Paclib

5 mL & 16.67 mL: 1st-line treatment of advanced ovarian cancer in combination w/ cisplatin. Subsequent treatment of advanced ovarian cancer. 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. Initial treatment of locally advanced or metastatic breast cancer in combination w/ an anthracycline or in patients for whom anthracycline therapy is suitable, or in combination w/ trastuzumab in patients who over-express human epidermal growth factor receptor 2 (HER-2) at a 3+ level as determined by immunohistochemistry & for whom anthracycline is not suitable. 1st-line treatment of patients w/ NSCLC who are not candidates for surgery &/or RT in combination w/ cisplatin. Palliative treatment of advanced or refractory AIDS-related Kaposi's sarcoma in patients who have failed prior lipos anthracycline therapy. 43.4 mL: Palliative treatment of stage 3 or 4 advanced local carcinoma of the ovary after surgical resection, in combination w/ cisplatin; advanced NSCLC in patients who are not candidates for potentially curative surgery &/or RT. Palliative management of metastatic carcinoma of the ovary after failure of 1st-line or subsequent chemotherapy. Metastatic carcinoma of the breast after failure of combination chemotherapy or relapse w/in 6 mth of adjuvant chemotherapy.

5 mL & 16.67 mL 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: <10 x ULN transaminase levels & 1.6-7.5 mg/dL bilirubin levels 50 mg/m², 2 to <10 x ULN transaminase levels & ≤1.5 mg/dL bilirubin levels 100 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. 43.4 mL Premed all patients w/ corticosteroids, antihistamines, & H₂-antagonists prior to paclitaxel administration eg, oral dexamethasone 20 mg approx 12 & 6 hr before paclitaxel, promethazine 25 mg IV 30-60 min before paclitaxel. Primary treatment of ovarian carcinoma Paclitaxel 135 mg/m² over 24 hr, followed by cisplatin 75 mg, every 3 wk. Secondary treatment of ovarian carcinoma Paclitaxel 175 mg/m² IV over 3 hr every 3 wk. Palliative treatment of advanced NSCLC Paclitaxel 175 mg/m² over 3 hr; followed by platinum compd, w/ 3 wk interval between courses.

5 mL & 16.67 mL: Hypersensitivity to paclitaxel, or 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. 43.4 mL: History of severe hypersensitivity to paclitaxel or other drugs formulated w/ polyoxyethylated castor oil. Patients w/ baseline neutrophils <1500/mm³.

Administer under the medical supervision experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic & treatment facilities are readily available. Pretreat all patients w/ corticosteroids, diphenhydramine/antihistamines & H₂-antagonists. Do not rechallenge patients who experience severe hypersensitivity reactions. Perform frequent peripheral blood cell counts to monitor the occurrence of bone marrow suppression. Perform continuous ECG/cardiac monitoring during subsequent therapy w/ paclitaxel in patients who develop significant cardiac function abnormalities during administration. Not recommended in patients w/ severely impaired hepatic function (transaminase levels ≥10 x ULN or bilirubin levels >7.5 mg/dL or >5 x ULN). Patients w/ moderate to severe liver failure/hepatic impairment. 5 mL & 16.67 mL: Monitor cardiac function in patients w/ preexisting cardiac abnormalities & when co-administered w/ doxorubicin in patients w/ metastatic breast cancer. Carefully monitor patients w/ pre-existing peripheral neuropathy & reduce all subsequent doses in severe cases. Exclude bowel perforation in patients who complain of abdominal pain w/ other signs & symptoms. Take extra precautions to reduce the risk of infection or bleeding. Consider risk-benefit in patients w/ varicella or recent exposure to such disease; herpes zoster; infection. Precaution in patients who have undergone therapies w/ cytotoxic drugs, including RT. May impair ability to perform hazardous activities requiring mental alertness following infusion (due to alcohol content), particularly when high doses are administered over short periods (eg, 3 hr). Concomitant use w/ CNS depressants should be done w/ caution. Patients w/ renal failure. Breastfeeding is not recommended during chemotherapy. Safety & efficacy have not been clearly established in the elderly. 43.4 mL: Closely monitor infusion site for possible infiltration during administration. Give paclitaxel before cisplatin when used in combination. Do not retreat until neutrophils recover to ≥1,500/mm³ (≥1,000/mm³ for Kaposi's sarcoma patients) & platelets recover to ≥100,000/mm³ (≥75,000/mm³ for Kaposi's sarcoma patients). Closely monitor for development of profound myelosuppression. Rare reports of severe cardiac conduction abnormalities w/ single-agent paclitaxel. Frequent vital sign monitoring, particularly during the 1st hr of infusion. Closely monitor cardiac function when used in combination w/ doxorubicin or trastuzumab for initial treatment of metastatic breast cancer. More frequent monitoring of cardiac function (eg, every 1-2 cycles) if further treatment is administered. Dose reduction of 20% (25% for Kaposi's sarcoma patients) for all subsequent courses in severe peripheral neuropathy. Take special care to avoid intra-arterial application. May contribute to the development of interstitial pneumonitis when used in combination w/ lung radiation. Contains anhydrous ethanol; consider possible CNS & other effects. Contains polyoxyl 35 castor oil which may cause severe allergic reactions. Rare reports of pseudomembranous colitis. Consider in differential diagnosis of severe or persistent diarrhoea occurring during or shortly after treatment. Reduce dose by 25% if severe mucositis occurs in Kaposi's sarcoma patients. Sexually active fertile male & female patients should use effective contraception during treatment & up to 6 mth after treatment. Women of childbearing potential should avoid becoming pregnant during therapy. Not to be used during pregnancy. Discontinue breastfeeding during treatment.

Nausea & vomiting, diarrhea; hair loss, nail changes. 5 mL & 16.67 mL: Bone marrow suppression, febrile neutropenia associated w/ infectious episode (eg, UTI & URTI); infectious complications (eg, sepsis, pneumonia & peritonitis); flushing, rash, skin reactions, dyspnea, hypotension, tachycardia, HTN, chest pains, angioedema, & generalized urticaria, abdominal pain, pain in extremities, diaphoresis, cutaneous reactions (eg, acral erythema, generalized pustular dermatosis, bullous fixed drug eruption); bradycardia, severe CV effects including arrhythmia (eg, asymptomatic ventricular/supraventricular/junctional tachycardia, bigeminy, atrial fibrillation), syncope, venous thrombosis, & severe conduction abnormalities, AV block, CHF, cardiomyopathy associated w/ acute renal failure, edema; peripheral neuropathy, burning pain, perioral numbness; arthralgia &/or myalgia; anorexia, taste perversion, mucositis characterized by diffuse ulceration of lips, oral cavity & pharynx, dysphagia, pain reflecting esophageal involvement; reversible alopecia, transient skin changes, radiation recall dermatitis & maculopapular rash, pruritus in high doses; abnormal LFTs, increased serum alkaline phosphatase, AST, ALT, bilirubin conc; renal toxicity including reversible increases in serum creatinine levels; radiation pneumonitis & interstitial pneumonia together w/ RT, transient pulmonary infiltrates; loss of visual acuity in high doses; dyspnea, burning eyes, sore throat; tingling, burning, redness; asthenia, malaise. 43.4 mL: Peripheral neuropathy, neutropenia, bone & muscle aches, fatigue, mucositis, amenorrhea.

5 mL & 16.67 mL: Sequence-dependent interactions w/ & may affect toxicities of other antineoplastic agents. Increased severity of myelosuppression w/ cisplatin; other myelosuppressive agents. Increased severity of neutropenia & thrombocytopenia w/ cyclophosphamide. Increased plasma levels of doxorubicin & active metabolite doxorubicinol. Inhibited action w/ fluorouracil pretreatment. 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/ drugs which induce or inhibit the action of cytochrome P-450 isoenzymes. Potential interaction w/ PIs (eg, ritonavir, saquinavir, indinavir & nelfinavir). Metabolism may be inhibited by ketoconazole. CNS depression due to the alcohol content of the formulation may be potentiated when used together w/ CNS depressants eg, antihistamines or opiates. Respond to the vaccine depends on the type & intensity of immunosuppression caused by paclitaxel. Postpone immunization w/ oral poliovirus vaccine in people who are in close contact w/ patients undergoing paclitaxel therapy. 43.4 mL: More profound myelosuppression & decreased clearance when given after cisplatin. Caution when co-administered w/ known substrates or inhibitors of cytochrome P450 isoenzymes CYP2C8 & CYP3A4.

Cytotoxic Chemotherapy

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

Rx