Amivantamab-vmjw (Monograph)

Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on Aug 10, 2025. Written by ASHP.

Introduction

Antineoplastic agent; bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) receptor.

Uses for Amivantamab-vmjw

Non-small Cell Lung Cancer

Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test, in combination with lazertinib as first-line therapy.

Treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with carboplatin and pemetrexed following progression on EGFR tyrosine kinase inhibitor therapy.

Treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, in combination with carboplatin and pemetrexed as first-line therapy.

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.

Guidelines from the American Society of Clinical Oncology (ASCO) on treatment of stage IV NSCLC harboring driver alterations (e.g., EGFR mutations) generally recommend amivantamab among first-line treatment options for its labeled indications.

Amivantamab-vmjw Dosage and Administration

General

Pretreatment Screening

Select patients for treatment based on the presence of epidermal growth factor receptor (EGFR) mutations in tumor or plasma specimens (see Table 1). If no mutation is detected in a plasma specimen, test tumor tissue.

Table 1. Patient Selection.1
Indication	Treatment Regimen	Source for Testing
First-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations	Amivantamab-vmjw in combination with lazertinib	Tumor or plasma specimens Testing may be performed at any time from initial diagnosis Testing does not need to be repeated once EGFR mutation status has been confirmed
Previously treated locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (progressive disease on an EGFR tyrosine kinase inhibitor)	Amivantamab-vmjw in combination with carboplatin and pemetrexed	Tumor or plasma specimens Testing may be performed at any time from initial diagnosis Testing does not need to be repeated once EGFR mutation status has been confirmed
First-line treatment of NSCLC with EGFR exon 20 insertion mutations	Amivantamab-vmjw in combination with carboplatin and pemetrexed	Tumor or plasma specimens Testing may be performed at any time from initial diagnosis Testing does not need to be repeated once EGFR mutation status has been confirmed
Previously treated NSCLC with EGFR exon 20 insertion mutations	Amivantamab-vmjw as a single agent	Tumor or plasma specimens Testing may be performed at any time from initial diagnosis Testing does not need to be repeated once EGFR mutation status has been confirmed

Verify pregnancy status in females of reproductive potential.

Patient Monitoring

Monitor for signs and symptoms of infusion reactions. Infuse in settings with cardiopulmonary resuscitation medication and equipment.
Monitor for new or worsening symptoms of interstitial lung disease or pneumonitis including dyspnea, cough, and fever.

Premedication and Prophylaxis

Premedicate before administration to reduce the risk of infusion-related reactions (see Table 2).
Premedicate with an antihistamine and antipyretic before every infusion. Administer glucocorticoids before the first 2 doses (days 1 and 2 of week 1) and upon reinitiation after prolonged dose interruptions, and then as needed for subsequent doses.
When administering amivantamab-vmjw in combination with lazertinib, administer anticoagulant prophylaxis to prevent venous thromboembolic (VTE) events for the first 4 months of treatment. If no signs or symptoms of VTE are observed within the first 4 months of treatment, the healthcare provider may consider stopping anticoagulant prophylaxis based on their clinical judgment.
When administering amivantamab-vmjw in combination with lazertinib, apply an alcohol-free emollient cream (e.g., free of isopropanol and ethanol) and advise patients to minimize sun exposure during treatment and for 2 months afterward. Patients should also wear protective clothing and use broad-spectrum ultraviolet (UV)A/UVB sunscreen to help prevent skin-related side effects. Preventative strategies, such as oral antibiotics, may be considered to reduce the likelihood of dermatologic reactions. For details on additional medications, consult the lazertinib prescribing information.

Required at initial dose (week 1 day 1).

Required at second dose (week 1 day 2); optional for subsequent doses.

Table 2. Premedication Requirements to Reduce Infusion-related Reactions.1
Medication	Dose	Route and Timing of Administration
Antihistamine	Diphenhydramine (25 to 50 mg) or equivalent	Administer IV 15–30 minutes prior to administration of amivantamab or orally 30–60 minutes prior to administration of amivantamab
Antipyretic	Acetaminophen (650 to 1000 mg)	Administer IV 15–30 minutes prior to administration of amivantamab or orally 30–60 minutes prior to administration of amivantamab
Glucocorticoid	Dexamethasone (20 mg or equivalent)	Administer IV 45–60 minutes prior to administration of amivantamab
Glucocorticoid	Dexamethasone (10 mg or equivalent)	Administer IV 45–60 minutes prior to administration of amivantamab

Administration

IV Administration

Administer as an IV infusion after dilution. Administer according to the infusion rates detailed in Tables 3 and 4.

Administer amivantamab-vmjw as a single agent infusion or in combination with lazertinib every 2 weeks IV.

Administer amivantamab-vmjw in combination with carboplatin and pemetrexed infusions every 3 weeks IV.

During weeks 1 and 2, infuse via a peripheral line due to the potential for infusion-related reactions during therapy initiation. May administer with a central line starting in week 3.

Administer using an infusion set made of polyurethane, polybutadiene, polyvinyl chloride (PVC), polypropylene (PP), or polyethylene (PE) that contains a flow regulator and an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone 0.2 micron filter. Prime the infusion set with either 5% dextrose or 0.9% sodium chloride.

Do not infuse concurrently in the same IV line as other medications.

Dilution

Determine the dose required and number of amivantamab-vmjw vials needed based on patient's baseline weight. Dilute in 250 mL of 5% dextrose or 0.9% sodium chloride injection prior to IV infusion. Remove and discard an amount of 5% dextrose injection or 0.9% sodium chloride injection from the 250 mL infusion bag that matches the volume of amivantamab-vmjw to be added. Final volume in the infusion bag should be 250 mL. The infusion bag must be made of one of the following materials: PVC, PP, PE, or polyolefin blend (PP + PE).

Administer the diluted solution within 10 hours (inclusive of the infusion time) at room temperature (15–25°C).

Rate of Administration

Recommended infusion rates for amivantamab-vmjw administration are summarized in Table 3 and Table 4.

Table 3. Infusion Rates of Amivantamab-vmjw in Combination with Lazertinib or Amivantamab-vmjw as Single Agent.1
Week	Dose (per 250 mL bag)	Initial Infusion Rate (mL/hour)	Subsequent Infusion Rate (mL/hour)
Body Weight <80 kg
Week 1, Day 1 (split dose infusion)	350 mg	50	75
Week 1, Day 2 (split dose infusion)	700 mg	50	75
Week 2	1050 mg	85	85
Week 3	1050 mg	125	125
Week 4	1050 mg	125	125
Week 5	1050 mg	125	125
Week 6	No dose administered
Weeky 7 and every 2 weeks thereafter	1050 mg	125	125
Body Weight ≥80 kg
Week 1, Day 1 (split dose infusion)	350 mg	50	75
Week 1, Day 2 (split dose infusion)	1050 mg	35	50
Week 2	1400	65	65
Week 3	1400	85	85
Week 4	1400	125	125
Week 5	1400	125	125
Week 6	No dose administered
Week 7 and every 2 weeks thereafter	1400 mg	125	125

In the absence of infusion-related reactions, increase the initial infusion rate to the subsequent infusion rate after 2 hours based on patient tolerance. Total infusion time is approximately 4–6 hours for day 1 and 6–8 hours for day 2. Subsequent infusion time is approximately 2 hours.

Table 4. Infusion Rates for Amivantamab-vmjw in Combination with Carboplatin and Pemetrexed for Treatment of NSCLC.1
Week	Dose (per 250 mL bag)	Infusion Rate (mL/hour)	Subsequent Infusion Rate (mL/hour)
Body Weight (<80 kg)
Week 1, Day 1 (split dose infusion)	350 mg	50	75
Week 1, Day 2 (split dose infusion)	1050 mg	33	50
Week 2	1400 mg	65	65
Week 3	1400 mg	85	85
Week 4	1400 mg	125	125
Weeks 5 and 6	No dose administered
Week 7 and every 3 weeks thereafter	1750 mg	125	125
Body Weight ≥80 kg
Week 1, Day 1 (split dose infusion)	350 mg	50	75
Week 1, Day 2 (split dose infusion)	1400 mg	25	50
Week 2	1750 mg	65	65
Week 3	1750 mg	85	85
Week 4	1750 mg	125	125
Weeks 5 and 6	No dose administered
Week 7 and every 3 weeks thereafter	2100 mg	125	125

Combination Regimens

With lazertinib, give lazertinib orally at any time before infusing amivantamab-vmjw. If administered on the same day, amivantamab-vmjw can be administered any time after lazertinib.

With carboplatin and pemetrexed, administer pemetrexed first, then carboplatin, then infuse amivantamab-vmjw last.

Dosage

Adults

Non-small Cell Lung Cancer with Exon 19 Deletions or Exon 21 L858R Substitution Mutations

IV

When used in combination with lazertinib, the recommended dose is based on baseline body weight (see Table 5). Administer until disease progression or unacceptable toxicity. Refer to the lazertinib prescribing information for recommended lazertinib dosing information.

When used in combination with carboplatin and pemetrexed, the recommended dose is based on baseline body weight (see Table 6). Administer until disease progression or unacceptable toxicity. Refer to the prescribing information for carboplatin and pemetrexed for specific dosing information.

Table 5. Recommended Dosage Schedule for Amivantamab-vmjw in Combination with Lazertinib.1
Body Weight (kg) at Baseline	Recommended Dose	Dosing Schedule
<80	1050 mg	Weekly (total of 5 doses) from weeks 1 to 5 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 5: Infusion on day 1 Week 6: No dose Then every 2 weeks starting at week 7 onwards
≥80	1400 mg	Weekly (total of 5 doses) from weeks 1 to 5 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 5: Infusion on day 1 Week 6: No dose Then every 2 weeks starting at week 7 onwards

Dose adjustment is not required for subsequent body weight change.

Table 6. Recommended Dosage of Amivantamab-vmjw in Combination with Carboplatin and Pemetrexed for the Treatment of NSCLC.1
Body Weight (kg) at Baseline	Recommended Dose	Dosing Schedule
<80	1400 mg	Weekly (total of 4 doses) from weeks 1 to 4 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 4: Infusion on day 1 Weeks 5 and 6: No dose
	1750 mg	Every 3 weeks starting at week 7 onwards
≥80	1750 mg	Weekly (total of 4 doses) from weeks 1 to 4 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 4: Infusion on day 1 Weeks 5 and 6: No dose
	2100 mg	Every 3 weeks starting at week 7 onwards

Dose adjustment is not required for subsequent body weight change.

Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

IV

When used as a single agent in patients with NSCLC that has progressed on or after platinum-based chemotherapy, , the recommended dose is based on baseline body weight (see Table 7). Administer until disease progression or unacceptable toxicity.

When used in combination with carboplatin and pemetrexed, the recommended dose is based on baseline body weight (see Table 8). Administer until disease progression or unacceptable toxicity. Refer to the prescribing information for carboplatin and pemetrexed for specific dosing information.

Table 7. Recommended Dosage Schedule for Amivantamab-vmjw as a Single Agent.1
Body Weight (kg) at Baseline	Recommended Dose	Dosing Schedule
<80	1050 mg	Weekly (total of 5 doses) from weeks 1 to 5 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 5: Infusion on day 1 Week 6: No dose Then every 2 weeks starting at week 7 onwards
≥80	1400 mg	Weekly (total of 5 doses) from weeks 1 to 5 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 5: Infusion on day 1 Week 6: No dose Then every 2 weeks starting at week 7 onwards

Dose adjustment is not required for subsequent body weight change.

Table 8. Recommended Dosage of Amivantamab-vmjw in Combination with Carboplatin and Pemetrexed for the Treatment of NSCLC.1
Body Weight (kg) at Baseline	Recommended Dose	Dosing Schedule
<80	1400 mg	Weekly (total of 4 doses) from weeks 1 to 4 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 4: Infusion on day 1 Weeks 5 and 6: No dose
	1750 mg	Every 3 weeks starting at week 7 onwards
≥80	1750 mg	Weekly (total of 4 doses) from weeks 1 to 4 Week 1: Split infusion on day 1 and day 2 Weeks 2 to 4: Infusion on day 1 Weeks 5 and 6: No dose
	2100 mg	Every 3 weeks starting at week 7 onwards

Dose adjustment is not required for subsequent body weight change.

Dosage Modification for Toxicity

If adverse effects occur during amivantamab-vmjw therapy, temporarily interrupt therapy, reduce dosage, and/or permanently discontinue drug. If dosage modification is required, reduce the dosage as described in Table 9.

Temporarily interrupt therapy, reduce dosage, and/or permanently discontinue amivantamab therapy in patients experiencing certain adverse effects (see Table 10).

If used in combination with lazertinib and an adverse reaction necessitates a dosage reduction after withholding treatment and resolution of the reaction, reduce the dose of amivantamab-vmjw first. Refer to lazertinib prescribing information for additional guidance.

If used in combination with carboplatin and pemetrexed, dosage changes may be needed for one or more of these medications. Refer to carboplatin and pemetrexed prescribing information for additional guidance.

Table 9. Dose Reductions for Adverse Reactions for Amivantamab-vmjw.1
Dose at Which the Adverse Reaction Occurred	First Dose Reduction	Second Dose Reduction	Third Dose Reduction
1050 mg	700 mg	350 mg	Discontinue
1400 mg	1050 mg	700 mg	Discontinue
1750 mg	1400 mg	1050 mg	Discontinue
2100 mg	1750 mg	1400 mg	Discontinue

Table 10. Recommended Dosage Modifications and Management for Amivantamab-vmjw.1
Adverse reaction and severity	Dosage modifications and management
Infusion-related reactions (Grade 1 to 2)	Stop infusion and monitor until symptom resolution. Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes. Give corticosteroid premedication before subsequent infusions.
Infusion-related reactions (Grade 3)	Stop infusion and administer supportive care medications. Monitor until resolution of symptoms. Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes. Give corticosteroid premedication before subsequent infusions. Permanently discontinue for recurrent Grade 3 infusion-related reactions.
Infusion-related reactions (Grade 4 or any grade anaphylaxis/anaphylactic reactions)	Permanently discontinue therapy.
Interstitial lung disease/pneumonitis (any grade)	Withhold therapy if interstitial lung disease/pneumonitis is suspected and permanently discontinue if confirmed.
Venous thromboembolic events (Grade 2 or 3; applies to the combination with lazertinib)	Withhold amivantamab-vmjw and lazertinib therapy. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, resume amivantamab-vmjw and lazertinib at the same dose level, at the discretion of the healthcare provider
Venous thromboembolic events (Grade 4 or recurrent Grade 2 or 3 despite therapeutic level anticoagulation; applies to the combination with lazertinib)	Withhold lazertinib and permanently discontinue amivantamab-vmjw therapy. Administer anticoagulant treatment as clinically indicated. Once anticoagulant treatment has been initiated, resume lazertinib at the same dose level, at the discretion of the healthcare provider
Dermatologic adverse reactions including dermatitis acneiform, pruritus, dry skin (Grade 1 or 2)	Provide supportive care. Consider dose reduction if rash does not improve after 2 weeks.
Dermatologic adverse reactions (Grade 3)	Withhold therapy and provide supportive care. Resume therapy at a reduced dose upon recovery to ≤Grade 2. Permanently discontinue therapy if there is no improvement within 2 weeks.
Dermatologic adverse reactions (Grade 4)	Permanently discontinue therapy.
Dermatologic adverse reactions (severe bullous, blistering or exfoliating skin conditions including toxic epidermal necrolysis [TEN])	Permanently discontinue therapy.
Other adverse reactions (Grade 3)	Withhold therapy until recovery to ≤Grade 1 or baseline. Resume at the same dose if recovery occurs in <1 week. Resume at a reduced dose if recovery occurs after 1 but within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 weeks.
Other adverse reactions (Grade 4)	Withhold therapy until recovery to ≤Grade 1 or baseline. Resume at a reduced dose if recovery occurs within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 weeks. Permanently discontinue therapy for recurrent Grade 4 reactions.

Special Populations

Hepatic Impairment

The manufacturer makes no specific dosage recommendations.

Renal Impairment

The manufacturer makes no specific dosage recommendations.

Geriatric Patients

The manufacturer makes no specific dosage recommendations.

Cautions for Amivantamab-vmjw

Contraindications

None.

Warnings/Precautions

Infusion-related Reactions

Amivantamab can cause infusion-related reactions (IRRs), including anaphylaxis.

Administer premedication with antihistamines, antipyretics, and glucocorticoids and infuse amivantamab as recommended. Administer amivantamab via a peripheral line during week 1 and week 2.

Monitor for IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt the infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue amivantamab based on IRR severity.

Interstitial Lung Disease/Pneumonitis

Amivantamab can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

Monitor for new or worsening symptoms of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately hold amivantamab in patients with suspected ILD/pneumonitis and permanently discontinue if confirmed.

Venous Thromboembolic Events

Combination of amivantamab-vmjw and lazertinib can cause serious and potentially fatal venous thromboembolic (VTE) events, such as deep vein thrombosis and pulmonary embolism.

Pause amivantamab-vmjw and lazertinib based on VTE severity. Resume both at the same dose after anticoagulation if appropriate. Permanently discontinue amivantamab-vmjw if VTE recurs despite anticoagulation; continue lazertinib if appropriate. Refer to lazertinib prescribing information for dose adjustments.

Dermatologic Reactions

Amivantamab can cause severe rash (including toxic epidermal necrolysis), dermatitis acneiform, pruritus, and dry skin.

Instruct patients to limit sun exposure, wear protective clothing, and use broad spectrum UVA/UVB sunscreen during and for 2 months after treatment with amivantamab. Alcohol-free (e.g. isopropanol-free, ethanol-free) emollient cream recommended for dry skin. Consider prophylactic measures (e.g., use of oral antibiotics) to reduce risk of adverse dermatologic reactions.

If a skin reaction develops, start topical corticosteroids and topical and/or oral antibiotics. For grade 3 reactions, add oral steroids and consider a dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, dose reduce, or permanently discontinue amivantamab depending on the severity of the dermatologic reaction.

Ocular Toxicity

Amivantamab can cause ocular toxicity.

Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce, or permanently discontinue amivantamab based on the severity of the ocular toxicity.

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm when administered to a pregnant woman. Impaired embryofetal development, embryolethality, and abortion have occurred in animals.

Advise female patients of reproductive potential to use effective contraception during treatment with amivantamab and for 3 months after the final dose. If used during pregnancy, apprise patient of the potential fetal harm.

Immunogenicity

Amivantamab is a therapeutic protein with potential for immunogenicity.

The effects of anti-drug antibodies on the pharmacokinetics, safety, and efficacy of amivantamab are unknown.

Specific Populations

Pregnancy

May cause fetal harm.

Lactation

Not known whether amivantamab or its metabolites are distributed into human milk, affect milk production, or affect nursing infants.

Women should not breastfeed while receiving the drug and for 3 months after the final dose.

Females and Males of Reproductive Potential

Verify the pregnancy status of females of reproductive potential prior to initiating therapy.

Utilize effective contraception during therapy and for 3 months after the last dose.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

In clinical trials, no overall differences in safety or efficacy relative to younger adults were reported.

Hepatic Impairment

Clinically meaningful differences in pharmacokinetics not observed with mild hepatic impairment.

Not studied in moderate to severe hepatic impairment.

Renal Impairment

Clinically meaningful differences not observed with mild or moderate renal impairment (eGFR 30–89 mL/min). Not studied in severe renal impairment (eGFR 15–29 mL/minute) or end-stage renal disease (eGFR <15 mL/min).

Common Adverse Effects

Most common (≥20%) adverse reactions for amivantamab in combination with lazertinib: rash, nail toxicity, infusion-related reaction, musculoskeletal pain, stomatitis, edema, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, ocular toxicity.

Most common grade 3 or 4 laboratory abnormalities (≥2%) for amivantamab in combination with lazertinib: decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, increased magnesium.

Most common (≥20%) adverse reactions for amivantamab in combination with carboplatin and pemetrexed: rash, nail toxicity, infusion-related reaction, fatigue, nausea, stomatitis, constipation, edema, decreased appetite, musculoskeletal pain, vomiting, COVID-19.

Most common grade 3 or 4 laboratory abnormalities (≥2%) for amivantamab in combination with carboplatin and pemetrexed: decreased neutrophils, decreased leukocytes, decreased platelets, decreased hemoglobin, decreased potassium, decreased sodium, increased ALT, increased GGT, decreased albumin.

Most common (≥20%) adverse reactions for amivantamab monotherapy : rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, vomiting.

Most common grade 3 or 4 laboratory abnormalities (≥2%) for amivantamab monotherapy: decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased GGT, decreased sodium.

Drug Interactions

No drug interaction information is available for amivantamab.

Amivantamab-vmjw Pharmacokinetics

Absorption

Bioavailability

Amivantamab exposure increased proportionally over the dose range of 350–1750 mg (0.33–1.7 times the approved recommended dosage, respectively).

Steady state concentrations occurred by week 13 for both the 2-week and 3-week dosing schedules, with a systemic accumulation ratio of 1.9.

Distribution

Extent

Not known whether amivantamab is distributed into human milk.

Elimination

Elimination Route

Not characterized.

Half-life

Mean terminal half-life 14 days.

Special Populations

Pharmacokinetics not affected by age (range 21–88 years), body weight (31–140 kg), sex, race, creatinine clearance, or mild hepatic impairment.

Volume of distribution and clearance increase with increasing body weight. Exposure is 30–40% lower in patients with body weight ≥80 kg compared to patients with lower body weight. Exposure to amivantamab was similar between patients with body weight <80 kg who received 1050 mg and patients with body weight ≥80 kg who received 1400 mg.

Stability

Storage

Parenteral

Injection concentrate

2–8°C in original carton to protect from light; do not freeze.

Actions

Bispecific antibody to the epidermal growth factor receptor (EGFR) and the mesenchymal-epithelial transition (MET) receptor.
Disrupts EGFR and MET signaling functions through blocking ligand binding or degradation of EGFR and MET in the presence of EGFR exon 20 insertion mutations, exon 19 deletions, and L858R substitutions, which allows tumor cells to be targeted for destruction.

Advice to Patients

Advise patients to read the FDA-approved patient labeling (Patient Information).
Advise patients that amivantamab can cause infusion-related reactions including anaphylaxis, the majority of which may occur with the first infusion. Advise patients to alert their healthcare provider immediately for any signs or symptoms of infusion-related reactions.
Advise patients of the risks of serious and life threatening venous thromboembolic events, including deep venous thrombosis and pulmonary embolism. Advise patients that prophylactic anticoagulants are recommended to be used for the first 4 months of treatment. Advise patients to immediately contact their healthcare provider for signs and symptoms of venous thromboembolism.
Advise patients of the risks of interstitial lung disease/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms.
Advise patients of the risk of dermatologic adverse reactions. Advise patients to limit direct sun exposure, to use broad spectrum UVA/UVB sunscreen, and to wear protective clothing during and for 2 months after treatment with amivantamab. Advise patients to apply alcohol-free emollient cream to reduce the risk of skin reactions. Consider prophylactic measures (e.g., use of oral antibiotics) to reduce the risk of dermatologic adverse reactions.
Advise patients of the risk of ocular toxicity. Advise patients to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated.
Advise patients of the risk of paronychia. Advise patients to contact their healthcare provider for signs or symptoms of paronychia.
Advise patients to inform clinicians if they are or plan to become pregnant or plan to breast-feed. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with amivantamab and for 3 months after the final dose. Advise patients not to breast-feed during treatment with amivantamab and for 3 months after the final dose.
Advise patients to inform their clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Amivantamab-vmjw is obtained through a specialty distribution network. Contact manufacturer or consult the Janssen Medical Information website ([Web]) for specific availability information.