Abraxane

Paclitaxel (as albumin bound nanoparticles)

Monotherapy for metastatic breast cancer in adults who have failed 1st-line treatment for metastatic disease & for whom standard, anthracycline containing therapy is not indicated. In combination w/ gemcitabine for the 1st-line treatment of adults w/ metastatic adenocarcinoma of the pancreas.

Breast cancer 260 mg/m² as IV over 30 min every 3 wk. Dose adjustment: Patients who experience severe neutropenia (neutrophil count <500 cells/mm³ for ≥1 wk) Reduce dose to 220 mg/m² for subsequent courses. Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m². Pancreatic adenocarcinoma In combination w/ gemcitabine: 125 mg/m² Abraxane as IV over 30 min on Days 1, 8 & 15 of each 28-day cycle, followed by concurrent recommended dose of 1,000 mg/m² gemcitabine as IV over 30 min immediately after the completion of  Abraxane. Dose adjustment: 1st dose level reduction: 100 mg/m² Abraxane & 800 mg/m² gemcitabine. 2nd dose level reduction: 75 mg/m² Abraxane & 600 mg/m² gemcitabine.

Hypersensitivity. Patients who have baseline neutrophil counts <1,500 cells/mm³. Lactation.

Discontinue treatment if hypersensitivity reactions occur. Do not substitute for, or w/ other paclitaxel formulations. Frequently monitor blood cell count & for occurrent cardiac events during treatment. Do not use subsequent cycles of Abraxane until neutrophils recover to >1,500 cells/mm³ & platelet to >100,000 cells/mm³. Withhold treatment in monotherapy for breast cancer, if Grade 3 sensory neuropathy develops until resolution to Grade 1 or Grade 2, followed by dose reduction; in combination therapy w/ gemcitabine for pancreatic adenocarcinoma if peripheral neuropathy develops. Initiate treatment w/ broad spectrum antibiotics if patients become febrile (regardless of neutrophil count). Withhold treatment in febrile neutropenia until fever resolves & ANC ≥1,500 cells/mm³, then resume treatment at reduced dose levels. Closely monitor patients for signs & symptoms of pneumonitis & profound myelosuppression. Patients w/ total bilirubin >5x ULN or AST >10x ULN, & those w/ metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin >1.5x ULN & AST ≤10x ULN). Cardiotoxicity. CNS metastases. GI symptoms. Do not co-administer w/ erlotinib. Women of childbearing potential should use effective contraception during treatment & up to 1 mth after treatment. Male patients must use effective contraception during & up to 6 mth after treatment. Minor or moderate influence on the ability to drive or use machines. Pregnancy. Elderly ≥75 yr. Patients on controlled Na diet.

Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression; anorexia; peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia; nausea, diarrhoea, vomiting, constipation, stomatitis; alopecia, rash; arthralgia, myalgia; fatigue, asthenia, pyrexia. Infection, UTI, folliculitis, URTI, candidiasis, sinusitis; febrile neutropenia; dehydration, decreased appetite, hypokalaemia; insomnia, depression, anxiety; peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence; increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis; vertigo; tachycardia, arrhythmia, supraventicular tachycardia; flushing, hot flushes, HTN, lymphoedema; interstitial pneumonitis, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhea; abdominal pain & distension, upper abdominal pain, dyspepsia, GERD, oral hypoaesthesia; nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes, pain in extremity, bone pain, back pain, muscle cramps, limb pain; peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, flu-like illness, malaise, lethargy, hyperpyrexia; decreased wt, increased ALT & AST, decreased haematocrit, decreased RBC count, increased body temp, increased γ-glutamyltransferase, increased blood alkaline phosphatase.

Increased toxicity w/ CYP2C8 or CYP3A4 inhibitors eg, ketoconazole & other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir & nelfinavir). Decreased exposure w/ CYP2C8 or CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine.

Cytotoxic Chemotherapy

L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.

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