IV Injection Pertuza 420 mg/14 ml
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About the Product
Full Description
Presentation
\nPertuza 420: Each vial contains Pertuzumab INN 420 mg in 14 ml solution for IV infusion
\n \nDescription
\nPertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular
\n \ndimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2).
\n \nPertuzumab targets the extracellular dimerization domain (Subdomain II) of the human epidermal
\n \ngrowth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of
\n \nHER2 with other HER family members, including EGFR, HER3, and HER4. As a result, Pertuzumab
\n \ninhibits ligand-initiated intracellular signaling through two major signal pathways, mitogen-activated
\n \nprotein (MAP) kinase, and phosphoinositide 3-kinase (PI3K). Inhibition of these signaling pathways
\n \ncan result in cell growth arrest and apoptosis, respectively. In addition, Pertuzumab mediates
\n \nantibody-dependent cell-mediated cytotoxicity
\n \nIndications
\nPertuzumab is a HER2/neu receptor antagonist indicated for:
\n \n- Use in combination with Trastuzumab and docetaxel for treatment of patients with HER2-positive
\n \nmetastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy
\n \nfor metastatic disease
\n \n- Use in combination with Trastuzumab and docetaxel as neoadjuvant treatment of patients with
\n \nHER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2
\n \ncm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
\n \nThis indication is based on demonstration of an improvement in pathological complete response
\n \nrate. No data are available demonstrating improvement in event-free survival or overall survival.
\n \nLimitations of Use:
\n \nThe safety of Pertuzumab as part of a doxorubicin-containing regimen has not been established
\n \nThe safety of Pertuzumab administered for greater than 6 cycles for early breast cancer has not been
\n \nestablished.
\n \nDosage & Administration
\nFor intravenous infusion only. It should not be administered as an intravenous push or bolus
\nThe initial Pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed
\nevery 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion
\nMBC: Pertuzumab should be administered with Trastuzumab and Docetaxel by intravenous infusion
\nevery 3 weeks
\nNeoadjuvant: Pertuzumab should be administered with Trastuzumab and Docetaxel by intravenous
\ninfusion preoperatively every 3 weeks for 3 to 6 cycles
\nInstruction of Uses
\nPertuzumab should be administered as an intravenous infusion only. It should not be administered as
\nan intravenous push or bolus. Pertuzumab should not be used with other drugs.
\n \nSide Effects
\n- Left Ventricular Dysfunction: Pertuzumab can result in subclinical and clinical cardiac failure
\nmanifesting as CHF, and decreased LVEF. Evaluate cardiac function prior to and during treatment.
\nDiscontinue Pertuzumab treatment for a confirmed clinically significant decrease in left ventricular
\nfunction
\n- Embryo-fetal Toxicity: Exposure to Pertuzumab can result in embryo-fetal death and birth defects.
\nStudies in animals have resulted in oligohydramnios, delayed renal development, and death.
\nPatients should be advised of these risks and the need for effective contraception.
\nMetastatic Breast Cancer
\nThe most common adverse reactions (> 30%) with Pertuzumab in combination with Trastuzumab
\nand Docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral
\nneuropathy.
\nNeoadjuvant Treatment of Breast Cancer:
\nThe most common adverse reactions (> 30%) with Pertuzumab in combination with Trastuzumab
\nand Docetaxel were alopecia, diarrhea, nausea, and neutropenia
\nThe most common adverse reactions (>30%) with Pertuzumab in combination with Trastuzumab
\nand Docetaxel when given for 3 cycles following 3 cycles of fluorouracil, epirubicin, and cyclophosphamide
\n(FEC) were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia
\nThe most common adverse reactions (>30%) with Pertuzumab in combination with Docetaxel,
\nCarboplatin, and Trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting,
\nneutropenia, thrombocytopenia, and anemia
\n \nPrecautions
\nLeft Ventricular Dysfunction: LVEF should be monitored and dosing should be withheld as appropriate
\nEmbryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman
\nInfusion-Related Reactions: Should be monitored for signs and symptoms. If a significant
\ninfusion-associated reaction occurs, the infusion should be slowed or interrupted and appropriate
\nmedical therapies should be administered
\nHypersensitivity Reactions/Anaphylaxis: Should be monitored for signs and symptoms. If a severe
\nhypersensitivity reaction/anaphylaxis occurs, the infusion should be discontinued immediately and
\nappropriate medical therapies should be administered
\n \nUse in Pregnancy & Lactation
\nPregnancy Category D
\nThere are no adequate and well-controlled studies of Pertuzumab in pregnant women. If Pertuzumab
\nis administered during pregnancy or if a patient becomes pregnant while receiving Pertuzumab or
\nwithin 7 months following the last dose of Pertuzumab in combination with Trastuzumab, the patient
\nshould be apprised of the potential hazard to the fetus
\nLactation
\nIt is not known whether Pertuzumab is excreted in human milk, but human IgG is excreted in human
\nmilk. Because many drugs are secreted in human milk and because of the potential for serious
\nadverse actions in nursing infants from Pertuzumab a decision should be made whether to discontinue
\nnursing, or discontinue drug, taking into account the elimination half-life of Pertuzumab and the
\nimportance of the drug to the mother
\nPediatric Use
\nSafety and effectiveness of Pertuzumab have not been established in pediatric patients.
\n \nDrug Interaction
\nPatients who receive anthracycline after stopping Pertuzumab may be at increased risk of cardiac
\ndysfunction because of Pertuzumab?s long wash out period. If possible, physicians should avoid
\nanthracycline-based therapy for up to 7 months after stopping Pertuzumab. If anthracyclines are
\nused, the patient?s cardiac function should be monitored carefully.
\n \nCommercial Pack
\nPertuza 420 IV infusion: Each box contains 1 vial of Pertuzumab 420 mg
\n
