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Per vial Pertuzumab 600 mg, trastuzumab 600 mg. Per vial Pertuzumab 1,200 mg, trastuzumab 600 mg

Early breast cancer (EBC): In combination w/ chemotherapy for neoadjuvant treatment of adults w/ human epidermal growth factor receptor (HER) 2-+ve, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node +ve) as part of complete treatment regimen for EBC & as adjuvant treatment of adults w/ HER2-positive EBC at high risk of recurrence. Metastatic breast cancer (MBC): In combination w/ docetaxel for adults 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 Administer in thigh only. EBC & MBC Loading dose: 1,200 mg/600 mg trastuzumab given for approx 8 min. Maintenance dose: 600 mg/600 mg trastuzumab given for approx 5 min. Patients receiving taxane Administer treatment prior to taxane. Recommended initial dose of docetaxel is 75 mg/m². EBC Neoadjuvant setting: 3-6 cycles depending on regimen chosen in combination w/ chemotherapy. Adjuvant setting: 1 yr (max of 18 cycles or until disease recurrence or unmanageable toxicity). Treatment should 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 use even if treatment w/ docetaxel is discontinued.

Hypersensitivity to pertuzumab, trastuzumab, or hyaluronidase.

Not to be administered IV. Hypersensitivity reactions/anaphylaxis. Symptomatic left ventricular systolic dysfunction; high risk of left ventricular ejection fraction (LVEF) decreases in patients who have received prior anthracyclines or prior 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; patients w/ decreases in LVEF <50% during prior trastuzumab adjuvant therapy. Assess LVEF prior to initiation of therapy & at regular intervals during treatment. Closely observe patient during & for 30 min after loading dose administration & during & for 15 min. Caution for fatal infusion-related reactions as this have been associated w/ pertuzumab IV in combination w/ trasztuzumab IV & chemotherapy. Minor influence on the ability to drive & use machines. Women of childbearing potential including partners of male patients should use effective contraception during treatment & for 7 mth following last dose. Pregnancy. Discontinue breastfeeding during therapy & for 7 mth after the last dose. Ped patients <18 yr.

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.

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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