帕罗嘉(帕妥珠单抗,Perjeta)

【Function and indications】
Pertuzumab (also known as 2C4, trade name Perjeta) is a monoclonal antibody. It is the first monoclonal antibody called “HER dimerization inhibitor”. By binding to HER2, it blocks the heterodimerization of HER2 and other HER receptors, thereby slowing down tumor growth.

Perjeta is used to treat HER2-positive metastatic breast cancer.

【Model and specification】
420mg/14ml single-use vial.

【Usage and dosage】
1. Only for intravenous infusion, do not administer by intravenous push or bolus.

2. The initial dose is 840mg for 60 minutes of intravenous infusion, followed by 420mg for 30 to 60 minutes of intravenous infusion every 3 weeks.

【Clinical research】
Pertuzumab has achieved certain success in early clinical trials of prostate cancer, breast cancer and ovarian cancer. In the key phase III clinical trial CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab), the initial dose of Pertuzumab was 840 mg intravenous drip, and the maintenance dose was 420 mg intravenous drip, with a three-week cycle. The pharmacokinetics of Pertuzumab and Docetaxel, which were administered intravenously at the same time, were not affected by age and drug interactions. Gillian Keating summarized the pharmacokinetic and pharmacodynamic properties of Pertuzumab in a retrospective study. In the randomized, double-blind phase III CLEOPATRA study, Pertuzumab combined with Trastuzumab plus Docetaxel significantly prolonged progression-free survival compared with placebo combined with Trastuzumab plus Docetaxel as the first-line treatment for HER2-positive metastatic breast cancer, without increasing cardiac toxicity.

【Precautions】
1. Embryo-fetal toxicity: However, fetal harm may occur when given to pregnant women.
2. Left ventricular dysfunction: Monitor LVEF and withdraw administration if appropriate.
3. Infusion-related reactions, hypersensitivity reactions, allergic reactions: monitor signs and symptoms. If a major infusion-related reaction occurs, the infusion should be slowed or interrupted and appropriate medical treatment should be given.
4. HER2 test: performed by a laboratory that demonstrates proficiency using an FDA-approved test.

[Adverse reactions and contraindications]
The most common adverse reactions of Perjeta combined with trastuzumab and docetaxel include diarrhea, alopecia, neutropenia, nausea, fatigue, rash, peripheral neuropathy, etc.

[Contraindications]
It is contraindicated for those who are allergic to any component of this product.

[Pregnant women use]
1. Nursing mothers: Discontinue breastfeeding or discontinue PERJETA, taking into account the importance of the drug to the mother.

2. Reproductive potential: During medication, doctors should advise women about pregnancy prevention and planning.

[Children use]
This product should not be used in children.

[Storage]
Before use, PERJETA should be frozen in the refrigerator and kept at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).

【Manufacturer】
Roche Pharmaceuticals, USA.