Trazimera

Trastuzumab

Adults w/ human epidermal growth factor receptor 2 (HER2) +ve metastatic breast cancer (MBC) as monotherapy in patients who have received at least 2 chemotherapy regimens for metastatic disease; in combination w/ paclitaxel in patients who have not received chemotherapy for metastatic disease & for whom anthracycline is not suitable; in combination w/ docetaxel in patients who have not received chemotherapy for metastatic disease; in combination w/ an aromatase inhibitor in postmenopausal patients w/ hormone-receptor +ve MBC not previously treated w/ trastuzumab. Adults w/ HER2 +ve early breast cancer (EBC) following surgery, chemotherapy & RT; following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide in combination w/ paclitaxel or docetaxel; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant therapy for locally advanced (including inflammatory) disease or tumors >2 cm in diameter. Patients w/ metastatic or EBC whose tumors have either HER2 overexpression or HER2 gene amplification as determined by accurate & validated assay. In combination w/ capecitabine or 5-fluorouracil & cisplatin in adults w/ HER +ve metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for metastatic disease. Adult w. metastatic gastric cancer (MGC) whose tumor have HER2 overexpression.

IV Administer loading dose as 90-min IV infusion. Administer subsequent doses as 30-min infusion if the initial loading dose is well tolerated. MBC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals beginning 3 wk after the loading dose. Wkly schedule: Initial loading dose: 4 mg/kg. Maintenance dose: 2 mg/kg wkly beginning 1 wk after the loading dose. Duration: Until disease progression. EBC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals beginning 3 wk after the loading dose. Wkly schedule: Initial loading dose: 4 mg/kg followed by 2 mg/kg every wk concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide. Duration: 1 yr or until disease recurrence. MGC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals beginning 3 wk after the loading dose. Duration: Until disease progression.

Hypersensitivity to trastuzumab or murine proteins. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary O₂ therapy.

Discontinue use should an infusion reaction occur. Do not administer IV push or bolus & SC. Increased risk of fatal infusion reaction in patients experiencing dyspnea at rest due to complications of advanced malignancy & comorbidities. Perform HER2 testing prior to initiation of therapy. Re-treatment of patients w/ previous exposure to Trazimera in adjuvant setting. Increased risk for developing CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction. Patients w/ increased cardiac risk eg, HTN, documented CAD, CHF, LVEF <55%, older age. All candidates for treatment especially those w/ prior anthracycline & cyclophosphamide exposure should undergo baseline cardiac assessment including history & physical exam, ECG, echocardiogram, &/or multigated acquisition (MUGA) scan or MRI, & should be repeated every 3 mth during treatment & every 6 mth following discontinuation until 24 mth from the last administration. Avoid anthracycline-based therapy for up to 7 mth after stopping treatment. Do not give concurrently w/ anthracyclines in the MBC & adjuvant treatment setting. Monitor patients who receive anthracycline-containing chemotherapy yrly up to 5 yr from last administration or longer if a continuous decrease of LVEF is observed in EBC patients. Patients w/ history of MI, angina pectoris requiring medical treatment, history of or existing CHF (NYHA class II-IV), LVEF <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled HTN (HTN controlled by standard medical treatment eligible), & hemodynamic effective pericardial effusion. Risk factors associated w/ ILD including prior or concomitant therapy w/ other anti-neoplastic therapies known to be associated w/ ILD eg, taxanes, gemcitabine, vinorelbine & RT; pneumonitis. May have a minor influence on the ability to drive or use machines. Women of childbearing potential should use effective contraception during treatment & for 7 mth after treatment has concluded. Avoid use during pregnancy. Do not breast feed during therapy & for 7 mth after the last dose. Elderly >65 yr.

Infection, nasopharyngitis, neutropenic sepsis, cystitis, herpes zoster, flu, sinusitis, skin infection, rhinitis, URTI, UTI, erysipelas, cellulitis, pharyngitis, sepsis; malignant neoplasm progression, neoplasm progression; febrile neutropenia, anemia, neutropenia, decreased WBC/leukopenia, thrombocytopenia, hypoprothrombinemia, immune thrombocytopenia; hypersensitivity, anaphylactic reaction/shock; decreased wt/wt loss, anorexia, tumor lysis syndrome, hyperkalemia; insomnia, anxiety, depression, abnormal thinking; tremor, dizziness, headache, paresthesia, dysgeusia, peripheral neuropathy, hypertonia, somnolence, ataxia, paresis, brain edema; conjunctivitis, increased lacrimation, dry eye, papilledema, retinal hemorrhage; deafness; decreased/increased BP, irregular heart beat, palpitation, cardiac flutter, decreased ejection fraction, cardiac failure (congestive), supraventricular tachyarrhythmia, cardiomyopathy, pericardial effusion, cardiogenic shock, pericarditis, bradycardia, present gallop rhythm; hot flush, hypotension, vasodilatation; wheezing, dyspnea, cough, epistaxis, rhinorrhea, pneumonia, asthma, lung disorder/infiltration, pleural effusion, pneumonitis, pulmonary fibrosis, resp distress/failure, acute pulmonary edema & resp distress syndrome, bronchospasm, hypoxia, decreased O₂ saturation, laryngeal/pulmonary edema, orthopnea, ILD; diarrhea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis, hemorrhoids, dry mouth; hepatocellular injury, hepatitis, liver tenderness, jaundice, hepatic failure; erythema, rash, swelling face, alopecia, nail disorder, palmar-plantar erythrodysesthesia syndrome, acne, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, pruritus, onychoclasis, dermatitis, urticaria, angioedema; arthralgia, muscle tightness, myalgia, arthritis, back/bone/neck/chest pain, muscle spasms, pain in extremity; renal disorder/failure, membranous glomerulonephritis, glomerulonephropathy; oligohydramnios, renal/pulmonary hypoplasia; breast inflammation/mastitis; asthenia, chills, fatigue, flu-like symptoms, infusion-related reaction, pain, pyrexia, mucosal inflammation, peripheral edema, malaise, edema; contusion.

May elevate the overall exposure of doxorubicin metabolite, 7-deoxy-13 dihydro-doxorubicinone, D7D.

Targeted Cancer Therapy

L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.

Rx