Hospira Docetaxel

Hospira Docetaxel

docetaxel

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
Combination w/ doxorubicin for locally advanced or metastatic breast cancer patients who have not previously received cytotoxic therapy; monotherapy for locally advanced or metastatic breast cancer after failure of cytotoxic therapy; combination w/ capecitabine for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy; combination w/ cisplatin for unresectable, locally advanced or metastatic non-small cell lung cancer in patients who have not previously received chemotherapy for this condition. Combination w/ prednisone or prednisolone for hormone refractory metastatic prostate cancer. Combination w/ cisplatin & 5-fluorouracil for metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction in patients who have not received prior chemotherapy for metastatic disease. Induction treatment in combination w/ cisplatin & 5-fluorouracil for inoperable locally advanced squamous cell carcinoma of the head & neck (SCCHN). Metastatic carcinoma of the ovary after failure of 1st-line or subsequent chemotherapy.
Dosage/Direction for Use
Breast, non-small cell lung, ovarian, gastric, head & neck cancer premed Oral corticosteroid eg, dexamethasone 16 mg/day for 3 days starting 1 day prior to docetaxel administration. Prostate cancer premed Oral dexamethasone 8 mg 12 hr, 3 hr & 1 hr before docetaxel infusion. IV Locally advanced or metastatic breast cancer Monotherapy: 100 mg/m2. 1st-line treatment: 75 mg/m2 in combination w/ doxorubicin 50 mg/m2. In combination w/ capecitabine: Docetaxel 75 mg/m2 every 3 wk & capecitabine 1,250 mg/m2 bd for 2 wk followed by 1-wk rest period. Non-small cell lung cancer (chemotherapy-naive) 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 min. After failure of prior platinum-based treatment: 75 mg/m2 as a single agent. Prostate cancer 75 mg/m2. Prednisone or prednisolone 5 mg orally bd. Gastric adenocarcinoma 75 mg/m2 as 1 hr infusion, followed by cisplatin 75 mg/m2 as 1-3 hr infusion (both on day 1), followed by 5-fluorouracil 750 mg/m2/day as 24 hr continuous infusion for 5 days starting at the end of cisplatin infusion. Repeated every 3 wk. Inoperable locally advanced SCCHN Induction: 75 mg/m2 as 1 hr infusion, followed by cisplatin 75 mg/m2 over 1 hr on day 1, followed by 5-fluorouracil as continuous infusion at 750 mg/m2/day for 5 days, administered every 3 wk for 4 cycles. Locally advanced SCHHN Induction: 75 mg/m2 as 1 hr IV infusion on day 1, followed by cisplatin 100 mg/m2 as 30 min to 3 hr infusion followed by 5-fluorouracil 1,000 mg/m2/day as continuous infusion from day 1-4, administered every 3 wk for 3 cycles. Ovarian cancer 100 mg/m2 as 1 hr infusion every 3 wk.
Contraindications
Hypersensitivity. Baseline neutrophil count <1,500 cells/mm3. Severe liver impairment. CI of other medicinal products when combined w/ docetaxel. Pregnancy & lactation.
Special Precautions
Hypersensitivity especially during the 1st & 2nd infusions. Frequent monitoring of complete blood count during treatment. Reduce subsequent doses if severe neutropenia (<500 cells/mm3 for ≥7 days). Mild to moderate reversible cutaneous reactions. Potential cutaneous lupus erythematosus & bullous eruptions, eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis & scleroderma-like changes; ototoxicity, hearing disorders &/or hearing loss. A premed consisting of an oral corticosteroid (eg, dexamethasone 16 mg/day) for 3 days starting 1 day prior to docetaxel administration, unless CI, can reduce the incidence & severity of fluid retention as well as the severity of hypersensitivity reactions. Closely monitor severe fluid retention (eg, pleural & pericardial effusion & ascites). Potentially fatal, acute resp distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis & resp failure; closely monitor for development of new or worsening pulmonary symptoms. Avoid concomitant use w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole). Reduce dose in case of development of severe peripheral neurotoxicity. Contains ethanol (182 mg/mL); possible CNS & other effects may occur. Refrain from driving or using machines. Hepatic impairment. PEG300 content may increase risk of nephrotoxicity in patients w/ renal impairment. Contraceptive measures must be taken by both men & women. May impair fertility. Women of childbearing potential/contraception. Childn & adolescents. Elderly ≥60 yr. Adjuvant treatment of breast cancer: Promptly evaluate & treat early abdominal pain & tenderness, fever, diarrhoea, w/ or w/o neutropenia. Monitor for CHF symptoms during therapy & the follow up period. Risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow up.
Adverse Reactions
Neutropenia, anaemia, peripheral sensory neuropathy, stomatitis, diarrhoea, nausea, vomiting, alopecia, skin reaction, anorexia, infections (including sepsis & pneumonia), fluid retention, asthenia; thrombocytopenia. Febrile neutropenia, peripheral motor neuropathy, nail disorders, myalgia, hypersensitivity, increased blood bilirubin, arrhythmia, constipation, hypotension. Dyspnoea, increased alkaline phosphatase, AST, ALT, abdominal pain, GI haemorrhage, arthralgia, infection associated w/ G4 neutropenia, mucositis, HTN, haemorrhage, infusion site reaction, noncardiac chest pain.
Drug Interactions
Metabolism may be modified by CYP450 3A induced, inhibited or metabolised compd eg, ciclosporin, terfenadine, ketoconazole, erythromycin & troleandomycin & to a lesser extent by doxorubicin, vinorelbine, vinblastine & nifedipine; increased by dexamethasone, phenobarbitone & clofibrate & unaffected by cimetidine, ranitidine, omeprazole, diazepam, imipramine, paracetamol, caffeine, tolbutamide & quinidine. Increased carboplatin clearance. Avoid concomitant use w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole). Caution during concomitant use w/ PIs (eg, ritonavir). Alcohol content may alter effects of other medicinal products.
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Presentation/Packing
Form
Hospira Docetaxel 80 mg per 8 mL conc for soln for infusion
Packing/Price
1's
Form
Hospira Docetaxel 20 mg per 2 mL conc for soln for infusion
Packing/Price
1's
Form
Hospira Docetaxel 160 mg per 16 mL conc for soln for infusion
Packing/Price
1's
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