FDA-filed SPL labeling · retrieved through openFDA

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection

A subcutaneous combination of pertuzumab, trastuzumab, and hyaluronidase used to treat HER2-positive early breast cancer and HER2-positive metastatic breast cancer.

Brand name Phesgo
Drug classes Her2/neu Receptor Antagonist
Rx Form 1 Route Subcutaneous
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 effectiveMay 21, 2026
AvailabilityRx
Earliest approval/marketing year 2020
FDA-listed product records 4
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Phesgo is a targeted combination therapy for HER2-positive breast cancer that attacks cancer cells from two angles while allowing fast under-the-skin delivery. It carries important risks for the heart, lungs, and an unborn baby, so close monitoring, reliable contraception, and open communication with your care team are essential throughout treatment. Always have your heart function checked on schedule and report any new symptoms — especially shortness of breath, swelling, or fever — right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Phesgo has three serious boxed warnings that every patient should know about.

Heart damage (cardiomyopathy): Phesgo can weaken the heart, sometimes seriously, causing reduced heart pumping function or heart failure. The risk is greatest when it is given alongside anthracycline-type chemotherapy. Your heart function will be tested before you start and regularly during treatment. If your heart is significantly affected, Phesgo will be paused or stopped permanently.

Harm to an unborn baby (embryo-fetal toxicity): Phesgo can cause severe birth defects or death of an unborn baby. This includes reduced amniotic fluid, abnormal lung and skeletal development, and newborn death. Do not use Phesgo if you are pregnant. Use reliable birth control during treatment and for 7 months after your last dose. Tell your doctor immediately if you become pregnant.

Lung toxicity: Phesgo can cause serious and potentially fatal lung reactions, including severe allergic reactions (anaphylaxis), lung inflammation (interstitial pneumonitis), and acute respiratory distress syndrome. Phesgo must be stopped permanently if any of these occur. Watch for new or worsening shortness of breath, wheezing, or swelling of the face or throat and seek emergency care immediately.

Read the full warning on DailyMed →

📖 Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection: Patient Information Guide

A plain-language walkthrough of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a targeted combination therapy approved for HER2-positive breast cancer in adults. All uses require confirmation of HER2-positive status through an FDA-authorized test before starting treatment.

  • Phesgo is used before surgery (neoadjuvant) with chemotherapy for HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor larger than 2 cm or with lymph node involvement), as part of a complete early breast cancer treatment plan
  • Phesgo is used after surgery (adjuvant) with chemotherapy for HER2-positive early breast cancer at high risk of returning
  • Phesgo is used with docetaxel chemotherapy for HER2-positive metastatic breast cancer (cancer that has spread to other areas of the body) in adults who have not yet received anti-HER2 therapy or chemotherapy for metastatic disease
⚙️How it works

HER2 is a protein on the surface of some breast cancer cells that acts like a growth accelerator — when it's overproduced, it drives cancer cells to multiply rapidly. Pertuzumab and trastuzumab are both antibodies designed to latch onto HER2, but they grab different spots. Pertuzumab blocks HER2 from linking up with neighboring proteins (a process called heterodimerization) that trigger growth signals inside the cell. Trastuzumab blocks a different region of HER2 to directly shut down cell proliferation. Together, they also flag cancer cells for destruction by the immune system — a process called antibody-dependent cell-mediated cytotoxicity (ADCC). The third ingredient, hyaluronidase, temporarily softens the tissue under the skin so the two antibodies can be absorbed quickly through a short injection rather than a lengthy IV infusion; this effect is local, reversible, and wears off within 24 to 48 hours.

💊How it's taken

Phesgo is given as a subcutaneous injection (under the skin of the thigh only) by a healthcare professional — never self-injected or given into a vein. The first dose is larger and takes about 8 minutes; all follow-up (maintenance) doses are smaller and take about 5 minutes, given every 3 weeks.

  • Before surgery (neoadjuvant): Phesgo is given every 3 weeks for 3 to 6 cycles alongside chemotherapy, then continued after surgery to complete 1 year of treatment (up to 18 total cycles)
  • After surgery (adjuvant): Phesgo is given every 3 weeks for up to 1 year (up to 18 cycles) as part of a complete regimen including chemotherapy
  • Metastatic breast cancer: Phesgo is given every 3 weeks with docetaxel until disease progresses or side effects become unmanageable
  • Missed doses: If less than 6 weeks have passed since the last dose, the maintenance dose is given without waiting for the next scheduled date; if 6 or more weeks have passed, a full initial dose is restarted — always follow your care team's guidance
🤒Side effects — in detail

The most common side effects with Phesgo in early breast cancer trials included:

  • Hair loss (alopecia)
  • Nausea
  • Diarrhea
  • Anemia (low red blood cell count)
  • Fatigue or weakness (asthenia)
  • Injection site reaction or pain
  • Muscle pain (myalgia) and joint pain (arthralgia)
  • Decreased appetite
  • Headache and nerve tingling (peripheral neuropathy)
  • Neutropenia (low white blood cell count), which can increase infection risk

Serious reactions to watch for and act on immediately include signs of heart problems (shortness of breath, unusual swelling, rapid weight gain), severe allergic or injection reactions (throat tightening, hives, difficulty breathing), lung symptoms (new cough, worsening breathlessness), or fever and signs of infection. Get medical help right away if any of these occur.

⚠️Warnings & precautions
  • Heart damage (cardiomyopathy): Phesgo can reduce the heart's pumping strength, sometimes causing heart failure. Risk is highest with anthracycline chemotherapy. Heart function (LVEF) is monitored before and regularly during treatment. Phesgo is paused or stopped if the heart is significantly affected.
  • Fetal harm (embryo-fetal toxicity): Phesgo can cause severe birth defects and fetal death. Effective birth control is required during treatment and for 7 months after the last dose. Pregnancy must be ruled out before starting.
  • Lung toxicity: Serious and potentially fatal lung reactions — including anaphylaxis, lung inflammation (interstitial pneumonitis), and acute respiratory distress syndrome — can occur. Phesgo is permanently stopped if these develop.
  • Worsening neutropenia: Phesgo can make chemotherapy-related low white blood cell counts worse, increasing the risk of serious infection.
  • Hypersensitivity and injection reactions: Reactions at the injection site or whole-body allergic reactions can occur; patients are monitored for at least 30 minutes after the first dose and 15 minutes after every maintenance dose. Emergency medications must be on hand.
🔀What it interacts with

Currently, the main known drug interaction with Phesgo involves heart risk with a specific class of chemotherapy:

  • Anthracycline chemotherapy (e.g., doxorubicin): Using anthracyclines after stopping Phesgo significantly raises the risk of heart damage because Phesgo remains in the body for a long time (long washout period). If anthracyclines must be used, avoid them for up to 7 months after the last Phesgo dose and monitor heart function carefully throughout.

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
  • Known allergy to pertuzumab, trastuzumab, or hyaluronidase: Phesgo is contraindicated — do not use it if you have had a serious allergic reaction to any of these ingredients
  • Heart problems or low heart pumping function: Your heart must be assessed (by echocardiogram or MUGA scan) before starting and regularly during treatment; Phesgo has not been studied in patients with an LVEF below 55% at the start of treatment
  • Pregnancy: Phesgo can cause serious fetal harm or death — pregnancy must be confirmed negative before starting, and effective contraception is required during and for 7 months after treatment
  • Breastfeeding: It is not known whether Phesgo passes into breast milk; the long washout period (7 months) must be factored into any decision about nursing
  • Lung disease: Patients with existing lung disease or extensive tumor involvement in the lungs may be at higher risk of severe pulmonary reactions
  • Older adults (65+): May have higher risk of heart dysfunction, decreased appetite, anemia, and nerve-related side effects — close monitoring is especially important
  • Children: Safety and effectiveness in pediatric patients have not been established; Phesgo is not approved for use in children
  • Prior anthracycline exposure: Patients who have received high cumulative doses of anthracyclines (above 360 mg/m² of doxorubicin or equivalent) have not been studied with Phesgo
📡Pharmacodynamics — effects in the body

The full relationship between Phesgo blood levels and its effects on safety and cancer outcomes has not been completely characterized. Studies of intravenous pertuzumab found no large changes in heart rhythm (QT interval) at standard doses, though a small effect cannot be entirely ruled out. Trastuzumab also showed no clinically meaningful effect on heart rhythm in patients with HER2-positive solid tumors.

🔬Pharmacokinetics — how your body processes it

Phesgo is given subcutaneously (under the skin), and hyaluronidase helps the pertuzumab and trastuzumab components absorb into the bloodstream quickly from the injection site. Pharmacokinetic studies (the FeDeriCa trial) compared subcutaneous Phesgo to standard intravenous pertuzumab and trastuzumab to confirm that the drug levels in the blood are therapeutically comparable. Maintenance doses are given every 3 weeks. Because both pertuzumab and trastuzumab stay in the body for a long time, a washout period of approximately 7 months is used for safety decisions, such as timing of pregnancy or anthracycline use after stopping treatment.

📦How to store it

Store PHESGO vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

📄 Written from Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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, Trastuzumab, and Hyaluronidase-zzxf Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Phesgo and why do I need three ingredients in one shot?
Phesgo combines two cancer-fighting antibodies — pertuzumab and trastuzumab — that work together to attack HER2, the protein driving your cancer's growth. They work at two different spots on HER2, so together they're more effective than either one alone. The third ingredient, hyaluronidase, temporarily softens the tissue under your skin so both antibodies can absorb quickly from a short under-the-skin injection, instead of requiring a long IV drip. Think of it as the delivery helper.
Will this affect my heart? What should I watch for?
Yes, heart effects are one of the most important things to monitor with Phesgo. It can weaken your heart's pumping strength — sometimes without any symptoms at first. Your care team will check your heart function before you start and regularly during treatment using an echocardiogram or a similar test. Call your doctor right away if you notice new or worsening shortness of breath, swelling in your legs or feet, a rapid heartbeat, or unusual tiredness. The risk is highest if you also receive anthracycline chemotherapy.
Can I get pregnant while on Phesgo?
No — Phesgo can cause very serious harm to an unborn baby, including birth defects and fetal death. You must use reliable birth control throughout your entire treatment and for 7 months after your very last dose, because Phesgo stays in your body for a long time. Before starting treatment, your doctor will confirm you're not pregnant. If you accidentally become pregnant during treatment or within 7 months after stopping, contact your healthcare team immediately.
How is the injection given, and will it hurt?
Phesgo is always given by a nurse or other healthcare professional — you won't do this at home. It goes into the skin of your thigh (not a vein), and the first injection takes about 8 minutes; follow-up doses take about 5 minutes. Injection site reactions and some pain at the site are the most common local side effects. You'll be observed for at least 30 minutes after your first dose and 15 minutes after each later dose, just to make sure you don't have any reaction.
What side effects are most likely and which ones mean I should call someone right away?
The most common side effects in studies were hair loss, nausea, diarrhea, low red blood cell counts (anemia), fatigue, and injection site reactions. Most of these are manageable with your care team's help. But call your doctor or seek emergency care immediately if you develop signs of a serious allergic reaction (throat tightening, hives, trouble breathing), chest pain or shortness of breath, fever or signs of infection, or any new breathing problems. These can be signs of serious heart, lung, or blood count issues that need prompt attention.
Can I switch to Phesgo if I've already been getting pertuzumab and trastuzumab through an IV?
Yes — if your doctor decides it's appropriate, you can transition from intravenous pertuzumab and trastuzumab to Phesgo. How the switch is done depends on how long it has been since your last IV dose. If it's been less than 6 weeks, you'd receive the smaller maintenance dose of Phesgo; if it's been 6 weeks or longer, you'd restart with the larger initial dose. Your care team will calculate the right timing for you. Just remember, Phesgo is not interchangeable with other trastuzumab products on a one-for-one basis.
Is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection available over the counter?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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, Trastuzumab, and Hyaluronidase-zzxf Injection first available?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection has been available in the United States since at least 2020, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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, Trastuzumab, and Hyaluronidase-zzxf Injection comes

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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

Under the skin
Brands Phesgo
How this form is used
What it may be used for
  • Phesgo is used with chemotherapy before surgery (neoadjuvant treatment) for HER2-positive locally advanced, inflammatory, or early-stage breast cancer
  • Phesgo is used with chemotherapy after surgery (adjuvant treatment) for HER2-positive early breast cancer at high risk of coming back
  • Phesgo is used with docetaxel for HER2-positive metastatic breast cancer in adults who have not yet had anti-HER2 therapy or chemotherapy for metastatic disease
Important instructions
  • Phesgo is injected subcutaneously (under the skin) into the thigh only — it must never be given intravenously
  • Phesgo must always be administered by a healthcare professional; the initial dose takes about 8 minutes and each maintenance dose takes about 5 minutes
  • Phesgo maintenance doses are given every 3 weeks; patients must be observed for at least 30 minutes after the first dose and 15 minutes after each subsequent dose
  • Phesgo should not be substituted for or with intravenous pertuzumab, intravenous trastuzumab, or other trastuzumab-based products
Available strengths 4 strengths
4 FDA-listed product records

📊 Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection across the U.S. market

How Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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
4
FDA-listed product records
2020
First marketed

📈 How widely Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection is used

A general measure of how commonly Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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, Trastuzumab, and Hyaluronidase-zzxf 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.

6,412
Medicaid prescriptions filled (Q1–Q4 2025)
$47.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection prescribed? Of the 1,594 medications we measure, Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection ranks #1,010 by Medicaid prescriptions — more than 37% of them.

Where Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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.

Other Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

6,412 Medicaid prescriptions (Q1–Q4 2025) 100% of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection prescriptions shown $47.5M gross reimbursement (before rebates) ≈ $7,411 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity.

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, Trastuzumab, and Hyaluronidase-zzxf 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 2 of 4 listed Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection NDCs with Medicaid activity.

🔍 Compare Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection products

A representative set of FDA-listed product records for Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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
PERTUZUMAB 600 mg/10 mL; TRASTUZUMAB 600 mg/10 mL; HYALURONIDASE (HUMAN RECOMBINANT) 20000 U/10 mL Subcutaneous Genentech, Inc. BLA View NDC →
PERTUZUMAB 1200 mg/15 mL; TRASTUZUMAB 600 mg/15 mL; HYALURONIDASE (HUMAN RECOMBINANT) 30000 U/15 mL Subcutaneous Genentech, Inc. BLA View NDC →
20000; 600; 600 U/10 mL; mg/10 mL; mg/10 mL Subcutaneous Genentech, Inc. BLA View NDC →
30000; 1200; 600 U/15 mL; mg/15 mL; mg/15 mL Subcutaneous Genentech, Inc. BLA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection NDCs →

🏷️ Sold under these brand names

Phesgo

🏭 Manufacturers & labelers

Genentech, Inc. 4

RxNorm drug class

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection belongs to the Endoglycosidase class.

Pharmacologic class Endoglycosidase
Drug family (ATC) Enzymes

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 May 21, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf 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, Trastuzumab, and Hyaluronidase-zzxf Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
1
Linked representative label
Genentech, Inc.
Linked label effective
May 21, 2026
Composite sections available
22
Linked SPL Set ID
27dd5e6b-72cd-458d-a015-cf4dab5800da
Linked SPL Document ID
9d068707-f189-4f0f-a74e-17bbe1f10476
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.