Important Safety Information
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  • RYBREVANT® (amivantamab-vmjw)

    INDICATIONS

    RYBREVANT® (amivantamab-vmjw) is indicated in combination with carboplatin and pemetrexed for the first-line 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, as detected by an FDA-approved test.

    RYBREVANT® (amivantamab-vmjw) is indicated 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.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    The safety population of RYBREVANT® with carboplatin and pemetrexed described in Warnings and Precautions was based on 151 patients in the PAPILLON study.

    The safety population of RYBREVANT® as a single agent described in Warnings and Precautions was based on 129 patients in the CHRYSALIS study.

    Infusion-Related Reactions

    RYBREVANT® can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting.

    RYBREVANT® with Carboplatin and Pemetrexed

    RYBREVANT® in combination with carboplatin and pemetrexed can cause infusion-related reactions. Based on the safety population, infusion-related reactions occurred in 42% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The incidence of infusion modifications due to IRR was 40%, and 0.7% of patients permanently discontinued RYBREVANT®.

    RYBREVANT® as a Single Agent

    Based on the safety population, IRR occurred in 66% of patients treated with RYBREVANT®. 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. Monitor patients for any 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.

    Interstitial Lung Disease/Pneumonitis

    RYBREVANT® can cause interstitial lung disease (ILD)/pneumonitis.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the safety population, Grade 3 ILD/pneumonitis occurred in 2.6% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed. All patients required permanent discontinuation.

    RYBREVANT® as a Single Agent

    Based on the safety population, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) 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.

    Dermatologic Adverse Reactions

    RYBREVANT® can cause rash (including dermatitis acneiform), pruritus, and dry skin.

    RYBREVANT® with Carboplatin and Pemetrexed

    RYBREVANT® in combination with carboplatin and pemetrexed can cause dermatologic adverse reactions. Based on the safety population, rash occurred in 89% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (19%) adverse reactions. Rash leading to dose reductions occurred in 19% of patients; 2% permanently discontinued RYBREVANT®, and 1.3% discontinued pemetrexed.

    RYBREVANT® as a Single Agent

    Based on the safety population, rash occurred in 74% of patients treated with RYBREVANT®, 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 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 emollient cream is recommended for dry skin.

    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, dose reduce, or permanently discontinue RYBREVANT® based on severity.

    Ocular Toxicity

    RYBREVANT® can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the safety population, RYBREVANT® in combination with carboplatin and pemetrexed can cause ocular toxicity including blepharitis, dry eye, conjunctival redness, blurred vision, and eye pruritus. All events were Grade 1-2.

    RYBREVANT® as a Single Agent

    Based on the safety population, 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 presenting with eye symptoms to an ophthalmologist. Withhold, dose reduce, 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. 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

    RYBREVANT® with Carboplatin and Pemetrexed

    For the 151 patients in the PAPILLON clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related reaction (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

    Serious adverse reactions occurred in 37% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in ≥2% of patients included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

    RYBREVANT® as a Single Agent

    For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT® as a single agent, the most common adverse reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

    Serious adverse reactions occurred in 30% of patients who received RYBREVANT®. Serious adverse reactions in ≥2% of patients included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

    Please read full Prescribing Information for RYBREVANT®.

    cp-213274v4

    INDICATION
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

Prescribing Information
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  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf

Help Your Patients Start and Stay on RYBREVANT®

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Help Your Patients Start and Stay on RYBREVANT®

  1. Janssen CarePath
  2. RYBREVANT®
  3. Treatment Support

We understand that you want to get your patients the help they may need while going through treatment. That’s why we’ve put together some support resources that can help them, whether they’re just starting a new medication or they’ve been taking it for years.

Janssen Compass®

Personalized 1-on-1 Support for Your Patients

Starting and staying on track with a new medication can feel overwhelming for patients. Janssen Compass® Care Navigators are here to help by offering free, personalized 1-on-1 support throughout their treatment journey.

Each patient who enrolls in the program will be paired with a dedicated Care Navigator. Their Care Navigator will partner with them to schedule check-ins via the phone.

On every phone call, patients will speak to their dedicated Care Navigator who will help guide them in 3 key areas:

  • Cost and Affordability: Discover resources that may be able to help patients afford their Janssen medication – no matter what type of insurance they have:
    • Commercially insured: Enroll eligible patients in Janssen CarePath Savings Program
    • Government-funded coverage: Determine Medicare Part D low-income subsidy (LIS) eligibility; refer to government resources or independent foundations
    • Uninsured and underinsured: Connection to independent foundations and other resources.
  • Medication and Disease Education: Educate patients to help them start and stay on the prescribed treatment plan, including:
    • Understanding their disease
    • Reinforcing dosing and administration for their Janssen medication
    • Conversation guides to facilitate communication with their care team
  • Practical and Emotional Support: Empower patients and caregivers with lifestyle and coping skills to help them manage stress. Plus, connect them to advocacy organizations for their practical and emotional support needs, which may include:
    • Finding support groups
    • Connection to transportation-related services
    • Health and wellness strategies

Get your patient connected with a Care Navigator today

Janssen Compass® is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient’s understanding of their therapy and is not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe a Janssen medication.

Janssen CarePath Patient Account

Your patients and their caregivers can create an online account at MyJanssenCarePath.com where they can learn about their insurance coverage. They can also:

  • Enroll in the Janssen CarePath Savings Program
  • Manage their benefits
  • Sign up for treatment reminders
  • Find support throughout their treatment journey

Care Coordination

Janssen CarePath gives your patients one-on-one support through our Care Coordinators. Our Care Coordinators will work closely with you and your patients to provide the support you direct, including coordination with an infusion provider.

Community Support

 Janssen CarePath has curated the following lung cancer communities and organizations to provide additional support beyond treatment.

EGFR Registers

 EGFR Registers is a grassroots patient-driven community dedicated exclusively to changing EGFR positive lung cancer into a manageable, chronic disease.

Exon 20 Group

 Exon 20 Group is dedicated to expediting exon 20-targeted drugs into—and through—clinical trials to benefit patients and the global oncology community.

The GO2 Foundation for Lung Cancer

 The mission of the GO2 Foundation for Lung Cancer is to change what it means to live with lung cancer and increase the survival rate of the world's number one cancer killer. It is a joint force between the Bonnie J. Addario Lung Cancer Foundation (ALFC) and the Lung Cancer Alliance (LCA).

The Lung Cancer Research Foundation

 The Lung Cancer Research Foundation has a mission to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of cancer.

LUNGevity Website

 LUNGevity is changing outcomes for people with lung cancer through research, education and support.

Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday−Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support available.

Sign up or log in to the Provider Portal at JanssenCarePathPortal.com where you can request and review benefits investigations, enroll eligible patients in the Janssen CarePath Savings Program, and view their Savings Program transactions.

Important Safety Information For

  • RYBREVANT®

    INDICATIONS

    RYBREVANT® (amivantamab-vmjw) is indicated in combination with carboplatin and pemetrexed for the first-line 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, as detected by an FDA-approved test.

    RYBREVANT® (amivantamab-vmjw) is indicated 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.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    The safety population of RYBREVANT® with carboplatin and pemetrexed described in Warnings and Precautions was based on 151 patients in the PAPILLON study.

    The safety population of RYBREVANT® as a single agent described in Warnings and Precautions was based on 129 patients in the CHRYSALIS study.

    Infusion-Related Reactions

    RYBREVANT® can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting.

    RYBREVANT® with Carboplatin and Pemetrexed

    RYBREVANT® in combination with carboplatin and pemetrexed can cause infusion-related reactions. Based on the safety population, infusion-related reactions occurred in 42% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The incidence of infusion modifications due to IRR was 40%, and 0.7% of patients permanently discontinued RYBREVANT®.

    RYBREVANT® as a Single Agent

    Based on the safety population, IRR occurred in 66% of patients treated with RYBREVANT®. 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. Monitor patients for any 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.

    Interstitial Lung Disease/Pneumonitis

    RYBREVANT® can cause interstitial lung disease (ILD)/pneumonitis.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the safety population, Grade 3 ILD/pneumonitis occurred in 2.6% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed. All patients required permanent discontinuation.

    RYBREVANT® as a Single Agent

    Based on the safety population, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) 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.

    Dermatologic Adverse Reactions

    RYBREVANT® can cause rash (including dermatitis acneiform), pruritus, and dry skin.

    RYBREVANT® with Carboplatin and Pemetrexed

    RYBREVANT® in combination with carboplatin and pemetrexed can cause dermatologic adverse reactions. Based on the safety population, rash occurred in 89% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (19%) adverse reactions. Rash leading to dose reductions occurred in 19% of patients; 2% permanently discontinued RYBREVANT®, and 1.3% discontinued pemetrexed.

    RYBREVANT® as a Single Agent

    Based on the safety population, rash occurred in 74% of patients treated with RYBREVANT®, 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 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 emollient cream is recommended for dry skin.

    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, dose reduce, or permanently discontinue RYBREVANT® based on severity.

    Ocular Toxicity

    RYBREVANT® can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the safety population, RYBREVANT® in combination with carboplatin and pemetrexed can cause ocular toxicity including blepharitis, dry eye, conjunctival redness, blurred vision, and eye pruritus. All events were Grade 1-2.

    RYBREVANT® as a Single Agent

    Based on the safety population, 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 presenting with eye symptoms to an ophthalmologist. Withhold, dose reduce, 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. 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

    RYBREVANT® with Carboplatin and Pemetrexed

    For the 151 patients in the PAPILLON clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related reaction (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

    Serious adverse reactions occurred in 37% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in ≥2% of patients included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

    RYBREVANT® as a Single Agent

    For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT® as a single agent, the most common adverse reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

    Serious adverse reactions occurred in 30% of patients who received RYBREVANT®. Serious adverse reactions in ≥2% of patients included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

    Please read full Prescribing Information for RYBREVANT®.

    cp-213274v4

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION