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Help for Uninsured Patients

The Genentech® Access to Care Foundation (GATCF) was created to help patients who are uninsured—or who have been denied coverage for XELODA® (capecitabine) by their health plans. GATCF might be able to help those patients receive XELODA treatment if they meet specific financial and medical criteria.

 

 


 

 

Is my patient eligible?

For your patient to be eligible for help from GATCF, certain specific criteria must be met:

  • Your patient must have no health insurance or the health plan has denied coverage for XELODA
  • Your patient’s annual household adjusted gross income must be $100,000 or less (special consideration may be given to patients with unique circumstances)
  • Your patient must meet medical criteria determined by the GATCF Clinical Advisory Board

 

 


 

 

How do I get started?

To apply to GATCF, you must complete and submit the Statement of Medical Necessity (SMN) form and have your patient complete and submit a Patient Authorization and Notice of Release of Information (PAN) form.

The SMN can be submitted online via My Patient Solutions or downloaded from our Forms and Documents.

When completing the SMN, be sure to complete all sections of the form.

 

 

Once we receive your patient’s information, XELODA Access Solutions will contact the patient within 24 hours with further instructions. This may include verifying financial eligibility.

 

Additional GATCF Program details:

  • Patients are eligible for free medicine for 1 year; patients must reapply annually
  • Patient assistance support may be given before treatment or up to 1 year post-treatment
  • GATCF assists with the cost of XELODA only, not the administration costs

 

GATCF has the right to modify or end this program at any time and to verify the accuracy of the information you submit.

Learn More About
XELODA
  • LEARN about treatment with XELODA
  • FIND the right patient assistance program with our Compass for Patient Access tool
  • Form Statement of Medical Necessity
  • Form Patient Authorization and Notice of Release of Information

XELODA Indications and Important Safety Information

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 Dukes’ C Stage (III) 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).

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 see complete XELODA Prescribing Information including Boxed WARNINGS for additional important safety information.

XELODA® is a registered trademark of Hoffmann-La Roche Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.