View Important Safety Information

Your patient may be eligible for the Genentech Oncology Co-pay Assistance Program

Co-pay Card Assistance

With the Genentech Oncology Co-pay Assistance Program, eligible patients with commercial insurance could pay as little as $0 per treatment for PHESGO. Co-pay assistance of up to $25,000 is provided per calendar year.

Patients may be eligible if they:

  • Have a valid prescription for PHESGO for an FDA-approved use
  • Reside in the United States or U.S. Territories
  • Are over the age of 18, or have a Legally Authorized Person over the age of 18 to manage the program
  • Have commercial (private or non-governmental) insurance. This includes plans available through state and federal health insurance exchanges
  • Are not currently receiving PHESGO from the Genentech Patient Foundation
  • Are not currently receiving assistance from any other charitable organization for any of their out-of-pocket costs that are covered by the Genentech Oncology Co-pay Assistance Program
  • Are not using a state or federal healthcare plan to pay for their medication. This includes, but is not limited to, Medicare, Medicaid and TRICARE

The Co-pay Program (“Program”) is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. Patients using Medicare, Medicaid or any other federal or state government program (collectively, “Government Programs”) to pay for their Genentech medicine are not eligible.

Under the Program, the patient may be required to pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details available at the Program website). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient’s out-of-pocket expenses for the Genentech medicine.

All participants are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. No party may seek reimbursement for all or any part of the benefit received through the Program. The value of the Program is intended exclusively for the benefit of the patient. The funds made available through the Program may only be used to reduce the out-of-pocket costs for the patient enrolled in the Program. The Program is not intended for the benefit of third parties, including without limitation third party payers, pharmacy benefit managers, or their agents. If Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the Program from counting towards the patient’s deductible or out-of-pocket cost limitations, Genentech may impose a per fill cap on the cost-sharing assistance available under the Program. Submission of true and accurate information is a requirement for eligibility and Genentech reserves the right to disqualify patients who do not comply from Genentech programs. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.

Additional terms and conditions apply. Please visit the Co-pay Program website for the full list of Terms and Conditions.

Contact Us

Questions? Contact a Genentech Oncology Co-pay Specialist

Call 855-692-6729 (Mon.–Fri., 6AM–5PM PST), except major holidays)

  • We are open from 6AM-5PM PST, Mon. through Fri., except for the following holidays:

    • New Year's Day
    • Memorial Day
    • Independence Day
    • Labor Day
    • Thanksgiving Holiday (Thursday and Friday)
    • Christmas Day

Important Safety Information & Indications

Indications

Early Breast Cancer

PHESGO® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for

  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC)
  • the adjuvant treatment of adult patients with HER2-positive early breast cancer (EBC) at high risk of recurrence

Select patients for therapy based on an FDA-approved companion diagnostic test.

Metastatic Breast Cancer

PHESGO is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic test.

BOXED WARNINGS: Cardiomyopathy, Embryo-Fetal Toxicity, and Pulmonary Toxicity

  • PHESGO administration can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving PHESGO with anthracycline-containing chemotherapy regimens. Evaluate cardiac function prior to and during treatment with PHESGO. Discontinue PHESGO treatment in patients receiving adjuvant therapy and withhold PHESGO in patients with metastatic disease for clinically significant decrease in left ventricular function
  • Exposure to PHESGO can result in embryo-fetal death and birth defects, including oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception

  • PHESGO administration can result in serious and fatal pulmonary toxicity. Discontinue PHESGO for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve

Contraindications

PHESGO is contraindicated in patients with known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients.

Additional Important Safety Information

Cardiomyopathy

  • PHESGO administration can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving PHESGO with anthracycline-containing chemotherapy regimens. An increased incidence of left ventricular ejection fraction (LVEF) decline has been observed in patients treated with intravenous pertuzumab, intravenous trastuzumab, and docetaxel

  • PHESGO can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death

  • PHESGO can also cause asymptomatic decline in LVEF

  • Patients who receive anthracycline after stopping PHESGO may also be at increased risk of cardiac dysfunction

  • Discontinue PHESGO treatment in patients receiving adjuvant therapy and withhold PHESGO in patients with metastatic disease for clinically significant decrease in left ventricular function

Cardiac Monitoring

  • Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of PHESGO

  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan

  • Monitor frequently for decreased left ventricular function during and after PHESGO treatment

  • Monitor more frequently if PHESGO is withheld for significant left ventricular cardiac dysfunction

Embryo-Fetal Toxicity

  • PHESGO can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of intravenous trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In an animal reproduction study, administration of intravenous pertuzumab to pregnant cynomolgus monkeys during the period of organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryo-fetal death at exposures 2.5 to 20 times the exposure in humans at the recommended dose, based on Cmax

  • Verify the pregnancy status of females of reproductive potential prior to the initiation of PHESGO. Advise pregnant women and females of reproductive potential that exposure to PHESGO during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PHESGO

  • There is a pregnancy pharmacovigilance program for PHESGO. If PHESGO is administered during pregnancy, or if a patient becomes pregnant while receiving PHESGO or within 7 months following the last dose of PHESGO, health care providers and patients should immediately report PHESGO exposure to Genentech at 1-888-835-2555

Pulmonary Toxicity

  • PHESGO can cause serious and fatal pulmonary toxicity. These adverse reactions have been reported with intravenous trastuzumab

  • Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

  • PHESGO may exacerbate chemotherapy-induced neutropenia. In randomized controlled clinical trials with intravenous trastuzumab, Grade 3-4 neutropenia and febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Hypersensitivity and Administration-Related Reactions

  • Severe administration-related reactions (ARRs), including hypersensitivity, anaphylaxis, and events with fatal outcomes, have been associated with intravenous pertuzumab and trastuzumab. Patients experiencing dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a severe or of a fatal ARR

  • In the FeDeriCa study the incidence of hypersensitivity was 1.2% in the PHESGO arm. ARRs occurred in 21% of patients who received PHESGO. In the PHESGO arm, the most common ARRs were injection site reaction (15%) and injection site pain (2%).

  • Closely monitor patients during and for 30 minutes after the injection of initial dose and during and for 15 minutes following subsequent injections of maintenance dose of PHESGO. If a significant injection-related reaction occurs, slow down or pause the injection and administer appropriate medical therapies. Evaluate and carefully monitor patients until complete resolution of signs and symptoms

  • Permanently discontinue treatment with PHESGO in patients who experience anaphylaxis or severe injection-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. For patients experiencing reversible Grade 1 or 2 hypersensitivity reactions, consider pre-medication with an analgesic, antipyretic, or an antihistamine prior to readministration of PHESGO

Most Common Adverse Reactions

Early Breast Cancer

The most common adverse reactions (>30%) with PHESGO were alopecia, nausea, diarrhea, anemia, and asthenia.

Metastatic Breast Cancer (based on IV pertuzumab)

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.