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Prescribing Information

NOW APPROVED


HYRNUO is for previously treated patients with
HER2
*-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
1

HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). 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).

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HYRNUO WAS EVALUATED IN NSCLC PATIENTS WITH
HER2
TKD ACTIVATING MUTATIONS¹

71% in a circle

71% OF PATIENTS TREATED WITH HYRNUO ACHIEVED AN OBJECTIVE RESPONSE
1†‡

(95% CI: 59, 82; N=70)
CR: 2.9%, PR: 69%

Calendar icon with text of 9.2 months

MEDIAN DoR OF HYRNUO WAS 9.2 MONTHS
1†§

(95% CI: 6.3, 15.0; N=50)

†Major efficacy outcomes were confirmed ORR and DoR as assessed by BICR using RECIST v1.1.

‡ORR (95% CI) calculated using the Clopper-Pearson method.

§Kaplan-Meier estimate.

CR=complete response; ORR=objective response rate; PR=partial response.

HYRNUO SAFETY PROFILE

The safety of HYRNUO was evaluated in 136 patients with locally advanced or metastatic NSCLC harboring
HER2
activating mutations who had received prior systemic therapy and received HYRNUO at 20 mg twice daily.
1¶

Safety was evaluated in 136 patients who had received prior systemic therapy but were naive to HER2-targeted treatment, and patients who had received prior systemic therapy including HER2-targeted ADC.
 

ADVERSE REACTIONS IN THE SAFETY POPULATION WERE MOSTLY LOW GRADE AND MANAGEABLE
1

  • HYRNUO was associated with mostly Grade 1-2 adverse reactions, with no Grade 4 events reported except for dyspnea (0.7%)
  • The most common adverse reactions (>20%) in patients who received HYRNUO were diarrhea (87%), rash (66%), paronychia (33%), stomatitis (29%), and nausea (21%)
  • Most diarrhea adverse reactions were low grade (1-2) and did not result in treatment discontinuation
  • Grade 3-4 adverse reactions included diarrhea (18%), decreased appetite (2.9%), vomiting (2.2%), stomatitis (1.5%), nausea (1.5%), rash (1.5%), pruritus (1.5%), dyspnea (1.5%), decreased weight (0.7%), fatigue (0.7%), and ocular toxicity (0.7%)
  • The most common Grade 3-4 laboratory abnormalities (≥2%) were decreased potassium (13%), increased lipase (12%), decreased lymphocyte count (6%), decreased sodium (4.4%), increased amylase (3.8%), increased AST (3%), and increased ALT (3%)
  • Serious adverse reactions occurred in 31% of patients
    • Most common (≥2%): diarrhea (6%), pneumonia (3.7%), dyspnea (2.2%), pleural effusion (2.2%)
  • These are not all the possible side effects of HYRNUO

MOST PATIENTS CONTINUED HYRNUO WITHOUT DOSE

 REDUCTION OR INTERRUPTION
1

72-percent

WERE TREATED WITH NO DOSE REDUCTIONS
1

Dose reductions due to adverse reactions occurred in 28% of patients who received HYRNUO

Most frequent (>2%) adverse

reactions leading to dose reductions:


diarrhea
rash
hypokalemia

54-Percent

CONTINUED TREATMENT WITHOUT INTERRUPTION
1

Dose interruptions due to adverse reactions occurred in 46% of patients who received HYRNUO

Most frequent (>3%) adverse

reactions leading to dose

interruptions:


diarrhea
hypokalemia
nausea
decreased appetite
pneumonia

Less than 4 Percent

DISCONTINUED TREATMENT DUE TO ADVERSE REACTIONS
1

Adverse reactions leading to discontinuation:


corneal epithelial microcysts
hepatic function abnormal
electrocardiogram QT prolonged
pain in extremity
dyspnea

Diarrhea did not result in any patient treatment discontinuations.

RECOMMENDED DOSING OF HYRNUO
1

Recommended dosing instructions for HYRNUO
Recommended dosing instructions for HYRNUO

No weight-based dosing is required.

The recommended dose is 20 mg (two 10 mg tablets) orally twice daily with food, for a total daily dose of 40 mg, until disease progression or unacceptable toxicity. Swallow tablets whole. Do not cut, crush, or chew tablets.

If a dose is missed, patients must take the missed dose as soon as they remember prior to the next scheduled dose. Patients should not take 2 doses at the same time to make up for a missed dose.

TO RECEIVE A PATIENT STARTER KIT, VISIT THE REQUEST A 

SPECIALIST PAGE.

COMPREHENSIVE SUPPORT THROUGHOUT YOUR PATIENTS’ TREATMENT JOURNEY

Once you've made the decision to prescribe HYRNUO, you can do so through our dedicated specialty pharmacy, Onco360TM. Acting as an extension of your office, Onco360TM provides oncology-focused care to your patients.

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FOR ALL PATIENTS

All patients NEW to HYRNUO are eligible for a 1-month free trial to help them start HYRNUO at no cost*

  • One-month supply of HYRNUO allows HCPs and patients to determine if it is the right treatment option at no cost to payer or patient. Enroll through a Bayer-contracted specialty pharmacy
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FOR PATIENTS WITH COMMERCIAL INSURANCE

Co-pay program

Eligible patients may pay as little as $0 for HYRNUO
†

  • Eligible patients will automatically be re-enrolled every January
  • Benefit limits apply
Enroll your patient
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FOR PATIENTS WITH MEDICARE

Patients may qualify for help to pay for out-of-pocket costs for HYRNUO

  • Ask patients with limited income and resources to check their eligibility for government-funded programs, such as Medicare Part D Extra Help, etc, at
    www.medicare.gov/basics/costs
  • Patients can opt in to the Medicare Prescription Payment Plan to help manage out-of-pocket drug costs by spreading them out over the year

*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.

†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.

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IF YOUR PATIENTS CANNOT AFFORD THEIR PRESCRIPTION MEDICATION, BAYER MAY BE ABLE TO HELP

The Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients get their Bayer prescription medicine at no cost. Please have your patient contact the program at

1-866-2BUSPAF (228-7723)
Monday–Friday, 9:00 AM–6:00 PM EST, or visit the foundation website at
www.patientassistance.bayer.us
 to see if they might qualify for assistance.