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Doribax (Doripenem) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of labeling:

  • Anaphylaxis and serious hypersensitivity reactions [see Warnings and Precautions ]
  • Seizures [see Warnings and Precautions ]
  • Interaction with sodium valproate [see Warnings and Precautions and Drug Interactions ]
  • Clostridium difficile-associated diarrhea [see Warnings and Precautions ]
  • Development of drug-resistant bacteria [see Warnings and Precautions ]
  • Pneumonitis with inhalational use [see Warnings and Precautions ]

Adverse Reactions from Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.

During clinical investigations, 1338 adult patients were treated with DORIBAX® (1076 patients received doripenem 500 mg administered over 1 hour every 8 hours and 262 patients received doripenem 500 mg administered over 4 hours every 8 hours); in some patients parenteral therapy was followed by a switch to an oral antimicrobial. [see Clinical Studies ]. The median age of patients treated with DORIBAX® was 54 years (range 18–90) in the comparative complicated urinary tract infections (cUTI) study, 46 years (range 18–94) in the pooled comparative complicated intra-abdominal infections (cIAI) studies, and 56 years (range 18-94) in the other Phase 3 trials. There was a female predominance (62%) in the comparative cUTI study and a male predominance (63% and 75%) in the comparative cIAI and other Phase 3 trials, respectively. The patients treated with DORIBAX® were predominantly Caucasian (79%) in the five comparator-controlled Phase 3 studies.

The most common adverse drug reactions (≥ 5%) observed in the five DORIBAX® comparator-controlled Phase 3 clinical trials were anemia, headache, nausea, diarrhea, rash, phlebitis, and elevated hepatic enzymes. During clinical trials, adverse events led to discontinuation of DORIBAX® in 4.1% (55 of 1338) of patients compared to 4.3% (58 of 1325) of comparator-treated patients.

Adverse reactions due to DORIBAX® 500 mg every 8 hours that occurred at a rate ≥ 1 % are listed in Table 4. Hypersensitivity reactions related to intravenous study drug occurred at a rate of less than 1%.

Table 4: Adverse Reactions with Incidence Rates (%) of ≥ 1% in the Controlled Phase 3 Clinical Trials
    Complicated Urinary Tract
Infections (one trial)
 Complicated Intra-Abdominal
Infections (two trials)
 Other Phase 3 Trials
(two trials)
 System organ class  DORIBAX®
500 mg administered every 8 hours
(n =376)
 Levofloxacin
250 mg administered IV every 24 hours
(n = 372)
 DORIBAX®
500 mg administered every 8 hours
(n = 477)
 Meropenem
1 g administered every 8 hours
(n = 469)
 DORIBAX®
500 mg administered every 8 hours
(n =485)
 Comparator 1
(n=484)
 Nervous system disorders            
 Headache  16  15  4  5  3  3
 Vascular disorders            
 Phlebitis  4  4  8  6  2  1
 Gastro-intestinal disorders            
 Nausea  4  6  12  9  7  7
 Diarrhea  6  10  11  11  12  14
 C. difficile colitis   <1  0  <1  0  1  2
 Blood and Lymphatic System Disorders                
 Anemia  2  1  10  5  5  6
 Skin and subcutaneous disorders            
 Pruritus  1  1  3  2  1  1
 Rash  1  1  4  2  6  5
 Investigations            
 Hepatic Enzyme elevation 2  2  4  2  4  7  6
 Infections and Infestations            
 Oral candidiasis  1  0  1  2  3  1
 Vulvomycotic infection  2  1  1  <1   0  <1

1 Comparators include piperacillin/tazobactam (4.5 g every 8 hours) and imipenem (500 mg every 6 hours or 1 g every 8 hours)
2 including preferred terms (alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased) and laboratory test values (ALT or AST ≤ ULN at baseline and >5 x ULN at End of Treatment (EOT))

In a Phase 1 study of healthy subjects receiving doripenem doses greater than the approved dose of 500 mg every 8 hours for 10 to 14 days, the incidence of rash was higher than that observed in subjects who received 500 mg every 8 hours. The rash resolved within 10 days after doripenem administration was discontinued.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doripenem. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
      Anaphylaxis
      Leukopenia
      Neutropenia
      Seizure
      Thrombocytopenia
      Toxic epidermal necrolysis, Stevens-Johnson Syndrome
      Interstitial pneumonia



REPORTS OF SUSPECTED DORIBAX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Doribax. The information is not vetted and should not be considered as verified clinical evidence.

Possible Doribax side effects / adverse reactions in 70 year old male

Reported by a physician from France on 2011-10-04

Patient: 70 year old male

Reactions: Bronchospasm, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Suspect drug(s):
Bumetanide
    Dosage: ;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-30
    End date: 2010-11-03

Eupressyl (Urapidil)
    Dosage: ;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-14
    End date: 2010-11-21

Claventin (Claventin /00973701/)
    Dosage: 10 gm; ;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-29
    End date: 2010-11-12

Doribax
    Dosage: 1 gm;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-11-15
    End date: 2010-11-26

Orgaran
    Dosage: ; sc
    Start date: 2010-10-25
    End date: 2011-01-26

Alprazolam
    Dosage: 0.25 mg; qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-11-15
    End date: 2010-12-06

Bactrim
    Dosage: 400 mg; ;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-29
    End date: 2010-11-06

Aldomet
    Dosage: ;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-11-15
    End date: 2011-01-10

Furosemide
    Dosage: ;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-14
    End date: 2011-01-17



Possible Doribax side effects / adverse reactions in 80 year old female

Reported by a consumer/non-health professional from Puerto Rico on 2011-10-21

Patient: 80 year old female

Reactions: Convulsion

Suspect drug(s):
Doribax

Other drugs received by patient: Zosyn; Vancomycin HCL; Ciprofloxacin



Possible Doribax side effects / adverse reactions in 48 year old female

Reported by a physician from Cyprus on 2011-10-27

Patient: 48 year old female weighing 73.0 kg (160.6 pounds)

Reactions: Blood Pressure Increased, Oxygen Saturation Decreased, Q Fever

Suspect drug(s):
Doribax
    Dosage: 4 hourly infusion
    Indication: Pneumonia
    Start date: 2011-05-25

Levofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-23



See index of all Doribax side effect reports >>

Drug label data at the top of this Page last updated: 2014-01-29

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