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Nerlynx

Generic Name: neratinib
Dosage Form: Tablets
Date of Approval: July 17, 2017
Company: Puma Biotechnology, Inc.

Treatment for: Breast Cancer - Adjuvant

FDA Approves Nerlynx

The U.S. Food and Drug Administration (FDA) has approved Nerlynx (neratinib), a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Nerlynx may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect, 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 two months (56 days) of treatment, and then as needed. To help prevent or reduce diarrhea:
    • You should start taking loperamide with your first dose.
    • Keep taking loperamide during the first two months (56 days) of 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 one or two bowel movements each day.
    • Tell your healthcare provider if you have more than two bowel movements in one 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 two months (56 days) of treatment, follow your healthcare provider’s instructions about taking loperamide as needed to control diarrhea.
    Your healthcare provider may change your dose, temporarily stop or completely stop Nerlynx if needed to manage your diarrhea.

See Nerlynx side effects for more information about side effects.

What is Nerlynx?

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.

Before taking Nerlynx

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems. You may need a lower dose.
  • 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 treatment.
    • You should use effective birth control (contraception) during treatment and for at least one month after your last dose.
    • 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.
    • Males with female partners who can become pregnant should use effective birth control during treatment and for three months after the last dose.
  • 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 one month after your last dose.

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. You should avoid taking these medicines during treatment.

How should I take Nerlynx?

  • Take Nerlynx exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose if needed.
  • Take the tablets with food.
  • Take the tablets at about the same time each day.
  • If you take an antacid medicine, take Nerlynx three hours after the antacid medicine.
  • Nerlynx is usually taken for one year.
  • If you miss a dose, skip that dose and take your next dose at your regular scheduled time.
  • If you take too much, or overdose, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid during treatment with Nerlynx?

You should avoid eating products that contain grapefruit during treatment.

Nerlynx side effects

Nerlynx may cause serious side effects, including:

See Important information.

  • 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 three months, and then every three months as needed during treatment. Your healthcare provider will stop your treatment 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
    • vomiting
    • pain in the right upper stomach-area (abdomen)
    • fever
    • rash
    • itching
    • yellowing of your skin or whites of your eyes

Common side effects include:

  • diarrhea
  • nausea
  • stomach-area (abdomen) pain
  • tiredness
  • vomiting
  • rash
  • dry or inflamed mouth, or mouth sores
  • decreased appetite
  • muscle spasms
  • upset stomach
  • nail problems including color change
  • dry skin
  • swelling of your stomach-area
  • weight loss
  • urinary tract infection

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Nerlynx?

  • Store the tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Nerlynx.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Nerlynx?

Active ingredient: neratinib

Inactive ingredients: 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.

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