Paclib

Paclitaxel

1st-line treatment of advanced ovarian cancer in combination w/ cisplatin. Adjuvant treatment of node +ve breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Breast cancer after failure of combination chemotherapy for metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy. Locally advanced or metastatic breast cancer in combination w/ an anthracycline or trastuzumab. 1st-line treatment of non-small cell lung cancer (NSCLC) in combination w/ cisplatin. Palliative treatment of advanced or refractory AIDS-related Kaposi's sarcoma in patients who have failed prior liposomal anthracycline therapy.

Premed all patients w/ oral dexamethasone (20 mg) approx 12 & 6 hr before paclitaxel administration, IV diphenhydramine or its equiv (50 mg) 30-60 min before paclitaxel & either IV cimetidine (300 mg) or IV ranitidine (50 mg) 30-60 min before paclitaxel. Patient w/ HIV infection may follow the same premed regimen w/ the exception of a reduced dose of oral dexamethasone (10 mg). Ovarian cancer Previously untreated ovarian cancer patient Paclitaxel 175 mg/m² IV over 3 hr followed by cisplatin 75 mg/m²; may be given every 3 wk or paclitaxel 135 mg/m² IV over 24 hr followed by cisplatin 75 mg/m²; may be given every 3 wk. Previously chemotherapy-treated ovarian cancer patient Paclitaxel 135 or 175 mg/m² IV over 3 hr; given every 3 wk. Breast cancer: Adjuvant treatment of node +ve breast cancer Paclitaxel 175 mg/m² IV over 3 hr given every 3 wk for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. After failure of initial chemotherapy for metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy Paclitaxel 175 mg/m² IV over 3 hr given every 3 wk. HER-2 overexpressing breast cancer Paclitaxel 175 mg/m² IV over 3 hr; given every 3 wk for 6 cycles. Administer trastuzumab 2 mg/kg IV once a wk until progression of disease after an initial loading dose of 4 mg/kg body wt. NSCLC Paclitaxel 135 mg/m² IV over 24 hr followed by cisplatin 75 mg/m²; given every 3 wk or paclitaxel 175 mg/m² IV over 3 hr followed by cisplatin 80 mg/m²; given every 3 wk. AIDS-related Kaposi's sarcoma Paclitaxel 135 mg/m² IV over 3 hr given every 3 wk or paclitaxel 100 mg/m² IV over 3 hr given every 2 wk (dose intensity 45-50 mg/m²/wk). Hepatic impairment 24 hr infusion: 2 to <10 x ULN transaminase levels & ≤1.5 mg/dL bilirubin levels 100 mg/m², <10 x ULN transaminase levels & 1.6-7.5 mg/dL bilirubin levels 50 mg/m², <2 x ULN transaminase levels & ≤1.5 mg/dL bilirubin levels 135 mg/m². 3 hr infusion: <10 x ULN transaminase levels & 2.01-5 ULN bilirubin levels 90 mg/m², <10 x ULN transaminase levels & 1.26-2 x ULN bilirubin levels 135 mg/m², <10 x ULN transaminase levels & ≤1.25 x ULN bilirubin levels 175 mg/m².

Hypersensitivity to paclitaxel & polyoxyethylated castor oil. Patients w/ solid tumors who have baseline neutrophil count <1,500 cells/mm³; AIDS-related Kaposi's sarcoma who have baseline neutrophil count <1,000 cells/mm³ & those w/ concurrent, serious, uncontrolled infections; hepatic dysfunction, alcoholism & epilepsy. Pregnancy. Childn.

Risk of anaphylaxis; severe hypersensitivity, inj site & GI reactions; infectious complications. Monitor cardiac function in patients w/ preexisting cardiac abnormalities & when paclitaxel is co-administered w/ doxorubicin in patients w/ metastatic breast cancer. Patients w/ severely impaired hepatic infection (transaminase levels ;≥10 x ULN or bilirubin levels >7.5 mg/dL or >5 x ULN) & renal impairment, preexisting peripheral neuropathy, varicella or recent exposure to such disease, herpes zoster, infection & those who have undergone therapies w/ cytotoxic drugs including radiotherapy. May impair ability to drive or operate machinery (due to alcohol content). Lactation. Elderly.

Bone marrow suppression, peripheral neuropathy, arthralgia, myalgia, hypersensitivity & inj site reactions. UTI & resp tract infection, fatal outcome, septic shock, pneumonia, peritonitis, sepsis, pseudomembranous colitis; acute myeloid leukemia, myelodysplastic syndrome, tumor lysis syndrome; blood & lymphatic; metabolism & nutrition; psychiatric; nervous system; ocular & otic; CV, resp, GI, hepatobiliary, dermatologic, musculoskeletal, renal effects. Severe elevation in AST, SGOT, alkaline phosphatase, bilirubin; increase in blood creatinine, abnormal ECG; phlebitis, radiation recall reaction, ototoxicity, epidermal necrolysis.

May affect toxicities of other antineoplastic drugs. Myelosuppressive agents. Risk of blood dyscrasia w/ aminopyrine, ACE inhibitors, anticonvulsants, TCAs, oral antidiabetics, NSAIDs, carbamazepine, chloramphenicol, clozapine, dapsone, foscarnet, levamisole, penicillamine, phenothiazine, primaquine, primidone, procainamide, propafenone, rifampicin, sulfonamides, thioxanthenes, trimethoprim, valproate & valproic acid. Decreased or increased plasma conc w/ CYP450 isoenzymes. Potential interaction w/ PIs (eg, ritonavir, saquinavir, indinavir & nelfinavir). Metabolism may be inhibited by ketoconazole. Risk of CNS depression w/ CNS depressants eg, antihistamines or opiates (due to alcohol content). Vaccines.

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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