Phesgo Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

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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.

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Overdosage

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Contraindications

Hypersensitivity.

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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 treatment & for 7 mth after last dose. Avoid use during pregnancy. Discontinue lactation during treatment & for 7 mth after last dose. Childn & adolescents <18 yr. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Trastuzumab: Elevated overall exposure of doxorubicin metabolite. Higher conc & longer t_½ of capecitabine.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Phesgo detailed prescribing information

Storage

View Phesgo storage conditions for details to ensure optimal shelf-life.

Description

View Phesgo description for details of the chemical structure and excipients (inactive components).

Action

View Phesgo mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Regulatory Classification

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

Phesgo

pertuzumab + trastuzumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma