05/06/2026
𝘼𝙈𝙄𝙑𝘼𝙉𝙏𝘼𝙈𝘼𝘽 (𝙍𝙭)
Brand and Other Names:𝙍𝙮𝙗𝙧𝙚𝙫𝙖𝙣𝙩, amivantamab-vmjw
Classes: MET Tyrosine Kinase Inhibitors; Antineoplastics, EGFR Inhibitors
Dosing & Uses
Dosing & Uses
Adult
Pediatric
Dosage Forms & Strengths
injectable solution
350mg/7mL (50mg/mL) single-dose vial
Non-Small Cell Lung Cancer (NSCLC)
Recommended premedications to administer prior to administering amivantamab doses to reduce risk of infusion reactions
Acetaminophen 650-1000 mg PO one dose 30-60 min before administration of therapy or IV 15-30 min before administration of therapy
Diphenhydramine 25-50 mg or equivalent PO one dose 30-60 min before administration of therapy or IV 15-30 min before administration of therapy
Glucocorticoid to administer prior to amivantamab doses
Week 1 Day -2
Dexamethasone 8 mg or equivalent BID PO as a split infusion 48 hr before administration of therapy (2 days prior to week 1 day 1)
Week 1 Day -1
Dexamethasone 8 mg or equivalent BID PO as a split infusion 24 hr before administration of therapy (1 day prior to week 1 day 1)
Dexamethasone 8 mg or equivalent PO one dose 1 hr before administration on week 1, day 1
Dexamethasone 20 mg IV one dose 45-60 min before administration of week 1 day 1 split dose
Dexamethasone 10 mg or equivalent IV one dose 45-60 min prior to week 1, day 2 split dose; optional (as needed for subsequent doses)
Single Agent
Indicated for locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy
1.5x ULN and any AST): Not studied
Dosing Considerations
Calculate dose based on baseline body weight
Administer premedications prior to infusion as recommended (see Administration)
When used in combination with lazertinib
Administer anticoagulant prophylaxis for first 4 months of treatment to prevent venous thromboembolic events (VTE); consider discontinuing prophylaxis if no signs or symptoms of VTE in first 4 months
Apply alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during and for 2 months after treatment
Avoid or limit sun exposure during and for 2 months after treatment; wear protective clothing, use broad spectrum UVA/UVB sunscreen, and consider other prophylactic measures (eg,oral antibiotics) to reduce the risk of dermatologic adverse reactions
To reduce the risk of infusion-related reactions, administer premedications before each amivantamab infusion as recommended
To reduce risk of infusion-related reactions, administer amivantamab via peripheral line for Week 1 Day 1 and 2 and Week 2
To reduce risk and severity of dermatologic adverse reactions with amivantamab, prophylactic and concomitant medications are recommended
To reduce risk of venous thromboembolic (VTE) events when administering amivantamab in combination with lazertinib, administer anticoagulant prophylaxis for first four months of treatment
Administer diluted amivantamab intravenously according to recommended infusion rates with initial dose as split infusion on Week 1 on Day 1 and Day 2
When administering amivantamab in combination with lazertinib, administer lazertinib orally any time before amivantamab infusion
When administering amivantamab in combination with carboplatin and pemetrexed, infuse pemetrexed first, carboplatin second, and amivantamab last
Patient selection
Select based on presence of EGFR exon 19 deletions, exon 20 insertions, or exon 21 L858R substitution mutations in tumor or plasma specimens
Perform testing at any time from initial diagnosis
Repeat testing not needed once EGFR mutation status established
FDA-approved test information available at: https://www.fda.gov/CompanionDiagnostics
Administration
Dosing & Uses
Adult
Pediatric
Dosage Forms & Strengths
injectable solution
350mg/7mL (50mg/mL) single-dose vial
Non-Small Cell Lung Cancer (NSCLC)
Recommended premedications to administer prior to administering amivantamab doses to reduce risk of infusion reactions
Acetaminophen 650-1000 mg PO one dose 30-60 min before administration of therapy or IV 15-30 min before administration of therapy
Diphenhydramine 25-50 mg or equivalent PO one dose 30-60 min before administration of therapy or IV 15-30 min before administration of therapy
Glucocorticoid to administer prior to amivantamab doses
Week 1 Day -2
Dexamethasone 8 mg or equivalent BID PO as a split infusion 48 hr before administration of therapy (2 days prior to week 1 day 1)
Week 1 Day -1
Dexamethasone 8 mg or equivalent BID PO as a split infusion 24 hr before administration of therapy (1 day prior to week 1 day 1)
Dexamethasone 8 mg or equivalent PO one dose 1 hr before administration on week 1, day 1
Dexamethasone 20 mg IV one dose 45-60 min before administration of week 1 day 1 split dose
Dexamethasone 10 mg or equivalent IV one dose 45-60 min prior to week 1, day 2 split dose; optional (as needed for subsequent doses)
Single Agent
Indicated for locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy
1.5x ULN and any AST): Not studied
Dosing Considerations
Calculate dose based on baseline body weight
Administer premedications prior to infusion as recommended (see Administration)
When used in combination with lazertinib
Administer anticoagulant prophylaxis for first 4 months of treatment to prevent venous thromboembolic events (VTE); consider discontinuing prophylaxis if no signs or symptoms of VTE in first 4 months
Apply alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during and for 2 months after treatment
Avoid or limit sun exposure during and for 2 months after treatment; wear protective clothing, use broad spectrum UVA/UVB sunscreen, and consider other prophylactic measures (eg,oral antibiotics) to reduce the risk of dermatologic adverse reactions
To reduce the risk of infusion-related reactions, administer premedications before each amivantamab infusion as recommended
To reduce risk of infusion-related reactions, administer amivantamab via peripheral line for Week 1 Day 1 and 2 and Week 2
To reduce risk and severity of dermatologic adverse reactions with amivantamab, prophylactic and concomitant medications are recommended
To reduce risk of venous thromboembolic (VTE) events when administering amivantamab in combination with lazertinib, administer anticoagulant prophylaxis for first four months of treatment
Administer diluted amivantamab intravenously according to recommended infusion rates with initial dose as split infusion on Week 1 on Day 1 and Day 2
When administering amivantamab in combination with lazertinib, administer lazertinib orally any time before amivantamab infusion
When administering amivantamab in combination with carboplatin and pemetrexed, infuse pemetrexed first, carboplatin second, and amivantamab last
Patient selection
Select based on presence of EGFR exon 19 deletions, exon 20 insertions, or exon 21 L858R substitution mutations in tumor or plasma specimens
Perform testing at any time from initial diagnosis
Repeat testing not needed once EGFR mutation status established
FDA-approved test information available at: https://www.fda.gov/CompanionDiagnostics
Adverse Effects
Combination therapy consisted of lazertinib or carboplatin plus pemetrexed
>50%
Single agent
All grades
Rash (84%)
Decrease albumin (79%)
Infusion-related reaction (64%)
Increased glucose (56%)
Increased alkaline phosphatase (53%)
Combination therapy
All grades
Decreased white blood cell (38-91%)
Decreased albumin (73-89%)
Rash (82-86%)
Decreased hemoglobin (47-79%)
Decreased neutrophils (15-76%)
Decreased platelet count (52-74%)
Nail toxicity (45-71%)
Decreased lymphocytes (61-69%)
Increased ALT (39-65%)
Infusion-related reaction (50-63%)
Increased AST (47-60%)
Decreased sodium (38-55%)
Increased alkaline phosphatase (42-51%)
Fatigue (32-51%)
>10-50%
Single agent
All grades
Paronychia (50%)
Musculoskeletal pain (47%)
Increased creatinine (46%)
Increased ALT (38%)
Dyspnea (37%)
Nausea (36%)
Decreased lymphocytes (36%)
Decreased phosphate (33%)
Increased AST (33%)
Fatigue (33%)
Decreased magnesium (27%)
Increased gamma-glutamyl transferase (GGT) (27%)
Decreased sodium (27%)
Edema (27%)
Decreased potassium (26%)
Stomatitis (26%)
Cough (25%)
Constipation (23%)
Vomiting (22%)
Hemorrhage (19%)
Pruritus (18%)
Diarrhea (16%)
Decreased appetite (15%)
Dry skin (14%)
Peripheral neuropathy (13%)
Pyrexia (13%)
Dizziness (12%)
Abdominal pain (11%)
Combination therapy
All grades
Musculoskeletal pain (30-47%)
Nausea (21-45%)
Decreased potassium (30-44%)
Edema (40-43%)
Stomatitis (35-43%)
Decreased calcium, corrected (25-41%)
Constipation (29-40%)
Increased GGT (30-39%)
Decreased magnesium (25-39%)
Venous thromboembolism (36%)
Decreased appetite (24-36%)
Paresthesia (35%)
Diarrhea (15-31%)
Increased creatinine (26%)
COVID-19 (21-26%)
Hemorrhage (14-25%)
Vomiting (12-25%)
Pruritus (15-24%)
Cough (14-19%)
Dry skin (15-17%)
Pyrexia (12-17%)
Ocular toxicity (16%)
Weight decreased (14%)
Dizziness (11-14%)
Dyspnea (11-14%)
Headache (13%)
Pneumonia (13%)
Hemorrhoids (10-12%)
Abdominal pain (11%)
Conjunctivitis (11%)
Grade 3 or 4
Decreased neutrophils (1.4-49%)
Decreased white blood cell (1-42%)
Decreased lymphocytes (11-28%)
Rash (15-26%)
Decreased platelet count (10-17%)
Decreased hemoglobin (3.8-12%)
Venous thromboembolism (11%)
Insomnia (10-11%)
Decreased sodium (7-11%)
Decreased potassium (5-11%)
Nail toxicity (2.3-11%)
1-10%
Single agent
All grades
Pneumonia (10%)
Headache (10%)
ILD/pneumonitis (3.3%)
Grade 3 or 4
Decreased albumin (8%)
Decreased phosphate (8%)
Decreased lymphocytes (8%)
Decreased potassium (6%)
Increased alkaline phosphatase (4.8%)
Increased glucose (4%)
Increased GGT (4%)
Decreased sodium (4%)
Rash (3.9%)
Diarrhea (3.1%)
Paronychia (3.1%)
Infusion-related reaction (3.1%)
Dyspnea (2.3%)
Fatigue (2.3%)
Increased ALT (1.6%)
Combination therapy
All grades
ILD/pneumonitis (2.1-3.1%)
Grade 3 or 4
Decreased albumin (3.8-8%)
Increased ALT (3.9-7%)
Fatigue (3.8-6%)
Infusion-related reaction (3.2-6%)
Pneumonia (5%)
Increased GGT (2.6-4%)
Stomatitis (2.3-4%)
Increased AST (≤3.8%)
Vomiting (≤3.3%)
Musculoskeletal pain (2.1-3.1%)
Diarrhea (1.5-3%)
Increased magnesium (2.6%)
Edema (1.3-2.6%)
Decreased appetite (1-2.6%)
COVID-19 (1.5-2%)
Decreased magnesium (≤2%)
ILD/pneumonitis (1.2-1.8%)
Paresthesia (1.7%)
Dyspnea (1.3-1.7%)
Decreased calcium, corrected (1-1.4%)
Nausea (≤1.2%)
Dry skin (1%)
Hemorrhage (≤1%)
Hemorrhoids (≤1%)
Increased alkaline phosphatase (≤1%)
Other serious ADRs in