Rybrevant Faspro 2240 mg/14mL
AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) · INJECTION · Janssen Biotech, Inc.
Rybrevant Faspro is a injection containing amivantamab and hyaluronidase-lpuj (human recombinant) at 2240 mg/14mL, taken subcutaneous. Manufactured by Janssen Biotech, Inc..
Key Facts
- Brand Name
- Rybrevant Faspro
- Generic Name
- AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)
- NDC Code (Product)
57894-514- Manufacturer
- Janssen Biotech, Inc.
- Strength
- 2240 mg/14mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761433
- Drug Class
- Endoglycosidase [EPC]
- Marketing Start
- 12/19/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. ( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. ( 1 , 2.2 ) as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ( 1 ,…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. (2.1) RYBREVANT FASPRO has different recommended dosage and administration than intravenous amivantamab products. ( 2.1 ) Administer each injection of RYBREVANT FASPRO subcutaneously in the abdomen over approximately 5 minutes. ( 2.1 ) The recommended dosage of RYBREVANT FASPRO is based on baseline body weight. ( 2.3 ) Administer premedications as recommended. ( 2.4 ) Recommended dosage for RYBREVANT FASPRO in combination with carboplatin and pemetrexed (every 3-week dosing), see Table 2 . ( 2.3 ) Recommended dosage for RYBREVANT FASPRO in combination with lazertinib or for RYBREVANT FASPRO as a single agent (every 4-week dosing), see Table 4 . ( 2.3 ) Recommended dosage for RYBREVANT FASPRO in combination with lazertinib or for RYBREVANT FASPRO as a single agent (every 2-week dosing), see Table 5 . ( 2.3 ) 2.1 Important Dosage and Administration Information RYBREVANT FASPRO is for subcutaneous use only. Do not administer RYBREVANT FASPRO intravenously. RYBREVANT FASPRO must be administered by a healthcare professional. To reduce the risk of medication errors, prior to administration, check the vial labels to ensure that the dr…
Contraindications
4 CONTRAINDICATIONS RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. Patients with known hypersensitivity to hyaluronidase or to any of its excipients. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Hypersensitivity and Administration-Related Reactions [see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Venous Thromboembolic Events with Concomitant Use with Lazertinib [see Warnings and Precautions (5.3) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.4) ] Ocular Toxicity [see Warnings and Precautions (5.5) ] RYBREVANT FASPRO in Combination with Lazertinib The most common adverse reactions (≥ 20%) were rash, nail toxicity, musculoskeletal pain, fatigue, stomatitis, edema, nausea, diarrhea, vomiting, constipation, decreased appetite, and headache. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased lymphocyte count, decreased sodium, decreased potassium, decreased albumin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, increased gamma-glutamyl transferase, and decreased hemoglobin. (6.1) Intravenous Amivantamab in Combination with Lazertinib The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related …
Frequently Asked Questions
What is Rybrevant Faspro used for?
Rybrevant Faspro contains AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT). It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is Rybrevant Faspro a controlled substance?
Rybrevant Faspro is not classified as a controlled substance by the DEA.
What is the generic name for Rybrevant Faspro?
The generic name for Rybrevant Faspro is AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT). There are no other listed brand versions of AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT).
What is the NDC code for Rybrevant Faspro 2240 mg/14mL?
The NDC (National Drug Code) for Rybrevant Faspro 2240 mg/14mL is 57894-514, listed by Janssen Biotech, Inc..
Other Rybrevant Faspro Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)