PERJETA Distribution
Authorized Distributors and Specialty Pharmacies
Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase PERJETA through the buy and bill model. Customers can purchase PERJETA through authorized specialty distributors and wholesalers that have made a commitment to product integrity. These partners have agreed to distribute only products purchased directly from Genentech and not to distribute PERJETA through secondary channels.
PERJETA Access Solutions works with SPs to help patients receive
their medicines. SPs can dispense Genentech medicines to your office.
The SPs can also provide coverage and reimbursement support.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Genentech does not influence or advocate the use of any one
specialty distributor or specialty pharmacy. We make no
representation or guarantee of service or coverage of any item.
About Buy and Bill
With buy and bill, the practice purchases the medication in advance,
then bills the patient’s health insurance plan for reimbursement. The
practice is responsible for storing and handling the drug as well as
collecting the patient’s co-pay for both the drug and its
administration. With buy and bill, practices can maintain a stock of
the drug, giving them the flexibility to treat patients when
clinically appropriate.
About Specialty Pharmacies
PERJETA Access Solutions works with specialty pharmacies (SPs) to help patients receive their medicines.
An SP may provide the following services:
- Reimbursement resources
- Clinical services to support patients throughout their treatment
- The
ability to manage the specialty handling and shipping needs linked
with many specialty therapies
You can work with your preferred SP or contact PERJETA Access
Solutions to learn which SP the patient’s health insurance plan
requires.
Genentech does not influence or advocate the use of any one specialty distributor of specialty pharmacy. We make no representation or guarantee of service or coverage of any item.
Spoilage Replacement Program
The Genentech Spoilage Replacement Program provides for replacement of infused, injected and self-administered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by Genentech. The purpose of the program is to support our commitment to protecting patient safety by preventing the use of spoiled, damaged or contaminated products.
Please contact Genentech Customer Service at (800) 551-2231 to submit a request for replacement of spoiled product or to obtain additional information about the Program.
To request replacement product:
- Contact Genentech Customer Service at (800) 551-2231 to obtain the Genentech Spoilage Replacement Program Form
- Complete the Genentech Spoilage Replacement Program Form and fax it back to Genentech Customer Service at (877) 329-6737 within 30 days of the spoilage event
- The request may take up to 3 business days to review. If approved by Genentech, further instructions for returning product or completing a Certificate of Destruction will be provided
- The spoiled product or
completed Certificate of Destruction must be received by Genentech
within 60 days of approval of the spoilage request
- Replacement product generally ships within 11 business days following receipt of the spoiled product or completed Certificate of Destruction
Important guidelines:
- Each instance of spoilage replacement requires completion of the Spoilage Replacement Program Form. Replacement is on a case-by-case basis at the sole discretion of Genentech; please retain all original product packaging for returns processing
- Genentech does not ship replacement product if the spoiled product has been used for an off-label indication
- Genentech does not ship replacement product if ANY portion of the product has been administered
- Genentech will only ship replacement product to licensed facilities
- All spoilage replacement requests are subject to review by Genentech; returned product is subject to analysis
- Replacement is not available if any amount has been billed to a patient or an insurance claim has been remitted to a payer
- Requests are subject to certain limitations and conditions. Genentech has the right to modify or discontinue the Spoilage Replacement Program at any time without notice
PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.
Important Safety Information & Indication
Indications
Metastatic Breast Cancer
- PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Early Breast Cancer
PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and chemotherapy for
- the neoadjuvant treatment of 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 patients with HER2-positive early breast cancer (EBC) at high risk of recurrence
Important Safety Information
BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
- PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
- Exposure to PERJETA can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception
Additional Important Safety Information
- PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
- PERJETA has been associated with severe and sometimes fatal infusion and hypersensitivity reactions/anaphylaxis
Most Common Adverse Reactions
In the treatment of metastatic breast cancer, the most common adverse reactions (>30%) seen with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy
In the neoadjuvant treatment of breast cancer
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles were alopecia, neutropenia, diarrhea, and nausea
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 3 cycles following 3 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) were diarrhea, nausea, alopecia, neutropenia, vomiting, and fatigue
- The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) administered for 6 cycles were diarrhea, alopecia, neutropenia, nausea, fatigue, vomiting, anemia, and thrombocytopenia
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and paclitaxel administered for 4 cycles following 4 cycles of dose-dense doxorubicin and cyclophosphamide (ddAC) were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia
In the adjuvant treatment of breast cancer, the most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting
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.