Amivantamab-vmjw

What is Amivantamab-vmjw

• Amivantamab-vmjw(Rybrevant) is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa.
• Amivantamab-vmjw (Rybrevant) injection for intravenous infusion is a sterile, preservative-free, colorless to pale yellow solution in single-dose vials.
• The pH is 5.7.

What are the uses of this medicine?

• Amivantamab-vmjw(Rybrevant) is 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, whose disease has progressed on or after platinum-based chemotherapy.

How does this medicine work?

• A human bispecific antibody targeting both epidermal growth factor receptor EGFR and hepatocyte growth factor receptor (HGFR; cMet), with potential antineoplastic activity.
• Upon administration, amivantamab simultaneously targets and binds to wild-type or certain mutant forms of both EGFR and cMet expressed on cancer cells, thereby preventing receptor phosphorylation.
• This prevents the activation of both EGFR- and cMet-mediated signaling pathways.
• In addition, binding results in receptor degradation, which further inhibits EGFR- and cMet-mediated signaling.
• JNJ-61186372 also causes antibody-dependent cellular cytotoxicity (ADCC).
• Altogether, this results in the inhibition of tumor cell proliferation.
• EGFR and cMet, both upregulated or mutated in a variety of tumor cell types, play key roles in tumor cell proliferation.

Who Should Not Use this medicine?

• Use is not recommended in pregnant patients because of its adverse effects on fetus.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Intravenous use.
• Administer via a peripheral line on Week 1 and Week 2.
• Administer weekly for 4 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 2 weeks thereafter.

Each Rybrevant vial contains 350 mg (50 mg/mL) Amivantamab-vmjw, EDTA disodium salt dihydrate (0.14 mg), L-histidine (2.3 mg), L-histidine hydrochloride monohydrate (8.6 mg), L-methionine (7 mg), polysorbate 80 (4.2 mg), sucrose (595 mg), and water for injection, USP.

What are the dosage forms and brand names of this medicine?

• Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.
• The recommended dosage of Rybrevant is based on baseline body weight and administered as an intravenous infusion after dilution.

1. Baseline body weight is less than 80 kg, recommended dose 1050 mg (3 vials).
2. Baseline body weight is greater than or equal to 80 kg, recommended dose 1400 mg (4 vials).

• Brand name: Rybrevant(TM)
• Packager: Janssen Biotech, Inc.
• NDC Code(s): 57894-501-00, 57894-501-01

What side effects can this medication cause?

• The most common adverse reactions (≥ 20%) were 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 decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.
• It can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis.

What special precautions should I follow?

• Administer both antihistamine and antipyretic prior to all infusions. Glucocorticoid administration required for Week 1, Days 1 and 2 doses only and as necessary for subsequent infusions.

What to do in case of emergency/overdose?

• Data regarding overdoses of Amivantamab-vmjw are not readily available. Patients experiencing an overdose should be treated with symptomatic and supportive measures.
• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings from animal models, Amivantamab-vmjw can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus.
• Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of Amivantamab-vmjw.

Can this medicine be used in children?

• The safety and efficacy of Rybrevant have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

• Dailymed label info on Amivantamab-vmjw
• FDA Amivantamab-vmjw

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