Overview

Dosing for RYBREVANT FASPRO™ + LAZCLUZE®

Premedications1

Administer antihistamine, antipyretic, and glucocorticoids*:

15 to 90 minutes prior to each injection according to the recommended premedications in the table below.

*Glucocorticoid administration is required for week 1, day 1 dose only and upon reinitiation after prolonged dose interruptions, then as necessary for subsequent injections.

See recommended premedications

Rapid injection1†

Stopwatch icon showing 5 minutes

†Administration time only; actual clinic time may vary.

See administration details

Proactive medications1

To help reduce the risk of select ARs

  • Dermatologic AR prophylaxis:
    • Oral/topical antibiotics and ceramide-based moisturizer​
    • Advise patients to limit direct sun exposure‡
  • VTE concomitant medications: Anticoagulant prophylaxis for the first 4 months of treatment

‡During and for 2 months after treatment.

See Proactive Therapy Management

AR, adverse reaction; VTE, venous thromboembolism.

RYBREVANT FASPRO™ dosing and administration guide thumbnail

RYBREVANT FASPRO™ Administration & Management Guide

Download a guide with comprehensive dosing, administration, and proactive therapy management details for RYBREVANT FASPRO™–based regimens.

Download

Dosing Schedule

Recommended dosing schedule for RYBREVANT FASPRO™ + LAZCLUZE® (Q2W)1,2

RYBREVANT FASPRO™ + LAZCLUZE® recommended dosing schedule RYBREVANT FASPRO™ + LAZCLUZE® recommended dosing schedule

*Dose adjustments not required for subsequent body weight changes.

RYBREVANT FASPRO™

The recommended dosage of RYBREVANT FASPRO™ is based on baseline body weight and administered as a subcutaneous injection. Please see the full Prescribing Information for RYBREVANT FASPRO™ for units of hyaluronidase for each dose and for any additional dosage and administration guidance.1

Contraindications

RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.1

With LAZCLUZE®

Administer RYBREVANT FASPRO™ any time after LAZCLUZE® when given on the same day.​ Refer to the full Prescribing Information for LAZCLUZE® for recommended LAZCLUZE® dosage and administration information.1

If switching from RYBREVANT® (amivantamab-vmjw) Q2W dosing to RYBREVANT FASPRO™ Q2W dosing, switch patients at their next scheduled dose on or after week 51

Q2W, once every 2 weeks.

Premedications

Premedications for RYBREVANT FASPRO™1

ARR management

Premedications for RYBREVANT® FASPRO™ chartPremedications for RYBREVANT® FASPRO™ chart

*Glucocorticoid administration is also required after prolonged dose interruptions, then as necessary for subsequent injections.

Prophylactic and concomitant medications1

Dermatologic AR prophylaxis

Prophylactic measures (eg, use of oral/topical antibiotics) are recommended to reduce the risk of dermatologic ARs. When initiating treatment with RYBREVANT FASPRO™, ceramide-based moisturizer is recommended.​

See additional strategies for dermatologic AR prophylaxis

VTE concomitant medications

When initiating treatment with RYBREVANT FASPRO™ in combination with LAZCLUZE®, implement anticoagulant prophylaxis to reduce the risk of 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
See additional information on VTE prophylaxis

Refer to the full Prescribing Information for LAZCLUZE® for information about concomitant medications.

ARR, administration-related reaction; IV, intravenous.

Preparation

Vial selection and dose volume1

RYBREVANT FASPRO™ with LAZCLUZE® or as a single agent (Q2W)

RYBREVANT FASPRO™ vial selection and dose volumeRYBREVANT FASPRO™ vial selection and dose volume

Please see the Prescribing Information for RYBREVANT FASPRO™ for units of hyaluronidase for each dose.

Preparation1

STEP

1

Remove from fridge

Remove the appropriate number of RYBREVANT FASPRO™ vials from refrigerated storage

  • During preparation and prior to administration, check the vial labels to ensure that the drug being prepared and administered is subcutaneous RYBREVANT FASPRO™ and not RYBREVANT®
  • Do not substitute RYBREVANT FASPRO™ for or with RYBREVANT®

STEP

2

Bring to room temp

Wait at least 15 minutes to allow vial(s) to reach room temperature

  • Do not warm any other way. Do not shake or dilute

STEP

3

Inspect visually

Once room temperature, inspect visually for particulate matter and discoloration prior to administration

  • RYBREVANT FASPRO™ is a clear to opalescent and colorless to pale yellow solution
  • Do not use if the solution is discolored or cloudy, or if foreign particles are present

STEP

4

Withdraw dose

Withdraw the required injection volume from the vial(s) into a syringe(s) using a transfer needle

  • RYBREVANT FASPRO™ is compatible with stainless steel injection needles, PP and PC syringes, and PE, PU, and PVC subcutaneous infusion sets. Administer using a 21G to 23G needle or infusion set to ensure ease of administration

Vial storage1

Store RYBREVANT FASPRO™ vials in a refrigerator in original carton to protect from light. Do not freeze or shake.

Syringe storage1

  • RYBREVANT FASPRO™ does not contain an antimicrobial preservative. The prepared syringes should be administered immediately
  • If immediate administration is not possible, replace the transfer needle with a syringe closing cap for transport, and store the prepared syringes of RYBREVANT FASPRO™ refrigerated at 36 °F to 46 °F (2 °C to 8 °C) for up to 24 hours followed by at room temperature of 59 °F to 86 °F (15 °C to 30 °C) for up to 24 hours
  • Discard the prepared syringe(s) if stored for more than 24 hours refrigerated or more than 24 hours at room temperature
  • If stored in the refrigerator, allow the solution to come to room temperature before administration

PC, polycarbonate; PE, polyethylene; PP, polypropylene; PU, polyurethane; PVC, polyvinyl chloride.

Administration

Administering subcutaneous RYBREVANT FASPRO™ with LAZCLUZE®1

Administer premedications before each RYBREVANT FASPRO™ dose as recommended to reduce the risk of ARRs.

Administering RYBREVANT FASPRO™1

RYBREVANT FASPRO™ is for subcutaneous use only. Do not administer RYBREVANT FASPRO™ intravenously

Once the syringe(s) are prepped, prepare to administer the injection​. RYBREVANT FASPRO™ must be administered by a healthcare professional

Faspro administration targeting the upper right side of the stomach
  • Inject the required volume of RYBREVANT FASPRO™ into the subcutaneous tissue of the abdomen over approximately 5 minutes to minimize injection site irritation
  • Do not inject into tattoos, scars, or areas where the skin is red, bruised, tender, hard, not intact, or within 2 inches (5 cm) around the periumbilical area
  • If the patient experiences pain, pause or slow down delivery
    • If the pain is not alleviated by pausing or slowing down the delivery rate, deliver the rest of the dose in a second injection site on the opposite side of the abdomen 
  • If administering with a subcutaneous infusion set, ensure the full dose is delivered through the infusion set. A 0.9% sodium chloride solution may be used to flush the remaining liquid through the line

Administering LAZCLUZE®2

When given in combination with LAZCLUZE®, administer RYBREVANT FASPRO™ any time after LAZCLUZE® when given on the same day

  • Administer LAZCLUZE® 240 mg orally once daily
  • Swallow LAZCLUZE® tablets whole (with or without food). Do not crush, split, or chew
  • 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 the full Prescribing Information for LAZCLUZE® for information regarding dosing and drug interactions.

BCRP, breast cancer resistance protein; CYP3A4, cytochrome P450 3A4.

References:

  1. RYBREVANT FASPRO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. LAZCLUZE® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.