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Trastuzumab (intravenous) including biosimilars: Drug information

Trastuzumab (intravenous) including biosimilars: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Trastuzumab (intravenous) including biosimilars: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Cardiomyopathy:

Trastuzumab product administration can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab products. Discontinue trastuzumab treatment in patients receiving adjuvant therapy, and withhold trastuzumab in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion reactions and pulmonary toxicity:

Trastuzumab product administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of trastuzumab administration. Interrupt trastuzumab infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Pregnancy:

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

Brand Names: US
  • Herceptin;
  • Herzuma;
  • Kanjinti;
  • Ogivri;
  • Ontruzant;
  • Trazimera
Brand Names: Canada
  • Herceptin;
  • Herzuma;
  • Kanjinti;
  • Ogivri;
  • Ontruzant;
  • Trazimera
Pharmacologic Category
  • Antineoplastic Agent, Anti-HER2;
  • Antineoplastic Agent, Monoclonal Antibody
Dosing: Adult

Note: Actively manage modifiable cardiac risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) before initiating treatment (Ref). Do NOT substitute conventional trastuzumab products for or with ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, pertuzumab/trastuzumab/hyaluronidase, or trastuzumab/hyaluronidase; products are different and are NOT interchangeable. Herzuma (trastuzumab-pkrb), Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dttb), and Trazimera (trastuzumab-qyyp) are approved as biosimilars to Herceptin. In Canada, Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera are biosimilars to Herceptin (trastuzumab).

Breast cancer, adjuvant treatment, HER2 positive

Breast cancer, adjuvant treatment, HER2 positive: Note: Extending adjuvant treatment beyond 1 year is not recommended.

With concurrent paclitaxel or docetaxel:

Initial loading dose: IV: 4 mg/kg infused over 90 minutes, followed by

Maintenance dose: IV: 2 mg/kg infused over 30 minutes weekly for total of 12 weeks, followed 1 week later (when concurrent chemotherapy completed) by 6 mg/kg infused over 30 to 90 minutes every 3 weeks for total therapy duration of 52 weeks.

With concurrent docetaxel/carboplatin:

Initial loading dose: IV: 4 mg/kg infused over 90 minutes, followed by

Maintenance dose: IV: 2 mg/kg infused over 30 minutes weekly for total of 18 weeks, followed 1 week later (when concurrent chemotherapy completed) by 6 mg/kg infused over 30 to 90 minutes every 3 weeks for total therapy duration of 52 weeks.

Following completion of multimodality anthracycline-based chemotherapy:

Initial loading dose: IV: 8 mg/kg infused over 90 minutes, followed by

Maintenance dose: IV: 6 mg/kg infused over 30 to 90 minutes every 3 weeks for total therapy duration of 52 weeks.

Duration of therapy: The standard duration of adjuvant trastuzumab therapy in early breast cancer is 1 year (52 weeks); however, for patients unable to tolerate 1 year of trastuzumab, a noninferiority study comparing 12 months versus 6 months of adjuvant trastuzumab therapy in early breast cancer suggests disease-free survival may not be inferior with a 6-month duration (Ref).

Breast cancer, early stage, locally advanced, or inflammatory, neoadjuvant treatment, HER2 positive

Breast cancer, early stage, locally advanced, or inflammatory, neoadjuvant treatment, HER2 positive (off-label use): Trastuzumab, pertuzumab, and docetaxel (in patients with operable disease who had received no prior chemotherapy): IV: Initial: 8 mg/kg (cycle 1) followed by 6 mg/kg every 3 weeks for a total of 4 neoadjuvant cycles; postoperatively, administer 3 cycles of adjuvant FEC [fluorouracil, epirubicin, and cyclophosphamide] chemotherapy and continue trastuzumab to complete 1 year of treatment (Ref).

Breast cancer, metastatic, HER2 positive

Breast cancer, metastatic, HER2 positive:

Either as a single agent or in combination with paclitaxel:

Initial loading dose: IV: 4 mg/kg infused over 90 minutes, followed by

Maintenance dose: IV: 2 mg/kg infused over 30 minutes weekly until disease progression.

Off-label combinations: Note: There are multiple trastuzumab-containing regimens for the treatment of HER2+ metastatic breast cancer; commonly used regimens are listed below:

Trastuzumab, pertuzumab, and docetaxel (in patients with no prior anti-HER2 therapy or chemotherapy to treat metastatic disease): IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks until disease progression or unacceptable toxicity (Ref).

Trastuzumab, pertuzumab, and weekly paclitaxel: IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks until disease progression (Ref).

Trastuzumab, tucatinib, and capecitabine (in patients with relapsed/refractory disease ± brain metastases): IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks (in combination with tucatinib and capecitabine); continue until disease progression or unacceptable toxicity (Ref).

Trastuzumab and lapatinib (in patients with progression on prior trastuzumab-containing therapy): IV: Initial: 4 mg/kg followed by a maintenance dose of 2 mg/kg every week (Ref).

Trastuzumab and an aromatase inhibitor: IV: Initial: 4 mg/kg followed by a maintenance dose of 2 mg/kg every week (in combination with anastrozole); continue until disease progression (Ref).

Other trastuzumab combinations: IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks until disease progression or unacceptable toxicity (in combination with docetaxel or vinorelbine) (Ref) or 4 mg/kg loading dose followed by a maintenance dose of 2 mg/kg weekly until disease progression (in combination with docetaxel) (Ref).

Colorectal cancer, metastatic, HER2 positive, with progression on conventional chemotherapy

Colorectal cancer, metastatic, HER2 positive, with progression on conventional chemotherapy (off-label use):

Trastuzumab and lapatinib: IV: Initial: 4 mg/kg followed by a maintenance dose of 2 mg/kg every week (in combination with lapatinib) until disease progression or unacceptable toxicity (Ref).

Trastuzumab and tucatinib: IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks (in combination with tucatinib) (Ref).

Endometrial cancer, uterine serous, advanced or recurrent, HER2 positive

Endometrial cancer, uterine serous, advanced or recurrent, HER2 positive (off-label use): IV: Initial: 8 mg/kg (cycle 1) followed by a maintenance dose of 6 mg/kg every 3 weeks (in combination with carboplatin and paclitaxel for ~6 cycles), followed by trastuzumab maintenance of 6 mg/kg every 3 weeks until disease progression or unacceptable toxicity (Ref).

Gastric cancer, metastatic, HER2 positive

Gastric cancer, metastatic, HER2 positive:

In combination with cisplatin and either capecitabine or fluorouracil for 6 cycles followed by trastuzumab monotherapy (Ref):

Initial loading dose: IV: 8 mg/kg infused over 90 minutes, followed by

Maintenance dose: IV: 6 mg/kg infused over 30 to 90 minutes every 3 weeks until disease progression.

Off-label dosing/combinations:

In combination with mFOLFOX: IV: Initial: 6 mg/kg on day 1 of cycle 1, followed by 4 mg/kg on day 1 every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin; modified FOLFOX regimen) until disease progression or unacceptable toxicity (Ref).

In combination with XELOX: IV: Initial:8 mg/kg on day 1 of cycle 1, followed by 6 mg/kg on day 1 every 3 weeks (in combination with capecitabine and oxaliplatin; XELOX regimen) for up to 6 cycles; after 6 cycles of combination chemotherapy, trastuzumab ± capecitabine were continued until disease progression or unacceptable toxicity (Ref).

In combination with pembrolizumab and fluoropyrimidine- and platinum-containing chemotherapy: IV: Initial: 8 mg/kg followed by a maintenance dose of 6 mg/kg once every 3 weeks (in combination with pembrolizumab and either cisplatin/fluorouracil or capecitabine/oxaliplatin) until disease progression or unacceptable toxicity or (in patients without disease progression) for up to 24 months; refer to protocol for further information (Ref).

Missed doses: A trastuzumab dose delay >1 week would require ~6 weeks to return to steady state range; if a maintenance dose is missed by >1 week, a reloading dose is required (Ref). If a trastuzumab dose is missed by 1 week or less, the usual maintenance dose (2 mg/kg weekly schedule or 6 mg/kg every 3 week schedule) should be administered as soon as possible (do not wait until the next planned cycle) and subsequent maintenance doses should be administered 7 or 21 days later (based on patient's maintenance dose/schedule); if a dose is missed by >1 week, then a re-loading dose (4 mg/kg if patient receives trastuzumab weekly; 8 mg/kg if on an every-3-week schedule) should be administered (over 90 minutes) as soon as possible, followed by the usual maintenance dose administered 7 or 21 days later (based on patient's maintenance dose/schedule).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl 30 to 90 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling, although no clinically significant pharmacokinetic differences have been observed.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

End-stage renal disease (ESRD) (with or without hemodialysis): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).

Dosing: Adjustment for Toxicity: Adult

Cardiotoxicity:

Asymptomatic heart disease: Consider initiating heart failure medications (eg, angiotensin-converting enzyme inhibitors or an angiotensin receptor blocker, and/or beta-blockers) in patients with asymptomatic (stage B) heart disease (Ref).

Mild cardiac dysfunction: Continue treatment with close cardiovascular monitoring (Ref).

Moderate cardiac dysfunction: Consider continuing treatment with close cardiovascular monitoring. Initiation of heart failure medications is recommended (Ref).

Severe cardiac dysfunction: Interrupt treatment and utilize a multidisciplinary approach when deciding if/when to restart. Initiation of heart failure medications is recommended (Ref).

Symptomatic heart disease: LVEF ≥16% decrease from baseline or LVEF below normal limits and ≥10% decrease from baseline: Withhold treatment for at least 4 weeks and repeat LVEF every 4 weeks. May resume trastuzumab treatment if LVEF returns to normal limits within 4 to 8 weeks and remains at ≤15% decrease from baseline value. Discontinue permanently for persistent (>8 weeks) LVEF decline or for >3 incidents of treatment interruptions for cardiomyopathy (manufacturer’s labeling). Initiate heart failure medications (Ref).

Mild cardiac dysfunction: Consider a multidisciplinary approach for decisions regarding treatment interruption versus continuation (Ref).

Moderate or severe cardiac dysfunction: Interrupt treatment; consider a multidisciplinary approach for decisions regarding treatment reinitiation (Ref).

Hypersensitivity/infusion-related events:

Anaphylaxis or angioedema: Discontinue trastuzumab.

Mild-moderate infusion reactions: Decrease trastuzumab infusion rate.

Dyspnea or clinically significant hypotension: Interrupt trastuzumab infusion and manage as appropriate (monitor until symptoms resolve).

Severe or life-threatening infusion reactions: Discontinue trastuzumab.

Pulmonary toxicity:

Interstitial pneumonitis or acute respiratory distress syndrome: Discontinue trastuzumab.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported with single-agent therapy.

>10%:

Cardiovascular: Decreased left ventricular ejection fraction (4% to 22%)

Dermatologic: Skin rash (4% to 18%)

Gastrointestinal: Abdominal pain (22%; upper abdominal pain: 2%), anorexia (14%), diarrhea (7% to 25%), nausea (6% to 33%), vomiting (4% to 23%)

Infection: Infection (20%)

Nervous system: Chills (5% to 32%), dizziness (4% to 13%), headache (10% to 26%), insomnia (14%), pain (47%)

Neuromuscular & skeletal: Asthenia (5% to 42%), back pain (5% to 22%)

Respiratory: Cough (5% to 26%), dyspnea (3% to 22%), pharyngitis (12%), rhinitis (2% to 14%)

Miscellaneous: Fever (6% to 36%), infusion related reaction (21% to 40%; severe infusion related reaction: 1%)

1% to 10%:

Cardiovascular: Cardiac arrhythmia (3%), cardiac failure (≤7%), edema (8%), hypertension (4%), palpitations (3%), peripheral edema (5% to 10%), tachycardia (5%)

Dermatologic: Acne vulgaris (2%), nail disease (2%), pruritus (2%)

Gastrointestinal: Constipation (2%), dyspepsia (2%)

Genitourinary: Urinary tract infection (3% to 5%)

Hematologic & oncologic: Anemia (4%; grade 3: <1%), leukopenia (3%)

Hypersensitivity: Hypersensitivity reaction (≤3%)

Infection: Influenza (4%), herpes simplex infection (2%)

Nervous system: Depression (6%), neuropathy (1%), paresthesia (2% to 9%), peripheral neuritis (2%)

Neuromuscular & skeletal: Arthralgia (6% to 8%), muscle spasm (3%), myalgia (4%), ostealgia (3% to 7%)

Respiratory: Epistaxis (2%), flu-like symptoms (2% to 10%), nasopharyngitis (8%), pharyngolaryngeal pain (2%), sinusitis (2% to 9%), upper respiratory tract infection (3%)

Miscellaneous: Accidental injury (6%)

<1%:

Cardiovascular: Cardiac disorder, ventricular dysfunction

Endocrine & metabolic: Thyroiditis (autoimmune)

Immunologic: Antibody development

Respiratory: Interstitial pneumonitis, pneumonitis, pulmonary hypertension, pulmonary infiltrates, respiratory failure

Frequency not defined:

Cardiovascular: Cardiomyopathy

Hematologic & oncologic: Neutropenia

Respiratory: Pulmonary fibrosis

Postmarketing:

Dermatologic: Madarosis of eyebrow (Agirgol 2020)

Genitourinary: Glomerulopathy, nephrotic syndrome, oligohydramnios

Hematologic & oncologic: Immune thrombocytopenia, tumor lysis syndrome

Hypersensitivity: Anaphylaxis, angioedema

Ophthalmic: Blurred vision (Ho 2013), conjunctivitis (Ho 2013), corneal disease (neovascularization inhibition) (Ho 2013), dry eye syndrome (Ho 2013), lacrimation (irritation related) (Ho 2013), maculopathy (bilateral ischemic) (Saleh 2011), vision loss (Saleh 2011)

Renal: Focal segmental glomerulosclerosis, glomerulonephritis (membranous, focal and fibrillary)

Respiratory: Acute respiratory distress syndrome, bronchospasm, hypoxia, non-cardiogenic pulmonary edema, pleural effusion

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Known hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiomyopathy: Trastuzumab products are associated with symptomatic and asymptomatic reductions in left ventricular ejection fraction (LVEF) and heart failure; the incidence is highest in patients receiving trastuzumab with an anthracycline-containing chemotherapy regimen. Extreme caution should be used in patients with pre-existing cardiac disease or dysfunction. Prior or concurrent exposure to anthracyclines or radiation therapy significantly increases the risk of cardiomyopathy; other potential risk factors include advanced age, high or low body mass index, smoking, diabetes, hypertension, and hyper-/hypothyroidism. Patients who receive anthracyclines after completion or discontinuation of trastuzumab are at increased risk of cardiac dysfunction (anthracyclines should be avoided for at least 7 months after the last trastuzumab dose, and then monitor cardiac function closely if anthracyclines are used. Cardiomyopathy due to trastuzumab is generally reversible over a period of 1 to 3 months after discontinuation. Long-term (8 years) follow-up in the adjuvant setting (trastuzumab for 1 or 2 years administered sequentially following chemotherapy and radiation therapy) has demonstrated a low incidence of cardiac events, which were generally reversible in most patients (de Azambuja 2014). Trastuzumab is also associated with arrhythmias, hypertension, mural thrombus formation, stroke, and even cardiac death.

According to American Society of Clinical Oncology (ASCO) guidelines for prevention and monitoring of cardiac dysfunction in adult survivors of cancer (ASCO [Armenian 2017]), the risk of cardiac dysfunction related to trastuzumab is increased with the following:

- Trastuzumab alone AND any of the following risk factors: Multiple cardiovascular risk factors (≥2 risk factors), including smoking, hypertension, diabetes, dyslipidemia, and obesity (during or after completion of therapy), or older age (≥60 years of age) at cancer treatment, or compromised cardiac function (eg, borderline low LVEF [50% to 55%], history of myocardial infarction, moderate or higher valvular heart disease) before or during treatment.

- Treatment with lower-dose anthracycline (eg, doxorubicin <250 mg/m2, epirubicin <600 mg/m2) followed by trastuzumab (sequential therapy).

• Infusion reactions: Infusion reactions (including fatalities) have been associated with trastuzumab products. Most reactions occur during or within 24 hours of the first infusion. Infusion reactions may consist of fever and chills, and may also include nausea, vomiting, pain, headache, dizziness, dyspnea, hypotension, rash, and weakness. Re-treatment of patients who experienced severe hypersensitivity reactions has been attempted (with premedication). Some patients tolerated re-treatment, while others experienced a second severe reaction.

• Pulmonary toxicity: Trastuzumab may cause serious pulmonary toxicity (dyspnea, hypoxia, interstitial pneumonitis, pulmonary infiltrates, pleural effusion, noncardiogenic pulmonary edema, pulmonary insufficiency, acute respiratory distress syndrome, and/or pulmonary fibrosis). Use caution in patients with pre-existing pulmonary disease or patients with extensive pulmonary tumor involvement; these patient populations may have more severe toxicity. Pulmonary events may occur during or within 24 hours of administration; delayed reactions have occurred.

• Renal toxicity: Rare cases of nephrotic syndrome with evidence of glomerulopathy have been reported, with an onset of 4 to 18 months from trastuzumab initiation; complications may include volume overload and heart failure. The incidence of renal impairment was increased in metastatic gastric cancer patients when trastuzumab is added to chemotherapy.

Concurrent drug therapy issues:

• Chemotherapy: When used in combination with myelosuppressive chemotherapy, trastuzumab may increase the incidence of neutropenia (moderate-to-severe) and febrile neutropenia. The incidence of anemia may be higher when trastuzumab is added to chemotherapy.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some diluent may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein-binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

• Do not interchange: Conventional trastuzumab products and ado-trastuzumab emtansine or trastuzumab/hyaluronidase are not interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors. Dosing and treatment schedules between conventional trastuzumab (Herceptin and trastuzumab biosimilars) and ado-trastuzumab emtansine (Kadcyla), fam-trastuzumab deruxtecan (Enhertu), pertuzumab/trastuzumab/hyaluronidase (Phesgo), or trastuzumab/hyaluronidase are different; confusion between the products may potentially cause harm to the patient.

Other warnings/precautions:

• HER2 expression: Establish HER2 status prior to treatment with an approved test, either HER2 protein overexpression by validated immunohistochemistry assay or gene amplification by fluorescence in situ hybridization assay. Due to differences in disease histopathology (eg, incomplete membrane staining and more frequent heterogeneous HER2 expression in gastric cancer), tests appropriate for the specific tumor type (breast or gastric) should be used to assess HER2 status. Unreliable results may occur from improper assay performance, such as use of suboptimally fixed tissue, failure to utilize specified reagents or to include appropriate controls for assay validation, or incorrectly following specific assay instructions. Information regarding HER2 diagnostic testing may be found at http://www.fda.gov/CompanionDiagnostics.

Product Availability

Hercessi (trastuzumab-strf): FDA approved April 2024; anticipated availability currently unknown. Information pertaining to this product within the monograph is pending revision. Hercessi is approved as a biosimilar to Herceptin. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Herzuma: Trastuzumab-pkrb 150 mg (1 ea); Trastuzumab-pkrb 420 mg (1 ea)

Herzuma: Trastuzumab-pkrb 420 mg (1 ea) [contains benzyl alcohol]

Kanjinti: Trastuzumab-anns 420 mg (1 ea) [contains benzyl alcohol]

Ogivri: Trastuzumab-dkst 420 mg (1 ea) [contains polyethylene glycol (macrogol)]

Ontruzant: Trastuzumab-dttb 420 mg (1 ea) [contains benzyl alcohol]

Solution Reconstituted, Intravenous [preservative free]:

Herceptin: 150 mg (1 ea)

Kanjinti: Trastuzumab-anns 150 mg (1 ea); Trastuzumab-anns 420 mg (1 ea)

Ogivri: Trastuzumab-dkst 150 mg (1 ea); Trastuzumab-dkst 420 mg (1 ea) [contains polyethylene glycol (macrogol)]

Ontruzant: Trastuzumab-dttb 150 mg (1 ea)

Trazimera: Trastuzumab-qyyp 150 mg (1 ea); Trastuzumab-qyyp 420 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Herceptin Intravenous)

150 mg (per each): $1,870.10

Solution (reconstituted) (Herzuma Intravenous)

150 mg (per each): $1,683.00

420 mg (per each): $4,712.40

Solution (reconstituted) (Kanjinti Intravenous)

150 mg (per each): $1,632.08

420 mg (per each): $4,569.82

Solution (reconstituted) (Ogivri Intravenous)

150 mg (per each): $1,128.61

420 mg (per each): $3,150.06

Solution (reconstituted) (Ontruzant Intravenous)

150 mg (per each): $1,589.59

420 mg (per each): $4,450.85

Solution (reconstituted) (Trazimera Intravenous)

150 mg (per each): $1,453.32

420 mg (per each): $4,069.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Herceptin: 440 mg (1 ea) [contains benzyl alcohol]

Herzuma: 150 mg (1 ea)

Herzuma: 440 mg (1 ea) [contains benzyl alcohol]

Kanjinti: 150 mg (1 ea); 420 mg (1 ea)

Ogivri: 150 mg (1 ea); 440 mg (1 ea) [contains polyethylene glycol (macrogol)]

Ontruzant: 150 mg (1 ea)

Ontruzant: 440 mg (1 ea) [contains benzyl alcohol]

Trazimera: 150 mg (1 ea)

Trazimera: 440 mg (1 ea) [contains benzyl alcohol]

Administration: Adult

IV: Administer by IV infusion; loading doses are infused over 90 minutes; maintenance doses may be infused over 30 minutes if tolerated. Do not administer with D5W. Do not administer IV push or by rapid bolus. Do not mix with any other medications.

Observe patients closely during the infusion for fever, chills, or other infusion-related symptoms. Treatment with acetaminophen, diphenhydramine, and/or meperidine is usually effective for managing infusion-related events.

Check label to ensure appropriate product is being administered (conventional trastuzumab products and ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, pertuzumab/trastuzumab/hyaluronidase, or trastuzumab/hyaluronidase are different products and are NOT interchangeable).

Use: Labeled Indications

Breast cancer, adjuvant treatment: Treatment (adjuvant) of HER2-overexpressing node positive or node negative (estrogen receptor/progesterone receptor negative or with 1 high-risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multimodality anthracycline-based therapy.

Breast cancer, metastatic: First-line treatment of HER2-overexpressing metastatic breast cancer (in combination with paclitaxel); single agent treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.

Gastric cancer, metastatic: Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (in combination with cisplatin and either capecitabine or 5-fluorouracil) in patients who have not received prior treatment for metastatic disease.

Limitations of use: Patients should be selected for breast and gastric cancer therapy based on an approved companion diagnostic test for tumor specimen for HER2 overexpression or HER2 gene amplification. Due to differences in disease histopathology (eg, incomplete membrane staining, more frequent heterogeneous HER2 expression in gastric cancer), tests appropriate for the specific tumor type (breast or gastric) should be used to assess HER2 status.

Note: Herzuma (trastuzumab-pkrb), Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dttb), and Trazimera (trastuzumab-qyyp) are approved as biosimilars to Herceptin (trastuzumab). In Canada, Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera are biosimilars to Herceptin (trastuzumab).

Use: Off-Label: Adult

Breast cancer, locally advanced, inflammatory or early, HER2 positive, neoadjuvant treatment; Breast cancer, metastatic, HER2-positive (in combination with pertuzumab and docetaxel) in patients who have not received prior anti-HER2 therapy or chemotherapy to treat metastatic disease; Breast cancer, metastatic, HER2-positive (in combination with pertuzumab and weekly paclitaxel); Breast cancer, metastatic, HER2-positive (in combination with either docetaxel or vinorelbine); Breast cancer, metastatic, HER2-positive, hormone receptor-positive (in combination with an aromatase inhibitor); Breast cancer, metastatic, HER2-positive (in combination with lapatinib) which had progressed on prior trastuzumab containing therapy; Colorectal cancer, metastatic, HER2 overexpressing, with progression on conventional chemotherapy; Endometrial cancer (uterine serous), advanced or recurrent, HER2-positive

Medication Safety Issues
Sound-alike/look-alike issues:

Herceptin may be confused with Herceptin Hylecta.

Trastuzumab (conventional) may be confused with ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, pertuzumab, pertuzumab/trastuzumab/hyaluronidase, trastuzumab/hyaluronidase.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Other safety concerns:

Conventional trastuzumab (Herceptin or trastuzumab biosimilars) may be confused with the US products ado-trastuzumab emtansine (Kadcyla), fam-trastuzumab deruxtecan (Enhertu), pertuzumab/trastuzumab/hyaluronidase (Phesgo), or trastuzumab/hyaluronidase (Herceptin Hylecta); products are not interchangeable.

Conventional trastuzumab (Herceptin or trastuzumab biosimilars) may be confused with the Canadian product trastuzumab emtansine (Kadcyla); products are not interchangeable.

Trastuzumab is for IV administration only. Do not substitute pertuzumab/trastuzumab/hyaluronidase (SubQ) or trastuzumab/hyaluronidase (SubQ) for trastuzumab (IV). Use caution during product selection, preparation, and administration.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Anthracyclines: Trastuzumab may enhance the cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with trastuzumab should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab. Monitor closely for cardiac dysfunction in patients receiving anthracyclines with trastuzumab. Risk D: Consider therapy modification

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Reproductive Considerations

[US Boxed Warning]: Advise patients of the risks of trastuzumab exposure in pregnancy and the need for effective contraception. Verify pregnancy status prior to initiation of therapy in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for at least 7 months after the last trastuzumab dose.

Pregnancy Considerations

Trastuzumab inhibits human epidermal growth receptor 2 (HER2) protein, which has a role in embryonic development. [US Boxed Warning]: Trastuzumab exposure during pregnancy may result in oligohydramnios and oligohydramnios sequence (pulmonary hypoplasia, skeletal malformations, and neonatal death). Advise patients of these risks. Oligohydramnios (reversible in some cases) has been reported with trastuzumab use alone or with combination chemotherapy. Monitor for oligohydramnios if trastuzumab exposure occurs during pregnancy or within 7 months prior to conception; conduct appropriate fetal testing if oligohydramnios occurs.

Herceptin: If Herceptin is administered during pregnancy, or if a patient becomes pregnant during or within 7 months after treatment, report exposure to Genentech Adverse Events at 1-888-835-2555.

European Society for Medical Oncology guidelines for cancer during pregnancy recommend delaying treatment with trastuzumab (and other HER2-targeted agents) until after delivery in pregnant patients with HER2-positive disease (ESMO [Peccatori 2013]).

Breastfeeding Considerations

It is not known if trastuzumab is present in human milk.

Because many immunoglobulins are secreted in milk, and the potential for serious adverse reactions in the breastfed infant exists, the decision to discontinue trastuzumab or discontinue breastfeeding during treatment should take into account the benefits of treatment to the mother. The 7-month wash out period for trastuzumab should be considered for decisions regarding breastfeeding after treatment is completed.

Monitoring Parameters

Assessment for HER2 overexpression and HER2 gene amplification by validated immunohistochemistry or fluorescence in situ hybridization methodology (pretherapy); test should be specific for cancer type (breast vs gastric cancer). Evaluate pregnancy status prior to treatment (in patients who could become pregnant). Conduct a comprehensive cardiovascular assessment prior to treatment initiation, including a history and physical examination. Assess left ventricular ejection fraction (by ECG or MUGA scan) at baseline (immediately prior to trastuzumab initiation), every 3 months during trastuzumab therapy, every 4 weeks if trastuzumab is withheld for significant left ventricular cardiac dysfunction, and every 6 months for at least 2 years following completion of adjuvant trastuzumab therapy. Monitor vital signs during infusion; monitor for hypersensitivity or infusion reaction; if a reaction occurs, monitor carefully until symptoms resolve completely. Monitor for signs/symptoms of cardiac dysfunction or pulmonary toxicity. If pregnancy inadvertently occurs during treatment, monitor amniotic fluid volume.

Additional cardiovascular monitoring (guideline recommendations): Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking (ASCO [Armenian 2017], ESC [Lyon 2022]). Obtain a baseline echocardiography (transthoracic preferred) and repeat every 3 months during treatment (may reduce to every 4 to 6 months if normal and asymptomatic), assess more frequently if clinically indicated and obtain echocardiography within 12 months after completion; in high- and very high-risk patients, assess troponin and natriuretic peptide at baseline and consider assessing every 2 to 3 cycles, and at 3 and 12 months after completion of therapy; in low- and moderate-risk patients, consider troponin and natriuretic peptide at baseline (post-anthracycline), every 3 months and 12 months after completion of therapy (ESC [Lyon 2022]).

The American Society of Clinical Oncology hepatitis B screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends hepatitis B virus (HBV) screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Trastuzumab is a monoclonal antibody which binds to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER-2); it mediates antibody-dependent cellular cytotoxicity by inhibiting proliferation of cells which overexpress HER-2 protein.

Pharmacokinetics (Adult Data Unless Noted)

Excretion: In most patients, trastuzumab concentrations will decrease to ~3% (~97% washout) by 7 months following discontinuation.

Clearance: Every week dosing: 0.201 to 0.244 L/day; Every 3 week dosing: 0.173 to 0.337 L/day (Quartino 2018).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Canhera | Herceptin | Herzuma | Kanjinti | Ogivri | Trazimera;
  • (AR) Argentina: Dafex | Herceptin | Kanjinti | Trazimera | Tuzepta;
  • (AT) Austria: Herceptin | Herwenda | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (AU) Australia: Herceptin | Herzuma | Kanjinti | Ontruzant | Trastucip | Trazimera | Tuzucip;
  • (BD) Bangladesh: Ogivri;
  • (BE) Belgium: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (BG) Bulgaria: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (BR) Brazil: Bio manguinhos trastuzumabe | Herceptin | Herzuma | Kanjinti | Ontruzant | Trazimera | Zedora;
  • (CH) Switzerland: Herzuma | Kanjinti | Ogivri | Trazimera | Zercepac;
  • (CL) Chile: Herceptin;
  • (CN) China: Herceptin | Zercepa;
  • (CO) Colombia: Bioceptin | Bisintex | Herceptin | Herticad | Herzuma | Kanjinti | Ogivri | Trazimera;
  • (CZ) Czech Republic: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (DE) Germany: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera;
  • (DO) Dominican Republic: Herceptin;
  • (EC) Ecuador: Herceptin | Herzuma | Kanjinti | Tartuz | Trazimera;
  • (EE) Estonia: Herceptin | Ogivri | Ontruzant | Zercepac;
  • (EG) Egypt: Herceptin | Hertraz;
  • (ES) Spain: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (ET) Ethiopia: Herceptin | Hertraz;
  • (FI) Finland: Herceptin | Herzuma | Kanjinti | Ontruzant | Trazimera | Zercepac;
  • (FR) France: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (GB) United Kingdom: Herceptin | Herzuma | Kanjinti | Ontruzant | Trazimera | Zercepac;
  • (GR) Greece: Herceptin | Kanjinti | Ogivri | Trazimera;
  • (HK) Hong Kong: Herceptin | Herzuma;
  • (HR) Croatia: Herceptin | Kanjinti;
  • (HU) Hungary: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (ID) Indonesia: Herceptin | Herzemab | Vivitra;
  • (IE) Ireland: Herceptin | Herzuma | Kanjinti | Ogivri | Trazimera | Zercepac;
  • (IN) India: Biceltis | Canmab | Eleftha | Herclon | Hermab | Hersima | Herti | Hertraz | Hervycta | Neuzumab | Priunta | Tarzed | Trazumab | Trumab | Vivitra;
  • (IT) Italy: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (JO) Jordan: Herceptin;
  • (JP) Japan: Herceptin | Trastuzumab bs | Trastuzumab bs daiichi sankyo;
  • (KE) Kenya: Herceptin | Hertraz | Trasturel;
  • (KR) Korea, Republic of: Herceptin | Herzuma | Samfenet;
  • (LB) Lebanon: Herceptin | Kanjinti | Mabtin | Trazimera;
  • (LT) Lithuania: Herceptin | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (LV) Latvia: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (MA) Morocco: Herceptin | Trazuva;
  • (MX) Mexico: Herceptin | Herzuma | Kanjinti | Trazimera;
  • (MY) Malaysia: Herceptin | Herzuma | Zuhera;
  • (NL) Netherlands: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (NO) Norway: Herceptin | Kanjinti | Trazimera;
  • (NZ) New Zealand: Herceptin | Herzuma;
  • (PE) Peru: Bisintex | Herceptin;
  • (PH) Philippines: Herceptin | Hertraz;
  • (PK) Pakistan: Herceptin | Hertraz | Trastuget;
  • (PL) Poland: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (PR) Puerto Rico: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera;
  • (PT) Portugal: Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (PY) Paraguay: Bisintex | Herceptin | Herclon | Hertraz;
  • (QA) Qatar: Herceptin | Herzuma | Kanjinti | Ontruzant;
  • (RO) Romania: Herceptin | Herzuma | Kanjinti | Ogivri | Trazimera | Zercepac;
  • (RU) Russian Federation: Herceptin | Herticad;
  • (SA) Saudi Arabia: Herceptin | Herzuma | Kanjinti;
  • (SE) Sweden: Herceptin | Kanjinti | Ogivri | Ontruzant | Trazimera | Zercepac;
  • (SG) Singapore: Herceptin | Herzuma | Kanjinti | Ogivri | Trazimera;
  • (SI) Slovenia: Herceptin | Herzuma | Kanjinti | Ontruzant | Trazimera;
  • (SK) Slovakia: Herceptin | Herzuma | Kanjinti | Ogivri | Trazimera | Zercepac;
  • (TH) Thailand: Herceptin | Herzuma | Ogivri;
  • (TN) Tunisia: Herceptin | Hertraz;
  • (TR) Turkey: Canhera | Herceptin | Herzuma | Trazimera;
  • (TW) Taiwan: Herceptin | Herzuma | Kanjinti | Ogivri;
  • (UA) Ukraine: Ogivri | Ontruzant;
  • (UG) Uganda: Herceptin;
  • (UY) Uruguay: Herceptin;
  • (ZA) South Africa: Herceptin | Herclon | Hersimi | Hertraz | Kanjinti | Ogivri | Trastuzumab cipla;
  • (ZM) Zambia: Hertraz;
  • (ZW) Zimbabwe: Herceptin
  1. Agirgol S, Çaytemel C, Pilanci KN. Dermatological side effects of targeted antineoplastic therapies: a prospective study. Cutan Ocul Toxicol. 2020;39(4):380-384. doi:10.1080/15569527.2020.1833028 [PubMed 33028137]
  2. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. doi:10.1067/mpd.2001.116281 [PubMed 11487763]
  3. Andersson M, Lidbrink E, Bjerre K, et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J Clin Oncol. 2011;29(3):264-271. [PubMed 21149659]
  4. Armenian SH, Lacchetti C, Barac A, et al. Prevention and monitoring of cardiac dysfunction in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2017;35(8):893-911. doi:10.1200/JCO.2016.70.5400 [PubMed 27918725]
  5. Bader AA, Schlembach D, Tamussino KF, et al. Anhydramnios Associated With Administration of Trastuzumab and Paclitaxel for Metastatic Breast Cancer During Pregnancy. Lancet Oncol. 2007;8(1):79-81. [PubMed 17196514]
  6. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-697. [PubMed 20728210]
  7. Baselga J, Albanell J, Molina MA, et al. Mechanism of Action of Trastuzumab and Scientific Update. Semin Oncol. 2001;28(5)(suppl 16):4-11.
  8. Baselga J, Carbonell X, Castaneda-Soto NJ, et al. Phase II Study of Efficacy, Safety, and Pharmacokinetics of Trastuzumab Monotherapy Administered on a 3-Weekly Schedule. J Clin Oncol. 2005;23(10):2162-2171. [PubMed 15800309]
  9. Baselga J, Cortés J, Kim SB, et al. Pertuzumab Plus Trastuzumab Plus Docetaxel for Metastatic Breast Cancer. N Engl J Med. 2012;366(2):109-119. [PubMed 22149875]
  10. Blackwell KL, Burstein HJ, Storniolo AM, et al. Overall Survival Benefit With Lapatinib in Combination With Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Final Results From the EGF104900 Study. J Clin Oncol. 2012;30(21):2585-2592. [PubMed 22689807]
  11. Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab-Refractory Metastatic Breast Cancer. J Clin Oncol. 2010;28(7):1124-1130. [PubMed 20124187]
  12. Bowles EJ, Wellman R, Feigelson HS, et al. Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study. J Natl Cancer Inst. 2012;104(17):1293-1305. [PubMed 22949432]
  13. Carver JR, Shapiro CL, Ng A, et al. American Society of Clinical Oncology Clinical Evidence Review on the Ongoing Care of Adult Cancer Survivors: Cardiac and Pulmonary Late Effects. J Clin Oncol. 2007;25(25):3991-4008. [PubMed 17577017]
  14. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol-United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  15. Dang C, Iyengar N, Datko F, et al. Phase II Study of Paclitaxel Given Once per Week Along With Trastuzumab and Pertuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2015;33(5):442-447. [PubMed 25547504]
  16. de Azambuja E, Procter MJ, van Veldhuisen DJ, et al. Trastuzumab-Associated Cardiac Events at 8 Years of Median Follow-Up in the Herceptin Adjuvant Trial (BIG 1-01). J Clin Oncol. 2014;32(20):2159-2165. [PubMed 24912899]
  17. Earl HM, Hiller L, Vallier A-L, et al. PERSEPHONE: 6 versus 12 months (m) of adjuvant trastuzumab in patients (pts) with HER2 positive (+) early breast cancer (EBC): Randomised phase 3 non-inferiority trial with definitive 4-year (yr) disease-free survival (DFS) results. [ASCO abstract 506]. J Clin Oncol. 2018;36S:506.
  18. Ewer SM, Ewer MS. Cardiotoxicity Profile of Trastuzumab. Drug Safety. 2008;31(6):459-467. [PubMed 18484781]
  19. Ewer MS, Vooletich MT, Durand JB, et al. Reversibility of Trastuzumab-Related Cardiotoxicity: New Insights Based on Clinical Course and Response to Medical Treatment. J Clin Oncol. 2005;23(31):7820-7826. [PubMed 16258084]
  20. Fader AN, Roque DM, Siegel E, et al. Randomized phase II trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-trastuzumab in uterine serous carcinomas that overexpress human epidermal growth factor receptor 2/neu. J Clin Oncol. 2018;36(20):2044-2051. [PubMed 29584549]
  21. Fedele C, Riccio G, Malara AE, et al. Mechanisms of Cardiotoxicity Associated With ErbB2 Inhibitors. Breast Cancer Res Treat. 2012;134(2):595-602. [PubMed 22674190]
  22. Feldman AM, Lorell BH, Reis SE. Trastuzumab in the Treatment of Metastatic Breast Cancer: Anticancer Therapy Versus Cardiotoxicity. Circulation. 2000;102(3):272-274. [PubMed 10899087]
  23. Floyd JD, Nguyen DT, Lobins RL, et al. Cardiotoxicity of Cancer Therapy. J Clin Oncol. 2005;23(30):7685-7696. [PubMed 16234530]
  24. Gianni L, Pienkowski T, Im YH, et al. Efficacy and Safety of Neoadjuvant Pertuzumab and Trastuzumab in Women With Locally Advanced, Inflammatory, or Early HER2-Positive Breast Cancer (Neosphere): A Randomised Multicentre, Open-Label, Phase 2 Trial. Lancet Oncol. 2012;13(1):25-32. [PubMed 22153890]
  25. Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32(19):2078-2099. [PubMed 24799465]
  26. Gong J, Liu T, Fan Q, et al. Optimal regimen of trastuzumab in combination with oxaliplatin/capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016;16:68. doi:10.1186/s12885-016-2092-9 [PubMed 26857702]
  27. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  28. Guarneri V, Lenihan DJ, Valero V, et al. Long-Term Cardiac Tolerability of Trastuzumab in Metastatic Breast Cancer: The M.D. Anderson Cancer Center Experience. J Clin Oncol. 2006;24(25):4107-4115. [PubMed 16908934]
  29. Herceptin (trastuzumab) [prescribing information]. South San Francisco, CA: Genentech Inc; February 2021.
  30. Herceptin (trastuzumab) [product monograph]. Mississauga, Ontario, Canada: Hoffmann-La Roche Ltd; May 2020.
  31. Herzuma (trastuzumab) [product monograph]. Toronto, Ontario, Canada: Teva Canada Limited; April 2021.
  32. Herzuma (trastuzumab-pkrb) [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA Inc; May 2019.
  33. Ho WL, Wong H, Yau T. The ophthalmological complications of targeted agents in cancer therapy: what do we need to know as ophthalmologists?. Acta Ophthalmol. 2013;91(7):604-609. doi:10.1111/j.1755-3768.2012.02518.x [PubMed 22970709]
  34. Hudis CA. Trastuzumab - Mechanism of Action and Use in Clinical Practice. N Engl J Med. 2007;357(1):39-51. [PubMed 17611206]
  35. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. Published online July 27, 2020. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  36. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. doi:10.1542/peds.99.2.268 [PubMed 9024461]
  37. Janjigian YY, Kawazoe A, Yanez P, et al. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021;600(7890):727-730. doi:10.1038/s41586-021-04161-3 [PubMed 34912120]
  38. Kanjinti (trastuzumab-anns) [prescribing information]. Thousand Oaks, CA: Amgen Inc; October 2019.
  39. Kanjinti (trastuzumab) [product monograph]. Mississauga, Ontario, Canada: Amgen Canada Inc; August 2021.
  40. Kaufman B, Mackey JR, Clemens MR, et al. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009;27(33):5529-5537. doi: 10.1200/JCO.2008.20.6847. [PubMed 19786670]
  41. Lemmens K, Doggen K, De Keulenaer GW. Role of Neuregulin-1/ErbB Signaling in Cardiovascular Physiology and Disease: Implications for Therapy of Heart Failure. Circulation. 2007;116(8):954-960. [PubMed 17709650]
  42. Leyland-Jones B, Gelmon K, Ayoub JP, et al. Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination With Paclitaxel. J Clin Oncol. 2003;21(21):3965-3971. [PubMed 14507946]
  43. Lyon AR, López-Fernández T, Couch LS, et al; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022;43(41):4229-4361. doi:10.1093/eurheartj/ehac244 [PubMed 36017568]
  44. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005;23(19):4265-4274. [PubMed 15911866]
  45. Moja L, Tagliabue L, Balduzzi S, et al. Trastuzumab Containing Regimens for Early Breast Cancer. Cochrane Database Syst Rev. 2012;4:CD006243. [PubMed 22513938]
  46. Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer [published correction appears in N Engl J Med. 2020;382(6):586]. N Engl J Med. 2020;382(7):597-609. doi:10.1056/NEJMoa1914609 [PubMed 31825569]
  47. Ogivri (trastuzumab) [product monograph]. Etobicoke, Ontario, Canada: BGP Pharma ULC; May 2023.
  48. Ogivri (trastuzumab-dkst) [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc; February 2021.
  49. Ontruzant (trastuzumab-dttb) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021.
  50. Ontruzant (trastuzumab) [product monograph]. Kirkland, Quebec, Canada: Organon Canada; January 2022.
  51. Peccatori FA, Azim HA Jr, Orecchia R, et al. Cancer, pregnancy and fertility: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(suppl 6):vi160-vi170. [PubMed 23813932]
  52. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752. [PubMed 25332249]
  53. Pituskin E, Haykowsky M, Mackey JR, et al. Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101--Breast): A Randomized, Placebo-Controlled Trial to Determine if Conventional Heart Failure Pharmacotherapy Can Prevent Trastuzumab-Mediated Left Ventricular Remodeling Among Patients With HER2+ Early Breast Cancer Using Cardiac MRI. BMC Cancer. 2011;11:318. [PubMed 21794114]
  54. Portera CC, Walshe JM, Rosing DR, et al. Cardiac Toxicity and Efficacy of Trastuzumab Combined With Pertuzumab in Patients With [Corrected] Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. Clin Cancer Res. 2008;14(9):2710-2716. [PubMed 18451236]
  55. Procter M, Suter TM, de Azambuja E, et al. Longer-Term Assessment of Trastuzumab-Related Cardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial. J Clin Oncol. 2010;28(21):3422-3428. [PubMed 20530280]
  56. Quartino AL, Li H, Kirschbrown WP, et al. Population pharmacokinetic and covariate analyses of intravenous trastuzumab (Herceptin®), a HER2-targeted monoclonal antibody, in patients with a variety of solid tumors. Cancer Chemother Pharmacol. 2019;83(2):329-340. doi:10.1007/s00280-018-3728-z [PubMed 30467591]
  57. Rivera F, Romera C, Jimenez-Fonseca P, et al. Phase II study to evaluate the efficacy of trastuzumab in combination with capecitabine and oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial [published correction appears in Cancer Chemother Pharmacol. 2019;84(6):1365]. Cancer Chemother Pharmacol. 2019;83(6):1175-1181. doi:10.1007/s00280-019-03820-7 [PubMed 30927036]
  58. Romond EH, Perez EA, Bryant J, et al, “Trastuzumab Plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer,” N Engl J Med, 2005, 353(16):1673-84. [PubMed 16236738]
  59. Rugo HS, Rumble RB, Macrae E, et al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American Society of Clinical Oncology Guideline. J Clin Oncol. 2016;34(25):3069-3103. doi:10.1200/JCO.2016.67.1487 [PubMed 27217461]
  60. Saleh M, Bourcier T, Noel G, Speeg-Schatz C, Gaucher D. Bilateral macular ischemia and severe visual loss following trastuzumab therapy. Acta Oncol. 2011;50(3):477-478. doi:10.3109/0284186X.2011.555781 [PubMed 21303229]
  61. Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016;17(6):738-746. doi:10.1016/S1470-2045(16)00150-9 [PubMed 27108243]
  62. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. [PubMed 21991949]
  63. Seicean S, Seicean A, Alan N, et al. Cardioprotective Effect of Beta-Adrenoceptor Blockade in Breast Cancer Patients Undergoing Chemotherapy: A Follow-Up Study of Heart Failure. Circ Heart Fail. 2013;6(3):420-426. [PubMed 23425978]
  64. Seidman A, Hudis C, Pierri MK, et al. Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience. J Clin Oncol. 2002;20(5):1215-1221. [PubMed 11870163]
  65. Sekar R, Stone PR. Trastuzumab Use for Metastatic Breast Cancer in Pregnancy. Obstet Gynecol. 2007;110(2, pt 2):507-510. [PubMed 17666645]
  66. Serrano C, Cortés J, De Mattos-Arruda L, et al. Trastuzumab-Related Cardiotoxicity in the Elderly: A Role for Cardiovascular Risk Factors. Ann Oncol. 2012;23(4):897-902. [PubMed 21828361]
  67. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of Chemotherapy Plus a Monoclonal Antibody Against HER2 for Metastatic Breast Cancer That Overexpresses HER2. N Engl J Med. 2001;344(11):783-792. [PubMed 11248153]
  68. Soulare E, Cohen R, Tournigand C, et al. Efficacy and safety of trastuzumab in combination with oxaliplatin and fluorouracil-based chemotherapy for patients with HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma patients: a retrospective study. Bull Cancer. 2015;102(4):324-331. doi:10.1016/j.bulcan.2014.08.001 [PubMed 25744576]
  69. Strickler JH. MOUNTAINEER: open-label, phase II study of tucatinib combined with trastuzumab for HER2-positive metastatic colorectal cancer (SGNTUC-017, trial in progress). J Clin Oncol. 2021;39(suppl 3; abstr TPS153). https://meetings.asco.org/abstracts-presentations/194211. Accessed January 26, 2023.
  70. Suter TM, Procter M, van Veldhuisen DJ, et al. Trastuzumab Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial. J Clin Oncol. 2007;25(25):3859-3865. [PubMed 17646669]
  71. Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372(8):724-734. [PubMed 25693012]
  72. Tarantini L, Gori S, Faggiano P, et al. Adjuvant Trastuzumab Cardiotoxicity in Patients Over 60 Years of Age With Early Breast Cancer: A Multicenter Cohort Analysis. Ann Oncol. 2012;23(12):3058-3063. [PubMed 22700991]
  73. Tolaney SM, Barry WT, Dang CT, et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015;372(2):134-141. [PubMed 25564897]
  74. Trazimera (trastuzumab-qyyp) [prescribing information]. New York, NY: Pfizer Labs; November 2020.
  75. Trazimera (trastuzumab) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; June 2021.
  76. Watson WJ. Herceptin (Trastuzumab) Therapy During Pregnancy: Association With Reversible Anhydramnios. Obstet Gynecol. 2005;105(3):642-643. [PubMed 15738038]
  77. Witzel ID, Muller V, Harps E, et al. Trastuzumab in Pregnancy Associated With Poor Fetal Outcome. Ann Oncol. 2008;19(1):191-192. [PubMed 18084047]
  78. Wolff AC, Hammond ME, Hicks DG, et al; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013. [PubMed 24101045]
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