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Phesgo

Phesgo

pertuzumab + trastuzumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 600 mg/600 mg vial Pertuzumab 600 mg, trastuzumab 600 mg. Per 1,200 mg/600 mg vial Pertuzumab 1,200 mg, trastuzumab 600 mg
Indications/Uses
Early breast cancer (EBC): In combination w/ chemotherapy for neoadjuvant treatment of HER2 +ve, locally advanced, inflammatory or early stage breast cancer (either >2 cm diameter or node +ve) as part of complete treatment regimen for EBC & as adjuvant treatment of HER2 +ve EBC at high risk of recurrence. Metastatic breast cancer (MBC): In combination w/ docetaxel for HER2 +ve metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease.
Dosage/Direction for Use
SC EBC & MBC Loading dose: Pertuzumab 1,200 mg/trastuzumab 600 mg for approx 8 min. Maintenance dose: Pertuzumab 600 mg/trastuzumab 600 mg for approx 5 min every 3 wk. Patient receiving taxane Administer prior to taxane. Recommended initial dose of docetaxel: 75 mg/m2. EBC Neoadjuvant (pre-op): 3-6 cycles depending on regimen chosen in combination w/ chemotherapy. Adjuvant (post-op): 1 yr (max: 18 cycles or until disease recurrence or unmanageable toxicity, whichever occurs 1st). Start on day 1 of 1st taxane-containing cycle & continue even if chemotherapy is discontinued. MBC Administer in combination w/ docetaxel until disease progression or unmanageable toxicity. May continue even if docetaxel is discontinued.
Contraindications
Special Precautions
Not for IV use. Discontinue use if w/ severe inj-related or serious hypersensitivity reactions occur. Patients w/ pretreatment left ventricular ejection fraction (LVEF) value of <55% (EBC) or <50% (MBC); history of CHF; conditions impairing left ventricular fraction eg, uncontrolled HTN, recent MI, serious cardiac arrhythmia. Regularly assess LVEF prior to initiation & during treatment. May affect ability to drive & use machines. Severe renal impairment. Women of childbearing potential & male partners should use effective contraception during & for 7 mth after last dose. Avoid use during pregnancy. Discontinue lactation during & for 7 mth after last dose. Childn & adolescents <18 yr. Elderly ≥65 yr.
Adverse Reactions
Neutropenia, anemia, febrile neutropenia, leukopenia; increased lacrimation; diarrhea, nausea, vomiting, stomatitis, constipation, dyspepsia, abdominal pain; fatigue, mucosal inflammation, asthenia, pyrexia, peripheral edema, inj site reactions; nasopharyngitis; decreased appetite; arthralgia, myalgia, pain in extremity; dysgeusia, headache, peripheral sensory neuropathy, peripheral neuropathy, dizziness, paraesthesia; insomnia; epistaxis, cough, dyspnea; alopecia, rash, nail disorder, pruritus, dry skin; hot flush. Left ventricular dysfunction; hypersensitivity, drug hypersensitivity; URTI, paronychia.
Drug Interactions
Trastuzumab: Elevated overall exposure of doxorubicin metabolite. Higher conc & longer t½ of capecitabine.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XY02 - pertuzumab and trastuzumab ; Belongs to the class of combinations of antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Phesgo soln for inj 1,200 mg/600 mg
Packing/Price
15 mL x 1's
Form
Phesgo soln for inj 600 mg/600 mg
Packing/Price
10 mL x 1's
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