Mozobil

Mozobil Manufacturers

• Genzyme Corporation
  

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  Mozobil | Genzyme Corporation

  

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  2.1 Recommended Dosage and Administration

  Vials should be inspected visually for particulate matter and discoloration prior to administration and should not be used if there is particulate matter or if the solution is discolored.

  Begin treatment with Mozobil after the patient has received G-CSF once daily for four days. [see Dosage and Administration (2.2)]  Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days.

  The recommended dose of Mozobil is 0.24 mg/kg body weight by subcutaneous (SC) injection. Use the patient’s actual body weight to calculate the volume of Mozobil to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation:

      0.012 X patient’s actual body weight (in kg) = volume to be administered (in mL)

  In clinical studies, Mozobil dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. Mozobil dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.

  Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day. [see Clinical Pharmacology (12.3)] 

  2.2 Recommended Concomitant Medications

  Administer daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis. [see Clinical Studies (14)]

  2.3 Dosing in Renal Impairment

  In patients with moderate and severe renal impairment (estimated creatinine clearance (CLCR) ≤ 50 mL/min), reduce the dose of Mozobil by one-third to 0.16 mg/kg as shown in Table 1. If CLCR is ≤ 50 mL/min the dose should not exceed 27 mg/day, as the mg/kg-based dosage results in increased plerixafor exposure with increasing body weight. [see Clinical Pharmacology (12.3)]  Similar systemic exposure is predicted if the dose is reduced by one-third in patients with moderate and severe renal impairment compared with subjects with normal renal function. [see Clinical Pharmacology (12.3)] 

  Table 1: Recommended Dosage of Plerixafor in Patients with Renal Impairment      Estimated Creatinine Clearance    
  (mL/min) Dose > 50     0.24 mg/kg once daily (not to exceed 40 mg/day)      ≤ 50     0.16 mg/kg once daily (not to exceed 27 mg/day)     

  The following (Cockroft-Gault) formula may be used to estimate CLCR: 

      Males:
      Creatinine clearance (mL/min) = weight (kg) X (140 – age in years)
                                                              72 X serum creatinine (mg/dL)

      Females:
      Creatinine clearance (mL/min) = 0.85 X value calculated for males

  There is insufficient information to make dosage recommendations in patients on hemodialysis.

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• Sanofi-aventis U.s. Llc
  

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  Mozobil | Sun Pharmaceutical Industries, Inc.

  

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  2.1     Dosing Information    
  Tizanidine Tablets, USP tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered.

  Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Tizanidine Capsules and Tizanidine Tablets, USP are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions [see Clinical Pharmacology (12.3)].

  The recommended starting dose is 2 mg. Because the effect of Tizanidine Tablets, USP peaks at approximately 1 to 2 hours post-dose and dissipates between 3 to 6 hours post-dose, treatment can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours.

  Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1 to 4 days between dosage increases, until a satisfactory reduction of muscle tone is achieved. The total daily dose should not exceed 36 mg. Single doses greater than 16 mg have not been studied.

  2.2     Dosing in Patients with Renal  Impairment      

  Tizanidine Tablets, USP should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased [see Warnings and Precautions (5.7)].

  2.3 Dosing in Patients with Hepatic Impairment 

  Tizanidine Tablets, USP should be used with caution in patients with any hepatic impairment. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected. [see Use in Specific Populations (8.7)]

  2.4 Drug Discontinuation   

  If therapy needs to be discontinued, particularly in patients who have been receiving high doses (20 mg to 36 mg daily) for long periods (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 mg to 4 mg per day) to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia [see Drug Abuse and Dependence (9.3)].

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