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Make DORIBAX® your carbapenem with a demonstrated safety and tolerability profile

Incidence of seizure in Phase 2 and 3 clinical trials1

Incidence of seizure in Phase 2 and 3 clinical trials

Safety Considerations

  • Due to a drug interaction, patients with seizure disorders controlled with valproic acid or sodium valproate will be at an increased risk for breakthrough seizures when treated with DORIBAX® concomitantly. In some reports, increasing the dose of valproic acid or sodium valproate did not result in increased valproic acid serum concentrations. Alternative antibacterial therapies should be considered for patients receiving valproic acid or sodium valproate. If administration of DORIBAX® is necessary, supplemental anticonvulsant therapy should be considered.

Rates of adverse drug reactions in pivotal cIAI and cUTI clinical trials

  • The most common adverse reactions (≥5%) observed in clinical trials were headache, nausea, diarrhea, rash, and phlebitis
    — During clinical trials, adverse reactions that led to discontinuation of DORIBAX® were nausea (0.2%), vulvomycotic infection (0.1%), and
    rash (0.1%)

Adverse drug reactions in Phase 2 and 3 clinical trials1

DORIBAX® – Adverse drug reactions in Phase 2 and 3 clinical trials

* Dosage for DORIBAX®: 500 mg every 8 h via 1-h or 4-h infusion.

† Comparator agents: levofloxacin, meropenem, piperacillin-tazobactam, and imipenem. Dosage for comparator agents included: levofloxacin, 250 mg every
24 h via 1-h infusion; meropenem, 1 g every 8 h via 3-5 min bolus injection; piperacillin-tazobactam, 4.5 g every 6 h via 30-min infusion; imipenem, 500 mg every 6 h via 30-min infusion or 1 g every 8 h via 1-h infusion.

Safety Considerations

  • Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against
    C difficile may need to be discontinued

Explore the favorable Stability Profile of DORIBAX®.

Please see Indications and Important Safety Information below.

Reference



 

INDICATIONS

  • DORIBAX® (doripenem for injection) is indicated as a single agent in adults (≥18 years of age) for the treatment of:
    • Complicated intra-abdominal infections caused by susceptible strains of
      E coli, K pneumoniae, P aeruginosa, B caccae, B fragilis, B thetaiotaomicron, B uniformis, B vulgatus, S intermedius, S constellatus, or P micros
    • Complicated urinary tract infections, including pyelonephritis caused by susceptible strains of E coli, including cases with concurrent bacteremia, K pneumoniae, P mirabilis, P aeruginosa, or A baumannii
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX® and other antibacterial drugs, DORIBAX® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

 

IMPORTANT SAFETY INFORMATION

Contraindications

  • DORIBAX® (doripenem for injection) is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems, or in patients who have demonstrated anaphylactic reactions to beta lactams

Warnings and Precautions

  • Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens
  • If an allergic reaction to DORIBAX® occurs, discontinue the drug. Serious acute anaphylactic reactions require emergency treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated
  • Due to a drug interaction, patients with seizure disorders controlled with valproic acid or sodium valproate will be at an increased risk for breakthrough seizures when treated with DORIBAX® concomitantly. In some reports, increasing the dose of valproic acid or sodium valproate did not result in increased valproic acid serum concentrations. Alternative antibacterial therapies should be considered for patients receiving valproic acid or sodium valproate. If administration of DORIBAX® is necessary, supplemental anticonvulsant therapy should be considered
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued
  • When doripenem has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX® should not be administered by this route
  • Safety and effectiveness in pediatric patients have not been established

Adverse Reactions

  • The most common adverse reactions (≥5%) observed in clinical trials were headache, nausea, diarrhea, rash, and phlebitis

Please click here to see full Prescribing Information for DORIBAX®.