FDA-filed SPL labeling · retrieved through openFDA

Pertuzumab Injection

Pertuzumab injection (Perjeta) is a targeted cancer therapy used with other medicines to treat HER2-positive metastatic breast cancer and HER2-positive early breast cancer.

Brand name Perjeta
Drug class Her2/neu Receptor Antagonist
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 30, 2026
AvailabilityRx
Earliest approval/marketing year 2012
FDA-listed product records 2
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Pertuzumab Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Perjeta (pertuzumab) is a targeted IV therapy for HER2-positive breast cancer — used before or after surgery for early breast cancer, or to treat metastatic breast cancer — always given alongside trastuzumab and chemotherapy. It requires close heart monitoring throughout treatment and must never be used during pregnancy. Work closely with your oncology team to watch for heart symptoms and infusion reactions throughout your course of treatment.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Perjeta carries two serious boxed warnings — the FDA's most urgent safety alert.

Heart problems: Perjeta can cause the heart to pump less effectively (decreased left ventricular ejection fraction), which can lead to clinical heart failure. Your heart function must be checked before you start and regularly during treatment. If a significant, confirmed decline in heart function occurs, Perjeta must be stopped.

Harm to an unborn baby: Perjeta can cause the death of a fetus or serious birth defects. If you are pregnant or could become pregnant, talk to your doctor immediately. Effective contraception is required during treatment and for 7 months after your last dose of Perjeta when used in combination with trastuzumab.

Read the full warning on DailyMed →

📖 Pertuzumab Injection: Patient Information Guide

A plain-language walkthrough of Pertuzumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Pertuzumab injection (Perjeta) is a HER2-targeted therapy approved for adults with HER2-positive breast cancer in the following settings:

  • Metastatic breast cancer: Perjeta is used with trastuzumab and docetaxel for adults whose cancer has spread and who have not yet received anti-HER2 therapy or chemotherapy for metastatic disease.
  • Neoadjuvant (pre-surgery) treatment of early breast cancer: Perjeta is used with trastuzumab and chemotherapy before surgery for adults with HER2-positive locally advanced, inflammatory, or early stage breast cancer (tumors larger than 2 cm or with lymph node involvement).
  • Adjuvant (post-surgery) treatment of early breast cancer: Perjeta is used with trastuzumab and chemotherapy after surgery for adults with HER2-positive early breast cancer who are at high risk of the cancer returning.
⚙️How it works

Pertuzumab is a monoclonal antibody that locks onto a specific region of the HER2 protein on cancer cells. HER2 is a receptor that, when overactive, tells cancer cells to grow and divide. By binding to HER2, pertuzumab prevents it from pairing (dimerizing) with other related receptors like HER3 and EGFR — a pairing cancer cells use to send growth signals. Blocking these signals can stop cancer cells from growing and trigger them to self-destruct (a process called apoptosis). Pertuzumab also recruits immune cells to attack the tumor directly, a process called antibody-dependent cell-mediated cytotoxicity (ADCC). When used together with trastuzumab — which targets a different part of HER2 — the combined effect on the tumor is greater than either drug alone.

💊How it's taken

Perjeta is given as an intravenous (IV) infusion in a clinic or infusion center — never at home, and never as a rapid injection. It is given once every 3 weeks throughout treatment. For metastatic breast cancer, it is given alongside trastuzumab and docetaxel every 3 weeks. For neoadjuvant treatment, it is given every 3 weeks for 3 to 6 cycles before surgery, followed by continued trastuzumab-based treatment after surgery. For adjuvant treatment, Perjeta is given with trastuzumab and chemotherapy every 3 weeks for a total of 1 year (up to 18 cycles).

  • Do not miss doses — if a dose is delayed, contact your care team right away, as the timing of the next dose matters.
  • Dose reductions are not recommended for Perjeta, but your other chemotherapy medicines may be adjusted.
  • Your heart function (LVEF) must be checked before starting and regularly during treatment.
🤒Side effects — in detail

The most common side effects of Perjeta (reported in more than 30% of patients) include:

  • Diarrhea
  • Hair loss (alopecia)
  • Nausea
  • Fatigue
  • Low white blood cell count (neutropenia)
  • Rash
  • Peripheral neuropathy (tingling, numbness, or weakness in hands or feet)
  • Vomiting

More serious reactions to act on quickly include signs of heart problems (shortness of breath, swelling, rapid heartbeat), severe infusion reactions (chills, fever, dizziness, trouble breathing), severe allergic reactions (anaphylaxis), or fever with low blood cell counts (febrile neutropenia, which is a medical emergency). Tell your care team immediately if any of these occur.

⚠️Warnings & precautions
  • Heart problems (left ventricular dysfunction): Perjeta can weaken the heart's pumping ability, potentially leading to heart failure. Heart function is checked before treatment starts and at regular intervals. If it drops significantly and does not recover, Perjeta must be permanently stopped. People who previously received anthracycline chemotherapy or chest radiation are at higher risk.
  • Serious harm to an unborn baby (embryo-fetal toxicity): Perjeta can cause fetal death or birth defects. Pregnancy must be ruled out before starting treatment. Effective contraception is required during treatment and for 7 months after the last dose when combined with trastuzumab.
  • Infusion reactions: Reactions during or just after the IV infusion — including potentially fatal events — can occur. Patients are monitored for 30–60 minutes after each infusion. If a significant reaction happens, the infusion is slowed or stopped and medical treatment is given.
  • Severe allergic reactions (anaphylaxis/hypersensitivity): Perjeta can cause life-threatening allergic reactions. If you develop throat swelling, hives, or difficulty breathing, get emergency help immediately.
🔀What it interacts with

The FDA label for Perjeta does not describe specific drug, food, or supplement interactions beyond the medicines used as part of the treatment regimen itself. Always tell your entire care team about every medicine, supplement, and herbal product you take.

  • Anthracycline chemotherapy (e.g., doxorubicin, epirubicin): When used in regimens that include anthracyclines, Perjeta and trastuzumab should be given after — not during — the anthracycline portion of treatment, due to combined risk of heart stress.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Heart conditions: Perjeta has not been studied in patients with a baseline low heart pumping function (LVEF below 50%), prior heart failure, significant heart rhythm problems requiring treatment, uncontrolled high blood pressure, or recent heart attack — tell your doctor about any heart history.
  • Prior chest radiation or anthracycline chemotherapy: These increase the risk of heart complications with Perjeta.
  • Allergy: Do not use Perjeta if you are allergic to pertuzumab or any ingredient in the product.
  • Pregnancy: Perjeta can cause fetal death and birth defects — pregnancy must be confirmed negative before starting, and effective contraception used during and for 7 months after treatment.
  • Breastfeeding: It is not known whether pertuzumab passes into breast milk. Discuss the risks and benefits with your doctor, taking into account the long elimination period of both Perjeta and trastuzumab.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults (65+): May be more likely to experience decreased appetite, anemia, nerve problems (peripheral neuropathy), fatigue, and low magnesium levels — monitoring is important.
  • Kidney impairment: Mild to moderate kidney impairment does not significantly change how the body handles pertuzumab; effects in severe kidney impairment are unknown — tell your doctor about any kidney problems.
  • Liver impairment: The effects of pertuzumab in patients with moderate to severe liver impairment are not known — inform your doctor of any liver conditions.
📡Pharmacodynamics — effects in the body

Perjeta works by blocking HER2 from pairing with other growth-signaling receptors, cutting off key pathways that drive tumor cell growth. At recommended doses, Perjeta has not been shown to cause a clinically meaningful increase in the heart's electrical interval (QTc), which means it does not significantly affect heart rhythm in the way some other cancer drugs can — though a very small effect cannot be entirely ruled out.

🔬Pharmacokinetics — how your body processes it

Pertuzumab behaves predictably in the body — its levels increase proportionally with dose. After an initial higher loading infusion followed by a maintenance infusion every 3 weeks, steady drug levels in the blood are reached after the very first maintenance dose. The drug has a half-life of about 18 days, meaning it takes roughly that long for half of it to be cleared from the body. Factors like age, sex, ethnicity, body weight, and mild to moderate kidney impairment do not meaningfully change how the body handles pertuzumab, so no dose adjustments are needed for those factors.

📦How to store it

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze.

📄 Written from Pertuzumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Pertuzumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Perjeta and why do I need it alongside other medicines?
Perjeta is a targeted therapy specifically designed for cancers that overexpress a protein called HER2. It works by attaching to the HER2 protein and blocking it from sending the growth signals that help cancer cells multiply. It's always used together with trastuzumab and a chemotherapy drug because the combination attacks HER2 from multiple angles and has been shown to work better than any single drug alone. Think of it as a coordinated approach to shutting down the cancer's ability to grow.
How will I receive Perjeta, and how long does it take?
Perjeta is given as an IV infusion by your care team in a clinic or infusion center — it goes directly into your vein through a drip. Each infusion takes between 30 and 60 minutes, though your first dose takes a full 60 minutes. After each infusion, you'll wait an additional 30 to 60 minutes so your team can make sure you're not having a reaction before you receive your other medicines. You'll come in for treatment once every 3 weeks, and the number of cycles depends on whether you're being treated before surgery, after surgery, or for metastatic disease.
What side effects are most likely, and which ones should make me call my doctor?
The most common side effects are diarrhea, hair loss, nausea, fatigue, low white blood cell counts, rash, and tingling or numbness in the hands and feet. Most of these can be managed with your care team's help. However, call your doctor right away — or go to the emergency room — if you develop a fever (which could signal a dangerous drop in infection-fighting cells), shortness of breath or swelling (which could signal heart problems), or severe symptoms during or right after an infusion like chills, dizziness, or trouble breathing (which could signal a serious infusion or allergic reaction).
Why does my doctor need to check my heart before and during treatment?
Perjeta can affect the heart's ability to pump blood effectively — this is one of its most important risks. Before you start, your care team will measure your heart's pumping strength (called the ejection fraction), and they'll continue checking it at regular intervals throughout treatment. If your heart function drops significantly and doesn't bounce back, your doctor may need to pause or stop Perjeta permanently. If you've previously had chest radiation or certain types of chemotherapy, you may need especially close monitoring. Let your team know right away if you feel short of breath, notice swelling in your legs, or feel your heart beating fast or irregularly.
Is it safe to get pregnant or breastfeed while on Perjeta?
No — Perjeta carries a serious warning about pregnancy. It can cause the death of a fetus or significant birth defects, so your doctor will confirm you are not pregnant before starting treatment. You'll need to use effective birth control throughout your treatment and for 7 months after your last dose (when Perjeta is used with trastuzumab). If you become pregnant or think you might be, contact your care team immediately. Breastfeeding is also something to discuss carefully with your doctor, keeping in mind how long it takes for the medicine to clear your body.
What happens if I miss an infusion appointment?
It's important to stay as close to your every-3-week schedule as possible. If you do miss a dose, contact your care team right away — don't just wait for the next scheduled appointment. If less than 6 weeks have passed, you'll typically receive your usual maintenance dose as soon as possible. But if it's been 6 weeks or more, you may need to restart with a higher loading dose before going back to the regular maintenance dose. Your team will guide you through exactly what to do based on your situation.
Is Pertuzumab Injection available over the counter?
Pertuzumab Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Pertuzumab Injection first available?
Pertuzumab Injection has been available in the United States since at least 2012, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Pertuzumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Pertuzumab Injection comes

Pertuzumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Perjeta
How this form is used
What it may be used for
  • Perjeta is used intravenously with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not had prior anti-HER2 therapy or chemotherapy for metastatic disease
  • Perjeta is used intravenously with trastuzumab and chemotherapy as neoadjuvant (pre-surgery) treatment for adults with HER2-positive locally advanced, inflammatory, or early stage breast cancer
  • Perjeta is used intravenously with trastuzumab and chemotherapy as adjuvant (post-surgery) treatment for adults with HER2-positive early breast cancer at high risk of recurrence
Important instructions
  • Perjeta is given only by intravenous infusion — never as a rapid IV push or bolus injection
  • Perjeta infusions are given once every 3 weeks by a healthcare professional in a clinical setting
  • After each Perjeta infusion, patients are observed for 30 to 60 minutes before any other medications in the regimen are given
  • If a dose is delayed or missed, follow your care team's guidance — a loading dose may be needed if 6 or more weeks have passed since the last dose
Available strengths 1 strength
2 FDA-listed product records

📊 Pertuzumab Injection across the U.S. market

How Pertuzumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
2
FDA-listed product records
2012
First marketed

📈 How widely Pertuzumab Injection is used

A general measure of how commonly Pertuzumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pertuzumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

13,810
Medicaid prescriptions filled (Q1–Q4 2025)
$97.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pertuzumab Injection prescribed? Of the 1,596 medications we measure, Pertuzumab Injection ranks #872 by Medicaid prescriptions — more than 45% of them.

Where Pertuzumab Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Pertuzumab Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

14 ML pertuzumab 30 MG/ML Injection

13,810 Medicaid prescriptions (Q1–Q4 2025) 100% of Pertuzumab Injection prescriptions shown $97.1M gross reimbursement (before rebates) ≈ $7,030 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1298948

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pertuzumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Pertuzumab Injection NDCs with Medicaid activity.

🔍 Compare Pertuzumab Injection products

A representative set of FDA-listed product records for Pertuzumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
30 mg/mL Intravenous Genentech, Inc. × 2 listings BLA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Pertuzumab Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pertuzumab Injection RxCUI 1298944 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1657572 In current FDA listings
    Clinical drug / strength (SCD) 14 ML pertuzumab 30 MG/ML RxCUI 1298948

Look up RxCUI 1298944 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Perjeta

🏭 Manufacturers & labelers

Genentech, Inc. 2

RxNorm drug class

Pertuzumab Injection belongs to the HER2/neu Receptor Antagonist class.

Pharmacologic class HER2/neu Receptor Antagonist
Drug family (ATC) HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
How it works HER2/Neu/cerbB2 Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 30, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pertuzumab Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pertuzumab Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label
Genentech, Inc.
Linked label effective
Apr 30, 2026
Composite sections available
21
Linked SPL Set ID
17f85d17-ab71-4f5b-9fe3-0b8c822f69ff
Linked SPL Document ID
dfebfe9c-a0c5-41d8-bf11-ed643627e264
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.