It is a microtubule inhibitor indicated for the treatment of: ? Metastatic breast cancer,after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ? Locally advanced or metastatic non-small cell lung cancer (NSCLC),as first-line treatment in combination with carboplatin,in patients who are not candidates for curative surgery or radiation therapy. ? Metastatic adenocarcinoma of the pancreas as first-line treatment,in combination with gemcitabine.
Nab-Paclitaxelis a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Metastatic Breast Cancer: Recommended dosage of Nab-Paclitaxe is 260 mg/m2 intravenously over 30 minutes every 3 weeks. ? Non-Small Cell Lung Cancer: Recommended dosage of Nab-Paclitaxe is 100 mg/m2 intravenously over 30 minutes on Days 1,8,and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after Nab-Paclitaxe. ? Adenocarcinoma of the Pancreas: Recommended dosage of Nab-Paclitaxe is 125 mg/m2 intravenously over 30-40 minutes on Days 1,8 and 15 of each 28-day cycle; administer gemcitabine on Days 1,8 and 15 of each 28-day cycle immediately after Nab-Paclitaxe. ? No adjustment is necessary for patients with mild hepatic impairment. Withhold Nab-Paclitaxe if AST > 10 x ULN or bilirubin > 5 x ULN. Reduce starting dose in patients with moderate to severe hepatic impairment. ? Dose Reductions: Dose reductions or discontinuation may be needed based on severe hematologic,neurologic,cutaneous,or gastrointestinal toxicities. ? Use caution when handling cytotoxic drugs. Closely monitor the infusion site for extravasation and infiltration. No premedication is required prior to administration.
The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering Nab-Paclitaxel concomitantly with medicines known to inhibit (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or induce (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) either CYP2C8 or CYP3A4.
Neutrophil counts of < 1,500 cells/mm3. ? Severe hypersensitivity reaction to Nab-Paclitaxe. Nab-Paclitaxe causes myelosuppression. Monitor CBC and withhold and/or reduce the dose as needed. ? Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ? Sepsis occurred in patients with or without neutropenia who received Nab-Paclitaxe in combination with gemcitabine; interrupt Nab-Paclitaxe and gemcitabine until sepsis resolves,and if neutropenic,until neutrophils are at least 1500 cells/mm3,then resume treatment at reduced dose levels. ? Pneumonitis occurred with the use of Nab-Paclitaxe in combination with gemcitabine; permanently discontinue treatment with Nab-Paclitaxe and gemcitabine. ? Severe hypersensitivity reactions with fatal outcome have been reported. Do not re-challenge with this drug. ? Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment; therefore administer with caution. ? Nab-Paclitaxe contains albumin derived from human blood,which has a theoretical risk of viral transmission. ? Fetal harm may occur when administered to a pregnant woman. Advise women of childbearing potential to avoid becoming pregnant while receiving Nab-Paclitaxe. ? Advise men not to father a child while on Nab-Paclitaxe.
alopecia,neutropenia,sensory neuropathy,abnormal ECG,fatigue/asthenia,myalgia/arthralgia,AST elevation,alkaline phosphatase elevation,anemia,nausea,infections,and diarrhea.anemia,neutropenia,thrombocytopenia,alopecia,peripheral neuropathy,nausea,and fatigue,anemia,neutropenia,thrombocytopenia,alopecia,peripheral neuropathy,nausea,and fatigue
should not be used in pregnancy,and in women of childbearing potential not using effective contraception,unless the clinical condition of the mother requires treatment with paclitaxel.Because of potential serious adverse reactions in breast-feeding infants,Nab-Paclitaxe is contraindicated during lactation.
There is no known antidote for Nab-Paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
Store the vials in original cartons at 20°C to 25°C. Retain in the original package to protect from bright light.
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