ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده: مورد

Pertuzumab: Drug information

Pertuzumab: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Pertuzumab: Patient drug information"

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

Pertuzumab can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue pertuzumab treatment for a confirmed clinically significant decrease in left ventricular function.

Pregnancy:

Exposure to pertuzumab can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.

Brand Names: US
  • Perjeta
Brand Names: Canada
  • Perjeta
Pharmacologic Category
  • Antineoplastic Agent, Anti-HER2;
  • Antineoplastic Agent, Monoclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Actively manage modifiable cardiac risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) before initiating treatment (Ref). Observe patients for 30 to 60 minutes after each pertuzumab infusion and before subsequent doses of trastuzumab products or docetaxel. Medications and equipment for the treatment of hypersensitivity should be available for immediate use during infusion. Do not substitute pertuzumab (IV) with pertuzumab/trastuzumab/hyaluronidase (SUBQ).

Clinical considerations: Select patients for treatment based on HER2 protein overexpression or HER2 gene amplification in tumor specimens. Refer to the protocol or institutional guidance for additional details of off-label dosing.

Biliary tract cancer, metastatic, HER2 positive

Biliary tract cancer, metastatic, HER2 positive (previously treated) (off-label use): Initial dose: IV: 840 mg followed by a maintenance dose of 420 mg once every 3 weeks (in combination with trastuzumab); continue until disease progression or unacceptable toxicity (Ref).

Breast cancer, early, HER2 positive, neoadjuvant treatment

Breast cancer, early, HER2 positive, neoadjuvant treatment: IV: 840 mg followed by a maintenance dose of 420 mg every 3 weeks for 3 to 6 cycles; may be administered as one of the regimens below. Postoperatively, continue pertuzumab and trastuzumab (or trastuzumab/hyaluronidase) to complete 1 year of treatment (up to 18 cycles) or until disease progression or unacceptable toxicity (whichever occurs first).

Four preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and docetaxel, followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) (Ref) or

Three or four preoperative cycles of FEC (alone) followed by 3 or 4 preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and docetaxel (Ref) or

Six preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), docetaxel, and carboplatin (Ref) or

Four preoperative cycles of dose-dense doxorubicin and cyclophosphamide alone, followed by 4 preoperative cycles of pertuzumab, trastuzumab (or trastuzumab/hyaluronidase), and paclitaxel (Ref).

Breast cancer, early, HER2 positive, adjuvant treatment

Breast cancer, early, HER2 positive, adjuvant treatment: IV: 840 mg followed by a maintenance dose of 420 mg every 3 weeks; continue for a total of 1 year (up to 18 cycles) or until disease progression or unacceptable toxicity (whichever occurs first); as part of a combination regimen containing trastuzumab (or trastuzumab/hyaluronidase) and including standard anthracycline- and/or taxane-based therapy; begin pertuzumab and trastuzumab (or trastuzumab/hyaluronidase) on day 1 of the first taxane-containing cycle (Ref).

Breast cancer, metastatic, HER2 positive

Breast cancer, metastatic, HER2 positive: IV: 840 mg followed by a maintenance dose of 420 mg every 3 weeks (in combination with trastuzumab [or trastuzumab/hyaluronidase] and docetaxel); continue until disease progression or unacceptable toxicity (Ref).

Colorectal cancer, metastatic, HER2 positive

Colorectal cancer, metastatic, HER2 positive (previously treated) (off-label use): IV: Initial dose: 840 mg followed by a maintenance dose of 420 mg once every 3 weeks (in combination with trastuzumab); continue until disease progression or unacceptable toxicity (Ref).

Missed doses or delays: If <6 weeks has elapsed, administer pertuzumab 420 mg (maintenance dose) as soon as possible; do not wait until the next planned dose. If ≥6 weeks has elapsed, readminister pertuzumab 840 mg (loading dose) over 60 minutes, and then follow with a maintenance dose of pertuzumab 420 mg (over 30 to 60 minutes) every 3 weeks thereafter.

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 mL/minute: No dosage adjustment necessary.

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

Dosing: Liver Impairment: Adult

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

Dosing: Adjustment for Toxicity: Adult

Note: Dose reductions are not recommended for pertuzumab; if trastuzumab (or trastuzumab/hyaluronidase) is withheld, pertuzumab should also be withheld; if the trastuzumab product is discontinued, permanently discontinue pertuzumab. Other concomitant anticancer therapies may also require treatment interruption, dosage reduction, and/or discontinuation.

Pertuzumab Dosage Modification for Adverse Reactionsa

Adverse reaction

Severity

Pertuzumab dose modification

a LVEF = Left ventricular ejection fraction.

b Manufacturer's labeling.

c ASCO [Armenian 2017].

d ESC [Lyon 2022].

Cardiotoxicity: Left ventricular dysfunction

Early breast cancer: Pretreatment LVEF ≥55% (LVEF ≥50% in patients receiving anthracycline-based chemotherapy following completion of anthracycline [before starting pertuzumab/ trastuzumab])

LVEF decline to <50% with a decrease of ≥10% below pretreatment values

Withhold treatment (pertuzumab and trastuzumab [or trastuzumab/ hyaluronidase]) for at least 3 weeks; may resume treatment if LVEF either returns to ≥50% or <10% below pretreatment values.

If LVEF declines and has not improved, or has declined further at the subsequent assessment, strongly consider discontinuing pertuzumab (and the trastuzumab product).b

Cardiotoxicity: Left ventricular dysfunction

Metastatic breast cancer: Pretreatment LVEF ≥50%

LVEF decline to <40%

or

LVEF 40% to 45% with a decrease of ≥10% below pretreatment values

Withhold treatment (pertuzumab and trastuzumab [or trastuzumab/ hyaluronidase]) for at least 3 weeks; may resume treatment if LVEF either returns to >45% or to 40% to 45% with a decrease of <10% points below pretreatment values.

If LVEF declines and has not improved, or has declined further at the subsequent assessment, strongly consider discontinuing pertuzumab (and the trastuzumab product).b

Cardiotoxicity: Asymptomatic heart disease

Any

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.c, d

Mild cardiac dysfunction

Continue treatment with close cardiovascular monitoring.d

Moderate cardiac dysfunction

Consider continuing treatment with close cardiovascular monitoring. Initiation of heart failure medications is recommended.d

Severe cardiac dysfunction

Interrupt treatment and utilize a multidisciplinary approach when deciding if/when to restart. Initiation of heart failure medications is recommended.d

Cardiotoxicity: Symptomatic heart disease

Any

Initiate heart failure medications.d

Mild cardiac dysfunction

Consider a multidisciplinary approach for decisions regarding treatment interruption versus continuation.d

Moderate or severe cardiac dysfunction

Interrupt treatment; consider a multidisciplinary approach for decisions regarding treatment reinitiation.d

Infusion-related reactions

Any

Slow or interrupt the infusion and administer appropriate medical management for significant infusion reactions. For severe infusion reactions, consider permanently discontinuing.b

Serious hypersensitivity or anaphylaxis

Any

Immediately discontinue pertuzumab.b

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions reported in combination therapy with trastuzumab and adjunctive chemotherapy.

>10%:

Dermatologic: Alopecia (61%), pruritus (14%), skin rash (26% to 34%), xeroderma (11% to 13%)

Gastrointestinal: Abdominal pain (12%; upper abdominal pain [10%]), decreased appetite (24% to 29%), diarrhea (67% to 71%; grades 3/4: 8% to 10%), dysgeusia (18% to 26%), nausea (69%; grades 3/4: 2%), stomatitis (19% to 28%; grades 3/4: ≤2%), vomiting (32%; grades 3/4: 2%)

Hematologic & oncologic: Anemia (23% to 28%; grades 3/4: 2% to 7%), febrile neutropenia (12% to 14%; grades 3/4: 12% to 13%), neutropenia (25% to 53%; grades 3/4: 16% to 49%)

Hypersensitivity: Hypersensitivity (≤11%; anaphylaxis), infusion-related reaction (13% to 21%)

Nervous system: Dizziness (13%), fatigue (49%), headache (21%), paresthesia (12%), peripheral neuropathy (33%; grades 3/4: 1%)

Respiratory: Cough (16%), epistaxis (18%), nasopharyngitis (13%), upper respiratory tract infection (17%)

Miscellaneous: Fever (19%), radiation injury (skin: 13%)

1% to 10%:

Cardiovascular: Left systolic heart failure (symptomatic: ≤1%), left ventricular dysfunction (4%)

Dermatologic: Paronychia (7%)

Hematologic & oncologic: Leukopenia (<10%)

Postmarketing: Cardiovascular: Decreased left ventricular ejection fraction

Contraindications

Known hypersensitivity to pertuzumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiotoxicity: Pertuzumab may cause left ventricular dysfunction, including symptomatic heart failure. Decreases in left ventricular ejection fraction (LVEF) have been reported with HER2 inhibitors, including pertuzumab. In the pertuzumab-treated patients with metastatic breast cancer, left ventricular dysfunction, including symptomatic left ventricular systolic dysfunction (LVSD), occurred in a small percentage of patients. Patients who received prior anthracycline therapy or chest irradiation may be at an increased risk for cardiotoxicity. In the early breast cancer neoadjuvant setting, left ventricular dysfunction, including asymptomatic left ventricular dysfunction and/or LVSD, was observed in patients treated with pertuzumab; however, LVEF recovered to ≥50% in a majority of patients. In the early breast cancer adjuvant setting, symptomatic heart failure (NYHA class III/IV) with a LVEF decline ≥10% and a drop to <50% occurred in a small number of patients (most of these events were reported in anthracycline-treated patients); almost half of the pertuzumab-treated patients who experienced symptomatic heart failure recovered. Asymptomatic or mildly symptomatic (NYHA class II) declines in LVEF ≥10% and a drop to <50% were reported in a small percentage of pertuzumab-treated patients, of whom a majority recovered at data cutoff. Of note, patients with pretreatment LVEF <50%, history of congestive heart failure, LVEF decreases to <50% during prior trastuzumab treatment, or conditions which could impair left ventricular function (eg, uncontrolled hypertension, recent myocardial infarction, serious arrhythmia requiring treatment, or cumulative lifetime anthracycline exposure >360 mg/m2 doxorubicin or its equivalent) were excluded from studies.

• GI adverse events: Diarrhea occurred more frequently in patients receiving pertuzumab in combination with trastuzumab and docetaxel, compared to patients receiving only trastuzumab and docetaxel. Diarrhea occurred more frequently in the first pertuzumab cycle and was generally grade 1 or 2; diarrhea was usually managed with loperamide and rarely required treatment delay (Swain 2017).

• Hypersensitivity: Pertuzumab may cause hypersensitivity reactions, including anaphylaxis. The overall frequency of hypersensitivity/anaphylaxis was 11%, with grade 3 and 4 events occurring in a small percentage of patients. Severe hypersensitivity, including anaphylaxis, has been reported; some events were fatal. Angioedema has also been reported.

• Infusion reaction: Pertuzumab may cause serious infusion-related reactions, including fatal events. Infusion reactions have occurred on the day of infusion in up to one-fourth of patients; grades 3 and 4 events have been reported in a small number of patients. The most common infusion reactions included fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting; reactions during cycle 2 included fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting.

Special populations:

• Older age: The incidence of adverse reactions (including decreased appetite, weight loss, anemia, weakness, dysgeusia, peripheral neuropathy, and hypomagnesemia) was increased in pertuzumab-treated patients ≥65 years of age (compared to patients <65 years of age).

Dosage form specific issues:

• Do not interchange: Pertuzumab (IV) and pertuzumab/trastuzumab/hyaluronidase (SUBQ) are not interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors. Dosing and treatment schedules differ between pertuzumab (Perjeta) and pertuzumab/trastuzumab/hyaluronidase (Phesgo).

Other warnings/precautions:

HER2 expression: Establish HER2 status (HER2 overexpression or HER2 gene amplification) in tumor specimen prior to treatment. Improper assay performance (including suboptimally fixed tissue, failure to use specified reagents, deviation from assay instructions, and failure to include appropriate assay controls) may lead to unreliable results. Information on tests is available at http://www.fda.gov/CompanionDiagnostics.

Dosage Forms: US

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

Solution, Intravenous [preservative free]:

Perjeta: 420 mg/14 mL (14 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Perjeta Intravenous)

420 mg/14 mL (per mL): $584.61

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, Intravenous:

Perjeta: 420 mg/14 mL (14 mL) [contains mouse (murine) and/or hamster protein]

Administration: Adult

IV: For IV infusion only, as a short infusion; infuse initial dose (840 mg) over 60 minutes; infuse maintenance dose (420 mg) over 30 to 60 minutes. Do not administer IV push or as a rapid bolus. Do not mix with other medications. Observe patients for 30 to 60 minutes after each pertuzumab infusion and before subsequent infusions of the trastuzumab product or docetaxel. Monitor for hypersensitivity reactions for 60 minutes following the initial pertuzumab infusion and for 30 minutes following subsequent infusions.

Administration sequence (for combination therapy):

In combination with a taxane-based regimen: When administered in combination with a taxane-based combination regimen, pertuzumab and the trastuzumab product may be administered in any order; however, administer the taxane after pertuzumab and the trastuzumab product.

In combination with anthracycline-based regimen: When administered in combination with an anthracycline-based combination regimen, administer pertuzumab (and the trastuzumab product) following completion of the anthracycline therapy.

Check label to ensure appropriate product is being administered; pertuzumab and pertuzumab/trastuzumab/hyaluronidase are different products and are NOT interchangeable.

Hazardous Drugs Handling Considerations

Pertuzumab was removed from the NIOSH list of hazardous drugs in healthcare settings with the 2024 update (NIOSH 2024).

Use: Labeled Indications

Breast cancer, early, HER2-positive, adjuvant treatment: Adjuvant treatment (in combination with trastuzumab and chemotherapy) of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer at high risk of recurrence in adults.

Breast cancer, early, HER2-positive, neoadjuvant treatment: Neoadjuvant treatment (in combination with trastuzumab and chemotherapy as part of a complete treatment regimen for early breast cancer) of locally advanced, inflammatory, or early stage HER2-positive, breast cancer (either greater than 2 cm in diameter or node positive) in adults.

Breast cancer, metastatic, HER2-positive: Treatment (in combination with trastuzumab and docetaxel) of HER2-positive metastatic breast cancer in adults who have not received prior anti-HER2 therapy or chemotherapy to treat metastatic disease.

Use: Off-Label: Adult

Biliary tract cancer, metastatic, HER2 positive (previously treated); Colorectal cancer, metastatic, HER2 positive (previously treated)

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

Perjerta may be confused with Phesgo.

Pertuzumab may be confused with ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, panitumumab, pertuzumab/trastuzumab/hyaluronidase, polatuzumab vedotin, trastuzumab, 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).

Administration issues:

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

Other safety concerns:

Pertuzumab (Perjeta) may be confused with pertuzumab/trastuzumab/hyaluronidase (Phesgo).

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.

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who could become pregnant. Advise patients of the risks of exposure during pregnancy and the need for effective contraception. Patients who could become pregnant should use effective contraception during therapy and for 7 months after the last dose of pertuzumab in combination with trastuzumab (or trastuzumab/hyaluronidase).

Pregnancy Considerations

Pertuzumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data following exposure to pertuzumab as monotherapy or in combination with trastuzumab or other agents during pregnancy are limited (Al-Shamsi 2023, Andrikopoulou 2021; Gougis 2023). Based on the mechanism of action of pertuzumab and data from animal reproduction studies, in utero exposure to pertuzumab may result in fetal death and birth defects. Oligohydramnios or oligohydramnios sequence may occur resulting in pulmonary hypoplasia, skeletal anomalies, and neonatal death. Monitor for oligohydramnios if exposure occurs during pregnancy or within 7 months prior to conception; conduct appropriate fetal testing if oligohydramnios occurs. Advise patients of the risks of fetal exposure.

European Society for Medical Oncology (ESMO) guidelines for managing breast cancer during pregnancy recommend delaying treatment with HER2-targeted agents until after delivery in pregnant patients with HER2-positive disease (ESMO [Loibl 2023]).

Advise patients to immediately report to health care provider if pregnancy is suspected during treatment. If pertuzumab exposure occurs during pregnancy or exposure to pertuzumab in combination with trastuzumab (or trastuzumab/hyaluronidase) occurs within 7 months following the last dose of pertuzumab, report the exposure to Genentech (888-835-2555).

Breastfeeding Considerations

It is not known if pertuzumab is present in breast milk.

Pertuzumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Immunoglobulin is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The extended half-life of pertuzumab and the 7-month wash out period for trastuzumab (or trastuzumab/hyaluronidase) should be considered for decisions regarding breastfeeding after treatment is completed.

Monitoring Parameters

Assess HER2 protein expression or HER2 gene amplification in tumor specimen prior to treatment. Evaluate pregnancy status (prior to treatment in patients who could become pregnant). Assess cardiac function, including LVEF at baseline, and approximately every 12 weeks during treatment (more frequently for declines). Monitor for infusion reaction, diarrhea, and hypersensitivity (monitor for hypersensitivity reactions for 60 minutes following the initial pertuzumab infusion and for 30 minutes following subsequent infusions).

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends 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.

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]).

Mechanism of Action

Pertuzumab is a recombinant humanized monoclonal antibody which targets the extracellular human epidermal growth factor receptor 2 protein (HER2) dimerization domain. Inhibits HER2 dimerization and blocks HER downstream signaling halting cell growth and initiating apoptosis. Pertuzumab binds to a different HER2 epitope than trastuzumab so that when pertuzumab is combined with trastuzumab, a more complete inhibition of HER2 signaling occurs (Baselga 2012).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 5.12 L (Gianni 2010).

Half-life elimination: Median: 18 days.

Excretion: Clearance: Median: 0.24 L/day.

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

  • (AE) United Arab Emirates: Perjeta;
  • (AR) Argentina: Perjeta;
  • (AT) Austria: Perjeta;
  • (AU) Australia: Perjeta;
  • (BE) Belgium: Perjeta;
  • (BG) Bulgaria: Perjeta;
  • (BR) Brazil: Perjeta;
  • (CH) Switzerland: Perjeta;
  • (CL) Chile: Perjeta;
  • (CO) Colombia: Perjeta;
  • (CR) Costa Rica: Perjeta;
  • (CZ) Czech Republic: Perjeta;
  • (DE) Germany: Perjeta;
  • (DO) Dominican Republic: Perjeta;
  • (EC) Ecuador: Perjeta;
  • (EE) Estonia: Perjeta;
  • (EG) Egypt: Perjeta;
  • (ES) Spain: Perjeta;
  • (FI) Finland: Perjeta;
  • (FR) France: Perjeta;
  • (GB) United Kingdom: Perjeta;
  • (GR) Greece: Perjeta;
  • (HK) Hong Kong: Perjeta;
  • (HR) Croatia: Perjeta;
  • (HU) Hungary: Perjeta;
  • (ID) Indonesia: Perjeta;
  • (IE) Ireland: Perjeta;
  • (IT) Italy: Perjeta;
  • (JO) Jordan: Perjeta;
  • (JP) Japan: Perjeta;
  • (KR) Korea, Republic of: Perjeta;
  • (KW) Kuwait: Perjeta;
  • (LB) Lebanon: Perjeta;
  • (LT) Lithuania: Perjeta;
  • (LV) Latvia: Perjeta;
  • (MX) Mexico: Perjeta;
  • (MY) Malaysia: Perjeta;
  • (NL) Netherlands: Perjeta;
  • (NO) Norway: Perjeta;
  • (NZ) New Zealand: Perjeta;
  • (PA) Panama: Perjeta;
  • (PE) Peru: Perjeta;
  • (PH) Philippines: Perjeta;
  • (PK) Pakistan: Perjeta;
  • (PL) Poland: Perjeta;
  • (PR) Puerto Rico: Perjeta;
  • (PT) Portugal: Perjeta;
  • (PY) Paraguay: Perjeta;
  • (QA) Qatar: Perjeta;
  • (RU) Russian Federation: Perjeta;
  • (SA) Saudi Arabia: Perjeta;
  • (SE) Sweden: Perjeta;
  • (SG) Singapore: Perjeta;
  • (SI) Slovenia: Perjeta;
  • (SK) Slovakia: Perjeta;
  • (TH) Thailand: Perjeta;
  • (TN) Tunisia: Perjeta;
  • (TR) Turkey: Perjeta;
  • (TW) Taiwan: Perjeta;
  • (UA) Ukraine: Perjeta;
  • (UY) Uruguay: Perjeta;
  • (ZA) South Africa: Perjeta
  1. Al-Shamsi HO, Abdelwahed N, Singh M, et al. First reported case of successful conception and delivery during stage IV breast cancer treatment: a case report and literature review. Cureus. 2023;15(10):e47201. doi:10.7759/cureus.47201 [PubMed 38021854]
  2. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  3. Andrikopoulou A, Apostolidou K, Chatzinikolaou S, et al. Trastuzumab administration during pregnancy: an update. BMC Cancer. 2021;21(1):463. doi:10.1186/s12885-021-08162-3 [PubMed 33902516]
  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. Baselga J, Cortés J, Kim SB, et al; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109-119. doi:10.1056/NEJMoa1113216 [PubMed 22149875]
  6. Baselga J, Gelmon KA, Verma S, et al. Phase II Trial of Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer That Progressed During Prior Trastuzumab Therapy. J Clin Oncol. 2010, 28(7):1138-44. [PubMed 20124182]
  7. Baselga J and Swain SM. CLEOPATRA: A Phase III Evaluation of Pertuzumab and Trastuzumab for HER2-Positive Metastatic Breast Cancer. Clin Breast Cancer. 2010;10(6):489-491. [PubMed 21147694]
  8. Cannon TL, Rothe M, Mangat PK, et al. Pertuzumab plus trastuzumab in patients with biliary tract cancer with ERBB2/3 alterations: results from the targeted agent and profiling utilization registry study. J Clin Oncol. 2024;42(27):3228-3237. doi:10.1200/JCO.23.02078 [PubMed 38748939]
  9. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  10. Denduluri N, Chavez-MacGregor M, Telli ML, et al. Selection of optimal adjuvant chemotherapy and targeted therapy for early breast cancer: ASCO Clinical Practice Guideline focused update. J Clin Oncol. 2018;36(23):2433-2443. [PubMed 29787356]
  11. Gianni L, Lladó A, Bianchi G, et al. Open-Label, Phase II, Multicenter, Randomized Study of the Efficacy and Safety of Two Dose Levels of Pertuzumab, a Human Epidermal Growth Factor Receptor 2 Dimerization Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2010;28(7):1131-1137. [PubMed 20124183]
  12. Gianni L, Pienkowski T, Im YH, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016;17(6):791-800. doi:10.1016/S1470-2045(16)00163-7 [PubMed 27179402]
  13. 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]
  14. 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):2078-99. [PubMed 24799465]
  15. Gougis P, Grandal B, Jochum F, et al. Treatments during pregnancy targeting ERBB2 and outcomes of pregnant individuals and newborns. JAMA Netw Open. 2023;6(10):e2339934. doi:10.1001/jamanetworkopen.2023.39934 [PubMed 37883083]
  16. 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. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  17. Javle M, Borad MJ, Azad NS, et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021;22(9):1290-1300. doi:10.1016/S1470-2045(21)00336-3 [PubMed 34339623]
  18. Loibl S, Azim HA Jr, Bachelot T, et al. ESMO expert consensus statements on the management of breast cancer during pregnancy (PrBC). Ann Oncol. 2023;34(10):849-866. doi:10.1016/j.annonc.2023.08.001 [PubMed 37572987]
  19. 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]
  20. Meric-Bernstam F, Hurwitz H, Raghav KPS, et al. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019;20(4):518-530. doi:10.1016/S1470-2045(18)30904-5 [PubMed 30857956]
  21. Miles D, Baselga J, Amadori D, et al. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013;142(1):89-99. [PubMed 24129974]
  22. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  23. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
  24. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
  25. Peccatori FA, Azim HA Jr, Orecchia R, et al; ESMO Guidelines Working Group. Cancer, pregnancy and fertility: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(suppl 6):vi160-vi170. [PubMed 23813932]
  26. Perjeta (pertuzumab) [prescribing information]. South San Francisco, CA: Genentech Inc; April 2025.
  27. Raghav KPS, Guthrie KA, Tan B Jr, et al. Trastuzumab plus pertuzumab versus cetuximab plus irinotecan in patients with RAS/BRAF wild-type, HER2-positive, metastatic colorectal cancer (S1613): a randomized phase II trial. J Clin Oncol. 2025;43(11):1348-1357. doi:10.1200/JCO-24-01710 [PubMed 39761503]
  28. Ramakrishna N, Temin S, Chandarlapaty S, et al. Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32(19):2078-99. [PubMed 24799487]
  29. Schneeweiss A, Chia, S, Hickish, T, et al. Pertuzumab Plus Trastuzumab in Combination With Standard Neoadjuvant Anthracycline-Containing and Anthracycline-Free Chemotherapy Regimens in Patients With HER2-Positive Early Breast Cancer: A Randomized Phase II Cardiac Safety Study (TRYPHAENA). Ann Oncol. 2013;24(9):2278-84. [PubMed 23704196]
  30. Swain SM, Baselga J, Kim SB, et al; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372(8):724-734. [PubMed 25693012]
  31. Swain SM, Ewer MS, Cortés J, et al. Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III study. Oncologist. 2013;18(3):257-264. [PubMed 23475636]
  32. Swain SM, Ewer MS, Viale G, et al. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018;29(3):646-653. [PubMed 29253081]
  33. Swain SM, Kim SB, Cortés J, et al. Pertuzumab, Trastuzumab, and Docetaxel for HER2-Positive Metastatic Breast Cancer (CLEOPATRA Study): Overall Survival Results from a Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study. Lancet Oncol. 2013;14(6):461-471. [PubMed 23602601]
  34. Swain SM, Miles D, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(4):519-530. doi:10.1016/S1470-2045(19)30863-0 [PubMed 32171426]
  35. Swain SM, Schneeweiss A, Gianni L, et al. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017;28(4):761-768. [PubMed 28057664]
  36. Sweeney CJ, Hainsworth JD, Bose R, et al. MyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: pertuzumab + trastuzumab treatment of a tissue-agnostic cohort of patients with human epidermal growth factor receptor 2-altered advanced solid tumors. J Clin Oncol. 2024;42(3):258-265. doi:10.1200/JCO.22.02636 [PubMed 37793085]
  37. von Minckwitz G, Procter M, de Azambuja E, et al; APHINITY Steering Committee and Investigators. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377(2):122-131. doi:10.1056/NEJMoa1703643 [PubMed 28581356]
  38. Wolff AC, Hammond ME, Hicks DG, et al. 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]
Topic 85639 Version 205.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟