J&J Medical Connect
RYBREVANT FASPRO™

(amivantamab and hyaluronidase-lpuj)

J&J Medical Connect

Connect with us

Connect with us

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

Medical Information

RYBREVANT FASPRO - Dosage and Administration

Last Updated: 12/19/2025

SUMMARY

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
  • LAZCLUZE (lazertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).2
  • RYBREVANT FASPRO is for SC use only. Do not administer intravenously (IV).3
  • RYBREVANT FASPRO must be administered by a healthcare professional.3
  • RYBREVANT FASPRO has different recommended dosage and administration than IV amivantamab products. Do not substitute RYBREVANT FASPRO for or with IV amivantamab products.3
  • Administer each injection of RYBREVANT FASPRO SC in the abdomen over approximately 5 minutes to minimize injection site irritation.3
  • The recommended dosage of RYBREVANT FASPRO is based on baseline body weight. The dosage of RYBREVANT FASPRO is provided in Table: Recommended Dosage for RYBREVANT FASPRO in Combination With Carboplatin and Pemetrexed (Q3W Dosing) and Table: Recommended Dosage for RYBREVANT FASPRO in Combination With LAZCLUZE or as a Single Agent (Q2W Dosing).3
    • Administer premedications to reduce the risk of administration-related reactions (ARRs) as recommended in Table: Premedications.
    • Administer prophylactic and concomitant medications as recommended to reduce the risk of dermatologic adverse reactions (ARs). See Prophylactic and Concomitant
    • Medications to Reduce the Risk of Dermatologic ARs.
    • Administer RYBREVANT FASPRO in combination with chemotherapy weekly (QW) for 3 weeks, then administer every 3 weeks (Q3W) starting at Week 4.
    • Administer RYBREVANT FASPRO in combination with LAZCLUZE or as a single agent QW for 4 weeks, then administer every 2 weeks (Q2W) starting at Week 5.
  • Adult patients currently receiving RYBREVANT IV at Q2W dosing regimen may switch to RYBREVANT FASPRO SC at Q2W dosing regimen at their next scheduled dose on or after Week 5.3
  • Adult patients currently receiving RYBREVANT IV at Q3W dosing regimen may switch to RYBREVANT FASPRO SC at Q3W dosing regimen at their next scheduled dose on or after Week 4.3
  • Monitor patients for any signs and symptoms of ARRs during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.3
  • Modify RYBREVANT FASPRO dosing for adverse reactions (ARs) as described in Table: RYBREVANT FASPRO Dose Reductions for ARs and Table: Recommended RYBREVANT FASPRO Dosage Modifications and Management for ARs.3
  • Please refer to the DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, WARNINGS AND PRECAUTIONS, and CLINICAL STUDIES sections of the full Prescribing Information for complete information.3

PRODUCT LABELING

DOSAGE AND ADMINISTRATION

Important Dosage and Administration Information

  • RYBREVANT FASPRO is for SC use only. Do not administer RYBREVANT FASPRO IV.3
  • RYBREVANT FASPRO must be administered by a healthcare professional.3
  • To reduce the risk of medication errors, prior to administration, check the vial labels to ensure that the drug being prepared and administered is SC RYBREVANT FASPRO and not IV amivantamab.3
  • RYBREVANT FASPRO has different recommended dosage and administration than IV amivantamab products. Do not substitute RYBREVANT FASPRO for or with IV amivantamab products.3
  • Adult patients currently receiving RYBREVANT IV at Q2W dosing regimen may switch to RYBREVANT FASPRO SC at Q2W dosing regimen at their next scheduled dose on or after Week 5.3
  • Adult patients currently receiving RYBREVANT IV at Q3W dosing regimen may switch to RYBREVANT FASPRO SC at Q3W dosing regimen at their next scheduled dose on or after Week 4.3
  • RYBREVANT FASPRO is not indicated for use in pediatric patients.3
  • Administer premedications before each RYBREVANT FASPRO dose as recommended, to reduce the risk of ARRs (Table: Premedications).3
  • Administer each injection of RYBREVANT FASPRO SC in the abdomen over approximately 5 minutes to minimize injection site irritation. Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard, not intact or within 2 inches (5 cm) around the periumbilical area.3
  • If the total dose requires multiple injections of RYBREVANT FASPRO, administer each injection consecutively in separate quadrants of the abdomen, with each injection taking approximately 5 minutes.3
  • Pause or slow the delivery rate if the patient experiences pain. In the event pain is not alleviated by pausing or slowing down delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.3
  • If administering with a SC infusion set, ensure that the full dose is delivered through the infusion set. A 0.9% sodium chloride solution may be utilized to flush remaining drug product through the line.3
  • Discard unused portion.3

Patient Selection

Select patients for treatment with RYBREVANT FASPRO based on the presence of a mutation as detected by a United States (US) Food and Drug Administration (FDA)-approved test (see table below). Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.3


Patient Selection3
Indication
Treatment Regimen
Source for Testing
First-line treatment of NSCLC with EGFR Exon19del or Exon 21 L858R substitution mutations
RYBREVANT FASPRO in combination with LAZCLUZE
  • Tumor or plasma specimens.
  • Testing may be performed at any time from initial diagnosis.
  • Testing does not need to be repeated once EGFR mutation status has been established.
Previously treated locally advanced or metastatic NSCLC with EGFR Exon19del or Exon 21 L858R substitution mutations (progressive disease on an EGFR tyrosine kinase inhibitor)
RYBREVANT FASPRO in combination with carboplatin and pemetrexed
First-line treatment of NSCLC with EGFR Exon20ins mutations
RYBREVANT FASPRO in combination with carboplatin and pemetrexed
Previously treated NSCLC with EGFR Exon20ins mutations
RYBREVANT FASPRO as a single agent
Abbreviations: EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; Exon20ins, Exon 20 insertion; NSCLC, non-small cell lung cancer.

Recommended Dosage

Recommended Dosage for RYBREVANT FASPRO in Combination With Carboplatin and Pemetrexed - Q3W Dosing

The recommended dosages of RYBREVANT FASPRO, administered every 3 weeks in combination with carboplatin and pemetrexed, based on baseline body weight are provided in the table below.3


Recommended Dosage for RYBREVANT FASPRO in Combination With Carboplatin and Pemetrexed (Q3W Dosing)3
Body Weight at Baselinea
Recommended Dose
Dosing Schedule
<80 kg
1600 mg amivantamab and 20,000 units hyaluronidase
  • First dose at Week 1 Day 1
2400 mg amivantamab and 30,000 units hyaluronidase
  • Weekly (total of 2 doses) from Weeks 2 to 3
    • Weeks 2 to 3 - injection on Day 1
  • Q3W starting at Week 4 onwards
≥80 kg
2240 mg amivantamab and 28,000 units hyaluronidase
  • First dose at Week 1 Day 1
3360 mg amivantamab and 42,000 units hyaluronidase
  • Weekly (total of 2 doses) from Weeks 2 to 3
    • Weeks 2 to 3 - injection on Day 1
  • Q3W starting at Week 4 onwards
Abbreviation: Q3W, every 3 weeks.
aDose adjustments not required for subsequent body weight changes.

Administer RYBREVANT FASPRO until disease progression or unacceptable toxicity.3

The recommended order of administration and regimen for RYBREVANT FASPRO in combination with carboplatin and pemetrexed are provided in the table below.3


Order of Administration and Regimen for RYBREVANT FASPRO in Combination With Carboplatin and Pemetrexed3
Administer the regimen in the following order: pemetrexed first, carboplatin second, and RYBREVANT FASPRO last.
Drug
Dose
Duration/Timing of Treatment
Pemetrexed
  • Pemetrexed 500 mg/m2 IV.
  • Refer to the pemetrexed Full PI for complete information.
  • Q3W, continue until disease progression or unacceptable toxicity.
Carboplatin
  • Carboplatin AUC 5 IV.
  • Refer to the carboplatin Full PI for complete information.
  • Q3W for up to 12 weeks.
RYBREVANT FASPRO
  • Q3W, continue until disease progression or unacceptable toxicity.
Abbreviations: AUC, area under curve; IV, intravenously; PI, Prescribing Information; Q3W, every 3 weeks; SC, subcutaneously.

Recommended Dosage for RYBREVANT FASPRO in Combination With LAZCLUZE or as a Single Agent - Q2W Dosing

The recommended dosages of RYBREVANT FASPRO, in combination with LAZCLUZE or as a single agent, based on baseline body weight are provided in the table below.3


Recommended Dosage for RYBREVANT FASPRO in Combination With LAZCLUZE or as a Single Agent (Q2W Dosing)3
Body Weight at Baselinea
Recommended Dose
Dosing Schedule
<80 kg
1600 mg amivantamab and 20,000 units hyaluronidase
  • Weekly (total of 4 doses) from Weeks 1 to 4
    • Weeks 1 to 4 - injection on Day 1
  • Q2W starting at Week 5 onwards
≥80 kg
2240 mg amivantamab and 28,000 units hyaluronidase
  • Weekly (total of 4 doses) from Weeks 1 to 4
    • Weeks 1 to 4 - injection on Day 1
  • Q2W starting at Week 5 onwards
Abbreviation: Q2W, every 2 weeks.
aDose adjustments not required for subsequent body weight changes.

Administer RYBREVANT FASPRO until disease progression or unacceptable toxicity.3

RYBREVANT FASPRO in Combination With LAZCLUZE

Order of Administration

When given in combination with LAZCLUZE, administer RYBREVANT FASPRO any time after LAZCLUZE when given on the same day. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosing information. Administer RYBREVANT FASPRO in combination with LAZCLUZE until disease progression or unacceptable toxicity.3

Recommended Premedications

Prior to the initial injection of RYBREVANT FASPRO (Week 1 Day 1), administer premedications as described in the table below to reduce the risk of ARRs.3

Glucocorticoid administration is required at the initial dose at Week 1 Day 1 only, and upon re‑initiation after prolonged dose interruptions, then as necessary for subsequent injections (see table below). Administer both antihistamine and antipyretic prior to all RYBREVANT FASPRO doses.3


Premedications3
Medication
Dose
Route of Administration
Dosing Window Prior to RYBREVANT FASPRO Administration
Antihistaminea
Diphenhydramine (25-50 mg) or equivalent
IV
15-30 minutes
Oral
30-60 minutes
Antipyretica
Acetaminophen (650-1000 mg) or equivalent
IV
15-30 minutes
Oral
30-60 minutes
Glucocorticoidb
Dexamethasone (20 mg) or equivalent
IV
45-60 minutes
Oral
At least 60 minutes
Glucocorticoidc
Dexamethasone (10 mg) or equivalent
IV
45-60 minutes
Oral
60-90 minutes
Abbreviations: ARR, administration-related reaction; IV, intravenous.
aRequired at all doses.
bRequired at initial dose (Week 1 Day 1) or at the next subsequent dose in the event of an ARR.
cOptional for subsequent doses.

Prophylactic and Concomitant Medications to Reduce the Risk of Dermatologic ARs

When initiating treatment with RYBREVANT FASPRO, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic ARs.3

  • Administer an oral antibiotic (doxycycline or minocycline, 100 mg orally twice daily) starting on Day 1 for the first 12 weeks of treatment.
  • After completion of oral antibiotic treatment, administer antibiotic lotion to the scalp (clindamycin 1% topical once daily) for the next 9 months of treatment.
  • Administer non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying agents) on the face and whole body (except scalp).
  • Wash hands and feet with 4% chlorhexidine solution once daily.
  • Limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen to reduce the risk of dermatologic ARs.

RYBREVANT FASPRO in Combination with LAZCLUZE: Concomitant Medications to Reduce the Risk of Venous Thromboembolic Events

When initiating treatment with RYBREVANT FASPRO in combination with LAZCLUZE, administer anticoagulant prophylaxis to prevent venous thromboembolic (VTE) events for the first 4 months of treatment. If there are no signs or symptoms of VTE events during the first 4 months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for information about concomitant medications.3

Missed Dose

  • For Q2W dosing schedule3:
    • If a dose of RYBREVANT FASPRO is missed between Weeks 1 to 4, administer within 24 hours.
    • If a dose of RYBREVANT FASPRO is missed from Week 5 onward, administer within 7 days.
  • For Q3W dosing schedule3:
    • If a dose of RYBREVANT FASPRO is missed between Weeks 1 to 3, administer within 24 hours.
    • If a dose of RYBREVANT FASPRO is missed from Week 4 onward, administer within 7 days.

If the missed dose is not administered according to this guidance, do not administer the missed dose and administer the next dose per the usual dosing schedule.3

Dosage Modifications for ARs

The recommended RYBREVANT FASPRO dose reductions for ARs are listed in the table below.3


RYBREVANT FASPRO Dose Reductions for ARs3
Dosea
1st Dose Reduction
2nd Dose Reduction
3rd Dose Reduction
1600 mg amivantamab and 20,000 units hyaluronidase
1050 mg amivantamab and 13,200 units hyaluronidaseb
700 mg amivantamab and 8800 units hyaluronidasec
Discontinue RYBREVANT FASPRO
2240 mg amivantamab and 28,000 units hyaluronidase
1600 mg amivantamab and 20,000 units hyaluronidased
1050 mg amivantamab and 13,200 units hyaluronidaseb
2400 mg amivantamab and 30,000 units hyaluronidase
1600 mg amivantamab and 20,000 units hyaluronidased
1050 mg amivantamab and 13,200 units hyaluronidaseb
3360 mg amivantamab and 42,000 units hyaluronidase
2240 mg amivantamab and 28,000 units hyaluronidasee
1600 mg amivantamab and 20,000 units hyaluronidased
Abbreviation: AR, adverse reaction.
aDose at which the AR occurred.
bThe dose volume should be 6.6 mL for 1050 mg amivantamab and 13,200 units hyaluronidase dose.
cThe dose volume should be 4.4 mL for 700 mg amivantamab and 8800 units hyaluronidase dose.
dThe dose volume should be 10 mL for 1600 mg amivantamab and 20,000 units hyaluronidase dose.
eThe dose volume should be 14 mL for 2240 mg amivantamab and 28,000 units hyaluronidase dose.

The recommended RYBREVANT FASPRO dosage modifications and management for ARs are provided in the table below.3


Recommended RYBREVANT FASPRO Dosage Modifications and Management for ARs3
AR
Severity
Dosage Modifications
Hypersensitivity and ARRs
Grade 1 or 2
  • Interrupt RYBREVANT FASPRO injection if ARR is suspected and monitor patient until reaction symptoms resolve.
  • Resume injection upon resolution of symptoms.
  • Include corticosteroid with premedications for subsequent dose (see Table: Premedications).
Grade 3
  • Interrupt RYBREVANT FASPRO injection and administer supportive care medications. Continuously monitor patient until reaction symptoms resolve.
  • Resume injection upon resolution of symptoms.
  • Include corticosteroid with premedications for subsequent dose (see Table: Premedications).
  • For recurrent grade 3 reactions, permanently discontinue RYBREVANT FASPRO.
Grade 4
  • Permanently discontinue RYBREVANT FASPRO.
ILD/pneumonitis
Any grade
  • Withhold RYBREVANT FASPRO if ILD/pneumonitis is suspected.
  • Permanently discontinue RYBREVANT FASPRO if ILD/pneumonitis is confirmed.
VTE events (applies to when used in combination with LAZCLUZE)
Grade 2 or 3
  • Withhold RYBREVANT FASPRO and LAZCLUZE.
  • Administer anticoagulation treatment as clinically indicated.
  • Once anticoagulant treatment has been initiated, resume RYBREVANT and LAZCLUZE at the same dose level, at the discretion of the treating physician.
Grade 4 or recurrent grade 2 or 3 despite therapeutic level anticoagulation
  • Withhold LAZCLUZE and permanently discontinue RYBREVANT FASPRO.
  • Administer anticoagulation treatment as clinically indicated.
  • Once anticoagulant treatment has been initiated, treatment can continue with LAZCLUZE at the same dose level at the discretion of the treating physician.
Dermatologic ARs (including dermatitis acneiform, pruritus, dry skin)
Grade 1 or 2
  • Initiate supportive care management as clinically indicated.
  • Reassess after 2 weeks; if rash does not improve, consider dose reduction.
Grade 3
  • Withhold RYBREVANT FASPRO and initiate supportive care management as clinically indicated.
  • Upon recovery to grade ≤2, resume RYBREVANT FASPRO at reduced dose.
  • If no improvement within 2 weeks, permanently discontinue treatment.
Grade 4 or
Severe bullous, blistering or exfoliating skin conditions (including TEN)
  • Permanently discontinue RYBREVANT FASPRO.
Other ARs
Grade 3
  • Withhold RYBREVANT FASPRO until recovery to grade ≤1 or baseline.
  • Resume at the same dose if recovery occurs within 1 week.
  • Resume at reduced dose if recovery occurs after 1 week but within 4 weeks.
  • Permanently discontinue if recovery does not occur within 4 weeks.
Grade 4
  • Withhold RYBREVANT FASPRO until recovery to grade ≤1 or baseline.
  • Resume at reduced dose if recovery occurs within 4 weeks.
  • Permanently discontinue if recovery does not occur within 4 weeks.
  • Permanently discontinue for recurrent grade 4 reactions.
Abbreviations: AR, adverse reaction; ARR, administration-related reaction; ILD, interstitial lung disease; TEN, toxic epidermal necrolysis; VTE, venous thromboembolic.

Recommended Dosage Modifications for ARs for RYBREVANT FASPRO in Combination With LAZCLUZE

When administering RYBREVANT FASPRO in combination with LAZCLUZE, if there is an AR requiring dose reduction after withholding treatment and resolution, reduce the dose of RYBREVANT FASPRO first. Refer to the LAZCLUZE Prescribing Information for information about dosage modifications for LAZCLUZE.3

Recommended Dosage Modifications for ARs for RYBREVANT FASPRO in Combination With Carboplatin and Pemetrexed

When administering RYBREVANT FASPRO in combination with carboplatin and pemetrexed, modify the dosage of 1 or more drugs. Withhold or discontinue RYBREVANT FASPRO as shown in Table: Recommended RYBREVANT FASPRO Dosage Modifications and Management for ARs. Refer to Prescribing Information for carboplatin and pemetrexed for additional dosage modification information.3

Preparation Instructions

  • Do not dilute RYBREVANT FASPRO.3
  • RYBREVANT FASPRO does not contain an antimicrobial preservative. Administer RYBREVANT FASPRO dose in prepared syringes immediately. If the RYBREVANT FASPRO dose is not administered immediately, refer to the "Storage" section.3
  • RYBREVANT FASPRO is a clear to opalescent and colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, or cloudy, or if foreign particles are present.3
  • Remove the appropriate number of RYBREVANT FASPRO vial(s) from refrigeration and equilibrate RYBREVANT FASPRO to room temperature (15°C to 30°C [59°F to 86°F]) for at least 15 minutes. Do not warm RYBREVANT FASPRO in any other way. Do not shake.3
  • Withdraw the required injection volume of RYBREVANT FASPRO from the vial(s) into a syringe(s) using a transfer needle (see Table: Recommended RYBREVANT FASPRO Dosing Volumes). Discard unused portion.3
  • RYBREVANT FASPRO is compatible with stainless steel injection needles, polypropylene and polycarbonate syringes, and polyethylene, polyurethane, and polyvinylchloride SC infusion sets. Use 0.9% sodium chloride injection to flush an infusion set, if needed.3
  • Administer using a 21 gauge (G) to 23G needle or infusion set to ensure ease of administration. If immediate administration is not possible, replace the transfer needle with a syringe closing cap for transport.3
  • Divide doses requiring greater than 15 mL into approximately equal volumes in 2 syringes and administer at separate injection sites. Do NOT exceed 15 mL in each syringe.3
  • The recommended vial selection and dose volume are provided in the table below.3

Recommended RYBREVANT FASPRO Dosing Volumes3
RYBREVANT FASPRO Total Dose
Total Dose Volume
1600 mg amivantamab and 20,000 units hyaluronidase
10 mL
2240 mg amivantamab and 28,000 units hyaluronidase
14 mL
2400 mg amivantamab and 30,000 units hyaluronidase
15 mLa
3360 mg amivantamab and 42,000 units hyaluronidase
21 mLa,b
aThe entire contents of all vials will not be needed. Discard unused portion.bDivide the 21 mL dose volume approximately equally into 2 syringes (each syringe should not exceed 15 mL).
  • NOTE: Preparation of RYBREVANT FASPRO doses of 2400 mg amivantamab and 30,000 units hyaluronidase and 3360 mg amivantamab and 42,000 units hyaluronidase will require more than 1 vial. The entire contents of all vials will not be needed. Discard unused portion.3

Storage

  • If immediate administration is not possible, store the prepared syringes of RYBREVANT FASPRO refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by at room temperature of 15°C to 30°C (59°F to 86°F) for up to 24 hours.3
  • 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.3

Dosage Forms and Strengths

Injection

  • 1600 mg amivantamab and 20,000 units hyaluronidase per 10 mL (160 mg and 2000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial.3
  • 2240 mg amivantamab and 28,000 units hyaluronidase per 14 mL (160 mg and 2000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial.3

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 08 December 2025.

References

Show
1 Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605.  
2 Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small cell lung cancer. Future Oncol. 2022;18(6):639-647.  
3 RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf