Pertuzumab with trastuzumab (Specialist drug)

DOSE IS IRRESPECTIVE OF BODY WEIGHT. PATIENT SELECTION: patients must have HER2-positive tumour status (IHC score 3+ and/or ISH ratio of at least 2) assessed by a validated test. OBSERVATION: 30 minutes after the loading dose and 15 minutes after each maintenance dose, for injection-related and hypersensitivity reactions; the observation period should be completed before any subsequent administration of chemotherapy. COMBINATION PARTNERS (as stated in the SPC): in patients receiving a taxane, Phesgo is given before the taxane; docetaxel recommended initial dose 75 mg/m2 subsequently escalated to 100 mg/m2 depending on the regimen and tolerability, or 100 mg/m2 on a 3-weekly schedule from the start (75 mg/m2 throughout with no escalation if a carboplatin-based regimen is used); in the adjuvant setting paclitaxel 80 mg/m2 once weekly for 12 weekly cycles. In patients receiving an anthracycline-based regimen, Phesgo is given after completion of the entire anthracycline regimen. INDICATIONS AND DURATION: metastatic breast cancer — give in combination with docetaxel; Phesgo may continue until disease progression or unmanageable toxicity even if docetaxel is stopped. Early breast cancer, neoadjuvant — 3 to 6 cycles in combination with chemotherapy. Early breast cancer, adjuvant — a total of one year (up to 18 cycles, or until disease recurrence or unmanageable toxicity, whichever occurs first), starting on Day 1 of the first taxane-containing cycle and continuing even if chemotherapy is discontinued. DELAYED OR MISSED DOSES: if less than 6 weeks between sequential injections, give the 600 mg/600 mg maintenance dose as soon as possible then continue 3-weekly; if 6 weeks or more, re-administer the 1200 mg/600 mg loading dose followed by 600 mg/600 mg every 3 weeks. SWITCHING FROM IV PERTUZUMAB AND TRASTUZUMAB: if less than 6 weeks since the last IV dose, give Phesgo as a 600 mg/600 mg maintenance dose then 3-weekly; if 6 weeks or more, give the 1200 mg/600 mg loading dose then 600 mg/600 mg every 3 weeks. DOSE MODIFICATION: dose reductions are not recommended; discontinuation may be needed at the physician's discretion. LEFT VENTRICULAR DYSFUNCTION: withhold for at least 3 weeks for any signs or symptoms suggestive of congestive heart failure, and discontinue if symptomatic heart failure is confirmed. Metastatic disease — pre-treatment LVEF at least 50%; withhold at least 3 weeks for a drop below 40%, or LVEF 40-45% with a fall of at least 10 percentage points below pre-treatment; may resume if LVEF recovers above 45%, or to 40-45% with a difference of less than 10 percentage points. Early breast cancer — pre-treatment LVEF at least 55% (at least 50% after completion of any anthracycline component); withhold at least 3 weeks for a drop below 50% with a fall of at least 10 percentage points; may resume if LVEF recovers to at least 50% or to within 10 percentage points of pre-treatment. INJECTION REACTIONS: the injection may be slowed or paused for injection-related symptoms; discontinue immediately and permanently for an NCI-CTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome. SETTING: once pertuzumab-based therapy has been safely established, the physician may determine the suitability of administration outside the clinical setting (for example at home) by a healthcare professional. ELDERLY: no dose adjustment required at 65 years and over; limited data above 75 years. HEPATIC IMPAIRMENT: not studied; patients are unlikely to require dose adjustment and no specific adjustment is recommended. PAEDIATRIC: safety and efficacy below 18 years have not been established and there is no relevant use in the paediatric population for breast cancer. SOURCE LIMITS: eMC §4.5 was not fetched and §4.4/§4.8 were truncated; no interaction section is reproduced in this draft. Note the openFDA provider in this bundle is the intravenous PERJETA (pertuzumab alone) US label, not the fixed-dose combination, so it was not used for dosing.