Metastatic Breast Cancer: Nab-Paclitaxel is indicated for the treatment of 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.
Non-Small Cell Lung Cancer: Nab-Paclitaxel is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Adenocarcinoma of the Pancreas: Nab-Paclitaxel is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Nab-Paclitaxel is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability inhibits the normal dynamic reorganization of the microtubule network, which is essential for vital interphase and mitotic cellular functions. Paclitaxel also induces abnormal bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Metastatic Breast Cancer: After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Nab-Paclitaxel is 260 mg/m² administered intravenously over 30 minutes every 3 weeks.

Non-Small Cell Lung Cancer: The recommended dose of Nab-Paclitaxel is 100 mg/m² administered as an intravenous infusion 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-Paclitaxel.

Adenocarcinoma Of The Pancreas: The recommended dose of Nab-Paclitaxel is 125 mg/m² administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Administer gemcitabine immediately after Nab-Paclitaxel on Days 1, 8 and 15 of each 28-day cycle.

Dosage In Patients With Hepatic Impairment: For patients with mild hepatic impairment (total bilirubin greater than ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN), no dose adjustments are required, regardless of indication.

Do not administer Nab-Paclitaxel to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN regardless of indication as these patients have not been studied.

The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution is required when Nab-Paclitaxel is used with medicines that inhibit these enzymes, such as ketoconazole, other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir, or with medicines that induce these enzymes, such as rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine.

Nab-Paclitaxel should not be used in patients with a baseline neutrophil count of less than 1,500 cells/mm³. Patients who have experienced a severe hypersensitivity reaction to Nab-Paclitaxel should not receive the medicine again.

The most common adverse reactions (≥20%) with single-agent Nab-Xelpac in metastatic breast cancer include alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, increased AST, elevated alkaline phosphatase, anemia, nausea, infections, and diarrhea.

When Nab-Xelpac is used in combination with carboplatin for non-small cell lung cancer, the most common adverse reactions (≥20%) are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

The most frequently reported serious adverse reactions with Nab-Xelpac plus carboplatin in non-small cell lung cancer are anemia (4%) and pneumonia (3%).

Adverse reactions most commonly leading to permanent discontinuation of Nab-Xelpac include neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%).

The most common adverse reactions requiring dose reduction of Nab-Xelpac are neutropenia (24%), thrombocytopenia (13%), and anemia (6%).

The most frequent adverse reactions causing dose delay or interruption of Nab-Xelpac include neutropenia (41%), thrombocytopenia (30%), and anemia (16%).

Pregnancy Category D. Nab-Paclitaxel may cause fetal harm when administered to a pregnant woman. In animal studies, administration of albumin-bound paclitaxel to pregnant rats at doses below the maximum recommended human dose (based on body surface area) resulted in embryo-fetal toxicities, including intrauterine death, increased resorptions, reduced numbers of live fetuses, and congenital malformations.

There are no adequate and well-controlled studies of Nab-Paclitaxel in pregnant women. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving it, the patient should be informed of the potential risk to the fetus. Women of reproductive potential should be advised to avoid becoming pregnant during treatment with Nab-Paclitaxel.

It is not known whether paclitaxel is excreted in human milk. However, paclitaxel and/or its metabolites have been found in the milk of lactating rats. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of the treatment to the mother.

Pediatric Use: The safety and effectiveness of Nab-Xelpac in pediatric patients have not been established.

Geriatric Use: Among 229 patients in a randomized study receiving Nab-Xelpac for metastatic breast cancer, 13% were aged 65 years or older and less than 2% were 75 years or older. No significant increase in toxicity was observed in older patients.

A pooled analysis of 981 patients treated with Nab-Xelpac monotherapy for metastatic breast cancer showed that 15% were aged 65 years or older and 2% were 75 years or older. Increased incidences of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema were observed in patients aged 65 years or older.

In a randomized study of 514 patients receiving Nab-Xelpac with carboplatin as first-line treatment for non-small cell lung cancer, 31% were aged 65 years or older and 3.5% were 75 years or older. Myelosuppression, peripheral neuropathy, and arthralgia were more common in patients aged 65 years or older compared to younger patients. No overall differences in effectiveness were observed between older and younger patients.

In another randomized study of 431 patients receiving Nab-Xelpac with gemcitabine for first-line treatment of pancreatic adenocarcinoma, 41% were aged 65 years or older and 10% were 75 years or older. No significant differences in effectiveness were observed between older and younger patients. However, diarrhea, decreased appetite, dehydration, and epistaxis were more frequently reported in patients aged 65 years or older. Clinical data are insufficient to determine whether patients aged 75 years or older respond differently compared to younger patients.

Patients With Hepatic Impairment: Paclitaxel exposure may be increased in patients with hepatic impairment. Reduce the starting dose of Nab-Xelpac in patients with moderate to severe hepatic impairment. Do not administer Nab-Xelpac to patients with total bilirubin >5 × ULN or AST >10 × ULN. Avoid use in patients with metastatic pancreatic adenocarcinoma who have moderate to severe hepatic impairment.

Patients With Renal Impairment: No adjustment of the starting dose is required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 mL/min). There are insufficient data to provide dosing recommendations for patients with severe renal impairment or end-stage renal disease (estimated creatinine clearance <30 mL/min).

There is no known antidote for Nab-Paclitaxel overdose. The main expected complications are bone marrow suppression, sensory neurotoxicity, and mucositis.

Cytotoxic Chemotherapy.

Store the vials in original cartons at 20°C to 25°C. Keep in the original package to protect from bright light.