Amivantamab-vmjw
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Amivantamab-vmjw is a bispecific EGF receptor that is FDA approved for the treatment of *adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- 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.
- 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.
- 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.. Common adverse reactions include ====RYBREVANT in Combination with Lazertinib====
• The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction, musculoskeletal pain, stomatitis, edema, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. • The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.
RYBREVANT in Combination with Carboplatin and Pemetrexed
• The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction, fatigue, nausea, stomatitis, constipation, edema, decreased appetite, musculoskeletal pain, vomiting, and COVID-19. • The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased neutrophils, decreased leukocytes, decreased platelets, decreased hemoglobin, decreased potassium, decreased sodium, increased alanine aminotransferase, increased gamma glutamyl transferase, and decreased albumin.
RYBREVANT as a Single Agent
• 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..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Amivantamab-vmjw FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amivantamab-vmjw in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amivantamab-vmjw in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Amivantamab-vmjw FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amivantamab-vmjw in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amivantamab-vmjw in pediatric patients.
Contraindications
There is limited information regarding Amivantamab-vmjw Contraindications in the drug label.
Warnings
There is limited information regarding Amivantamab-vmjw Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Amivantamab-vmjw Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Amivantamab-vmjw Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Amivantamab-vmjw Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Amivantamab-vmjw in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amivantamab-vmjw in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Amivantamab-vmjw during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Amivantamab-vmjw in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Amivantamab-vmjw in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Amivantamab-vmjw in geriatric settings.
Gender
There is no FDA guidance on the use of Amivantamab-vmjw with respect to specific gender populations.
Race
There is no FDA guidance on the use of Amivantamab-vmjw with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Amivantamab-vmjw in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Amivantamab-vmjw in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Amivantamab-vmjw in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Amivantamab-vmjw in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Amivantamab-vmjw Administration in the drug label.
Monitoring
There is limited information regarding Amivantamab-vmjw Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Amivantamab-vmjw and IV administrations.
Overdosage
There is limited information regarding Amivantamab-vmjw overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Amivantamab-vmjw Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Amivantamab-vmjw Mechanism of Action in the drug label.
Structure
There is limited information regarding Amivantamab-vmjw Structure in the drug label.
Pharmacodynamics
There is limited information regarding Amivantamab-vmjw Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Amivantamab-vmjw Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Amivantamab-vmjw Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Amivantamab-vmjw Clinical Studies in the drug label.
How Supplied
There is limited information regarding Amivantamab-vmjw How Supplied in the drug label.
Storage
There is limited information regarding Amivantamab-vmjw Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Amivantamab-vmjw Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Amivantamab-vmjw interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Amivantamab-vmjw Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Amivantamab-vmjw Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.