Pertuzumab, Trastuzumab and Hyaluronidase-zzxf

Cytostatic · Enzyme/Monoclonal antibody

Indications

Early breast cancer: Used in combination with chemotherapy as: (a) Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (b) Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Metastatic breast cancer: Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Dosage

For SC use in the thigh only. Do not administer intravenously. SC: Initially 1200 mg pertuzumab, 600 mg trastuzumab and 30,000 units hyaluronidase administered SC over approx. 8 mins, followed every 3 wks by a dose of 600 mg pertuzumab, 600 mg trastuzumab and 20,000 units hyaluronidase administered SC over approx. 5 mins. Neoadjuvant: Administer by SC inj every 3 wks and chemotherapy by IV inf preoperatively for 3-6 cycles. Adjuvant: Administer by SC inj every 3 wks and chemotherapy by IV inf postoperatively for a total of 1 yr (up to 18 cycles). MBC: Administer by SC inj and docetaxel by IV infusion every 3 wks.

Administration

For both the initial and maintenance dose, each corresponding PHESGO vial is ready-to-use for one SC inj and should not be diluted. A syringe, a transfer needle, and an injection needle are needed to withdraw soln from the vial and inject it subcutaneously. PHESGO may be injected using 25G-27G (3/8”-5/8”) hypodermic injection needles. To avoid needle clogging, attach the hypodermic injection needle to the syringe immediately prior to adm followed by vol adjustment to 15 mL (initial dose) and 10 mL (maint. dose). If the dose is not to be adm immediately, and the soln of PHESGO has been withdrawn from the vial into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe with the peel-off sticker and store the syringe in the refrigerator (2°C to 8°C) for up to 24 hrs and at room temp (20°C to 25°C) for up to 4 hrs and avoid unnecessary storage. The SC inj…

Adverse Effects

Neoadjuvant and adjuvant treatment of breast cancer: Alopecia, nausea, diarrhea, anaemia, and asthenia. Metastatic breast cancer (based on IV pertuzumab): Diarrhoea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients. Precautions: Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. Evaluate cardiac function prior to and during treatment. Discontinue for cardiomyopathy. Following completion of PHESGO, continue to monitor for cardiomyopathy and assess LVEF measurements every 6 months for at least 2 years as a component of adjuvant therapy. Advise patients of the risks of embryo-fetal toxicity and the need for effective contraception. Risk of pulmonary toxicity; discontinue medication for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Interactions

Avoid: Anthracyclines, docetaxel, paclitaxel.

Advice to Patient

Females of reproductive potential must use effective contraception during treatment and for 7 months following the last dose. Discontinue nursing during therapy and for 7 months after the last dose. Report immediately any of the following symptoms: New onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, nausea, chills, fever, vomiting, diarrhea, urticaria, chest pain.

Pharmacokinetics

Bioavailability: Absolute: Pertuzumab: 0.71. Trastuzumab: 0.77. Time to peak, plasma: 3.8 days.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.