Phesgo

Per 600/600 mg soln for inj Pertuzumab 600 mg, trastuzumab 600 mg. Per 1,200/600 mg soln for inj Pertuzumab 1,200 mg, trastuzumab 600 mg

Early breast cancer (EBC): In combination w/ chemotherapy in neoadjuvant treatment of adult patients w/ HER2 +ve, locally advanced inflammatory or early stage breast cancer at high risk of recurrence; adjuvant treatment of adult patients w/ HER2 +ve EBC at high risk of recurrence. Metastatic breast cancer (MBC): In combination w/ docetaxel in adult patients w/ HER2 +ve metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

SC Adult EBC Loading dose: 1,200/600 mg given for approx 8 min. Maintenance dose: 600/600 mg given for approx 5 min every 3 wk. Neoadjuvant setting: 3-6 cycles in combination w/ chemotherapy. Adjuvant setting: 1 yr (up to 18 cycles, until disease recurrence or unmanageable toxicity, whichever occurs first). Start on day 1 of 1st taxane-containing cycle & continue even if chemotherapy is discontinued. MBC Loading dose: 1,200/600 mg given for approx 8 min. Maintenance dose: 600/600 mg given for approx 5 min every 3 wk. Administer in combination w/ docetaxel until disease progression or unmanageable toxicity even if treatment w/ docetaxel is discontinued. Patient receiving taxane Administer prior to taxane. Recommended initial dose of docetaxel: 75 mg/m² & subsequently escalated to 100 mg/m² depending on chosen regimen & tolerability of initial dose; can be given at 100 mg/m² on a 3-wkly schedule.

Hypersensitivity.

Immediately & permanently discontinue use if patient experiences NCI-CTCAE grade 4 reaction (anaphylaxis), bronchospasm or acute resp distress syndrome. Not for IV administration. Not recommended for dose reductions. W/hold for at least 3 wk for any signs & symptoms suggestive of CHF; discontinue use if symptomatic heart failure is confirmed. High incidence of symptomatic left ventricular systolic dysfunction. High risk of left ventricular ejection fraction (LVEF) declines in patients who have received prior anthracyclines or RT to chest area. Patients w/ pretreatment LVEF value of <55% (EBC) or <50% (MBC); prior history of CHF; conditions that could impair left ventricular function (eg, uncontrolled HTN, recent MI, serious cardiac arrhythmia requiring treatment or cumulative prior anthracycline exposure to >360 mg/m² of doxorubicin or its equivalent); decreased LVEF <50% during prior trastuzumab adjuvant therapy. Assess LVEF prior to treatment initiation & at regular intervals during treatment; consider discontinuation if LVEF has declined & has not improved or has declined further at subsequent assessment. Potential higher cardiac toxicity risk in concomitant use w/ anthracyclines; carefully consider cardiac risk & balanced against the medical need of individual patient before using w/ anthracycline. Closely observe patient during & for 30 min after loading dose administration, during & for 15 min following maintenance dose administration. Slow down or pause inj if significant inj-related reaction (IRR) occurs. Consider permanent discontinuation in patients w/ IRRs. Increased risk of febrile neutropenia in combination w/ taxane. May elicit severe diarrhoea. Reports of severe pulmonary events; ILD including lung infiltrates, acute resp distress syndrome, pneumonia, pneumonitis, pleural effusion, acute pulmonary oedema, resp distress & insufficiency. Contains Na 23 mg/dose. Patients experiencing inj-related reactions or dizziness; minor influence on ability to drive & use machines. Hepatic & severe renal impairment. Women of childbearing potential should use effective contraception while receiving treatment & for 7 mth following last dose. Avoid use during pregnancy. Do not breastfeed during therapy & for at least 7 mth following last dose. Childn & adolescent <18 yr. Elderly >75 yr; higher risk of diarrhoea in the elderly ≥65 yr.

Nasopharyngitis; febrile neutropenia, neutropenia, leucopenia, anaemia; infusion reaction; decreased appetite; insomnia; peripheral & sensory neuropathy, headache, dysgeusia, dizziness, paraesthesia; increased lacrimation; hot flush; cough, epistaxis, dyspnoea; diarrhoea, vomiting, stomatitis, nausea, constipation, dyspepsia, abdominal pain; alopecia, rash, nail disorder, pruritus, dry skin; myalgia, arthralgia, extremity pain; mucosal inflammation, peripheral oedema, pyrexia, fatigue, asthenia, inj site reaction. Paronychia, URTI; hypersensitivity, drug hypersensitivity; left ventricular dysfunction; chills, pain, oedema.

Targeted Cancer Therapy

L01FY01 - pertuzumab and trastuzumab ; Belongs to the class of combinations of monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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