{ "query": "pertuzumab", "ingredient": "pertuzumab", "slug": "pertuzumab", "rxcui": "1298944", "brands": [ "Perjeta" ], "names": [ "pertuzumab" ], "classes": [ { "id": "L01FD", "name": "HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors" } ], "alternatives": [ "ado-trastuzumab emtansine", "margetuximab", "trastuzumab", "trastuzumab deruxtecan", "zanidatamab" ], "label": { "route_mode": "INTRAVENOUS", "route_counts": { "INTRAVENOUS": 1 }, "boxed_warning": "WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) (8.3) ]. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.3 , 5.1 , 6.1 ) Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo...", "indications_and_usage": "is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ( 1.2 , 2.2 , 14.2 ) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence ( 1.2 , 2.2 , 14.3 ) 1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] . 1.2 Early Breast Cancer (EBC) PERJETA is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, lo...", "contraindications": "is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients [see Warnings and Precautions (5.4)]. PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients. ( 4 )", "warnings_and_cautions": "Infusion-Related Reactions: PERJETA can cause serious infusion reactions, including fatal events: Monitor for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies. ( 5.3 ) Hypersensitivity Reactions/Anaphylaxis: PERJETA can cause hypersensitivity reactions, including anaphylaxis: Monitor for signs and symptoms, including angioedema. If a severe hypersensitivity reaction/anaphylaxis occurs, discontinue the infusion immediately and administer appropriate medical therapies. ( 5.4 ) 5.1 Left Ventricular Dysfunction PERJETA can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including PERJETA. Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of PERJETA and trastuzumab [see Dosage Modification for Adverse Reactions (2.5) ] . In the PERJETA-treated patients with MBC in CLEOPATRA, left ve...", "warnings": "", "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the label: Left Ventricular Dysfunction [see Warnings and Precautions (5.1) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.2) ] Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions/Anaphylaxis [see Warnings and Precautions (5.4) ] Metastatic Breast Cancer The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. ( 6.1 ) Neoadjuvant Treatment of Breast Cancer The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia. ( 6.1 ) The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia. ( 6.1 ) The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thr...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Left Ventricular Dysfunction Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [ see Warnings and Precautions (5.1) ]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential that exposure to PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm [ see Warnings and Precautions (5.2) ] . Advise female patients to contact their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Encourage women who are exposed to PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception to report their pregnancy to Genentech [see Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PERJETA in combination with trastuzumab [see Use in Specific Populations (8.3) ]. Hypersensitivit...", "spl_medguide": "", "clinical_studies": "14.1 Metastatic Breast Cancer CLEOPATRA (NCT00567190) was a multicenter, double-blind, placebo-controlled trial of 808 patients with HER2-positive metastatic breast cancer. HER2 overexpression was defined as a score of 3+ IHC or FISH amplification ratio of 2.0 or greater as determined by a central laboratory. Patients were randomly allocated 1:1 to receive placebo plus trastuzumab and docetaxel or PERJETA plus trastuzumab and docetaxel. Randomization was stratified by prior treatment (prior or no prior adjuvant/neoadjuvant anti-HER2 therapy or chemotherapy) and geographic region (Europe, North America, South America, and Asia). Patients with prior adjuvant or neoadjuvant therapy were required to have a disease-free interval of greater than 12 months before trial enrollment. PERJETA was given intravenously at an initial dose of 840 mg, followed by 420 mg every 3 weeks thereafter. Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks thereafter. Patients were treated with PERJETA and trastuzumab until progression of disease, withdrawal of consent, or unacceptable toxicity. Docetaxel was given as an initial dose of 75 mg/m 2 by intravenou...", "brand_name": "PERJETA", "manufacturer": "Genentech, Inc.", "application_number": "BLA125409", "pharm_class_epc": [ "HER2/neu Receptor Antagonist [EPC]" ], "route": [ "INTRAVENOUS" ], "effective_time": "20260430", "set_id": "17f85d17-ab71-4f5b-9fe3-0b8c822f69ff", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 26082, "serious": 21967, "death": 2416, "hospitalization": 8699, "primary_suspect": 26055, "top_reactions": [ [ "Diarrhoea", 3725 ], [ "Off Label Use", 2361 ], [ "Nausea", 1919 ], [ "Fatigue", 1895 ], [ "Alopecia", 1561 ], [ "Myelosuppression", 1556 ], [ "Vomiting", 1278 ], [ "Disease Progression", 1252 ], [ "Dyspnoea", 1141 ], [ "Neuropathy Peripheral", 1110 ], [ "Pyrexia", 1023 ], [ "Neutropenia", 978 ], [ "Death", 929 ], [ "Rash", 907 ], [ "Anaemia", 868 ] ], "by_year": { "2019": 2291, "2020": 2538, "2021": 2958, "2022": 2698, "2023": 2752, "2024": 3063, "2025": 2025, "2026": 934 }, "by_year_primary": { "2019": 2291, "2020": 2538, "2021": 2958, "2022": 2691, "2023": 2746, "2024": 3062, "2025": 2012, "2026": 934 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 0, "anda": 0, "first_approval": "20120608", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [ "GENENTECH" ], "unapproved": false, "first_approval_fmt": "06/08/2012" }, "trials": { "total": 446, "completed": 129, "terminated": 39, "with_results": 101, "industry": 206, "phase3": 92, "results_share": 0.7829457364341085, "terminated_share": 0.08744394618834081 }, "pubmed": { "rct": 115, "meta": 17, "recent_rct": 59, "cochrane": [] }, "payments": { "year": "2024", "usd": 37453.0, "records": 403, "by_name": [ [ "Perjeta", 37453.0 ] ], "names_checked": [ "pertuzumab", "Perjeta" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1480, "beneficiaries": 236, "spend": 10407108.31, "by_brand": [ { "brand": "Perjeta", "claims": 1480, "per_claim": 7031.8299392, "is_generic": false } ], "per_claim": 7031.82993918919 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "ApplicationRejected", "name": "pertuzumab", "matched": "pertuzumab", "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 65, "letter": "C", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "Death share in reports is near or below the FAERS average (1.0x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 60, "letter": "D", "why": [ "115 randomized trials and 17 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 100, "letter": "A", "why": [ "No recalls on record since 2016" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $37,453 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "5 same-class alternatives exist" ], "weight": 0.1 } }, "total": 75, "grade": "C", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, fatigue. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over ado-trastuzumab emtansine, margetuximab, trastuzumab? What would make you pick one of those instead?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }