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Treatment Name: Lapatinib (Tykerb®) + Capecitabine (Xeloda®)

Lapatinib (Tykerb®) + Capecitabine (Xeloda®) is a Chemotherapy Regimen for Breast Cancer - metastatic

How does lapatinib work?
Lapatinib is designed to stop breast cancer cells from growing and dividing.

How does capecitabine work?
Capacitabine is designed to stop breast cancer cells from growing and dividing.

Goals of therapy:
Lapatinib + capacitabine are taken daily to shrink tumors. They are often taken for months to years to prevent breast cancer from spreading and to reduce symtpoms caused by the cancer. Lapatinib + capecitabine are not usually taken with the goal of cure.

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Schedule

  • Lapatinib, five 250 mg tablets (1250 mg total dose) once daily on an empty stomach, one hour before or after a meal, on Days 1 through 21
  • Capecitabine, multiple tablets, taken twice daily by mouth, within 30 minutes after food, on Days 1 through 14

These two medications are dispensed by a pharmacy and taken at home. Each Cycle is 21 days. Treatment continues unless the patient has unacceptable toxicity or the cancer progresses (gets worse).

Click here for common Lapatinib + Capecitabine starting doses.

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Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects with lapatinib + capecitabine are shown here:

  • Diarrhea (60%)
  • Hand-foot syndrome (49%)
  • Nausea (44%)
  • Rash (27%)
  • Vomiting (26%)
  • Fatigue (18%)
  • Mouth inflammation (15%)
  • Poor appetite [anorexia] (15%)
  • Abdominal pain (15%)
  • Pain in extremity [arms & legs] (13%)
  • Shortness of breath (11%)
  • Dry skin (11%)
  • Upset stomach (11%)
  • Constipation (10%)
  • Back pain (10%)
  • Headache (9%)
  • Lack of energy (6%)

13% of patients discontinued lapatinib plus capecitabine due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingFatigue Fatigue PainPainConstipationConstipation

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each chemotherapy cycle. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment, then again after several cycles to see if the cancer has stabilized or decreased in size. Imaging may include: computerized tomography (CT) scans, magnetic resonance imaging (MRI), or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue this chemotherapy as planned, or delay or switch therapy.

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ChemoExperts Tips

  • Do not divide up the daily dose of lapatinib; take at same time every day. It is okay to wait several minutes between swallowing each of the five tablets
  • Talk to your doctor immediately or go to the emergency department if any side effects keep you from taking your doses
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for metastatic breast cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Lapatinib (Tykerb®) + Capecitabine (Xeloda®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Lapatinib (Tykerb®) + Capecitabine (Xeloda®). Depending upon your income, they may be able to help cover the cost of:

  • Lapatinib
  • Capecit­abine

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Lapatinib (Tykerb®) + Capecitabine (Xeloda®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Lapatinib (Tykerb®) + Capecitabine (Xeloda®)

Individual Drug Label Information

Lapatinib (Tykerb®)

  • Lapatinib iIs an oral 250 mg tablet
  • Take on an empty stomach, one hour before or after food
  • Avoid grapefruit juice. This may increase blood levels of lapatinib and increase toxicities
  • Dividing the once-daily dose is not recommended
  • Severe liver dysfunction and toxicity can occur. Liver function tests should be monitored regularly
  • If a dose is missed, do not double-up on the next dose
  • Dosage adjustments may be required for the following: heart problems, liver impairment, diarrhea, interactions with other medications
  • May interact with many drugs.  Have a doctor or pharmacist do a full drug interaction check before starting lapatinib
  • Lapatinib can cause fetal harm, do not take during pregnancy
General Lapatinib (Tykerb) Side Effects
  • Diarrhea
  • Hand-foot syndrome. Treat with a non-alcoholic moisturizer
  • Rash
  • Nausea
  • Vomiting
  • Mouth inflammation (stomatitis)
  • Liver toxicity. Baseline and regular blood tests are necessary
  • Low white and red blood cell counts
  • Fatigue
  • Pain
  • Heart problems.  Baseline and regular heart tests are common
  • Shortness of breath (dyspnea)
  • Dry skin
  • Constipation
  • Click on the lapatinib (Tykerb) package insert for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Capecit­abine (Xeloda®)

  • Capecitabine Is an oral tablet with two strengths: 150 mg and 500 mg tablets
  • Swallow tablets whole with water.  Take within 30 minutes after eating a meal
  • A dose may combine both tablet strengths and multiple tablets of each (see manufacturer’s package insert for dose/tablet calculation table)
  • Doses are usually divided; taken twice daily, 12 hours apart
  • There is a strong drug interaction with certain blood thinner medications (anticoagulants) like warfarin (Coumadin) that can increase bleeding.  Doses of both capecitabine and the anticoagulants may have to be adjusted.  Immediately report any bleeding  while on capecitabine
  • There are drug interactions with phenytoin (Dilantin) and leucovorin.  Ask your doctor or pharmacist to review your medications before starting capecitabine
  • May cause fetal harm, avoid this drug during pregnancy
General Capecitabine (Xeloda) Side Effects
  • Diarrhea
  • Nausea and vomiting
  • Abdominal pain
  • Heart problems
  • Fatigue
  • Dehydration and kidney failure
  • Mouth sores (stomatitis)
  • Constipation
  • Hand-foot syndrome. Treat with a non-alcoholic moisturizer
  • Dry skin
  • Eye irritation
  • Nerve pain, tingling sensation in fingers and toes
  • Lack of appetite (anorexia)
  • Bleeding
  • Liver toxicity. Baseline and regular blood tests are necessary
  • Age greater than 60 years is associated with a higher incidence of all side effects
  • Click on the capecitabine (Xeloda) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

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References

Geyer C, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355:2733-2743.

Created: November 23, 2015 Updated: September 22, 2018

What is Breast Cancer - metastatic?

What is Metastatic Breast Cancer?
A disease of the milk-producing glands known as lobules, milk ducts, or other cells found in the breast. Metastatic breast cancer is one that has moved from the breast to other areas of the body, which may include the brain, liver, or bone. Breast cancer is one of the most common types of cancers in women, but may rarely affect men as well. Known causes of breast cancer include genetic causes, such as the BRCA mutation, or obesity. The effectiveness of the treatment may depend upon the stage at diagnosis.

Types of metastatic breast cancer:
1. Hormone-receptor positive or negative (60 - 65% of patients)

  • Estrogen Receptor positive (ER)+ or negative (ER)-
  • Progestin Receptor positive (PR)+ or negative (PR)-

2. Hormone Epidermal growth factor Receptor-2 (HER-2) positive or negative (20 - 25% of patients)

  • HER-2 +
  • HER-2 -

3. Triple Negative (15 - 18% of patients)

  • ER- and PR- and (HER-2)-
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Starting Doses

  • Lapatinib, five 250 mg tablets (1250 mg total) once daily, Days 1 - 21
  • Capecitabine, 2000 mg/m2/day, dose divided--taken twice daily, Days 1 - 14

Cycle is 21 days

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.