight, and impaired immune function were observed in the absence of maternal toxicity

              Lactation

              There are no data on the presence of rozanolixizumab in human milk, effects on breastfed infants, or effects on milk production

              Maternal IgG is known to be present in human milk

              Pregnancy Categories

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

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

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

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

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

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in decreased 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

              Absorption

              Steady-state achieved at ~2 days

              Distribution

              Vd: 6.6 L

              Metabolism

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

              Elimination

              Clearance: 0.89 L/day

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              Administration

              SC Preparation

              Should only be prepared by a healthcare provider

              Refer to infusion pump manufacturer's instructions for full preparation and administration information

              Use pumps where administered volume can be preset as each vial contains excess volume for priming of infusion line

              Use aseptic technique when preparing and administering

              Before use, allow vials to reach room temperature for ~30 min; keep vial in original carton to protect from light until ready to use; do not shake

              Do not use heating devices

              Infuse within 4 hr of puncturing vial; immediately administer after priming infusion set

              Visually inspect parenteral drug products for particulate matter and discoloration before administering, whenever solution and container permit; solution should be colorless to pale brownish-yellow, clear to slightly opalescent

              Discard if liquid looks cloudy, contains foreign particles, or has changed color

              Use transfer needles to fill syringe

              Remove needle from syringe and attach infusion set to syringe

              Follow device manufacturer's instructions to prepare pump and prime tubing

              SC Administration

              SC administration only using an infusion pump

              Recommended for administration

              • Syringe pump occlusion alarm limits should be at the maximum setting
              • Administration tubing length should be ≤61 cm
              • Use infusion set with a needle of ≥26 gauge

              Infusion rate

              • Administer SC infusion using an infusion pump weekly for 6 weeks
              • Infuse at constant flow rate up to 20 mL/hour
              • Monitor during administration and for 15 min after completion for clinical signs and symptoms of hypersensitivity reactions
              • If hypersensitivity reaction occurs during administration, discontinue administration and institute appropriate supportive measures
              • Once infusion is complete, do NOT flush infusion line as volume of infusion has been adjusted considering losses in the line
              • Each vial is for one-time use only; does not contain preservatives; discard any remaining solution
              • Subsequent cycles: Administer based on clinical evaluation; safety of initiating subsequent cycles <63 days from start of previous treatment cycle not established

              Infusion site

              • Choose an infusion site in lower right or lower left part of abdomen below navel and clean with an alcohol wipe
              • Do not infuse where skin is tender, bruised, red, or hard
              • Avoid infusing into tattoos, scars, or stretch marks
              • Rotate infusion sites for subsequent administrations
              • Insert infusion set needle into infusion site and secure needle to skin with sterile gauze and tape or a transparent dressing

              Missed dose

              • May administer missed dose up to 4 days after scheduled time point
              • Then, resume original dosing schedule until treatment cycle is completed

              Storage

              Unopened vials

              • Keep in original carton to protect from light until ready to use
              • Do not shake
              • Refrigerate at 36-46ºF (2-8ºC) in the original carton to protect from light until the time of use; do not freeze
              • Store at room temperature up to 77ºF (25ºC) for a single period of up to 30 days in original carton

              Punctured vials

              • Use within 4 hr
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              Images

              No images available for this drug.
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              Patient Handout

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

              FormularyPatient Discounts

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

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

              Adding plans allows you to:

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

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

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