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Nerlynx (neratinib) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with breast cancer.
These insights are based on 241 comments about Nerlynx from MyBCTeam members. These are the experiences of a small number of people and are not meant to be medical advice.
Benefits:
Considerations:
Nerlynx is a type of medication called a kinase inhibitor. It blocks proteins called epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. These proteins can help cancer cells grow and divide.
In HER2-positive breast cancer, blocking these proteins may help slow abnormal cancer cell growth.
Doctors prescribe Nerlynx when certain adults with HER2-positive breast cancer need treatment. The exact use depends on the stage of cancer and prior treatment. Nerlynx may be used:
Nerlynx is given as a tablet by mouth, usually once a day with food and at about the same time each day. The tablets should be swallowed whole.
For early-stage disease, treatment is usually taken continuously for up to one year or until the cancer comes back. For advanced or metastatic disease, Nerlynx is taken on days 1 through 21 of a 21-day cycle, with capecitabine on days 1 through 14. Treatment usually continues until the cancer gets worse or side effects become unacceptable or intolerable.
For early-stage disease, the recommended dose is 240 milligrams by mouth once daily with food, taken continuously for up to one year or until the cancer comes back.
For advanced or metastatic disease, the recommended dose is 240 milligrams by mouth once daily with food on days 1 through 21 of a 21-day cycle, used with capecitabine 750 milligrams per square meter by mouth twice daily on days 1 through 14 of the same cycle. Treatment usually continues until the cancer gets worse or side effects become unacceptable.
Doctors may pause treatment, lower the dose, delay treatment, or stop treatment if side effects are serious or too hard to manage.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
These insights are based on 241 comments about Nerlynx from MyBCTeam members.
Members who use Nerlynx often say the biggest practical challenge is managing digestive side effects, especially early on. Many also encourage staying in close contact with the oncology team, asking about dose adjustments if side effects are hard to handle, and using support programs when cost becomes a barrier.
Ask whether dose changes or extra medicines could help with side effects.
“I started on one pill for a week, then titrated up to six. I took budesonide for a month. Imodium and Lomotil as well. Now I only need one Imodium. It matters how it is administered!”
Ask your doctor about preventing diarrhea from the start.
“As long as I take the antidiarrhea meds, I am able to control that. It is definitely the biggest side effect and most common. They should have you take antidiarrhea meds along with it right away.”
Take Nerlynx with food and keep a steady routine.
“I take the pills with my evening meal.”
Tell your care team quickly if side effects get severe.
“Onc took me off after my first week because my D was so bad, and I was vomiting too. After I restarted Nerlynx, it’s been more manageable.”
Look into financial assistance and peer support.
“When June came and my out-of-pocket was in a new cycle, I applied for copay assist through the drug company and only paid $10/mo.”
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In clinical trials of Nerlynx used alone for adults with early-stage HER2-positive breast cancer after adjuvant trastuzumab-based therapy, the most common side effects occurred in at least 5 percent of people taking Nerlynx. These side effects include:
When Nerlynx is used with capecitabine for adults with advanced or metastatic HER2-positive breast cancer, the most common side effects occurred in at least 5 percent of people taking Nerlynx with capecitabine. These side effects include:
Nerlynx can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Puma Biotechnology, the manufacturer of Nerlynx, offers the Puma Patient Lynx program. Eligible people with commercial insurance may pay as little as $10 per prescription.
The Puma Patient Lynx program also offers a patient assistance program, a Nerlynx Quick Start program, an antidiarrheal support program, copay support, and a mentor program. The Nerlynx Quick Start program provides a free three-week supply for eligible people whose access is delayed. The antidiarrheal support program provides vouchers for a free supply of certain antidiarrheal medicines, with a prescription.
The $10 copay offer requires commercial insurance and is not valid for people with Medicare, Medicaid, or any other federal or state healthcare program. To learn more, visit the Nerlynx patient support page, or call 855-816-5421.
Before starting Nerlynx, your doctor will check your liver blood tests.
Tell your doctor if you have any allergies to neratinib or any ingredients in Nerlynx.
Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, and supplements.
If you miss a dose, skip it and take your next dose at the usual time.
Nerlynx can harm your baby if you are pregnant. Your doctor may give you a pregnancy test before you start treatment. Females who can become pregnant should use effective birth control during treatment and for one month after the last dose.
Males with female partners who can become pregnant should use effective birth control during treatment and for three months after the last dose. Do not breastfeed during treatment with Nerlynx and for one month after the last dose.
These answers are fact-checked by our editorial staff.
How effective is Nerlynx?
In a study of people with early-stage HER2-positive breast cancer who had finished trastuzumab-based treatment, invasive disease-free survival at 24 months was 94.2 percent with Nerlynx and 91.9 percent with placebo (an inactive treatment). Cancer events occurred in 4.7 percent of people taking Nerlynx, compared with 7.5 percent taking placebo.
After a median follow-up of eight years, overall survival was not statistically different between groups, with five-year overall survival of 94.1 percent with Nerlynx and 93.3 percent with placebo.
Can Nerlynx cause diarrhea in people taking it for breast cancer?
Yes. Diarrhea is very common with Nerlynx and can be severe. In the early-stage breast cancer study, 95 percent of people had diarrhea, 40 percent had severe diarrhea, and most cases started in the first month.
Severe diarrhea can lead to dehydration, low blood pressure, and kidney failure, so people are told to contact their healthcare provider right away if diarrhea is severe or happens with weakness, dizziness, or fever. Your doctor may start you on antidiarrheal medications before Nerlynx to help prevent severe diarrhea.
What tests or monitoring are needed with Nerlynx for breast cancer?
Liver blood tests are needed before starting Nerlynx, every month for the first three months, and then every three months after that, or as needed. These tests include total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase.
People taking Nerlynx should also be monitored for diarrhea, and stool cultures may be done if clinically needed.
On MyBCTeam, people share their experiences with breast cancer, get advice, and find support from others who understand.
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