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Invanz

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Invanz

Side Effects
Interactions

SIDE EFFECTS

The following are described in greater detail in the WARNINGS AND PRECAUTIONS section.

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizure Potential [see WARNINGS AND PRECAUTIONS]
  • Interaction with Valproic Acid [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea (CDAD) [see WARNINGS AND PRECAUTIONS]
  • Caution with Intramuscular Administration [see WARNINGS AND PRECAUTIONS]
  • Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
  • Laboratory Tests [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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

Adults Receiving INVANZ as a Treatment Regimen

Clinical trials enrolled 1954 patients treated with INVANZ; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies]. Most adverse experiences reported in these clinical trials were described as mild to moderate in severity. INVANZ was discontinued due to adverse experiences in 4.7% of patients. Table 3 shows the incidence of adverse experiences reported in ≥ 2.0% of patients in these trials. The most common drug-related adverse experiences in patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).

Table 3 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With INVANZ in Clinical Trials

Adverse Events INVANZ* 1 g daily
(N=802)
Piperacillin/ Tazobactam* 3.375 g q6h
(N=774)
INVANZ†1 g daily
(N=1152)
Ceftriaxone†1 or 2 g daily
(N=942)
Local:
  Infused vein complication 7.1 7.9 5.4 6.7
Systemic:
  Death 2.5 1.6 1.3 1.6
  Edema/swelling 3.4 2.5 2.9 3.3
  Fever 5.0 6.6 2.3 3.4
  Abdominal pain 3.6 4.8 4.3 3.9
  Hypotension 2.0 1.4 1.0 1.2
  Constipation 4.0 5.4 3.3 3.1
  Diarrhea 10.3 12.1 9.2 9.8
  Nausea 8.5 8.7 6.4 7.4
  Vomiting 3.7 5.3 4.0 4.0
  Altered mental status‡ 5.1 3.4 3.3 2.5
  Dizziness 2.1 3.0 1.5 2.1
  Headache 5.6 5.4 6.8 6.9
  Insomnia 3.2 5.2 3.0 4.1
  Dyspnea 2.6 1.8 1.0 2.4
  Pruritus 2.0 2.6 1.0 1.9
  Rash 2.5 3.1 2.3 1.5
  Vaginitis 1.4 1.0 3.3 3.7
* Includes Phase IIb/III Complicated intra-abdominal infections, Complicated skin and skin structure infections and Acute pelvic infections trials
† Includes Phase IIb/III Community acquired pneumonia and Complicated urinary tract infections, and Phase IIa trials
‡ Includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor

In patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving INVANZ and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.

In clinical trials, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with INVANZ, 0.3% of patients treated with piperacillin/tazobactam and 0% of patients treated with ceftriaxone [see WARNINGS AND PRECAUTIONS].

Additional adverse experiences that were reported with INVANZ with an incidence > 0.1% within each body system are listed below

Body as a Whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, asthenia/fatigue, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis, flank pain, syncope

Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage

Digestive System: acid regurgitation, oral candidiasis, dyspepsia, gastrointestinal hemorrhage, anorexia, flatulence, C. difficile-associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis

Musculoskeletal System: leg pain

Nervous System & Psychiatric: anxiety, nervousness, seizure [see WARNINGS AND PRECAUTIONS], tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo

Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance

Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria

Special Senses: taste perversion

Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.

In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with INVANZ, the adverse experience profile was generally similar to that seen in previous clinical trials.

Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery

In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of INVANZ 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for INVANZ in previous clinical trials. Table 4 shows the incidence of adverse experiences other than those previously described above for INVANZ that were reported regardless of causality in ≥ 2.0% of patients in this trial.

Table 4 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With INVANZ for Prophylaxis of Surgical Site Infections Following Elective Colorectal Surgery

Adverse Events INVANZ 1 g
(N = 476)
Cefotetan 2 g
(N = 476)
Anemia 5.7 6.9
Small intestinal obstruction 2.1 1.9
Pneumonia 2.1 4.0
Postoperative infection 2.3 4.0
Urinary tract infection 3.8 5.5
Wound infection 6.5 12.4
Wound complication 2.9 2.3
Atelectasis 3.4 1.9

Additional adverse experiences that were reported in this prophylaxis trial with INVANZ, regardless of causality, with an incidence > 0.5% within each body system are listed below:

Gastrointestinal Disorders: C. difficile infection or colitis, dry mouth, hematochezia

General Disorders and Administration Site Condition: crepitations

Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess

Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion

Musculoskeletal and Connective Tissue Disorders: muscle spasms

Nervous System Disorders: cerebrovascular accident

Renal and Urinary Disorders: dysuria, pollakiuria

Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.

Pediatric Patients Receiving INVANZ as a Treatment Regimen

Clinical trials enrolled 384 patients treated with INVANZ; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 shows the incidence of adverse experiences reported in ≥ 2.0% of pediatric patients in clinical trials. The most common drug-related adverse experiences in pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%).

Table 5 : Incidence (%) of Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Pediatric Patients Treated With INVANZ in Clinical Trials

Adverse Events INVANZ*†
(N-384)
Ceftriaxone*
(N-100)
Ticarcillin/ Clavulanate†
(N-24)
Local:
  Infusion Site Erythema 3.9 3.0 8.3
  Infusion Site Pain 7.0 4.0 20.8
Systemic:
  Abdominal Pain 4.7 3.0 4.2
  Constipation 2.3 0.0 0.0
  Diarrhea 11.7 17.0 4.2
  Loose Stools 2.1 0.0 0.0
  Vomiting 10.2 11.0 8.3
  Pyrexia 4.9 6.0 8.3
  Upper Respiratory Tract Infection 2.3 3.0 0.0
  Headache 4.4 4.0 0.0
  Cough 4.4 3.0 0.0
  Diaper Dermatitis 4.7 4.0 0.0
  Rash 2.9 2.0 8.3
* Includes Phase IIb Complicated skin and skin structure infections, Community acquired pneumonia and Complicated urinary tract infections trials in which patients 3 months to 12 years of age received INVANZ 15 mg/kg IV twice daily up to a maximum of 1 g or ceftriaxone 50 mg/kg/day IV in two divided doses up to a maximum of 2 g, and patients 13 to 17 years of age received INVANZ 1 g IV daily or ceftriaxone 50 mg/kg/day IV in a single daily dose.
† Includes Phase IIb Acute pelvic infections and Complicated intra-abdominal infections trials in which patients 3 months to 12 years of age received INVANZ 15 mg/kg IV twice daily up to a maximum of 1 g and patients 13 to 17 years of age received INVANZ 1 g IV daily or ticarcillin/clavulanate 50 mg/kg for patients < 60 kg or ticarcillin/clavulanate 3.0 g for patients > 60 kg, 4 or 6 times a day.

Additional adverse experiences that were reported with INVANZ with an incidence > 0.5% within each body system are listed below:

Gastrointestinal Disorders: nausea

General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth

Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess

Metabolism and Nutrition Disorders: decreased appetite

Musculoskeletal and Connective Tissue Disorders: arthralgia

Nervous System Disorders: dizziness, somnolence

Psychiatric Disorders: insomnia

Reproductive System and Breast Disorders: genital rash

Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea

Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion

Vascular Disorders: phlebitis.

Post-Marketing Experience

The following additional adverse reactions have been identified during the post-approval use of INVANZ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: teeth staining

Immune System Disorders: anaphylaxis including anaphylactoid reactions

Musculoskeletal and Connective Tissue Disorders: muscular weakness

Nervous System Disorders: coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor

Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations

Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)

Adverse Laboratory Changes In Clinical Trials

Adults Receiving INVANZ as Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥ 2.0% of adult patients treated with INVANZ in clinical trials are presented in Table 6. Drug-related laboratory adverse experiences that were reported during therapy in ≥ 2.0% of adult patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, in clinical trials were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), and platelet count increased (2.8%). INVANZ was discontinued due to laboratory adverse experiences in 0.3% of patients.

Table 6 : Incidence* (%) of Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Adult Patients Treated With INVANZ in Clinical Trials

Adverse laboratory experiences INVANZ†1 g daily
(n†=766)
Piperacillin/ Tazobactam‡ 3.375 g q6h
(n†=755)
INVANZ§ 1g daily
(n†=1122)
Ceftriaxone§ 1 or 2 g daily
(n†=920)
ALT increased 8.8 7.3 8.3 6.9
AST increased 8.4 8.3 7.1 6.5
Serum alkaline phosphatase increased 6.6 7.2 4.3 2.8
Eosinophils increased 1.1 1.1 2.1 1.8
Hematocrit decreased 3.0 2.9 3.4 2.4
Hemoglobin decreased 4.9 4.7 4.5 3.5
Platelet count increased 6.5 6.3 4.3 3.5
Urine RBCs increased 2.5 2.9 1.1 1.0
Urine WBCs increased 2.5 3.2 1.6 1.1
* Number of patients with laboratory adverse experiences/Number of patients with the laboratory test
† Number of patients with one or more laboratory tests
‡ Includes Phase IIb/III Complicated intra-abdominal infections, Complicated skin and skin structure infections and Acute pelvic infections trials
§ Includes Phase IIb/III Community acquired pneumonia and Complicated urinary tract infections, and Phase IIa trials

Additional laboratory adverse experiences that were reported during therapy in > 0.1% of patients treated with INVANZ in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, W BC, platelet count, and segmented neutrophils.

In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with INVANZ, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.

Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery

In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of INVANZ 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall laboratory adverse experience profile was generally comparable to that observed for INVANZ in previous clinical trials.

Pediatric Patients Receiving INVANZ as a Treatment Regimen

Laboratory adverse experiences that were reported during therapy in ≥ 2.0% of pediatric patients treated with INVANZ in clinical trials are presented in Table 7. Drug-related laboratory adverse experiences that were reported during therapy in ≥ 2.0% of pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, in clinical trials were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%).

Table 7 : Incidence* (%) of Specific Laboratory Adverse Experiences Reported During Study Therapy Plus 14-Day Follow-Up in ≥ 2.0% of Pediatric Patients Treated With INVANZ in Clinical Trials

Adverse laboratory experiences INVANZ
(n†=379)
Ceftriaxone
(n†=97)
Ticarcillin/ Clavulanate
(n*=24)
ALT Increased 3.8 1.1 4.3
AST Increased 3.8 1.1 4.3
Neutrophil Count Decreased 5.8 3.1 0.0
* Number of patients with laboratory adverse experiences/Number of patients with the laboratory test; where at least 300 patients had the test
† Number of patients with one or more laboratory tests

Additional laboratory adverse experiences that were reported during therapy in > 0.5% of patients treated with INVANZ in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.

Read the Invanz (ertapenem injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Probenecid

Probenecid interferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem [see CLINICAL PHARMACOLOGY]. Co-administration of probenecid with ertapenem is not recommended.

Valproic Acid

Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid [see WARNINGS AND PRECAUTIONS].

Read the Invanz Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/16/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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