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Prescribing Information

Patient Prescribing Information

Safety First

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Safety First


What is the most important safety information I should know about XELODA?

It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots. He or she will change the dose of the blood thinner, if needed.

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The XELODA Support Program is here for you

The XELODA Support Program, sponsored by Genentech, gives you helpful tips, advice about how to identify and manage side effects, and other information about XELODA based on where you are in your treatment cycle. Your Support Program benefits will also include phone calls from registered oncology nurses to help you at key points during your treatment cycles. This program is for educational purposes only. It does not take the place of talking to your healthcare team about your medical condition or treatment.

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Genentech BioOncology Co-pay Card Program

Helping you connect to your treatment

At Genentech, we are committed to helping patients access the treatment they need.

That’s why we offer the Genentech BioOncology Co-pay Card. If you qualify, this program can help you with the out-of-pocket costs like co-payments, co-insurance, or deductibles for your medicine. Out-of-pocket costs are the part of your treatment that your healthcare plan requires you to pay.

Do I qualify?

To qualify, you must:

  • Be age 18 years or older
  • Be covered by a private healthcare plan
    • You cannot be covered by a government-funded healthcare plan. This includes Medicare, Medicaid, Medigap, VA, DoD, and TRICARE
    • Government employees can qualify for the card (for example, postal workers or teachers' unions)
  • Live and get treated in the United States or Puerto Rico
  • NOT be getting help from the Genentech® Access to Care Foundation

What if I do not qualify?

If you do not qualify but need help paying for your treatment, we can still help you by referring you to a co-pay assistance foundation for financial assistance. If you do not have insurance, you may be able to get free treatment through the Genentech® Access to Care Foundation. Visit www.copayassistancenow.com or call (888) 249-4918 to find out more.

*Patients must qualify for this program.

We cannot guarantee you will get help from a co-pay assistance foundation. These co-pay assistance foundations each have their own rules, including financial rules. Genentech does not influence or control these co-pay assistance foundations. But Genentech BioOncology Access Solutions can help you. We can refer you to an appropriate co-pay assistance foundation. We can also help with the application process.

How can this card help me?

If your yearly household income is more than $100,000, your card limit is $9000 per year. You are only required to tell us your income when you get the card. Later, you might have to provide proof of income.

If you are taking more than 1 Genentech medicine, you might be able to get more help. You find out if you can when you sign up for the card.

How do I get started?

If you are renewing your card, you must call (855) MY-COPAY. If you are getting the card for the first time, you can either call (855) MY-COPAY OR visit www.copayassistancenow.com.

Terms and conditions

Use of the card does not obligate you to use or continue using any specific product or provider. If you have any questions regarding your eligibility or benefits, or if you wish to no longer be part of the program, contact Genentech BioOncology Co-pay Card at 1-855-MYCOPAY (1-855-692-6729).

You may receive additional program information about the Genentech BioOncology Co-pay Card once you are enrolled. Genentech BioOncology™ Access Solutions® can also activate this card for you.

No person or entity may seek reimbursement from any third-party payer for any amount provided using the card program. Use of this card must be consistent with all relevant health insurance requirements and payer agreements. Participating patients and pharmacies are obligated to inform third-party payers about this card as provided for under the applicable insurance or as otherwise required by contract or law. Genentech USA, Inc. reserves the right to deny payment under the card to anyone deemed ineligible in accordance with the stated program criteria.

Who is XELODA for?

XELODA is used to treat:

  • Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body. This is called metastatic colorectal cancer (mCRC). XELODA is used as a single medicine to treat mCRC. In medical studies, people lived longer when they took other cancer medicines at the same time that they took 5-fluorouracil (5-FU) and leucovorin. In medical studies, XELODA used as a single medicine was no worse than 5-FU and leucovorin taken together. XELODA did not improve survival compared with these 2 medicines.
  • Cancer of the colon after surgery.
  • Breast cancer that has spread to other parts of the body. This is called metastatic breast cancer (mBC). For this kind of breast cancer, XELODA is taken together with another medicine called docetaxel.
  • Breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines. These medicines include paclitaxel and anthracycline-containing medicine such as doxorubicin.

What is the most important safety information I should know about XELODA?

It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots. He or she will change the dose of the blood thinner, if needed.

Who should not take XELODA?

Do not take XELODA if:

  • You are nursing a baby. XELODA may pass through your breast milk and to the baby and harm the baby
  • You are allergic to the chemotherapy medicines 5-FU and capecitabine or to any of the ingredients in XELODA
  • Your body doesn't have enough of the enzyme DPD (dihydropyrimidine dehydrogenase)

What should I tell my doctor before taking XELODA?

Tell your doctor if you:

  • Take a blood thinner, such as warfarin (COUMADIN)
  • Take phenytoin (DILANTIN®)
  • Are pregnant or think you may be pregnant. XELODA may harm your unborn child. Men and women should use effective birth control while taking XELODA
  • Have kidney, liver, or heart problems
  • Take folic acid, a B complex vitamin, or a multivitamin containing folic acid

Stop taking XELODA immediately and contact your doctor right away if you have any of these serious common side effects or any other side effects that worry you:

  • Diarrhea* — if you have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night
  • Throwing up (vomiting)* — more than once in 24 hours
  • Feeling sick to your stomach (nausea)* — if you don't feel like eating and if the amount of food you eat each day is much less than usual
  • Pain, redness, swelling, or sores in your mouth (stomatitis)*
  • Hand-and-foot syndrome — pain, swelling, or redness of your hands or feet that prevents normal activity
  • Fever or infection — a temperature of 100.5°F or higher or other signs of infection

If you do have any of the side effects listed above, or if you have other side effects that worry you, your doctor can change your dose of XELODA or stop your XELODA treatment for a while. This may help to reduce the side effects and stop them from getting worse.

What are the other common side effects of XELODA?

  • Stomach area pain* or upset stomach
  • Constipation*
  • Loss of appetite*
  • Too much water loss from the body (dehydration)*
  • Rash or dry, itchy, discolored skin
  • Nail problems
  • Hair loss
  • Tiredness or weakness
  • Dizziness or headache
  • Fever
  • Pain, including chest, back, joint, or muscle pain
  • Trouble sleeping
  • Problems with your sense of taste

*This side effect is more common in patients 80 years and older.

You may have different side effects if you take XELODA with docetaxel. Please talk with your doctor about possible side effects that may be caused by taking XELODA with docetaxel or other medicines.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please be sure to talk with your doctor if you have any questions about your cancer or treatment.

Please see the full Prescribing Information for Additional Important Safety Information.

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