Medication-info.com Search Menu

Lapatinib (Tykerb): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
250 mg
Brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Lapatinib

What are lapatinib tablets?

Lapatinib tablets are a prescription medicine used:

  • with the medicine capecitabine to treat people with breast cancer that is advanced or that has spread to other parts of the body (metastatic), and:

    • that is HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and

    • who have already had certain other breast cancer treatments

      Before taking lapatinib tablets with capecitabine, your breast cancer should have gotten worse (progressed) with the medicine trastuzumab.

  • with the medicine letrozole to treat women who:

    • have gone through the change of life (postmenopausal), and
    • who have metastatic breast cancer that is hormone receptor-positive, HER2-positive, and hormonal therapy is a treatment option for them.

It is not known if lapatinib tablets are safe and effective in children.

Do not take lapatinib tablets if you are allergic to any of the ingredients in lapatinib tablets. A complete list of ingredients in lapatinib tablets can be found at the end of this Patient Information.

Before taking lapatinib tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have liver problems. You may need a lower dose of lapatinib tablets.

For females, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. Lapatinib tablets can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start taking lapatinib tablets. You should use effective birth control (contraception) during treatment with lapatinib tablets and for 1 week after the last dose of lapatinib tablets. Tell your healthcare provider right away if you become pregnant during treatment with lapatinib tablets.

  • are breastfeeding or plan to breastfeed. It is not known if lapatinib passes into your breast milk. You should not breastfeed during treatment with lapatinib tablets and for 1 week after the last dose of lapatinib tablets. Talk to your healthcare provider about the best way to feed your baby if you breastfeed.

For males with female partners who are able to become pregnant:

  • use effective contraception during treatment with lapatinib tablets and for 1 week after the last dose.
  • if your female partner becomes pregnant during treatment with lapatinib tablets, tell your healthcare provider right away.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lapatinib tablets may affect the way other medicines work, and other medicines may affect the way lapatinib tablets work.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. Do not take other medicines during treatment with lapatinib tablets without first talking with your healthcare provider.

How should I take lapatinib tablets?

  • Take lapatinib tablets exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of lapatinib tablets if needed.
  • For people with advanced or metastatic breast cancer, lapatinib tablets and capecitabine are taken in 21-day cycles. The usual dose of lapatinib tablets is 1,250 mg (5 tablets) taken by mouth all at the same time, 1 time a day on Days 1 to 21.
  • Your healthcare provider will tell you the dose of capecitabine you should take and when you should take it.
  • Take capecitabine with food or within 30 minutes after food.
  • For people with hormone receptor-positive, HER2-positive breast cancer, lapatinib tablets and letrozole are taken every day. The usual dose of lapatinib tablets is 1,500 mg (6 tablets) taken by mouth all at the same time, 1 time a day. Your healthcare provider will tell you the dose of letrozole you should take and when you should take it.
  • Take lapatinib tablets at least 1 hour before, or at least 1 hour after a meal.
  • Avoid eating or drinking grapefruit products during treatment with lapatinib tablets.
  • If you miss a dose of lapatinib tablets, take your next dose at your regular time the next day.
  • If you take too many lapatinib tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of lapatinib tablets?

Lapatinib tablets may cause serious side effects, including:

  • heart problems, including decreased pumping of blood from the heart and an abnormal heartbeat. Signs and symptoms of an abnormal heartbeat include:
  • feeling like your heart is pounding or racing
  • dizziness
  • tiredness
  • feeling lightheaded
  • shortness of breath

Your healthcare provider should check your heart function before you start taking lapatinib tablets and during treatment.

  • liver problems. Liver problems can be severe and deaths have happened. Signs and symptoms of liver problems include:

    • itching
    • yellowing of your skin or the white part of your eyes
    • dark urine
    • pain or discomfort in the right upper stomach area

Your healthcare provider should do blood tests to check your liver before you start taking lapatinib tablets and during treatment.

  • diarrhea. Diarrhea is common with lapatinib tablets and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and some deaths have happened. Call your healthcare provider right away if you have a change in bowel pattern or if you have severe diarrhea. Follow your healthcare provider’s instructions for what to do to help prevent or treat diarrhea.
  • lung problems. Symptoms of a lung problem with lapatinib tablets include a cough that will not go away or shortness of breath.
  • severe skin reactions. Lapatinib tablets may cause severe skin reactions. Tell your healthcare provider right away if you develop a skin rash, red skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever, or any combination of these. As severe skin reactions can be life-threatening, your healthcare provider may tell you to stop taking lapatinib tablets.

Call your healthcare provider right away if you have any of the signs or symptoms of the serious side effects listed above.

Common side effects of lapatinib tablets in combination with capecitabine or letrozole include:

  • diarrhea
  • red, painful hands and feet
  • nausea
  • rash
  • vomiting
  • inflamed mouth, digestive tract and airways
  • mouth sores
  • headache
  • unusual hair loss or thinning
  • shortness of breath
  • dry skin
  • itching
  • tiredness
  • painful arms, legs and back
  • loss of appetite
  • indigestion
  • nose bleeds
  • nail disorders, such as nail bed changes, nail pain, infection and swelling of the cuticles
  • difficulty sleeping

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of lapatinib tablets. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also get side effects from the other medicines taken with lapatinib tablets. Talk to your healthcare provider about possible side effects you may get during treatment.

How should I store lapatinib tablets?

  • Store lapatinib tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not keep medicine that is out of date or that you no longer need.

Keep lapatinib tablets and all medicines out of the reach of children.

General information about the safe and effective use of lapatinib tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use lapatinib tablets for a condition for which they were not prescribed. Do not give lapatinib tablets 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 about lapatinib tablets that is written for health professionals.

What are the ingredients in lapatinib tablets?

Active ingredient: Lapatinib.

Inactive ingredients: iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol (part hydrolyzed), povidone, sodium starch glycolate Type A, talc, and titanium dioxide.

Manufactured In Israel By: Teva Pharmaceuticals Ind. Ltd., Kfar Saba, 4410202, Israel

Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054

For more information, call 1-888-838-2872.

This Patient Information has been approved by the U.S. Food and Drug Administration. Iss. 3/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 217968 · View the label on DailyMed

Revision date stated in the text: March 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lapatinib

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Kinase Inhibitor
Active ingredient Lapatinib ditosylate 250 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) TEVA PHARMS USA INC
FDA approval ANDA 217968Abbreviated New Drug Application (ANDA) – generic drug Approved August 16, 2024
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
250 mg – 150 in 1 bottle NDC 0480-3237-51

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.