Treatment Name: Neratinib (Nerlynx®)
How does neratinib (Nerlynx®) work?
Neratinib is a tyrosine kinase inhibitor (TKI) designed to bind to and block the function of Epidermal Growth Factor Receptor (EGFR) and Human Epidermal Growth Factor Receptor 2 (HER2), which are overactive proteins that tell breast cancer cells to grow and divide. By blocking the function of these proteins, neratinib slows the growth of the breast cancer and causes some of the breast cancer cells to die.
Goals of therapy:
Neratinib (Nerlynx®) is taken within 2 years after completion of trastuzumab-based therapy to help keep the cancer in remission longer, and prevent recurrent disease.
- Usual neratinib starting dose: 240 mg (six 40 mg tablets) by mouth Once Daily with food taken continuously for one year
- Neratinib should be taken at about the same time each day
- Drink 2 liters of fluid or more per day to avoid dehydration if any diarrhea is experienced
Loperamide, an anti-diarrheal medication, is taken during treatment with neratinib to help prevent diarrhea caused by neratinib. Loperamide is taken on a scheduled basis during the first eight weeks of therapy with neratinib, then on an as needed basis only during the remainder of therapy.
Loperamide (Imodium®) dosing schedule:
- Weeks 1 and 2 (Days 1 – 14): Loperamide 4 mg (two 2 mg tablets or capsules) by mouth three times daily scheduled
- Weeks 3 through 8 (Days 15 – 56): Loperamide 4 mg (two 2 mg tablets or capsules) by mouth twice daily scheduled
- Weeks 9 through 52 (Days 57 – 365): Loperamide 4 mg (two 2 mg tablets or capsules) by mouth as needed (maximum 16 mg per day). Beginning Day 57, follow regular dosing of loperamide to treat diarrhea
The dose of loperamide may need to be adjusted by your doctor to successfully reach a target of 1 to 2 bowel movements per day. Loperamide is available over-the-counter (OTC) in most pharmacies.
Neratinib is usually taken at home and is taken every day for 12 consecutive months.
Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.
In clinical studies, the most commonly reported side effects of neratinib (Nerlynx®) are shown here:
- Diarrhea* (95%)
- Nausea (43%)
- Fatigue (27%)
- Vomiting (26%)
- Abdominal pain (24%)
- Headache (20%)
- Upper abdominal pain (15%)
- Rash (15%)
- Mouth sores, mild (14%)
- Decreased appetite (12%)
- Muscle spasms (11%)
- Heartburn (10%)
- Dizziness (10%)
- Nail changes (8%)
- Joint pain (6%)
- Weight loss (5%)
- Nose bleed (5%)
- Dehydration (4%)
- Dry mouth (3%)
On average, 26% of patients discontinue treatment due to unacceptable side effects with diarrhea being the most common reason [17%].
Severity of neratinib-related diarrhea in clinical trials:
- Mild - Moderate: 55% of patients had an increase of up to 6 stools per day over baseline
- Severe: 40% of patients had an increase of 7 or more stools per day over baseline; hospitalization was indicated in some cases
- Life-threatening: 1 in 1000 patients
Onset of neratinib-related diarrhea in clinical trials:
The majority of patients [93%] experienced diarrhea in the first 30 days of treatment. Half of patients experience the first episode of diarrhea in the first 8 days and half experience the first episode after 8 days
Duration of neratinib-related diarrhea in clinical trials:
Half of patients experience diarrhea lasting less than 5 days and half of patients experience diarrhea lasting for more than 5 days.
Neratinib dose reductions due to a side effect occurred in 31% of patients in clinical trials
How often is monitoring needed?
Labs (blood tests) may be checked before treatment, every month for the first 3 months, then every 3 months thereafter until stable. Labs often include: Liver function tests found in a Comprehensive Metabolic Panel (CMP), alkaline phosphatase, plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked during treatment at the discretion of your doctor. Imaging may include: mammograms, bone scans, or computerized tomography (CT) scans.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue neratinib as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.
If severe diarrhea occurs, your doctor may recommend intravenous (I.V.) fluids, electrolyte supplements, and additional anti-diarrhea medicines
- Diarrhea is a very common side effect of neratinib. Loperamide should be taken as directed during therapy. If you are still having diarrhea while taking loperamide, contact your doctor as additional anti-diarrheal medications may be required
- Although neratinib may cause heartburn, you should not take commonly used medications to treat heartburn such as omeprazole (Prilosec®), lansoprazole (Prevacid®), esomeprazole (Nexium®), or these over-the-counter antacids: famotidine (Pepcid®), or ranitidine (Zantac®). Antacids decrease absorption of neratinib and may decrease its effectiveness. If medication is needed to treat heartburn, short-acting antacids such as Tums® or Mylanta® may be used. Do not take your neratinib dose until 3 hours have passed after the last dose of Tums® or Mylanta®
- Neratinib may interact with other prescription or over-the-counter medications you are taking. A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for breast cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Neratinib (Nerlynx®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Neratinib (Nerlynx®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Neratinib (Nerlynx®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Neratinib (Nerlynx®)