CYCLES 1-3
VYVGART Hytrulo and VYVGART: 2 options for ongoing treatment for effective symptom management1,2*
Recommended dose and dose schedules from Prescribing Information:
VYVGART HYTRULO: 1 TREATMENT CYCLE2
The recommended dose of VYVGART Hytrulo is 1,008 mg/11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase), given in treatment cycles of once-weekly subcutaneous injections for 4 weeks.
VYVGART: 1 TREATMENT CYCLE1
The recommended dose of VYVGART (efgartigimod alfa-fcab) is 10 mg/kg, given in treatment cycles of once-weekly, 1-hour IV infusions for 4 weeks.§
Administer subsequent treatment cycles based on clinical evaluation1,2
The safety of initiating subsequent cycles sooner than 4 weeks from the last injection or infusion of the previous treatment cycle has not been established.1,2
*MG-ADL response was defined as a ≥2-point reduction in total MG-ADL score compared to the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last injection or infusion of the cycle.1,2
†Refers to actual injection time of VYVGART Hytrulo. Allow for appropriate storage, preparation, and setup time before use.2
‡In patients weighing 265 lb (120 kg) or more, the recommended dose of VYVGART is 1,200 mg (3 vials) per infusion.1
§In the ADAPT phase 3 clinical trial, all patients received an initial cycle, with subsequent cycles administered according to individual clinical evaluation when their MG-ADL score was at least 5 (with >50% MG-ADL nonocular) and if the patient was an MG-ADL responder, when they no longer had a clinically meaningful decrease (defined as having a ≥2-point improvement in total MG-ADL score) compared to baseline. The minimum time between treatment cycles, specified by study protocol, was 4 weeks from the last infusion. A maximum of 3 cycles were possible in the 26-week study.1,3
IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; SC=subcutaneous.
An example approach to dosing with VYVGART Hytrulo and VYVGART
Based on the most commonly observed schedule from a post-hoc analysis of ADAPT-SC+ and ADAPT+4*†
CYCLES 4+
For cycles 1-3, this example approach shows 4 weeks on and 4 weeks off therapy for 3 cycles.
For subsequent cycles, continue evaluating the appropriate time off therapy based on clinical evaluation.
Limitations: The distribution of average cycle duration in ADAPT-SC+ and ADAPT+ were post-hoc descriptive analyses not controlled for multiplicity and not powered; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*ADAPT-SC+ and ADAPT+ were single-arm, open-label studies evaluating the long-term safety and tolerability of VYVGART Hytrulo and VYVGART.5,6
†Analysis included all complete cycles, defined as cycles not interrupted by the cut-off/final study date of December 1, 2022 or a single incomplete cycle of at least 28 days.4
‡Four weeks off starts after the last infusion or injection of the most recent cycle.4
§A cycle consists of 4 once-weekly doses over 22 days.4
Curious about dosing & administration with VYVGART Hytrulo?
Calculate your patient’s appropriate dose of VYVGART for IV infusion
In patients weighing 265 lb (120 kg) or more, the recommended dose is 1,200 mg (3 vials) per infusion. Please see the full Dosage and Administration section in the Prescribing Information.1
This tool is being provided for the purpose of convenience, and is intended to automate the dosing calculations provided in the VYVGART Prescribing Information (see Section 2.2 Recommended Dose and Dose Schedules and Section 2.3 Preparation and Administration Instructions).
lbs
Dose
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mg
No. of vials per dose
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Drug volume
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mL
NaCl 0.9%
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mL
IV=intravenous; NaCl=sodium chloride.
Planning treatment cycles for patients on VYVGART Hytrulo or VYVGART
This tool may help you plan the dates of your patient's upcoming treatment cycle(s). Remember, subsequent treatment cycles should be administered based on clinical evaluation.1,2
To begin, select the start date of your patient's treatment cycle.
Subsequent treatment cycle
Time off treatment based on clinical evaluation:
Subsequent treatment cycle
Time off treatment based on clinical evaluation:
Subsequent treatment cycle
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If a scheduled dose is missed, VYVGART Hytrulo or VYVGART may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.1,2
The safety of initiating subsequent cycles sooner than 4 weeks from the last infusion or injection of the previous treatment cycle has not been established.1,2
Reach out to a Field Clinical Educator (FCE)
FCEs are registered nurses who can provide education on VYVGART Hytrulo and VYVGART, as well as personalized support through all steps of the treatment journey.
