Amivantamab Application Scope

EGFR Exon 19 del or Exon 21 L858R (first-line): In combination with lazertinib for locally advanced or metastatic NSCLC.
EGFR Exon 19 del/L858R (post-EGFR TKI): In combination with carboplatin + pemetrexed.
EGFR Exon20 insertion (first-line): In combination with carboplatin + pemetrexed.
EGFR Exon20 insertion (post-platinum): Single-agent.

rybrevant amivantamab

Amivantamab Characteristics

Ingredients: Each single-dose vial contains amivantamab-vmjw 350 mg/7 mL (50 mg/mL) with excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine HCl monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Properties: Bispecific human IgG1 monoclonal antibody targeting EGFR and MET; sterile, preservative-free, colorless to pale yellow solution for IV infusion.
Packaging Specification: Single-dose vial 350 mg/7 mL (50 mg/mL); one vial per carton
Storage: Refrigerate 2–8 °C (36–46 °F) in original carton; protect from light; do not freeze.
Expiry Date: As printed on the vial/carton; do not use beyond the labeled expiration date.
Executive Standard: US FDA Prescribing Information (USPI), revised 02/2025.
Approval Number: US BLA 761210.
Date of Revision: February 2025 (02/2025).
Manufacturer: Janssen Biotech, Inc. (Johnson & Johnson Innovative Medicine).

Guidelines for the Use of Rybrevant

Dosage and Administration:
- Recommended Dose: Weight-based as above; premedications required prior to each infusion; use peripheral line for Week 1–2 to reduce IRR risk.
- Administration: Dilute in 0.9% NaCl; split the initial dose over Day 1 and Day 2 (Week 1); follow label-specified infusion rates; monitor closely for infusion-related reactions (IRR), especially first infusion.
- Missed Dose: Administer the missed dose as soon as possible and adjust to maintain the q2-week (lazertinib/single-agent) or q3-week (chemo combo) schedule thereafter.
Adverse Reactions:
- Common Adverse Reactions:
  - With lazertinib: rash, nail toxicity, IRR, musculoskeletal pain, stomatitis, edema, VTE, paresthesia, fatigue, diarrhea/constipation, bleeding, dry skin, ↓appetite, pruritus, nausea, ocular effects.
  - With carboplatin+pemetrexed: rash, nail toxicity, IRR, fatigue, nausea, stomatitis, constipation, edema, ↓appetite, musculoskeletal pain, vomiting.
  - Single-agent: rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, vomiting.
- Serious Adverse Reactions: ILD/pneumonitis, severe IRR (incl. anaphylaxis), VTE (esp. with lazertinib), severe dermatologic reactions (incl. TEN), ocular toxicity, and embryo-fetal toxicity. Manage with withhold/reduce/discontinue per severity.
Contraindications: None listed.
Precautions:
- IRR: most occur on first infusion; premedicate and use peripheral line early.
- ILD/pneumonitis: withhold if suspected; discontinue if confirmed.
- VTE with lazertinib: prophylactic anticoagulation recommended for first 4 months; monitor/manage.
- Dermatologic/Ocular toxicity: institute prophylaxis (emollients; consider oral antibiotics), UV protection; prompt ophthalmology referral for symptoms.
- Embryo-fetal toxicity: use effective contraception; avoid breastfeeding.

Amivantamab Interactions

Metabolism/PK: As a monoclonal antibody, not CYP-metabolized; clinically meaningful CYP-mediated DDIs are unlikely.
Regimen-specific risks: With lazertinib, increased VTE risk → use anticoagulant prophylaxis initially. With platinum/pemetrexed, anticipate additive myelosuppression and GI toxicity.
Vaccines: Avoid live vaccines during and shortly after therapy; inactivated vaccines may be used as appropriate.
QT/CYP effects on co-meds: No evidence that amivantamab prolongs QT or induces/inhibits CYP enzymes.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.