Get answers to common questions about support and resources from Genentech for patients who have been prescribed PHESGO.
Finding support FAQs
Regardless of the type of health insurance your patients have – and even if they don't have any – there may be options available to help them afford PHESGO.
You can check patient eligibility online. The financial assistance tool will guide the patient through some of their options and let them know which financial support programs may be right for them.
Here are a few things you or your patient may need on hand:
- Patient information: full name, date of birth, mailing address, email, phone (home and/or mobile) and insurance information
- Prescribing doctor's information: complete contact information, primary diagnosis code and prescription details
- Patient's financial eligibility information: number of people in the patient's household (including patient) and annual net household income
Each program has its own time period in which eligible patients will receive assistance.
PHESGO Access Solutions may be able to help patients understand how to get the medicine they need. PHESGO Access Solutions can find out:
- If the health insurance plan covers the PHESGO medicine
- How much the co-pay will be
Even with health insurance, there may be concerns about the cost of treatment. PHESGO Access Solutions can refer patients to financial assistance options.
To learn more about how PHESGO Access Solutions can help, visit Genentech-Access.com/PHESGO/patients.
Insurance coverage FAQs
No matter what type of health insurance your patients have, and even if they have none at all, there may be options available to help afford PHESGO.
PHESGO Access Solutions is your resource for access and reimbursement support after PHESGO is prescribed. You can:
- Get helpful resources for your practice, including what you'll need to get started.
- Log in or sign up for My Patient Solutions to enroll patients and manage service requests.
No. If the patient's health insurance plan denied coverage for PHESGO (after submission of a Prior Authorization, if required), the patient can apply for help from the Genentech Patient Foundation. The patient does not need to send proof of the appeal to get help.
Learn more about the Genentech Patient Foundation, including eligibility criteria and how to apply.
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® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) 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 were 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 were 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 trial 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.