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Prescribing Information

Safety First

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Safety First

Boxed WARNING and Contraindications

Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.

XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, severe renal impairment, or known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil.

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Genentech BioOncology Co-pay Card Program helps patients reduce their out-of-pocket co-pay expenses. Learn more

Genentech BioOncology Co-pay Card Program

Financial assistance to help patients pay their out-of-pocket costs for oral
Genentech cancer therapies

Genentech BioOncology Co-pay Card program helps patients reduce their out-of-pocket co-pay expenses

How does the card work?

There is now one card for all of our Genentech cancer therapies, with one set of eligibility criteria, one set of benefits and one number to call.

The card reduces out-of-pocket costs for your eligible patients, regardless of income.*

Out-of-pocket costs are defined as the co-pay, co-insurance or deductible for your patients’ therapy. This must be clearly defined on the Explanation of Benefits when submitted.

Who is eligible?

* If your patients’ annual household income is >$100,000 per year, the card limit is reduced.

How much does the card cover?

* Patients who make a household income of >$100,000 per year have a yearly limit of $1,500. Patients only need to provide a verbal statement to verify their income when they enroll. Proof of documentation at a later date may be required.

How do I enroll my patients?

† Your patients will need to provide the 9-digit code on their card and answer a few simple questions, including their name, address, phone number, ZIP code and date of birth.

Tell your patients to enroll now at www.CopayAssistanceNow.com

How do I talk to my patients about the card?

Ask your Genentech Clinical Oncology Specialist or BioOncology Field Reimbursement Manager for patient brochures with enclosed cards. You can use these brochures to guide your patients through the card and start the enrollment process.

What about my patients who are not eligible?

A Genentech BioOncology™ Access Solutions® Specialist can refer ineligible patients to an independent, nonprofit organization (INO)‡ that may be able to help. Uninsured patients may be able to get free therapy through GATCF. Contact Genentech BioOncology Access Solutions at 1-888-249-4918 from 9AM to 8PM EST, Monday - Friday, or visit BioOncologyAccessSolutions.com to find out more.

‡ Genentech BioOncology does not influence or control the operations of these INOs, but Genentech BioOncology Access Solutions can assist patients in navigating the process of seeking co-pay assistance by making an appropriate referral based on a patient’s diagnosis and by assisting with the application process. We cannot guarantee co-pay assistance once a patient has been referred by Genentech BioOncology Access Solutions. The INOs to which we refer patients each have their own criteria for patient eligibility, including financial eligibility.

Terms and conditions

Pharmacist/Physician: You may be obligated under your contracts with payers to disclose acceptance of funds provided through the card program as payment for the products dispensed to your patient. You may not advertise or otherwise use the card as a means of promoting your services or Genentech's products to patients. For questions regarding enrollment, claim transmission, patient eligibility, or other issues, contact Genentech BioOncology Co-pay Card:

Via phone at 1-855-MYCOPAY (1-855-692-6729) from 9AM—8PM EST, Monday - Friday.
On our website at www.CopayAssistanceNow.com

General: 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.

Indications

XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and overall survival (OS), when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.

XELODA is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

XELODA monotherapy is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.

XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

Boxed WARNING and Additional Important Safety Information

Boxed WARNING
Warfarin Interaction — Coagulopathy

  • Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly.
  • A clinically important XELODA-warfarin drug interaction was demonstrated in a clinical pharmacology trial.
  • Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
  • Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR have been observed in patients who were stabilized on anticoagulants at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA therapy, and infrequently within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases.
  • Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
  • XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, or severe renal impairment. XELODA is also contraindicated in patients with known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil.
  • Additional serious adverse reactions include diarrhea, cardiotoxicity, hand-and-foot syndrome, and hyperbilirubinemia. XELODA can cause fetal harm. Advise women of the potential risk to the fetus. Do not treat patients with neutrophil counts <1.5 x 109/L or thrombocyte counts <100 x 109/L.
  • The most common adverse reactions (≥30%) reported with XELODA were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported.

Monotherapy in Adjuvant Colon Cancer

In a phase 3 study of XELODA monotherapy in colon cancer in the adjuvant setting, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving either XELODA or 5-FU/LV (%;%) were increase in bilirubin (20;7), hand-foot syndrome (17;<1), decrease in lymphocytes (13;13), diarrhea (12;14), decrease in neutrophils/granulocytes (3;27), decrease in neutrophils (3;27), stomatitis (2;14), and neutropenia (<1;5). The most common adverse events for all grades occurring in ≥30% of patients receiving either XELODA or 5-FU/LV were hand-foot syndrome (60;9), diarrhea (47;65), nausea (34;47), and stomatitis (22;60). A total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 8 (0.8%) patients randomized to XELODA and 10 (1.0%) randomized to 5-FU/LV.

Monotherapy in mCRC

In two phase 3 trials of XELODA monotherapy in metastatic colorectal cancer, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving either XELODA or 5-FU/LV (%;%) were hyperbilirubinemia (23;6), hand-foot syndrome (17;1), diarrhea (15;12), abdominal pain (<10;5), vomiting (<5;<5), ileus (5;3), stomatitis (<3;15), and neutropenia (3;21). The most common adverse events for all grades occurring in ≥30% of patients receiving either XELODA or 5-FU/LV were anemia (80;79), diarrhea (55;61), hand-foot syndrome (54;6), hyperbilirubinemia (48;17), nausea (43;51), fatigue/weakness (42;46), abdominal pain (35;31), vomiting (27;30), appetite decrease (26;31), stomatitis (25;62), and neutropenia (13;46). A total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 50 (8.4%) patients randomized to XELODA and 32 (5.4%) randomized to 5-FU/LV.

Monotherapy in mBC

In a single arm study of XELODA monotherapy in metastatic breast cancer, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving XELODA (%) were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11), fatigue (8), stomatitis (7), and dehydration (5). The most common adverse events for all grades occurring in ≥30% of patients receiving XELODA were lymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), nausea (53), fatigue (41), dermatitis (37), and vomiting (37).

Combination Therapy with Docetaxel in mBC

In a phase 3 study of XELODA combination therapy (XELODA plus docetaxel) in metastatic breast cancer, serious adverse events (grade 3/4) occurring at a ≥2% higher incidence in patients receiving XELODA plus docetaxel vs docetaxel alone (%;%) were lymphocytopenia (89;84), hand-foot syndrome (24;1), stomatitis (<18;5), diarrhea (<15;<6), anemia (10;<6), hyperbilirubinemia (9;4), nausea (7;2), vomiting (5;2), constipation (2;0), and nail disorder (2;0). The most common adverse events for all grades occurring at a ≥5% higher incidence in patients receiving XELODA plus docetaxel vs docetaxel alone were diarrhea (67;48), stomatitis (67;43), hand-foot syndrome (63;8), nausea (45;36), thrombocytopenia (41;23), vomiting (35;24), abdominal pain (30;24), hyperbilirubinemia (20;6), weakness (16;11), dyspepsia (14;8), lacrimation increase (12;7), and appetite decrease (10;5).

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