• Neoadjuvant treatment of human epidermal growth factor receptor 2 protein (HER2)-positive locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node-positive) (in combination with chemotherapy).
• Adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence (in combination with chemotherapy).
• HER2-positive metastatic breast cancer in patients who have not yet been treated with anti-HER2 agents or chemotherapy (in combination with docetaxel).

Contraindicated in:

• Hypersensitivity
• OB: Pregnancy.

Use Cautiously in:

• HF, uncontrolled hypertension, recent MI, arrhythmias, prior anthracycline exposure (equivalent to >360 mg/m² of doxorubicin)
• Pulmonary disease or extensive tumor involvement of lungs (↑ risk of pulmonary toxicity)
• Dyspnea at rest (↑ risk of hypersensitivity reaction)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: arrhythmias, HF, hypertension, peripheral edema.

Derm: alopecia, dry skin, rash, dermatitis, erythema, nail discoloration, palmar-plantar erythrodysesthesia syndrome.

EENT: epistaxis, ↑ lacrimation, dry eyes, rhinorrhea.

Endo: hypoglycemia.

F and E: hyperkalemia, hyponatremia, hypernatremia, hypokalemia.

GI: ↓ appetite, ↓ weight, ↑ liver enzymes, constipation, diarrhea, dyspepsia, hypoalbuminemia, nausea, stomatitis, vomiting, abdominal pain, hemorrhoids, hyperbilirubinemia.

GU: ↑ serum creatinine, urinary tract infection.

Hemat: anemia, leukopenia, lymphocytopenia, neutropenia, thrombocytopenia.

Local: injection site pain, injection site reaction.

MS: arthralgia, myalgia, muscle spasm, pain.

Neuro: dizziness, dysgeusia, fatigue, headache, insomnia, paresthesia, peripheral neuropathy.

Resp: cough, dyspnea, upper respiratory tract infection, ACUTE RESPIRATORY DISTRESS SYNDROME, INTERSTITIAL PNEUMONITIS, pleural effusion, PULMONARY EDEMA, PULMONARY FIBROSIS.

Misc: fever, hypersensitivity reactions (including anaphylaxis and angioedema).

Drug-Drug:

• Use of an anthracycline (daunorubicin, doxorubicin, or idarubicin) following therapy may ↑ risk of cardiotoxicity; if possible, avoid anthracycline-based therapy for up to 7 mo following completion of therapy.

• Solution for injection: pertuzumab 60 mg, trastuzumab 60 mg, and hyaluronidase 2,000 units/mL; pertuzumab 80 mg, trastuzumab 40 mg, and hyaluronidase 2,000 units/mL;

Neoadjuvant Treatment of Breast Cancer

• SC (Adults): Initial dose: Pertuzumab 1,200 mg/trastuzumab 600 mg/hyaluronidase 10,000 units followed by maintenance dose in 3 wk; Maintenance dose: Pertuzumab 600 mg/trastuzumab 600 mg/hyaluronidase 20,000 units every 3 wk for 3–6 cycles as part of a treatment regimen for early breast cancer. Following surgery, continue pertuzumab/trastuzumab/hyaluronidase to complete 1 yr of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first, as a part of a complete regimen for early breast cancer. In patients receiving an anthracycline-based regimen for early breast cancer, administer pertuzumab/trastuzumab/hyaluronidase following completion of the anthracycline. In patients receiving docetaxel or paclitaxel, administer docetaxel or paclitaxel after pertuzumab/trastuzumab/hyaluronidase.

Adjuvant Treatment of Breast Cancer

• SC (Adults): Initial dose: Pertuzumab 1,200 mg/trastuzumab 600 mg/hyaluronidase 10,000 units followed by maintenance dose in 3 wk; Maintenance dose: Pertuzumab 600 mg/trastuzumab 600 mg/hyaluronidase 20,000 units every 3 wk for a total of 1 yr (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first, as part of a complete regimen for early breast cancer. In patients receiving an anthracycline-based regimen for early breast cancer, administer pertuzumab/trastuzumab/hyaluronidase following completion of the anthracycline. In patients receiving docetaxel or paclitaxel, administer docetaxel or paclitaxel after pertuzumab/trastuzumab/hyaluronidase.

Metastatic Breast Cancer

• SC (Adults): Initial dose: Pertuzumab 1,200 mg/trastuzumab 600 mg/hyaluronidase 10,000 units followed by maintenance dose in 3 wk; Maintenance dose: Pertuzumab 600 mg/trastuzumab 600 mg/hyaluronidase 20,000 units every 3 wk until disease recurrence or unmanageable toxicity. Administer docetaxel after pertuzumab/trastuzumab/hyaluronidase.

Phesgo

• Pertuzumab and trastuzumab: monoclonal antibody that binds to HER2 sites in breast cancer tissue and inhibits proliferation of cells that overexpress HER2; Hyaluronidase: Acts locally by depolymerizing hyaluronan, which increases permeability of the SUBQ tissue.

• Regression of breast cancer and metastases.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: HER2/neu receptor antagonists, monoclonal antibodies

Pertuzumab

Absorption: 70% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

Trastuzumab

Absorption: 80% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

(plasma concentrations)

• Explain purpose of Phesgo and regimen to patient.
• Advise patient to notify health care professional immediately if signs and symptoms of cardiomyopathy (new onset or worsening shortness of breath, cough, swelling of ankles or legs, swelling of face, palpitations, weight gain >5 pounds in 24 hr, dizziness, loss of consciousness) or hypersensitivity and administration-related reactions (dizziness, nausea, chills, fever, vomiting, diarrhea, urticaria, swelling of face or neck, breathing problems, chest pain) occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding for 7 mo after last dose. If Phesgo is administered during pregnancy, or if a patient becomes pregnant while receiving Phesgoor within 7 mo following last dose of Phesgo, health care providers and patients should immediately report Phesgo exposure to pharmacovigilance program at Genentech at 1-888-835-2555.

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