1. Indications and Usage
\nEarly Breast Cancer (EBC):
\nIndicated as a single agent for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based therapy.
\nMetastatic Breast Cancer (MBC):
\nIndicated as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior treatment for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Intravenous (IV) Infusion ONLY. Do not administer as an IV push or bolus.
\nRecommended Dosage:
\nDose: 3.6 mg\/kg body weight.
\nSchedule: Administered once every 3 weeks (21-day cycle).
\nAdministration Instructions:
\nFirst Infusion: Administer over 90 minutes. Observe the patient for at least 90 minutes post-infusion.
\nSubsequent Infusions: If well tolerated, administer over 30 minutes. Observe the patient for at least 30 minutes post-infusion.
\nTreatment Duration:
\nEarly Breast Cancer: A total of 14 cycles unless disease recurrence or unacceptable toxicity occurs.
\nMetastatic Breast Cancer: Until disease progression or unacceptable toxicity.
\nMissed Dose:
\nIf a dose is delayed or missed, administer it as soon as possible; do not wait until the next planned cycle. Adjust the schedule to maintain a 3-week interval.
\n3. Mechanism of Action
\nAntibody-Drug Conjugate (ADC):
\nTrastuzumab emtansine combines a humanized anti-HER2 IgG1 monoclonal antibody (trastuzumab) covalently linked to a microtubule inhibitor (DM1, a maytansine derivative) via a stable thioether linker (MCC).
\nTargeted Cytotoxicity:
\nUpon binding to the HER2 receptor subdomain IV, the conjugate undergoes receptor-mediated internalization and lysosomal degradation, releasing DM1 intracellularly. DM1 binds to tubulin, disrupting the microtubule network, leading to cell cycle arrest and apoptotic cell death. It also retains the ADCC and HER2 signaling inhibition properties of trastuzumab.
\n4. Safety and Warnings
\nHepatotoxicity:
\nCan cause severe liver injury, including nodular regenerative hyperplasia, portal hypertension, and hepatic failure. Monitor liver function tests (AST\/ALT and bilirubin) prior to each dose. Dose reduction or permanent discontinuation is required for severe elevations.
\nCardiac Toxicity:
\nCan cause left ventricular dysfunction. Assess LVEF prior to initiation and periodically during treatment. Discontinue if symptomatic heart failure or significant LVEF decline occurs.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 7 months after the final dose.
\nPulmonary Toxicity:
\nInterstitial lung disease (ILD) and pneumonitis can occur. Permanently discontinue Kadcyla in patients diagnosed with ILD or pneumonitis.
\nBleeding & Thrombocytopenia:
\nSevere and fatal bleeding events have occurred. Monitor platelet counts before each dose. Interrupt or reduce the dose for severe thrombocytopenia.
\n5. Adverse Reactions
\nMost Common (Incidence \u226525%):
\nFatigue, nausea, musculoskeletal pain, hemorrhage, headache, elevated transaminases, thrombocytopenia, and peripheral neuropathy.
\nSerious Adverse Reactions (>0.5%):
\nHemorrhage, pyrexia, thrombocytopenia, dyspnea, abdominal pain, musculoskeletal pain, and vomiting.
\n6. Drug Interactions
\nNo formal drug-drug interaction studies have been conducted. Because DM1 is metabolized by CYP3A4\/5 and is a P-gp substrate, caution is advised when co-administering with strong CYP3A4 inhibitors or inducers, though clinical significance is currently unknown.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Trastuzumab emtansine.
\nExcipients: Succinic acid, sodium hydroxide, polysorbate 20, sucrose.
\nAppearance: White to off-white sterile lyophilized powder cake for IV infusion.
\nStorage:
\nStore vials refrigerated at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F). Do not freeze or shake. Reconstituted solutions must be stored at 2\u00b0C\u20138\u00b0C and used within 24 hours.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u8d6b\u8d5b\u83b1 \u00ae\uff08Kadcyla\u00ae\uff09
\n\u2022 Generic Name: Trastuzumab Emtansine
\n\u2022 Strength: 100 mg per vial, 1 vial per box
\n\u2022 Manufacturer: F. Hoffmann-La Roche Ltd
\n\u2022 Marketing Authorization Holder: Roche Pharma (Schweiz) AG\uff1bRoche Pharma (Schweiz) AG (Switzerland); domestic filing entity: Roche (China) Investment Co., Ltd.
\n\u2022 Approval Date in China: January 21, 2020
\n\u2022 Registration Number:\u56fd\u836f\u51c6\u5b57 S20200002 \/ S20200003
\n\u2022 Storage: Store in the original carton at 2\u00b0C\u20138\u00b0C (36\u00b0F\u201346\u00b0F), protected from light. Do not freeze or shake. Keep out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Trastuzumab Emtansine \uff08Kadcyla\uff09<\/p>\n","protected":false},"featured_media":3842,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[79],"product_cat":[25],"product_tag":[],"class_list":["post-3841","product","type-product","status-publish","has-post-thumbnail","product_brand-roche","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n