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IMPORTANT SAFETY INFORMATION
What is the most important information I should know about NERLYNX (ner
NERLYNX® (neratinib) may cause serious side effects,
Diarrhea. Diarrhea is a common side effect of NERLYNX,
but it can also be severe. You may lose too much body salts and fluid, and
get dehydrated. When you start NERLYNX, your healthcare provider should
prescribe the medicine loperamide for you during your first 2 months (56
days) of NERLYNX and then as needed. Be sure that your healthcare provider
prescribes anti-diarrheals with NERLYNX. Anti-diarrheals must be started
with the first dose of NERLYNX. 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 this medicine.
Your healthcare provider may also need to give you other medicines to
manage diarrhea when you start treatment with NERLYNX. Follow your
healthcare provider’s instructions on how to use these anti-diarrheal
Always take anti-diarrheals exactly as your healthcare provider tells
While taking anti-diarrheals, 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.
After 2 months (56 days) of treatment with NERLYNX, follow your
healthcare provider’s instructions about taking loperamide as needed
to control diarrhea.
Your healthcare provider may change your dose of NERLYNX, temporarily stop
or completely stop NERLYNX if needed to manage your diarrhea.
See "What are the possible side effects of NERLYNX?" for
more information about side effects.
What is NERLYNX?
NERLYNX is a prescription medicine used alone to treat adults with
early-stage human epidermal growth factor receptor 2 (HER2)-positive
breast cancer and who have previously been treated with
NERLYNX is also used with a medicine called capecitabine to treat adults
with HER2-positive breast cancer that has spread to other parts of the
body (metastatic) and who have received 2 or more
anti-HER2 therapy medicines for metastatic breast cancer.
It is not known if NERLYNX is safe and effective in children.
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
You should use effective birth control (contraception) during
treatment and for at least 1 month after your last dose of 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 your
last dose of NERLYNX.
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. You
should avoid taking these medicines during treatment with NERLYNX.
What are the possible side effects of NERLYNX?
NERLYNX may cause serious side effects, including:
See "What is the most important information I should know about NERLYNX?"
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:
pain in the right upper stomach-area (abdomen)
yellowing of your skin or whites of your eyes
The most common side effects of NERLYNX when used alone
stomach-area (abdomen) pain
dry or inflamed mouth, or mouth sores
nail problems including color change
swelling of your stomach-area
urinary tract infection
The most common side effects of NERLYNX in combination with
urinary tract infection
upper respiratory tract infection
swelling of your stomach-area
These are not all of the possible side effects of NERLYNX. For more
information, ask your Healthcare Provider.
Tell your doctor if you have any side effects that bother you or that does
not go away. Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.