Docefrez

Docefrez Manufacturers

• Sun Pharma Global Fze
  

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  Docefrez | Sun Pharma Global Fze

  

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  For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7)].
  
  Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

  2.1 Breast Cancer For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of DOCEFREZ is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks. 2.2 Non-Small Cell Lung Cancer For treatment after failure of prior platinum-based chemotherapy, docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)].For chemotherapy-naïve patients, docetaxel was evaluated in combination with cisplatin. The recommended dose of DOCEFREZ is 75 mg/m2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m2 over 30 to 60 minutes every 3 weeks [see Dosage and Administration (2.7)]. 2.3 Prostate Cancer For hormone-refractory metastatic prostate cancer, the recommended dose of DOCEFREZ is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously [see Dosage and Administration (2.7)]. 2.6 Premedication Regimen

   All patients should be premedicated with oral corticosteroids (see below for prostate cancer) such as dexamethasone 16 mg per day (e.g., 8 mg twice daily) for 3 days starting 1 day prior to DOCEFREZ administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.4)]. 
  For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the DOCEFREZ infusion [see Warnings and Precautions (5.4)].

  2.7 Dosage Adjustments During Treatment
  

  Breast Cancer
  
  Patients who are dosed initially at 100 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, or severe or cumulative cutaneous reactions during DOCEFREZ therapy should have the dosage adjusted from 100 mg/m2 to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be decreased from 75 mg/m2 to 55 mg/m2 or the treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during DOCEFREZ therapy may tolerate higher doses. Patients who develop ≥grade 3 peripheral neuropathy should have DOCEFREZ treatment discontinued entirely.
   
  Non-Small Cell Lung Cancer
  
  Monotherapy with DOCEFREZ for NSCLC treatment after failure of prior platinum-based chemotherapy
  
  Patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3/4 non-hematological toxicities during DOCEFREZ treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop ≥grade 3 peripheral neuropathy should have DOCEFREZ treatment discontinued entirely.
  
  
  Combination therapy with DOCEFREZ for chemotherapy-naïve NSCLC
  For patients who are dosed initially at DOCEFREZ 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the DOCEFREZ dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 is recommended. For cisplatin dosage adjustments, see manufacturers’ prescribing information. 
   
  Prostate Cancer
  
  Combination therapy with DOCEFREZ  for hormone-refractory metastatic prostate cancer
  
  DOCEFREZ should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during DOCEFREZ therapy should have the dosage of DOCEFREZ reduced from 75 mg/m² to 60 mg/m². If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
   
  Combination Therapy with Strong CYP3A4 inhibitors:
  
  Avoid using concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole).  There are no clinical data with a dose adjustment in patients receiving strong CYP3A4 inhibitors. Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require coadministration of a strong CYP3A4 inhibitor. [see Drug Interactions (7), Clinical Pharmacology (12.3)].

  2.8 Administration Precautions
  

  DOCEFREZ is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing DOCEFREZ solutions. The use of gloves is recommended. Please refer to [see How Supplied/ Storage and Handling (16.3)].
  
  If DOCEFREZ  lyophilized powder, reconstituted solution, or infusion solution should come into contact with the skin, immediately and thoroughly wash with soap and water. If DOCEFREZ lyophilized powder, reconstituted solution or infusion solution should come into contact with mucosa, immediately and thoroughly wash with water.
  
  Contact of the DOCEFREZ reconstituted solution with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the  DOCEFREZ infusion solution should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
  
  DOCEFREZ (Lyophilized Powder for Injection and Diluent)
  
  
  DOCEFREZ for Injection requires reconstitution with Diluent and one further dilution with infusion solution prior to administration. Please follow the preparation instructions provided below.
  
  The table below provides the fill range of the Diluent, the volume of Diluent to be added for the reconstitution and the concentration of the reconstituted solution for DOCEFREZ 20 mg and DOCEFREZ 80 mg (See Table 1).

  
  Table 1- Reconstitution of DOCEFREZ (docetaxel) for Injection Product Fill Range of the Diluent (35.4% w/w ethanol in polysorbate 80) Volume of Diluent to be added for the reconstitution Concentration of the reconstituted solution Docetaxel 20 mg vial
  1.10 – 1.15 mL
  1 mL
  20 mg/0.8 mL
  Docetaxel 80 mg vial
  4.13 – 4.29 mL
  4 mL
  24 mg/mL
  
  2.9 Preparation and Administration
  

  DOCEFREZ (Lyophilized Powder for Injection and Diluent)
   A. Preparation of the Reconstituted Solution 

  DOCEFREZ vials should be stored between 2°C and 8°C (36°F and 46°F). Allow the appropriate number of vials of DOCEFREZ (docetaxel) for Injection and diluent (35.4% ethanol in polysorbate 80) vials to stand at room temperature for approximately 5 minutes. a) For DOCEFREZ 20: Use 1 mL syringe with needle of 18- to 21-gauge, 1½-inch for withdrawing diluent for DOCEFREZ 20.
  b) For DOCEFREZ 80: Use 4 mL syringe with needle of 18- to 21-gauge, 1½-inch for withdrawing diluent for DOCEFREZ 80. a) For DOCEFREZ 20: Aseptically withdraw 1 mL from the diluent vial into a syringe by partially inverting the vial, and transfer it to product vial of DOCEFREZ (docetaxel) for Injection.
  b) For DOCEFREZ 80:  Aseptically withdraw 4 mL from the diluent vial into a syringe by partially inverting the vial, and transfer it to product vial of DOCEFREZ (docetaxel) for Injection . Shake the reconstituted vial well in order to completely dissolve the docetaxel powder present in the vial. For the 20 mg vial, the resultant concentration is 20 mg/0.8 mL. For the 80 mg vial, the resultant concentration is 24 mg/mL .
  

  The reconstituted DOCEFREZ solution should be clear; however, there may be some air bubbles in the solution due to the polysorbate 80. Allow the solution to stand for a few minutes to allow any air bubbles to dissipate. 
  The reconstituted solution may be used immediately or stored either in the refrigerator or at room temperature for a maximum of 8 hours.
  
  B.   Preparation of the Infusion Solution

  Aseptically withdraw the required amount of reconstituted DOCEFREZ solution with a calibrated syringe and inject into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 to 0.74 mg/mL. If a dose greater than 200 mg of DOCEFREZ is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL docetaxel is not exceeded. Thoroughly mix the infusion by manual rotation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the DOCEFREZ reconstituted solution or infusion solution is not clear or appears to have precipitation, these should be discarded. DOCEFREZ reconstituted solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

  The final DOCEFREZ infusion solution should be administered intravenously as a 1-hour infusion under ambient room temperature (below 25° C) and lighting conditions.

  2.10 Stability

  DOCEFREZ infusion solution, if stored between 2°C and 25°C (36°F and 77°F) is stable for 6 hours. DOCEFREZ infusion solution (in either 0.9% Sodium Chloride solution or 5% Dextrose solution) should be used within 6 hours (including the 1 hour intravenous administration).
  
  In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C and 8°C (36°F and 46°F).

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