Rybrevant

Rybrevant (amivantamab-vmjw) instructions

Common name: amivantamab-vmjw

Trade name: Rybrevant

Full names: Rybrevant, amivantamab-vmjw

Indications :

RYBREVANT is a bispecific antibody directed against the EGF receptor and MET receptor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, tested under FDA approval, and whose disease has progressed on or after platinum-based chemotherapy.

Dosage:

The recommended dose of RYBREVANT is based on baseline body weight and is administered as an intravenous infusion after dilution.

Administer prescribed medications as recommended.

Manage via perimeter lines in Weeks 1 and 2.

Administer RYBREVANT weekly for 4 weeks, beginning with an initial bolus infusion on Days 1 and 2 of Week 1, then every 2 days for several weeks thereafter.

Administer diluted RYBREVANT intravenously according to the infusion.

Adverse Reactions:

The most common adverse reactions (≥20%) are rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation and vomiting.

The most common grade 3 or 4 laboratory abnormalities (≥2%) were lymphopenia, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.

Taboos:

None.

Precautions:

Infusion-related reaction (IRR): Interrupt the infusion at the first sign of IRR. Reduce infusion rate or permanently discontinue RYBREVANT based on severity.

Interstitial Lung Disease (ILD)/Pneumonia: Monitor for new or worsening symptoms indicating ILD. Immediately discontinue RYBREVANT in hospitalized patients with suspected ILD/pneumonitis and permanently discontinue treatment if ILD/pneumonitis is confirmed.

Adverse skin reactions: May cause rashes, including acneiform dermatitis and toxic epidermal necrolysis. Discontinue, reduce dose, or permanently discontinue RYBREVANT based on severity.

Ocular toxicity: Promptly refer patients with worsening ocular symptoms to an ophthalmologist. Discontinue, reduce dose, or permanently discontinue RYBREVANT based on severity.

Embryo-fetal toxicity: Can cause fetal harm. Advise women at potential fetal reproductive risk to use an effective method of contraception.

Storage:

Store in original carton in refrigerator at 2°C to 8°C (36°F to 46°F), protected from light.

Mechanism of action:

Amivantamab-vmjw is a bispecific antibody that binds to the extracellular domains of EGFR and MET.

In in vitro and in vivo studies, amivantamab-vmjw was able to disrupt EGFR and MET signaling functions by blocking ligand binding and disrupting EGFR and MET in an exon 20 insertion mutation model. The presence of EGFR and MET on the surface of tumor cells also enables these cells to be destroyed by immune effector cells (such as natural killer cells and macrophages) through antibody-dependent cytotoxicity (ADCC) and photocytosis mechanisms, respectively.

Safety and efficacy:

The researchers evaluated the efficacy of Rybrevant in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations who had progressed after platinum-based chemotherapy. The results of the study showed that the overall response rate was 40%; the median response time of u2003 was 11.1 months; 63% of the patients had a response time of 6 months or longer.