DOSAGE AND ADMINISTRATION
1L dosing information
Recommended dosing schedule for RYBREVANT® + chemotherapy (Q3W)
The recommended dosage of RYBREVANT® is based on baseline body weight and administered as an intravenous infusion after dilution
Each vial of RYBREVANT® contains 350 mg of amivantamab-vmjw
1L, first line; AUC, area under the curve; D1, Day 1; D2, Day 2; Q3W, once every 3 weeks.
Recommended dosing schedule for chemotherapy1
When used in combination with chemotherapy, RYBREVANT® should be administered after the other drugs in the following order: pemetrexed, carboplatin, and then RYBREVANT®.1
AUC 5, under the concentration-time curve of 5 mg per milliliter per minute.
In the PAPILLON trial, infusion times decreased over time with RYBREVANT®2
Clinical trial median infusion times by hours*
Total infusion time is approximately 4-6 hours for Day 1 and 6-8 hours for Day 2. Day 2 chair time is longer because of increased dose and decreased infusion rate from Day 1. Subsequent infusion time is approximately 2 hours.1
*Data reflect results from 3-week dosing in the PAPILLON study.
*Dosage adjustments are not required for subsequent body weight changes.
Q2W, every 2 weeks.
1L administration information (Q3W)
Administration of RYBREVANT® + chemotherapy1
Prior to initial infusion of RYBREVANT® (Week 1, Day 1 and Day 2), administer premedication as described in premedications (see below) to reduce the risk of IRRs.
Administer RYBREVANT® in combination with chemotherapy every 3 weeks intravenously according to the infusion rates (see below).
Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 given the high incidence of IRRs during initial treatment.
- RYBREVANT® may be administered via central line for subsequent weeks
- For the initial infusion, prepare RYBREVANT® as close to administration time as possible to allow for the possibility of extended infusion time in the event of an IRR
See the full Prescribing information for additional preparation information.
When administering RYBREVANT® in combination with chemotherapy, infuse pemetrexed first, carboplatin second, and RYBREVANT® last.
1L, first line; IRR, infusion-related reaction; Q3W, once every 3 weeks.
Order of administration and regimen for RYBREVANT® + chemotherapy1
AUC, area under the curve; Q3W, once every 3 weeks.
*In the absence of infusion-related reactions, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4-6 hours for Day 1 and 6-8 hours for Day 2. Subsequent infusion time is approximately 2 hours.1
2L administration information (Q2W)
Administration of RYBREVANT® as a single agent1
- Administer RYBREVANT® as a single agent infusion every 2 weeks intravenously according to the infusion rates
- Administer RYBREVANT® via a peripheral line on Week 1 and Week 2, given the high incidence of infusion-related reactions during initial treatment
- RYBREVANT® may be administered via central line for subsequent weeks
- For the initial infusion, prepare RYBREVANT® as close to administration time as possible to allow for the possibility of extended infusion time in the event of an infusion-related reaction
For additional dosage and administration for RYBREVANT® as a single agent, please see the Prescribing Information.
2L, second line; Q2W, once every 2 weeks; Q3W, once every 3 weeks..
*In the absence of infusion-related reactions, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4-6 hours for Day 1 and 6-8 hours for Day 2. Subsequent infusion time is approximately 2 hours.
Premedication for RYBREVANT®
Administer premedication to reduce the risk of IRRs prior to initial infusion of RYBREVANT® (Week 1, Days 1 and 2)1
Prior to the initial infusion of RYBREVANT® (Week 1, Day 1 and 2), administer premedication to reduce the risk of infusion-related reactions.
Glucocorticoid administration is required for Week 1, Day 1 and 2 dose only and upon re-initiation after prolonged dose interruptions, then as necessary for subsequent infusions. Administer both antihistamine and antipyretic prior to all infusions.
Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity.
Monitoring and management of RYBREVANT®1
Recommended RYBREVANT® dosage reductions for ARs
*Dose at which the AR occurred.
See below for the recommended RYBREVANT® dosage modifications for ARs.
Based on the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)3
†Instrumental activities of daily living (ADL) refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.
‡Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
Recommended RYBREVANT® management and dosage modifications for ARs1
AE, adverse event; AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events; IRR, infusion-related reaction.
Explore
Discover how RYBREVANT® may help your patients.
References
1. RYBREVANT® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
2. Data on file. Janssen Biotech, Inc.
3. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE): Version 5.0. Published November 27, 2017. Accessed April 10, 2024.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf