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Invanz

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Invanz

Invanz

Invanz Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Invanz (ertapenem) is a carbapenem antibiotic used to treat moderate to severe infections (abdominal, skin, lung, or other organ systems) caused by bacteria susceptible to this drug. Invanz is also used in adults for the prevention of surgical site infections following elective colorectal surgery. Invanz is available as generic ertapenem in other countries. Common side effects of Invanz are fever, swelling, diarrhea, vaginal itching, and confusion or headache; if these symptoms persist or worsen, they can be considered serious side effects.

Each vial of Invanz contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem; the vials are single use and the drug is administered IV or IM after reconstitution with 10 ml of appropriate diluent. The dose of Invanz in patients 13 years of age and older is 1 gram (g) given once a day; in younger patients (3 months to 12 years of age) the dose is 15 mg/kg twice daily (not to exceed 1 g/day). Invanz may be administered by intravenous infusion for up to 14 days or by intramuscular injection for up to 7 days. Invanz should be infused over a period of 30 minutes when administered IV. Serious side effects of Invanz include anaphylactic reactions, seizures and Clostridium difficile associated diarrhea, bloody diarrhea, and behavioral changes. Use of Invanz with valproic acid is not advised as seizures may occur. Invanz has not been adequately studied in pregnant women; however, the Invanz is known to be excreted in breast milk. Risk versus benefit should be carefully considered if used in pregnant or women who are breastfeeding.

Our Invanz Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Invanz in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • tremors, twitching, or rigid (very stiff) muscles;
  • seizures (black-out or convulsions); or
  • diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild nausea or diarrhea, constipation;
  • vaginal itching or discharge;
  • headache; or
  • pain, redness, or mild swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Invanz (Ertapenem Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Invanz Overview - Patient Information: Side Effects

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause upset stomach, headache, nausea, vomiting, or diarrhea. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: seizures, unusual weakness.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, vaginal irritation/itching, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Invanz (Ertapenem Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Invanz FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following are described in greater detail in the W arnings and Precautions section.

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, -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.

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*‡ g daily
(n†=766)
Piperacillin/ Tazobactam‡ 3.375 g q6h
(n†=755)
INVANZ§1 g 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
* 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 entire FDA prescribing information for Invanz (Ertapenem Injection) »

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Invanz - User Reviews

Invanz User Reviews

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Here is a collection of user reviews for the medication Invanz sorted by most helpful. Patient Discussions FAQs

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