What is NERLYNX (Neratinib)?
NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which:
- is HER2-positive and
- has previously been treated with the medicine trastuzumab..
It is not known if NERLYNX is safe and effective in children.
What is the most important information I should know about NERLYNX?
NERLYNX can cause serious side effects. These serious side effects include:
- Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:
- You should start taking loperamide with your first dose of NERLYNX.
- Keep taking loperamide during the first 2 months (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide
- Always take loperamide exactly as your healthcare provider tells you.
- While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
- Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away.
- Call your healthcare provider right away, as instructed, if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.
- Your healthcare provider may also need to give you other medicines to manage diarrhea if loperamide does not work well enough.
- After 2 months (56 days) of treatment with NERLYNX, follow your healthcare provider’s instructions about taking loperamide as needed to control diarrhea.
- Liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. Your healthcare provider will stop your treatment with NERLYNX if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
- Tiredness
- Nausea
- Pain in the right upper stomach-area (abdomen)
- yellowing of your skin or whites of your eyes
- Vomiting
- Rash
- Fever
- Itching
- Common side effects of NERLYNX include:
- Diarrhea
- Nausea
- Stomach-area (abdomen) pain
- Tiredness
- Vomiting
- Rash
- Dry or inflamed mouth, or mouth sores
- Urinary tract infection
- Decreased appetite
- Muscle spasms
- Upset stomach
- Nail problems including color change
- Dry skin
- Swelling of your stomach-area
- Weight loss
How should I take NERLYNX?
- Take NERLYNX exactly as your healthcare provider tells you to take it.
- Your healthcare provider may change your dose of NERLYNX if needed.
- Take NERLYNX with food.
- Take NERLYNX at about the same time each day.
- If you take an antacid medicine, take NERLYNX 3 hours after the antacid medicine.
- NERLYNX is usually taken for 1 year.
- If you miss a dose of NERLYNX, skip that dose and take your next dose at your regular scheduled time.
- If you take too much NERLYNX, call your healthcare provider right away or go to the nearest hospital emergency room.
Important Safety Information
- You should avoid eating products that contain grapefruit during treatment with NERLYNX.
- You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX.
- Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX.
- Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking NERLYNX?
Tell your healthcare provider about all of your medical conditions, including if you:
- Have liver problems. You may need a lower dose of NERLYNX.
- Are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby.
- If you are a female who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking NERLYNX.
- Talk with your healthcare provider about forms of birth control that you can use during this time
- Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX
- Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX.
- If you are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs, and H-2 receptor antagonists.
General information about NERLYNX
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NERLYNX for a condition for which it was not prescribed. Do not give NERLYNX to other people, even if they have the same symptoms that you have. It may harm them
What are the ingredients in NERLYNX?
Active ingredient: Neratinib
Inactive ingredient: Tablet Core: colloidal silicon dioxide, mannitol, microcrystalline cellulose, crospovidone, povidone, magnesium stearate & purified water. Coating: red film coat: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red.