For APPs & Nurses

Initiating therapy

Premedications for RYBREVANT®1

RYBREVANT® premedication dosing chartRYBREVANT® premedication dosing chart

Prior to the initial infusion of RYBREVANT® (Week 1, Day 1 and 2), administer premedication to reduce the risk of IRRs.

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.

Concomitant Medications1

When initiating treatment with RYBREVANT® in combination with LAZCLUZE™, administer anticoagulant prophylaxis to prevent VTE events for the first 4 months of treatment. The use of Vitamin K antagonists is not recommended.

If there are no signs or symptoms of VTE during the first 4 months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider. Refer to the full LAZCLUZE™ Prescribing Information for information about concomitant medications.

Consider prophylactic measures (eg, use of oral antibiotics) to reduce the risk of dermatologic adverse reactions.

IRR, infusion-related reaction; VTE, venous thromboembolism.

Preparation

Preparation for RYBREVANT®1

Dilute and prepare RYBREVANT® for intravenous infusion before administration

Step 1

Check that the RYBREVANT® solution is colorless to pale yellow. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present

Step 2

Determine the dose and number of vials of RYBREVANT® needed based on patient's baseline weight

  • Each vial of RYBREVANT® contains 350 mg of amivantamab-vmjw
Step 3

Withdraw and then discard a volume of either 5% dextrose injection or 0.9% sodium chloride injection from the 250-mL infusion bag equal to the volume of RYBREVANT® to be added (ie, discard 7 mL diluent from the infusion bag for each RYBREVANT® vial)

  • Only use infusion bags made of PVC, PP, PE, or PP+PE
Step 4

Withdraw 7 mL of RYBREVANT® from each vial and add it to the infusion bag. The final volume in the infusion bag should be 250 mL

  • Discard any unused portion left in the vial
Step 5

Gently invert the bag to mix the solution. Do not shake

Step 6

Diluted solutions should be administered within 10 hours (including infusion time) at room temperature 59°F to 77°F (15°C to 25°C)

Administration

Administration for RYBREVANT®1

  • Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding PES filter (pore size 0.2 micrometer)
  • Administration sets must be made of either PU, PBD, PVC, PP, or PE.
  • The administration set with filter must be primed with either 5% dextrose injection or 0.9% sodium chloride injection prior to the initiation of each RYBREVANT® infusion
  • Do not infuse RYBREVANT® concomitantly in the same intravenous line with other agents

RYBREVANT® + LAZCLUZE™ or RYBREVANT® as a single agent1

  • Administer RYBREVANT® as a single agent infusion every 2 weeks intravenously until disease progression or unacceptable toxicity according to the infusion rates
  • 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 a 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
  • When given in combination with LAZCLUZE™, administer RYBREVANT® any time after LAZCLUZE™ when given on the same day

RYBREVANT® in combination with carboplatin and pemetrexed1

  • Administer RYBREVANT® in combination with carboplatin and pemetrexed infusions every 3 weeks intravenously until disease progression or unacceptable toxicity according to the infusion rates
  • 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 a 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
  • Administer the pemetrexed infusion first, carboplatin infusion second, and the RYBREVANT® infusion last

Dosing Information for LAZCLUZE™ when given in combination with RYBREVANT®2

  • Swallow LAZCLUZE™ tablets whole (with or without food). Do not crush, split, or chew. Continue treatment until disease progression or unacceptable toxicity
  • If a patient misses a dose of LAZCLUZE™ within 12 hours, instruct the patient to take the missed dose. If more than 12 hours have passed since the dose was to be given, instruct the patient to take the next dose at its scheduled time
  • If vomiting occurs any time after taking LAZCLUZE™, instruct the patient to take the next dose at its next regularly scheduled time

Drug interactions with LAZCLUZE™2

Avoid concomitant use of LAZCLUZE™ with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

Please see full LAZCLUZE™ Prescribing Information for information regarding dosing and drug interactions.

BCRP, breast cancer resistance protein; CYP3A4, cytochrome P450 3A4; PBD, polybutadiene; PE, polyethylene; PES, polyethersulfone; PP, polypropylene; PU, polyurethane;
PVC, polyvinylchloride.

RYBREVANT® (amivantamab) and LAZCLUZE™ dosing and administration breakdown over timeRYBREVANT® (amivantamab) and LAZCLUZE™ dosing and administration breakdown over time

*In the absence of IRRs, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4 to 6 hours for Day 1 and 6 to 8 hours for Day 2. Subsequent infusion time is approximately 2 hours.

RYBREVANT® (amivantamab) with carboplatin and pemetrexed dosing and administration breakdown over timeRYBREVANT® (amivantamab) dosing and administration breakdown over time

*In the absence of IRRs, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4 to 6 hours for Day 1 and 6 to 8 hours for Day 2. Subsequent infusion time is approximately 2 hours.

Reference:

1. RYBREVANT® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

2. LAZCLUZE™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.