DORIBAX™ Powder for Injection 500mg

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

**Posology and Method of Administration** The recommended dose of DORIBAX™ is 500 mg administered every 8 hours by intravenous infusion. The recommended dosage and administration by infection is described in Table 1:  The usual treatment duration for patients with nosocomial pneumonia, including ventilator-associated pneumonia, is 7 to 14 days and is often in the upper range for patients infected with non-fermenting gram-negative pathogens (such as _Pseudomonas_ spp. and _Acinetobacter_ spp.). Treatment should be guided by the severity of illness, infecting pathogen and the patient’s clinical response. In a Phase 3 study in patients with ventilator-associated pneumonia, a 7-day course of DORIBAX™ (1 gram every 8 hours as a 4 hour infusion) has been associated with a higher mortality rate and a lower clinical cure rate compared to a 10-day course of imipenem/cilastatin therapy. Consideration should be given to treat patients with ventilator-associated pneumonia for more than 7 days \[see _Undesirable Effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **Patients with Renal Impairment** In patients whose creatinine clearance (CrCl) is > 50 ml/min, no dosage adjustment is necessary. In patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 ml/min), the dosage of DORIBAX™ should be 250 mg administered every 8 hours. In patients with severe renal impairment (CrCl > 10 to < 30 ml/min), the dosage of DORIBAX™ should be 250 mg administered every 12 hours. (See _Preparation of 500 mg dose of DORIBAX™ solution for infusion and Preparation of 250 mg dose of DORIBAX™ solution for infusion for patients with moderate or severe renal impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Due to limited clinical data and an expected increased exposure to doripenem, DORIBAX™ should be used with caution in patients with severe renal impairment (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The following formula may be used to estimate CrCl. The serum creatinine used in the formula should represent a steady state of renal function.  **Patients on Dialysis** DORIBAX™ dosing and administration recommendations for patients on continuous renal replacement therapies are shown in Table 2:  Dosing recommendations for pathogens with MIC >1 mcg/ml have not been established for continuous renal replacement therapy due to the potential for accumulation of doripenem and doripenem-M-1 metabolite \[see _Continuous Renal Replacement Therapy and Patients on Dialysis_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Close safety monitoring is advised for patients on continuous renal replacement therapy, due to limited clinical data and an expected increased exposure to doripenem-M-1 metabolite \[see _Continuous Renal Replacement Therapy_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. There is insufficient information to make dose adjustment recommendations for patients on other forms of dialysis \[see _Patients on Dialysis_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **Patients with Hepatic Impairment** No dosage adjustment is necessary. **Age, Gender and Race** No dosage adjustment is recommended based on age (18 years of age and older) gender or race.