Trastuzumab Injection
Trastuzumab injection (Herceptin, Herzuma, Ogivri, Ontruzant) is a targeted cancer therapy used to treat HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction cancer in adults.
🧬 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 4 clinical label sets 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Trastuzumab carries serious FDA boxed warnings for four major risks:
- Heart damage (cardiomyopathy): Trastuzumab can weaken the heart, sometimes causing heart failure. This risk is greatest when it is given with anthracycline-type chemotherapy. Heart function must be checked before and throughout treatment, and trastuzumab must be stopped if significant heart damage occurs.
- Serious infusion reactions: Dangerous reactions — including anaphylaxis (life-threatening allergic reaction), severe swelling (angioedema), and very low blood pressure — can happen during or shortly after the IV infusion. The infusion must be slowed or stopped if serious symptoms develop.
- Harm to an unborn baby (embryo-fetal toxicity): If trastuzumab is used during pregnancy, it can cause very low amniotic fluid (oligohydramnios), abnormal fetal bone development, underdeveloped lungs, and neonatal death. Women who could become pregnant must use effective birth control during treatment and for 7 months after the last dose.
- Serious lung problems (pulmonary toxicity): Trastuzumab can cause life-threatening lung reactions including acute respiratory distress syndrome and interstitial pneumonitis. The infusion must be stopped permanently if these occur.
📖 Trastuzumab Injection: Patient Information Guide
A plain-language walkthrough of Trastuzumab 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▾
Trastuzumab injection is a targeted therapy used in adults whose tumors test positive for high levels of the HER2 protein. Patients must be selected using FDA-approved HER2 testing before starting treatment.
- Adjuvant breast cancer (early-stage, after surgery): Ontruzant is used as part of combination chemotherapy regimens for HER2-overexpressing node-positive or certain high-risk node-negative breast cancer, for a total of 52 weeks of therapy.
- Metastatic breast cancer (spread to other parts of the body): Ontruzant is used with paclitaxel as first-line treatment for HER2-overexpressing metastatic breast cancer, or alone for patients who have already received one or more chemotherapy regimens for metastatic disease.
- Metastatic gastric or gastroesophageal junction adenocarcinoma: Ontruzant is used in combination with cisplatin and capecitabine or 5-fluorouracil for HER2-overexpressing metastatic gastric or gastroesophageal junction cancer in adults who have not previously been treated for metastatic disease.
- Ogivri is approved as a biosimilar for the same breast cancer and metastatic gastric cancer indications as the reference trastuzumab product, for the same conditions of use and routes of administration.
⚙️How it works▾
Trastuzumab is a monoclonal antibody — a targeted protein engineered to seek out and attach to the HER2 receptor, a protein found at abnormally high levels on the surface of certain cancer cells. By binding to HER2, trastuzumab blocks signals that tell cancer cells to grow and multiply. It also activates the immune system to attack HER2-overexpressing tumor cells directly, through a process called antibody-dependent cellular cytotoxicity (ADCC), where immune cells are guided to destroy the cancer cells.
Trastuzumab's effects are selective — it is preferentially active against cancer cells that overexpress HER2, compared to cancer cells that do not. This is why HER2 testing is required before treatment begins.
💊How it's taken▾
Trastuzumab injection is always given intravenously (IV into a vein) by a trained healthcare provider — it is not taken by mouth and cannot be given as a rapid IV push. The first dose is infused slowly over 90 minutes; if tolerated well, later doses may be given over a shorter period. Depending on the cancer being treated and the regimen prescribed, it is given either once a week or once every three weeks.
- For adjuvant breast cancer treatment, Ontruzant is typically continued for a total of 52 weeks.
- For metastatic breast cancer or metastatic gastric cancer, Ontruzant is generally continued until disease progression.
- If a dose is missed by one week or less, it should be given as soon as possible without waiting for the next scheduled cycle; if missed by more than one week, a higher re-loading dose is needed before returning to the regular schedule.
🤒Side effects — in detail▾
The most common side effects reported with trastuzumab include:
- Fever, chills, and flu-like symptoms — especially around the time of infusion
- Nausea, vomiting, or diarrhea
- Headache
- Fatigue or weakness
- Cough or shortness of breath
- Rash
- Muscle or joint pain
- Infections (such as colds, upper respiratory infections, or urinary tract infections)
- Low red blood cell counts (anemia) or low white blood cell counts (neutropenia), especially when given with chemotherapy
Seek immediate help if you experience difficulty breathing, chest pain, severe dizziness, signs of a serious allergic reaction (swelling of the face or throat, hives), signs of heart trouble (leg swelling, rapid weight gain, feeling faint), or signs of serious infection such as high fever. These can be signs of life-threatening reactions that require urgent attention.
⚠️Warnings & precautions▾
- Heart damage (cardiomyopathy): Trastuzumab can cause the heart to pump less effectively — from a mild, symptom-free decline in heart function to full heart failure. The risk is highest when it is combined with anthracycline chemotherapy. Heart function (measured as LVEF) must be tested before starting treatment and checked every 3 months during treatment. The drug may need to be paused or stopped permanently if significant heart damage occurs.
- Serious infusion reactions: Life-threatening reactions including anaphylaxis, severe low blood pressure, and breathing difficulty can occur during or shortly after infusion. Patients are monitored closely. The infusion is slowed, paused, or stopped permanently depending on severity.
- Fetal harm (embryo-fetal toxicity): Trastuzumab can cause very low amniotic fluid, fetal skeletal abnormalities, and neonatal death if used during pregnancy. Effective contraception is required during treatment and for 7 months after the last dose. Pregnancy must be ruled out before starting.
- Serious lung toxicity: Trastuzumab can cause interstitial pneumonitis (lung inflammation), fluid around the lungs, respiratory failure, and acute respiratory distress syndrome. Patients with existing lung disease or heavy tumor involvement in the lungs are at higher risk.
- Worsened chemotherapy-induced low white blood cells (neutropenia): When combined with certain chemotherapy drugs, trastuzumab can increase the risk of dangerously low white blood cell counts, raising infection risk.
🔀What it interacts with▾
Formal drug interaction studies with trastuzumab have not been conducted in humans, but one clinically important interaction has been identified:
- Anthracycline chemotherapy (e.g., doxorubicin): Trastuzumab stays in the body for up to 7 months after the last dose. Starting anthracycline-type chemotherapy during this washout period may increase the risk of serious heart damage. Doctors should avoid anthracyclines for up to 7 months after stopping trastuzumab whenever possible, and should monitor heart function carefully if anthracyclines must be used.
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 problems: Anyone with a history of heart disease, heart failure, or prior anthracycline chemotherapy should discuss this with their doctor — baseline and ongoing heart monitoring is essential for everyone.
- Pregnancy: Trastuzumab is harmful to a developing baby. Pregnancy status must be checked before starting treatment. Do not use during pregnancy unless the benefit clearly outweighs the serious risk.
- Contraception: Women who could become pregnant must use effective birth control during treatment and for 7 months after the last dose.
- Breastfeeding: It is not known whether trastuzumab passes into human breast milk. The 7-month washout period should be considered when deciding about breastfeeding.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Older patients have a higher risk of cardiac (heart) side effects and should be monitored especially carefully.
- Lung disease: Patients with significant pre-existing lung disease or extensive tumor involvement in the lungs are at higher risk of serious pulmonary (lung) toxicity.
- Benzyl alcohol sensitivity: Some trastuzumab vials are reconstituted with a solution containing benzyl alcohol as a preservative. Patients with known hypersensitivity to benzyl alcohol should inform their healthcare team, as an alternative diluent can be used.
- Severe kidney or liver impairment: The pharmacokinetics of trastuzumab in patients with severe kidney impairment, end-stage kidney disease, or liver impairment is not well characterized.
🚑If you take too much▾
There is no clinical experience with trastuzumab overdose in humans, and doses higher than 8 mg/kg as a single dose have not been tested. If an overdose is suspected, contact a healthcare provider or poison control center immediately.
📡Pharmacodynamics — effects in the body▾
Trastuzumab works by targeting HER2-overexpressing cancer cells, blocking their growth signals and directing immune cells to destroy them. Studies in patients with HER2-positive solid tumors showed that trastuzumab does not meaningfully affect the heart's electrical activity (QTc interval), meaning it does not appear to cause dangerous heart rhythm changes through that mechanism. The full relationship between trastuzumab blood levels and its effects on tumors has not been completely characterized.
🔬Pharmacokinetics — how your body processes it▾
Trastuzumab is given intravenously and its clearance from the body involves two parallel pathways — one that is proportional to the concentration in the blood and one that is not, meaning it clears faster at lower concentrations. Steady-state blood levels (a stable, consistent concentration) are typically reached around 9–12 weeks into treatment depending on the dosing schedule and the cancer being treated. After stopping trastuzumab, it takes approximately 7 months for the drug to clear from at least 95% of patients' systems to very low residual levels — an important consideration for pregnancy planning and for timing of anthracycline chemotherapy. Age, race, and mild-to-moderate kidney impairment do not appear to meaningfully affect how trastuzumab behaves in the body.
📦How to store it▾
Store Herceptin vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.
📄 Written from Trastuzumab 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 Trastuzumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is trastuzumab used for — is it just for breast cancer? ▾
How will I receive this medication? Do I take it as a pill? ▾
What side effects should I expect, and which ones mean I should call someone right away? ▾
Is it true this medication can affect my heart? Should I be worried? ▾
Can I get pregnant or try to conceive while on trastuzumab? ▾
What happens if I miss a dose? ▾
Is Trastuzumab Injection available over the counter? ▾
When was Trastuzumab Injection first available? ▾
Who makes Trastuzumab Injection? ▾
💬 Answers drafted from Trastuzumab 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 Trastuzumab Injection comes
Trastuzumab 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
How this form is used
- Ontruzant is indicated for adjuvant treatment of HER2-overexpressing node-positive or certain node-negative breast cancer in adults, as part of specific chemotherapy regimens
- Ontruzant is indicated for first-line treatment of HER2-overexpressing metastatic breast cancer in combination with paclitaxel, or as a single agent after prior chemotherapy for metastatic disease
- Ontruzant is indicated in combination with cisplatin and capecitabine or 5-fluorouracil for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in adults who have not received prior treatment for metastatic disease
- Ogivri is indicated for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, as a biosimilar to the reference trastuzumab product
- Ontruzant is given by intravenous infusion only — never as an IV push or bolus injection — and must not be mixed with other drugs in the same bag
- Ontruzant has different dosing instructions than subcutaneous (under-the-skin) trastuzumab products and must not be substituted for ado-trastuzumab emtansine or fam-trastuzumab deruxtecan
- The first infusion of Ontruzant is given over 90 minutes; if well tolerated, later infusions may be given over a shorter period, either weekly or every three weeks depending on the treatment plan
- Ogivri pregnancy status must be verified in females of reproductive potential before starting treatment, and effective contraception is required during and for 7 months after the last dose
Show 3 more strengths Show fewer strengths
📊 Trastuzumab Injection across the U.S. market
How Trastuzumab 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Trastuzumab Injection is used
A general measure of how commonly Trastuzumab 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 Trastuzumab 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.
How commonly is Trastuzumab Injection prescribed? Of the 1,596 medications we measure, Trastuzumab Injection ranks #649 by Medicaid prescriptions — more than 59% of them.
Utilization by Trastuzumab 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.
fam-trastuzumab deruxtecan-nxki 100 MG Injection Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2267576
trastuzumab-dkst 21 MG/ML Injectable Solution
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2179760
trastuzumab 150 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922509
ado-trastuzumab emtansine 100 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658084
trastuzumab-qyyp 21 MG/ML Injectable Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2280732
trastuzumab-anns 21 MG/ML Injectable Solution
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2174804
ado-trastuzumab emtansine 160 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658089
trastuzumab-anns 150 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2257297
trastuzumab-dkst 150 MG Injection
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2179753
trastuzumab-qyyp 150 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2472791
trastuzumab-dttb 21 MG/ML Injectable Solution
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2289234
trastuzumab-dttb 150 MG Injection
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2289227
trastuzumab-pkrb 21 MG/ML Injectable Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2107053
trastuzumab-pkrb 150 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2169359
Other Trastuzumab Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 17 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 Trastuzumab 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 19 of 47 listed Trastuzumab Injection NDCs with Medicaid activity.
🔍 Compare Trastuzumab Injection products
A representative set of FDA-listed product records for Trastuzumab 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 | ||||
| 100 mg/5 mL | — | Bamboo US Bidco LCC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg/7.4 mL | Intravenous | Biocon Biologics Inc. | BLA | View NDC → |
| 20 mg/mL | — | BSP Pharmaceuticals S.p.A. × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg/7.15 mL | Intravenous | Cephalon, Inc. × 2 listings | BLA | View NDC → |
| 150 mg/20 mL | Intravenous | Cephalon, Inc. | BLA | View NDC → |
| 150 mg/6.36 mL | — | Fareva | DRUG FOR FURTHER PROCESSING | View NDC → |
| 420 mg/17.6 mL | — | Fareva | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg/7.4 mL | Intravenous | Genentech, Inc. × 2 listings | BLA | View NDC → |
| 150 mg | Intravenous | Merck Sharp & Dohme Corp. | BLA | View NDC → |
| 150 mg/7.4 mL | Intravenous | Mylan Institutional LLC × 2 listings | BLA | View NDC → |
| 420 mg/20 mL | Intravenous | Mylan Institutional LLC | BLA | Find on DailyMed ↗ |
| 150 mg | Intravenous | Organon LLC × 3 listings | BLA | View NDC → |
| 150 mg/7.4 mL | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Trastuzumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trastuzumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trastuzumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Trastuzumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 224905 2 dose forms · 17 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 377216In current FDA listingsClinical drug / strength (SCD) anns 21 MG/MLRxCUI 2174804dkst 21 MG/MLRxCUI 2179760dttb 21 MG/MLRxCUI 2289234pkrb 21 MG/MLRxCUI 2107053qyyp 21 MG/MLRxCUI 2280732strf 21 MG/MLRxCUI 270072722 MG/MLRxCUI 806573 -
Dose form (SCDF) Injection RxCUI 1922508In current FDA listingsClinical drug / strength (SCD) ado-trastuzumab emtansine 100 MGRxCUI 1658084ado-trastuzumab emtansine 160 MGRxCUI 1658089anns 150 MGRxCUI 2257297dkst 150 MGRxCUI 2179753dttb 150 MGRxCUI 2289227fam-trastuzumab deruxtecan-nxki 100 MGRxCUI 2267576pkrb 150 MGRxCUI 2169359qyyp 150 MGRxCUI 2472791strf 150 MGRxCUI 2700718150 MGRxCUI 1922509
Look up RxCUI 224905 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.
📦 Supply & shortage status
Whether Trastuzumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Trastuzumab Injection belongs to the HER2/neu Receptor Antagonist class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets 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. Mylan Institutional LLC 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.