SUMMARY

• RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).¹
• Verify the pregnancy status of patients of reproductive potential prior to initiating RYBREVANT FASPRO.²
• Based on the mechanism of action and findings in animal models, RYBREVANT FASPRO can cause fetal harm when administered to a pregnant patient. Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus.²
  • Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO.
• Because of the potential for serious adverse reactions from RYBREVANT FASPRO in breastfed children, advise patients not to breastfeed during treatment with RYBREVANT FASPRO and for 3 months after the last dose.²
• Please refer to RYBREVANT FASPRO product labeling for additional information.²

USE IN PATIENTS OF REPRODUCTIVE POTENTIAL AND LACTATING PATIENTS

Use in Patients of Reproductive Potential

RYBREVANT FASPRO can cause fetal harm when administered to a pregnant patient.²

Pregnancy Testing

• Verify the pregnancy status of patients of reproductive potential prior to initiating RYBREVANT FASPRO.²

Contraception

Females

• Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO.²

Use in Pregnant Patients

• Based on the mechanism of action and findings in animal models, RYBREVANT FASPRO can cause fetal harm when administered to a pregnant patient. There are no available data on the use of RYBREVANT FASPRO in pregnant patients or animal data to assess the risk of RYBREVANT FASPRO in pregnancy.²
• Administration of other epidermal growth factor receptor (EGFR) inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryo lethality, and abortion. Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus.²

Use in Lactating Patients

• There are no data on the presence of amivantamab or hyaluronidase in human milk or its effects on the breastfed child, or on milk production.²
• The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to RYBREVANT FASPRO are unknown.²
• Because of the potential for serious adverse reactions from RYBREVANT FASPRO in breastfed children, advise patients not to breastfeed during treatment with RYBREVANT FASPRO and for 3 months after the last dose.²

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.