Zuellig Pharma
Concise Prescribing Info
Metastatic breast cancer (MBC) w/ tumors that overexpress human epidermal growth factor receptor 2 (HER2): as monotherapy for patients who have received ≥1 chemotherapy regimens; in combination w/ paclitaxel or docetaxel for patients who have not received chemotherapy; in combination w/ an aromatase inhibitor for patients w/ hormone-receptor positive MBC. HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) & radiotherapy (if applicable); following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide, in combination w/ paclitaxel or docetaxel; in combination w/ adjuvant chemotherapy consisting of docetaxel and carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant treatment, for locally advanced (including inflammatory) breast cancer or tumours >2 cm in diameter. In combination w/ capecitabine or IV 5-fluorouracil & a platinum agent for HER2 positive advanced adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment.
Dosage/Direction for Use
Administer loading dose as a 90-min IV infusion. If initial loading dose is well-tolerated, subsequent dose can be administered as 30-min infusion. MBC 3-wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals beginning 3 wk after loading dose. Wkly schedule: Initial loading dose: 4 mg/kg. Maintenance dose: 2 mg/kg at wkly intervals beginning 1 wk after the loading dose. In combination w/ paclitaxel or docetaxel: Administer the day following 1st dose & immediately after the subsequent doses. In combination w/ an aromatase inhibitor: Administer from day 1. Duration of treatment: Until disease progression. EBC 3-wkly & wkly schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg at 3-wkly intervals, beginning 3 wk after 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 of treatment: 1 yr or until disease recurrence, whichever occurs 1st. Advanced gastric cancer (AGC) 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 of treatment: Until disease progression.
Hypersensitivity to trastuzumab, murine proteins. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Special Precautions
Do not administer as IV push or bolus. Not intended for SC administration. Increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction. Patients w/ increased cardiac risk eg, HTN, documented CAD, CHF, left ventricular ejection fraction (LVEF) of <55%, diastolic dysfunction, older age. Perform baseline cardiac assessment including history & physical exam, ECG, echocardiogram &/or multigated acquisition (MUGA) scan or MRI & repeat every 3 mth during treatment, & every 6 mth following discontinuation until 24 mth from the last dose. Avoid anthracycline-based therapy for up to 7 mth after stopping treatment. Carefully monitor cardiac function if anthracyclines are to be used. Withhold therapy & repeat LVEF assessment if LVEF percentage drops ≥10 points from baseline & to <50%; discontinue therapy if LVEF has not improved, declined further, or symptomatic CHF has developed. Monitor patients receiving anthracycline-containing chemotherapy yrly up to 5 yr from the last dose, or longer if a continuous LVEF decrease is observed. Not recommended in patients w/ history of MI, angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II-IV), LVEF of <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. Increased incidence of symptomatic & asymptomatic cardiac events in patients w/ EBC when treatment is administered after anthracycline-containing chemotherapy. Should be used concurrently w/ anthracyclines only in chemotherapy-naive patients & only w/ low-dose anthracycline regimens ie, max cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2 in patients w/ EBC eligible for neoadjuvant-adjuvant treatment. Serious infusion-related reactions (IRRs). Should not be used in patients experiencing dyspnoea at rest due to complications of advanced malignancy & comorbidities. Severe pulmonary events. Pneumonitis, especially in patients treated concomitantly w/ taxanes. Minor influence on the ability to drive or use machines. Women of childbearing potential should use effective contraception during treatment & 7 mth after. Pregnancy. Avoid lactation during therapy & 7 mth after the last dose. Elderly >65 yr.
Adverse Reactions
Cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections & pulmonary adverse reactions. Nasopharyngitis, neutropenic sepsis, cystitis, herpes zoster, flu, sinusitis, skin infection, rhinitis, upper resp tract infection, UTI, erysipelas, cellulitis, pharyngitis, sepsis; malignant neoplasm progression, neoplasm progression; febrile neutropenia, anaemia, decreased WBC/leukopenia, thrombocytopenia, hypoprothrombinaemia, immune thrombocytopenia; hypersensitivity, anaphylactic reaction, anaphylactic shock; decreased wt/wt loss, anorexia, tumour lysis syndrome, hyperkalaemia; insomnia, anxiety, depression, abnormal thinking; tremor, dizziness, headache, paraesthesia, dysgeusia, peripheral neuropathy, hypertonia, somnolence, ataxia, paresis, brain oedema; conjunctivitis, increased lacrimation, dry eye, papilloedema, retinal haemorrhage; deafness; increased/decreased 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, vasodilation; wheezing, dyspnoea, cough, epistaxis, rhinorrhoea, pneumonia, asthma, lung disorder, pleural effusion, pneumonitis, pulmonary fibrosis, resp distress/failure, lung infiltration, acute pulmonary oedema & resp distress syndrome, bronchospasm, hypoxia, decreased oxygen saturation, laryngeal oedema, orthopnoea, pulmonary oedema, interstitial lung disease; diarrhoea, vomiting, nausea, lip swelling, abdominal pain, dyspepsia, constipation, stomatitis, haemorrhoids, dry mouth; hepatocellular injury, hepatitis, liver tenderness, jaundice, hepatic failure; erythema, rash, swelling face, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome, acne, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, pruritus, onychoclasis, dermatitis, urticaria, angioedema; arthralgia, muscle tightness, myalgia, arthritis, back, bone & neck pain, muscle spasms, pain in extremity; renal disorder, glomerulonephritis membranous, glomerulonephropathy, renal failure; oligohydramnios, renal & pulmonary hypoplasia; breast inflammation/mastitis; asthenia, chest pain, chills, fatigue, influenza-like symptoms, infusion-related reaction, pain, pyrexia, mucosal inflammation, peripheral oedema, malaise, oedema; contusion.
Drug Interactions
May elevate overall exposure of 1 doxorubicin metabolite.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC03 - trastuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Trazimera powd for infusion 150 mg
Trazimera powd for infusion 440 mg
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