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Excella Gmbh Drugs

• Hepsera
  

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  Hepsera

  

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  2.1 Chronic Hepatitis B

  The recommended dose of HEPSERA in chronic hepatitis B patients for patients ≥12 years of age with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.

  HEPSERA is not recommended for use in children less than 12 years of age.

  2.2 Dose Adjustment in Renal Impairment

  Significantly increased drug exposures were seen when HEPSERA was administered to adult patients with renal impairment [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of HEPSERA should be adjusted in adult patients with baseline creatinine clearance <50 mL/min using the following suggested guidelines (see Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.

  Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with HEPSERA. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

  Table 1. Dosing Interval Adjustment of HEPSERA in Adult Patients with Renal Impairment Creatinine Clearance (mL/min)* ≥50 30–49 10–29 Hemodialysis Patients * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Recommended doseand dosing interval 10 mg every24 hours 10 mg every48 hours 10 mg every72 hours 10 mg every 7 days followingdialysis

  The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients.

  No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [see Warnings and Precautions (5.2)].

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• Emtriva
  

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  Emtriva

  

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  2.1 Recommended Dose

  EMTRIVA may be taken without regard to food.

  2.2 Adult Patients (18 years of age and older)

  EMTRIVA capsules: one 200 mg capsule administered once daily orally. EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.

  2.3 Pediatric Patients (0–3 months of age)

  EMTRIVA oral solution: 3 mg/kg administered once daily orally.

  2.4 Pediatric Patients (3 months through 17 years)

  EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally. EMTRIVA capsules: for children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

  2.5 Dose Adjustment in Adult Patients with Renal Impairment

  Significantly increased drug exposures were seen when EMTRIVA was administered to patients with renal impairment [See Clinical Pharmacology (12.3)]. Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance <50 mL/min using the following guidelines (see Table 1). The safety and effectiveness of these dose adjustment guidelines have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

  Table 1 Dose Adjustment in Adult Patients with Renal Impairment Creatinine Clearance (mL/min) Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis* * Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours Oral Solution (10 mg/mL) 240 mg every 24 hours (24 mL) 120 mg every 24 hours (12 mL) 80 mg every 24 hours (8 mL) 60 mg every 24 hours (6 mL)

  Although there are insufficient data to recommend a specific dose adjustment of EMTRIVA in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval similar to adjustments for adults should be considered.

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