Prescription medicine
Pertuzumab Brand names: Perjeta
Pertuzumab (Perjeta) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pertuzumab FDA label on DailyMed (effective April 30, 2026, Genentech, Inc.); the BLA 125409 record on Drugs@FDA; every pertuzumab label on DailyMed.
Highlights of the record
FDA label of April 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LEFT VENTRICULAR.
DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3), Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) (8.3) ]. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.3 , 5.1 , 6.1 ) Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.
Used for
From the label: indications and usagePERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Forms and strengths
- 30 mg/ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- June 8, 2012 Perjeta, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 27,027 through July 30, 2026
What is pertuzumab used for?
From the label: indications and usagePERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults 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. […]
Conditions named in the indications of pertuzumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: HER2/neu Receptor Antagonist.
Source: FDA drug label (PERJETA), Genentech, Inc., effective April 30, 2026 (SPL set 17f85d17-ab71-4f5b-9fe3-0b8c822f69ff), via openFDA; the full label on DailyMed
Is there a generic for pertuzumab (Perjeta)?
No generic pertuzumab is approved (Drugs@FDA, October 8, 2026).
- 2012 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has pertuzumab been recalled?
The FDA's Enforcement Report lists 1 recall naming pertuzumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pertuzumab label say about other medicines?
The pertuzumab label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name pertuzumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Docetaxel | warnings and precautions | Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period. |
| Doxorubicin | warnings and precautions | … serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m 2 of doxorubicin or its equivalent. |
| Paclitaxel | warnings and precautions | Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period. |
| Trastuzumab | warnings and precautions | Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period. |
Source: FDA drug label (PERJETA), Genentech, Inc., effective April 30, 2026 (SPL set 17f85d17-ab71-4f5b-9fe3-0b8c822f69ff), via openFDA; the full label on DailyMed
What do FAERS reports show for pertuzumab?
The FDA Adverse Event Reporting System holds 27,027 reports that list pertuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,685 are coded as a death and 9,119 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pertuzumab?
12 other medicines are given the same way (intravenous) and in the same FDA class as pertuzumab or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
| Docetaxel | Breast cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer | 10 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as pertuzumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pertuzumab
- 12 medicines for the same use
- Other her2/neu receptor antagonists
- the pharmacologic class, with prices and generics
- Pertuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other