DORIBAX™ POWDER FOR INJECTION 500MG [SIN13613P]

Product Info

DORIBAX™ POWDER FOR INJECTION 500MG

[SIN13613P]

Therapeutic Indications
DORIBAX™ is a carbapenem antibiotic indicated as a single agent for the treatment of the following infections caused by susceptible bacteria: (See Microbiology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

• Complicated intra-abdominal infections

• Complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia

Doribax is also indicated for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, caused by susceptible bacteria. In the nosocomial pneumonia clinical studies, adjunctive use of an aminoglycoside was permitted.

Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, DORIBAX™ can be considered for treatment of complicated and mixed infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to doripenem. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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.

Contraindications
DORIBAX™ is contraindicated in patients with known serious hypersensitivity to doripenem or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.