RYBREVANT® (amivantamab-vmjw) Patient Support

Supporting Treatment

Helping you help your patients get started with the RYBREVANT® treatment you prescribed and supporting them along the way

Once you've determined that RYBREVANT® is right for your patients, we're committed to helping them get started on treatment and stay on track. Click here for the Janssen CarePath Resource Guide.

We understand how important it is for your patients to take their RYBREVANT® medication as you've prescribed. Janssen CarePath provides ongoing support that may help your patients stay on track with their RYBREVANT® treatment.

Janssen Compass

Janssen Compass™ is a free, personalized patient support program that provides one-on-one guidance, information, and educational resources to your patients about their disease. It also may help them understand their insurance coverage and cost support options, as well as tips to help them get started and stay on track with their treatment.

Janssen Compass™ Care Navigators offer education support in the following areas:

  • Cost & Access: We can help patients who qualify identify potential ways to afford their medication. We provide them with savings options, can sign them up for the Janssen savings program, and, for Medicare Part D patients, we'll check to see if they're eligible for the Extra Help program and guide them through the application process.
  • Learning About Their Treatment: A Janssen Compass™ Care Navigator will support and guide your patients as they start and continue treatment by providing ongoing education about their Janssen therapy.
  • Support the Whole Way: While on their Janssen therapy, patients can work with their Janssen Compass™ Care Navigator to discover tips, strategies, and resources for caring for themselves during treatment, help set goals for living with cancer, and connect with advocacy groups and a wider community of support. Janssen Compass™ Care Navigators are a phone call away.

As part of the program, Janssen Compass™ Care Navigators are ready to answer your patients' questions. They can call us at 844-NAV-1234 (844-628-1234), Monday through Friday, 8:30 AM to 8:30 PM ET.

Let's get started!

To get started in Janssen Compass™, you can schedule an introductory call for your patients by completing a short request form, which you can find here.

Janssen CarePath Patient Account

Your patients and caregivers can create an online account at MyJanssenCarePath.com where they can learn about their health insurance coverage, enroll in the Janssen CarePath Savings Program and manage their benefits, sign up for treatment reminders, and find support throughout their treatment journey.

Support

Janssen CarePath offers additional support to keep your patients informed about RYBREVANT® and provides ongoing resources and services to help them stay on track with their RYBREVANT® treatment as you've prescribed. We offer:

  • Ongoing e-mails throughout your patients' journey
  • Personalized, live appointment reminder calls

Tools to help your patients track and meet their health and wellness goals

Lung cancer communities and organizations

EGFR Registers Website

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 Website

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 Website

The GO2 Foundation for Lung Cancer
The GO2 Foundation for Lung Cancer's mission 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 Website

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

INDICATION

RYBREVANT® (amivantamab-vmjw) is indicated for the 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, whose disease has progressed on or after platinum-based chemotherapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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.

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. 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. 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®.

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. 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 final dose of RYBREVANT®.

Adverse Reactions

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%).

Please read full Prescribing Information for RYBREVANT®.

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