Formulation and specifications: Injection: 420mg (14ml)/bottle
Indications:
1. Breast cancer adjuvant therapy: This product is used in combination with trastuzumab and chemotherapy for the adjuvant treatment of HER2-positive early-stage breast cancer patients with high risk of recurrence. Patuximab in combination with trastuzumab can also be used with adjuvant endocrine therapy.
2. Neoadjuvant treatment of breast cancer: It is used in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (tumor diameter >2cm or positive lymph nodes).
3. Treatment of recurrent metastatic breast cancer: This product is used in combination with trastuzumab and paclitaxel-based chemotherapy for patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer. Patients should have received no prior anti-HER2 therapy for metastatic disease or have received anti-HER2 therapy in the prior adjuvant phase and have recurrent metastases more than one year after discontinuation of anti-HER2 therapy.
Key points for rational drug use:
1. Tissue specimens from lesions of patients treated with pertuzumab should be tested for HER2 in a qualified pathology laboratory and should be applied only in HER2-positive patients.
2. The recommended starting dose of pertuzumab is 840 mg by intravenous infusion over 60 minutes, and thereafter it is administered every 3 weeks at a dose of 420 mg over 30-60 minutes. After each completed pertuzumab infusion, 30 to 60 minutes of observation is recommended. Follow-up trastuzumab or chemotherapy should be given only after the observation time is over.
3. Both pertuzumab and trastuzumab must be administered sequentially, but in either order. In combination with pertuzumab, trastuzumab is recommended to be administered every 3 weeks; for patients receiving paclitaxel, pertuzumab and trastuzumab should be administered before paclitaxel; for patients receiving anthracycline, pertuzumab and trastuzumab should be given after the completion of the complete anthracycline regimen.
4. Dilute pertuzumab in 250 ml of 0.9% sodium chloride. 5% dextrose solution should not be used to dilute pertuzumab, and also should not be mixed or diluted with other drugs. After configuration, the infusion bag should be gently inverted to mix the solution to avoid blistering.
5. When used for preoperative neoadjuvant therapy, patients are recommended to receive 4 to 6 cycles of combination therapy containing pertuzumab. When used for adjuvant therapy (post-surgery), patuximab should be used in combination with trastuzumab for one year as part of a complete treatment regimen for early-stage breast cancer (including standard anthracycline and/or paclitaxel chemotherapy). When used for the treatment of recurrent metastatic breast cancer, pertuzumab in combination with trastuzumab and paclitaxel-based chemotherapeutic agents until disease progression or uncontrollable toxicity occurs, treatment with pertuzumab and trastuzumab may continue even after termination of chemotherapy.
6. Assess LVEF prior to first treatment with pertuzumab and periodically during treatment (see Table 6 for approximately 4 cycles) to ensure that LVEF is within the normal range (>50%). If the decrease in LVEF does not improve or decreases further at follow-up assessment, discontinuation of pertuzumab and trastuzumab should be considered.
7. Clinical studies have confirmed that the combination of patuximab and trastuzumab may further increase the clinical benefit in patients with HER2-positive recurrent metastatic breast cancer treated with other chemotherapeutic agents or endocrine agents.
8. The safety and efficacy of pertuzumab in children and adolescents younger than 18 years of age have not been established.
Table 6 Dosing Recommendations for Patuximab in Left Ventricular Insufficiency
| LVEF before treatment: | LVEFMonitoring interval: | Pattuzumab and trastuzumab suspended for at least 3 weeks when LVEF decreases to the following levels: | Re-introduce patuximab and trastuzumab after 3 weeks if LVEF remits to the following levels: | ||||
| metastatic breast cancer | ≥50% | about 12 weeks | 40% to 45%, ≥10% reduction in absolute values compared to pre-treatment | >45% or | 40% to 45%, <10% reduction from pre-treatment absolute values | ||
| Early stage breast cancer | ≥55%* | about 12 weeks (monitored once during neoadjuvant therapy) | <50% and ≥10% reduction in absolute values compared to pre-treatment | ≥50% or | <10% reduction from pre-treatment absolute values | ||
* For patients receiving anthracycline chemotherapy, an LVEF of ≥50% is required after completion of anthracycline chemotherapy and before the first patuximab and trastuzumab.