For the use of a Registered Oncologist or Hospital or Laboratory only. Pertuzumab Injection 420 mg / 14 ml (SIGRIMA™).
Indications: Pertuzumab is indicated for, 1) Metastatic Breast Cancer (MBC) – Pertuzumab along with trastuzumab and docetaxel is indicated for the treatment of patients having HER2-positive metastatic breast cancer and those who have not received prior anti-HER2 treatment or chemotherapy for metastatic breast cancer. 2) Early Breast Cancer (EBC) – Pertuzumab along with trastuzumab and chemotherapy is indicated for, a) Neoadjuvant treatment in patients having HER2-positive, inflammatory, locally advanced, or early-stage breast cancer (larger than 2 cm in diameter or node positive) as part of a whole treatment for early breast cancer. b) Adjuvant treatment of patients with HER2-positive who are at a high recurrence risk.
Method of administration: The initial dose administered for pertuzumab is 840 mg intravenously with 60-minute infusion period, followed by the intravenous administration (30 to 60 minutes) of a dose of 420 mg every 3 weeks. Pertuzumab, trastuzumab, and taxane must be administered consecutively. Taxane must be administered after administering pertuzumab and trastuzumab. Pertuzumab and trastuzumab must be administered after completion of anthracycline in patients who are on anthracycline-based regimen.
Contraindications: Pertuzumab is not recommended in patients with known hypersensitivity to pertuzumab or to any of the excipients of the drug product.
Use in Special populations:
a) Pregnancy: Patients must be informed of potential risks of pertuzumab to a fetus. There are clinical considerations if pertuzumab is used in combination with trastuzumab during pregnancy or within 7 months prior to conception. The assessed risk of major birth defects and miscarriage for the indicated population is not known.
b) Breast-feeding: a judgment should be made by considering the developmental and health benefits of breastfeeding, mother’s need of pertuzumab treatment, and any potential adverse events in breastfed child (driven by pertuzumab or underlying maternal condition).
c) Females and Males of Reproductive Potential: Pregnant women and those with reproductive potential should be informed that exposure to pertuzumab in combination with trastuzumab during pregnancy or within 7 months prior to conception may result in fetal harm, including embryo-fetal death or major birth defects.
d) Pediatric use: Efficacy and safety of pertuzumab remain unstudied in pediatric population.
e) Geriatric use: In patients aged ≥65 years and ≥75 years who received pertuzumab, the most common (≥10%) Grade 3-4 adverse reactions were neutropenia (22% and 23%, respectively), febrile neutropenia (12% and 13%, respectively), anemia (15% ≥75 years), and diarrhea (15% and 17%, respectively).
f) Renal Impairment: Pertuzumab dose adjustments are not required in patients with mild (creatinine clearance [CLcr] 60 to 90 mL/min) or moderate (CLcr 30 to 60 mL/min) renal impairment. For patients with severe renal impairment (CLcr less than 30 mL/min), dose adjustment cannot be recommended due to limited pharmacokinetics data availability.
g) Hepatic Impairment: Clinical studies determining the impact of hepatic impairment on the efficacy and safety of pertuzumab are not available.
Adverse effects: The most frequently reported treatment-emergent adverse events (TEAEs) (reported in >10% of subjects) were diarrhea, vomiting, pyrexia, alopecia, and rash. The TEAEs reported in >2% of subjects that considered to be related to the study medication were anemia, constipation, diarrhea, nausea, stomatitis, vomiting, asthenia, chills, fatigue, pain, pyrexia, hypersensitivity, myalgia, headache, peripheral neuropathy, alopecia, pruritus, and rash. The serious TEAEs reported in >1% subject were febrile neutropenia, diarrhea and gastroenteritis.
WARNING: Left ventricular dysfunction: Pertuzumab may lead to subclinical and clinical cardiac failure, manifesting as decreased LVEF and CHF. Hence, it is important to evaluate cardiac function prior to and during treatment. If a clinically significant decrease in LVEF is observed, discontinue pertuzumab. Dose adjustments are mentioned the package insert.
Drug interactions: No drug-drug interactions were observed between pertuzumab and docetaxel, carboplatin or paclitaxel, pertuzumab, and trastuzumab.
Storage: Store at 2 − 8 °C. Do not freeze or shake. Protect from light.
For detailed information kindly refer to full prescribing information.