Amivantamab-vmjw

Amivantamab-vmjw
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Infusion-Related Reactions

• RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.
• RYBREVANT with Lazertinib
  • RYBREVANT in combination with lazertinib can cause infusion-related reactions. In MARIPOSA, , IRRs occurred in 63% of patients treated with RYBREVANT in combination with lazertinib, including Grade 3 in 5% and Grade 4 in 1% of patients. The incidence of infusion modifications due to IRR was 54%, and IRRs leading to dose reduction of RYBREVANT occurred in 0.7% of patients. Infusion-related reactions leading to permanent discontinuation of RYBREVANT occurred in 4.5% of patients receiving RYBREVANT in combination with lazertinib.
• RYBREVANT with Carboplatin and Pemetrexed
  • Based on the pooled safety population, IRR occurred in 50% of patients treated with RYBREVANT in combination with carboplatin and pemetrexed, including Grade 3 (3.2%) adverse reactions. The incidence of infusion modifications due to IRR was 46%, and 2.8% of patients permanently discontinued RYBREVANT due to IRR.
• RYBREVANT as a Single Agent
  • In CHRYSALIS, IRR occurred in 66% of patients treated with RYBREVANT as a single agent. **Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1–2, 2.2% were Grade 3, and 0.4% were Grade 4.
  • The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62%, and 1.3% of patients permanently discontinued RYBREVANT due to IRR.
  • Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended.
  • Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions.
  • Monitor patients for signs and symptoms of infusion reactions during RYBREVANT infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity.If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

• RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.
  • RYBREVANT with Lazertinib

In MARIPOSA , ILD/pneumonitis occurred in 3.1% of patients treated with RYBREVANT in combination with lazertinib, including Grade 3 in 1% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and lazertinib due to ILD/pneumonitis.

• • RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population,ILD/pneumonitis occurred in 2.1% treated with RYBREVANT in combination with carboplatin and pemetrexed with 1.8% of patients experiencing Grade 3 **ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

• • RYBREVANT as a Single Agent
• In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT as a single agent, with 0.7 % of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

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

Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT and Lazertinib

• RYBREVANT in combination with lazertinib can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. The majority of these events occurred during the first four months of therapy.
• In MARIPOSA VTEs occurred in 36% of patients receiving RYBREVANT in combination with lazertinib, including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, 1% of patients had VTE leading to dose reductions of RYBREVANT, and 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the first four months of treatment.
• The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate.
• Withhold RYBREVANT and lazertinib based on severity . Once anticoagulant treatment has been initiated, resume RYBREVANT and lazertinib at the same dose level at the discretion of the healthcare provider .In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT. Treatment can continue with lazertinib at the same dose level at the discretion of the healthcare provider]. Refer to the lazertinib prescribing information for recommended lazertinib dosage modification.

Dermatologic Adverse Reactions

• RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry skin.
• RYBREVANT with Lazertinib

In MARIPOSA, rash occurred in 86% of patients treated with RYBREVANT in combination with lazertinib, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions of RYBREVANT occurred in 37% of patients, rash leading to dose reductions of RYBREVANT occurred in 23% of patients, and rash leading to permanent discontinuation of RYBREVANT occurred in 5% of patients. RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population, rash occurred in 82% of patients treated with RYBREVANT in combination with carboplatin and pemetrexed, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued *RYBREVANT and 3.1% discontinued pemetrexed. RYBREVANT as a Single Agent

• In CHRYSALIS , rash occurred in 74% of patients treated with RYBREVANT as a single agent, including Grade 3 rash in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT was permanently discontinued due to rash in 0.7% of patients.
• Toxic epidermal necrolysis (TEN) occurred in one patient (0.3%) treated with RYBREVANT as a single agent.

Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is recommended for dry skin.

• When initiating treatment with RYBREVANT, administer alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (e.g., use of oral antibiotics) to reduce the risk of dermatologic adverse reactions. If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, reduce the dose, or permanently discontinue RYBREVANT based on severity.

Ocular Toxicity

• RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis.
  • RYBREVANT with Lazertinib

In MARIPOSA , ocular toxicity occurred in 16% of patients treated with RYBREVANT in combination with lazertinib, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT and continue lazertinib based on severity.

• • • RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population ocular toxicity occurred in 16% of patients treated with **8RYBREVANT in combination with carboplatin and pemetrexed. All events were Grade 1 or 2. RYBREVANT as a Single Agent

• • In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with **RYBREVANT. All events were Grade 1–2.

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

Embryo-Fetal Toxicity

• Based on its mechanism of action and findings from animal models, RYBREVANT can cause fetal harm when administered to a pregnant woman.
• Administration of other EGFR inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryo lethality, and abortion. 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 last dose of RYBREVANT.

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.