To reduce the development of drug-resistant bacteria and maintain the effectiveness of Invanz® and other antibacterial drugs, Invanz should be used only to treat or prevent 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 or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Treatment
Invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].
Complicated Intra-Abdominal Infections
Invanz is indicated for the treatment of complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.
Complicated Skin and Skin Structure Infections, Including Diabetic Foot Infections without Osteomyelitis
Invanz is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. Invanz has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14)].
Community Acquired Pneumonia
Invanz is indicated for the treatment of community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis.
Complicated Urinary Tract Infections Including Pyelonephritis
Invanz is indicated for the treatment of complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.
Acute Pelvic Infections Including Postpartum Endomyometritis, Septic Abortion and Post Surgical Gynecologic Infections
Invanz is indicated for the treatment of acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.
Prevention
Invanz is indicated in adults for:
Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
Invanz is indicated for the prevention of surgical site infection following elective colorectal surgery.
Invanz Dosage and Administration
Instructions for Use in All Patients
For Intravenous or Intramuscular Use
DO NOT MIX OR CO-INFUSE Invanz WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
Invanz may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, Invanz should be infused over a period of 30 minutes. Intramuscular administration of Invanz may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.
Treatment Regimen
13 years of age and older
The dose of Invanz in patients 13 years of age and older is 1 gram (g) given once a day [see Clinical Pharmacology (12.3)].
3 months to 12 years of age
The dose of Invanz in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).
Table 1 presents treatment guidelines for Invanz.
Table 1: Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function and Body Weight
| Infection |
Daily Dose
(IV or IM)
Adults and Pediatric Patients 13 years of age and older |
Daily Dose
(IV or IM)
Pediatric Patients 3 months to 12 years of age |
Recommended Duration of Total Antimicrobial Treatment |
|
| Complicated intra-abdominal infections |
1 g |
15 mg/kg
twice daily |
5 to 14 days |
Complicated skin and skin structure infections, including diabetic foot infections |
1 g |
15 mg/kg
twice daily‡ |
7 to 14 days |
Community acquired pneumonia |
1 g |
15 mg/kg
twice daily‡ |
10 to 14 days |
Complicated urinary tract infections, including pyelonephritis |
1 g |
15 mg/kg
twice daily‡ |
10 to 14 days# |
Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections |
1 g |
15 mg/kg
twice daily‡ |
3 to 10 days |
Prophylactic Regimen in Adults
Table 2 presents prophylaxis guidelines for Invanz.
Table 2: Prophylaxis Guidelines for Adults
| Indication |
Daily Dose
(IV)
Adults |
Recommended Duration of Total Antimicrobial Treatment |
| Prophylaxis of surgical site infection following elective colorectal surgery |
1 g |
Single intravenous dose given 1 hour prior to surgical incision |
Patients with Renal Impairment
Invanz may be used for the treatment of infections in adult patients with renal impairment. In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary. Adult patients with severe renal impairment (creatinine clearance ≤30 mL/min/1.73 m2) and end-stage renal disease (creatinine clearance ≤10 mL/min/1.73 m2) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.
Patients on Hemodialysis
When adult patients on hemodialysis are given the recommended daily dose of 500 mg of Invanz within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If Invanz is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.
When only the serum creatinine is available, the following formula may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males: (weight in kg) x (140-age in years)
(72) x serum creatinine (mg/100 mL)
Females: (0.85) x (value calculated for males)
Patients with Hepatic Impairment
No dose adjustment recommendations can be made in patients with hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Preparation and Reconstitution for Administration
Vials
Adults and pediatric patients 13 years of age and older
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE Invanz WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
Invanz MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of Invanz with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection.
- Shake well to dissolve and immediately transfer contents of the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection.
- Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
Invanz MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of Invanz with 3.2 mL of 1.0% lidocaine HCl injection (without epinephrine). Shake vial thoroughly to form solution.
- Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
- The reconstituted IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.
Pediatric patients 3 months to 12 years of age
Preparation for intravenous administration:
DO NOT MIX OR CO-INFUSE Invanz WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
Invanz MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of Invanz with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection.
- Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and dilute in 0.9% Sodium Chloride Injection to a final concentration of 20 mg/mL or less.
- Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
Invanz MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
- Reconstitute the contents of a 1 g vial of Invanz with 3.2 mL of 1.0% lidocaine HCl injection2 (without epinephrine). Shake vial thoroughly to form solution.
- Immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
- The reconstituted IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.
ADD-Vantage® Vials
Invanz in ADD-Vantage® vials should be reconstituted with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection.
INSTRUCTIONS FOR USE OF
Invanz®
(Ertapenem for Injection)
IN ADD-Vantage VIALS
For I.V. Use Only.
To Open Diluent Container:
Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening. (SEE FIGURE 1.) Pull the ring approximately half way around the cap and then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: DO NOT ACCESS VIAL WITH SYRINGE.
To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)
Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.)
Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
Label appropriately.
To Prepare Admixture:
Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)
Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
Mix container contents thoroughly and use within the specified time.
Preparation for Administration:
(Use Aseptic Technique)
Confirm the activation and admixture of vial contents.
Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
Storage
Invanz (Ertapenem for Injection) 1 g single dose ADD-Vantage® vials should be prepared with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Invanz (Ertapenem for Injection) maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Invanz should not be frozen.
Before administering, see accompanying package circular for Invanz (Ertapenem for Injection).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Solutions of Invanz range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.
Dosage Forms and Strengths
Vials
Invanz is a sterile lyophilized powder in a vial containing 1.046 g ertapenem sodium equivalent to 1 g ertapenem for intravenous infusion or for intramuscular injection.
ADD-Vantage® Vials
Invanz is a lyophilized powder in an ADD-Vantage® vial containing 1.046 g ertapenem sodium equivalent to 1 g ertapenem for intravenous infusion.
Contraindications
- Invanz is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.
- Due to the use of lidocaine HCl as a diluent, Invanz administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.
Warnings and Precautions
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam. Before initiating therapy with Invanz, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to Invanz occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.
Seizure Potential
Seizures and other central nervous system (CNS) adverse experiences have been reported during treatment with Invanz [see Adverse Reactions (6.1)]. During clinical investigations in adult patients treated with Invanz (1 g once a day), seizures, irrespective of drug relationship, occurred in 0.5% of patients during study therapy plus 14-day follow-up period [see Adverse Reactions (6.1)]. These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal function. Close adherence to the recommended dosage regimen is urged, especially in patients with known factors that predispose to convulsive activity. Anticonvulsant therapy should be continued in patients with known seizure disorders. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anticonvulsant therapy if not already instituted, and the dosage of Invanz re-examined to determine whether it should be decreased or discontinued.
Interaction with 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 in 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. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of Invanz is necessary, supplemental anti-convulsant therapy should be considered [see Drug Interactions (7.2)].
Clostridium difficile-Associated Diarrhea (CDAD)
CDAD has been reported with use of nearly all antibacterial agents, including ertapenem, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile.
Clostridium difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of Clostridium difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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 two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against Clostridium difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of Clostridium difficile, and surgical evaluation should be instituted as clinically indicated.
Caution with Intramuscular Administration
Caution should be taken when administering Invanz intramuscularly to avoid inadvertent injection into a blood vessel [see Dosage and Administration (2.7)].
Development of Drug-Resistant Bacteria
As with other antibiotics, prolonged use of Invanz may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Prescribing Invanz in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Laboratory Tests
While Invanz possesses toxicity similar to the beta-lactam group of antibiotics, periodic assessment of organ system function, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
Adverse Reactions
The following are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
- Seizure Potential [see Warnings and Precautions (5.2)]
- Interaction with Valproic Acid [see Warnings and Precautions (5.3)]
- Clostridium difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4)]
- Caution with Intramuscular Administration [see Warnings and Precautions (5.5)]
- Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6)]
- Laboratory Tests [see Warnings and Precautions (5.7)]
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 (14)]. 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
|
Invanz
1 g daily |
Piperacillin/ Tazobactam*
3.375 g q6h |
Invanz
1 g daily |
Ceftriaxone†
1 or 2 g daily |
| Adverse Events |
(N=802) |
(N=774) |
(N=1152) |
(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 |
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 (5.2)].
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 (5.2)], 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 (14)]. 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
|
Invanz, |
Ceftriaxone* |
Ticarcillin/ Clavulanate† |
| Adverse Events |
(N=384) |
(N=100) |
(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 |
|
