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Treatment Name: Neratinib (Nerlynx®)

Neratinib (Nerlynx®) is a Treatment Regimen for Breast Cancer - early stage

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.


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  • 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.

Side Effects

In clinical studies, the most commonly reported neratinib (Nerlynx®) side effects 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.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingFatigue Fatigue PainPain


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

ChemoExperts Tips

  • 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 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:

  • Neratinib

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.

Emotional Wellness

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®)

Individual Drug Label Information

Neratinib (Nerlynx®)

  • Neratinib is available as an oral 40 mg tablet
  • Is usually taken with food. Swallow whole and do not chew, crush or split tablets
  • If you miss a dose, do not take the missed dose and resume your normal dosing schedule the following day
  • Store neratinib at room temperature (68°F to 77°F)
  • Interruptions in therapy or dosage adjustments may be required for severe side effects or liver problems 
  • May interact with certain antifungal, antibacterial, seizure, or antiviral medications
  • Common heartburn medications like omeprazole (Prilosec®) and ranitidine (Zantac®) may decrease absorption of neratinib by more than 50% and decrease its effectiveness
  • May interact with grapefruit and grapefruit juice, pomegranate, star fruit, or seville oranges (in marmalade) causing increased blood levels of neratinib. This could increase your risk of experiencing side effects. Avoid eating or drinking these foods during treatment 
  • May cause fetal harm if taken while pregnant. Women should use effective contraception during treatment and for at least 1 month after the last dose of neratinib. Breast-feeding is not recommended during treatment with neratinib
General side effects from neratinib (Nerlynx®)
  • Diarrhea
  • Nausea
  • Fatigue
  • Vomiting
  • Abdominal pain
  • Headache
  • Mouth sores
  • Rash
  • Decreased appetite
  • Muscle spasms
  • Heartburn
  • Dizziness
  • Joint pain
  • Fingernail changes
  • Dry skin
  • Urinary tract infection
  • Click on the neratinib (Nerlynx®) package insert below for reported side effects, possible drug interactions, and other neratinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPain

See DailyMed package insert.

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Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2016;17:367-377.

Created: July 22, 2017 Updated: November 8, 2018

What is Breast Cancer - early stage?

What is Early Stage Breast Cancer?
A disease of either the milk-producing glands known as lobules, or milk ducts, or other cells found in the breast. Early stage breast cancer may also affect the lymph nodes, but has not usually spread to other areas of the body. Breast cancer is the most common type of cancer diagnosed in women, but may rarely affect men as well. Breast cancer cells may have increased expression of estrogen receptors (ER positive or negative), progestin receptors (PR positive or negative), and/or HER-2 receptors (HER-2 positive or negative). The presence or lack of these receptors will help determine the most effective chemotherapy medications to give.

Genetic causes, such as the BRCA (pronounced "Bracka") mutation, significantly increase the risk of developing breast cancer. Other risk factors for breast cancer include family history of breast cancer, high fat diet, and obesity. The stage of breast cancer can vary at diagnosis and throughout treatment. Stages of breast cancer include I, II, III, and IV. The effectiveness of the treatment may depend upon the stage at diagnosis.

Types of breast cancer:
1. Hormone-receptor positive or negative (60 - 65% of patients)

  • Estrogen Receptor positive (ER)+ or negative (ER)-
  • Progestin Receptor positive (PR)+ or negative (PR)-

2. Hormone Epidermal growth factor Receptor-2 (HER-2) positive or negative (20 - 25% of patients)

  • HER-2 + (positive)
  • HER-2 -  (negative)

3. Triple Negative (15 - 18% of patients)

  • ER- and PR- and (HER-2)-
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

14) Serum calcium