Paclitaxel Protein Bound

DEA Class; Rx

Common Brand Names; Abraxane

• Antineoplastics, Antimicrotubular

Neutrophils <1500 cells/mm³

Documented hypersensitivity to drug or excipients

• Alopecia (90%)
• Neutropenia (<2 x 10^9/L) (80%)
• Sensory neuropathy, any (71%)
• Abnormal EKG, all patients (60%)
• Asthenia (47%)
• Myalgia/arthralgia (44%)
• AST increased (39%)
• Alkaline phosphatase increased (36%)
• Abnormal EKG, patients normal at baseline (35%)
• Anemia (<11 g/dL) (33%)
• Nausea (30%)
• Diarrhea (27%)
• Infections (24%)
• Vomiting (18%)
• Dyspnea (12%)
• NSCLC (47%)
• Pancreatic cancer (38%)
• Metastatic breast cancer (34%)

Sepsis occurred in 5% of patients with or without neutropenia; biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis; if a patient becomes febrile (regardless of ANC) initiate treatment with broad-spectrum antibiotics; for febrile neutropenia, interrupt this drug and gemcitabine until fever resolves and ANC ≥ 1500, then resume treatment at reduced dose levels

Pneumonitis, including fatalities, occurred in 4% of patients; monitor patients for signs and symptoms of pneumonitis and interrupt this drug and gemcitabine during evaluation of suspected pneumonitis; after ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with this drug and gemcitabine

Contains albumin (human), a derivative of human blood; based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases; a theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote; no cases of transmission of viral diseases or CJD have ever been identified for albumin

CYP3A4 and CYP2C8 substrate; inducers or inhibitors of these isoenzymes may alter metabolism; if coadministered, monitor closely

Grade 3 peripheral neuropathy reported; no patients developed Grade 4 peripheral neuropathy; upon suspension of dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days; of paclitaxel-treated patients with Grade 3peripheral neuropathy, 44% resumed paclitaxel at a reduced dose; may require dose reduction or treatment interruption (see Dosage Modifications)

Based on its mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman; there are no available human data to inform drug-associated risk

There are no data on presence of drug in human milk, or effect on breastfed child or on milk production