HYRNUO
^®
IS NOW APPROVED

HYRNUO (pronounced "Her noo' oh") is a prescription medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that:

has spread within your chest or to other parts of the body, and
has a certain abnormal human epidermal growth factor receptor 2 (HER2) gene(s), and*
who have received a previous treatment (systemic therapy).

Your healthcare provider will perform a test to make sure HYRNUO is right for you.

It is not known if HYRNUO is safe and effective in children.

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

*HER2 is sometimes referred to as ERBB2 (erb-b2 receptor tyrosine kinase 2).

Learn more about HYRNUO

Financial assistance

Taking HYRNUO

Study Results

Side Effects

Educational Materials

Stay Updated

HYRNUO IS A TABLET

Follow your doctor’s instructions while taking HYRNUO.

Swallow two 10 mg tablets whole, twice a day for a total dose of 40 mg daily. HYRNUO should be taken with food, once in the morning and once in the evening. Do not cut, crush or chew tablets.

Recommended dosing instructions for HYRNUO

Getting started is simple, with no weight-based dosing.

If you miss a dose of HYRNUO, take your prescribed dose as soon as you remember before the next scheduled dose. Do not take 2 doses at the same time to make up for a missed dose.

For additional information on how to take HYRNUO,

click here

HOW WAS HYRNUO STUDIED?

HYRNUO was studied in people with HER2-mutated* locally advanced or metastatic NSCLC who received previous treatment.

As part of a larger study, a subgroup of 70 people had previously received treatment for advanced NSCLC but were new to treatment that targets HER2 mutations.

_{*A mutation is an abnormal change in a gene.}

WHAT WERE THE STUDY RESULTS?

Icon of 10 people with 7 out of the 10 white and 3 outlined in pink

71% of people had a response to treatment with HYRNUO.

^*†

*2.9% of people had a complete response (n=2). 69% of people had a partial response (n=48). There were 70 people in the study.

25 out of 50 people who responded to HYRNUO had a response that lasted at least 9.2 months.

^†A partial response is a decrease in the size of cancer of 30% or more. A complete response is the disappearance of all signs of cancer.

WHAT ARE THE POSSIBLE SIDE EFFECTS?

HYRNUO may cause serious side effects, including:

Diarrhea.

Diarrhea is common and can be severe during treatment with HYRNUO and usually occurs in the first week of treatment. Diarrhea can cause the loss of body fluids (dehydration) and salts (electrolyte imbalances).

At the first signs of diarrhea (loose stool) or increased bowel movements:

tell your healthcare provider right away
drink plenty of fluids
start treatment for diarrhea as soon as possible. You should have an anti-diarrhea medicine available before you start taking HYRNUO

Liver problems.

HYRNUO can cause increases in liver blood tests which may be severe. Your healthcare provider will do blood tests to check your liver function before you start taking and during treatment with HYRNUO. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems including:

yellowing of the skin or white part of your eyes (jaundice)
dark urine
pale stools
tiredness or weakness
nausea or vomiting
loss of appetite
pain on the upper right side of your stomach

Lung problems.

HYRNUO may cause severe lung problems. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems during treatment with HYRNUO, including:

cough
fever
shortness of breath or trouble breathing

Eye problems.

HYRNUO can cause eye problems that can lead to temporary loss of vision. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you develop new or worsening eye problems during treatment with HYRNUO.

Pancreas problems.

HYRNUO may cause increases in certain pancreatic lab tests (amylase and lipase). Your healthcare provider will do blood tests to check your pancreatic function before and during treatment with HYRNUO. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including:

upper stomach pain that may spread to your back and get worse with eating
weight loss
nausea or vomiting

Your healthcare provider may change your dose, temporarily stop, or completely stop your treatment with HYRNUO if you have certain side effects.

Most common side effects

rash
nail problems including infection and inflammation
mouth sores
nausea
changes in certain blood tests

These are not all the possible side effects of HYRNUO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT RESOURCES CAN SUPPORT ME?

The following downloadable resources may help guide and support you.

CAN I GET SUPPORT WITH HYRNUO?

Personalized support from exclusive specialty pharmacy

Your journey with HYRNUO is supported every step of the way through our dedicated specialty pharmacy partner, Onco360^TM. Participating patients will receive:

One-on-one outreach
from oncology-trained nurses and pharmacists to guide you through your first few weeks on treatment
Ongoing check-ins
at key moments in your treatment journey, including reminders to fill your HYRNUO prescription
Helpful tips and resources
to manage potential side effects and stay on track with your care plan. For example, once prescribed HYRNUO you will receive a patient starter kit
Clear guidance
on how to take your medication, including dosing instructions and dietary considerations to help you get the most from your treatment
Insurance navigation and affordability options
to help minimize out-of-pocket costs and ensure access to therapy

If you are receiving product through an in-office dispensing (IOD) pharmacy, you can reach out to your care team for additional support.

Get the free trial flashcard

FREE TRIAL PROGRAM
^*†

All patients new to HYRNUO can receive 1 month of free therapy.

HYRNUO is delivered to your home
Any patient new to HYRNUO is able to participate, regardless of insurance type or status

IF YOU HAVE COMMERCIAL INSURANCE
^‡

Co-Pay Program

Eligible patients may pay as little as $0 for HYRNUO
Eligible patients will automatically be re-enrolled every January
Apply now at hyrnuo-us.com/copay-program

IF YOU HAVE MEDICARE OR MEDICAID

Check your eligibility for government-funded programs, such as Medicare Part D Extra Help, State Health Insurance Assistance Programs (SHIPs), and State Pharmaceutical Assistance Programs (SPAPs), at

www.medicare.gov/your-medicare-costs

IF YOU DO NOT HAVE INSURANCE

Visit www.patientassistance.bayer.us to see if you qualify for assistance, or call 1-866-228-7723 Monday-Friday 9:00 AM-6:00 PM (ET) for more information.

Footnotes
a
*Participation in the HYRNUO Free Trial Program is limited to 1 time only per product (patients currently using HYRNUO are not eligible for a Free Trial of their current product). The Free Trial Program includes 1 month supply. The Free Trial Program for HYRNUO is available to patients 18 years of age and older. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.
b
†The medication provided through this program is at no cost to the patient and is not contingent on future use of this medication. Reselling or billing any third party for free product provided by this program is prohibited by law.
c
‡Patients are eligible if they are commercially insured and may pay as little as $0 per month. Benefit limitations apply. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, eg, Co-Pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in the Bayer US Patient Assistance Foundation are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the HYRNUO $0 Co-Pay Program at any time, including but not limited to this commercial Co-Pay assistance program.