Ertapenem Injection

Ertapenem injection comes as a powder to be mixed with liquid to be injected intravenously (into a vein) or intramuscularly (into a muscle). It is infused (injected slowly) intravenously over a period of at least 30 minutes once or twice a day for up to 14 days. It is also may be given once or twice a day intramuscularly for up to 7 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to use ertapenem injection. After your condition improves, your doctor may switch you to another antibiotic that you can take by mouth to complete your treatment.

You may receive ertapenem injection in a hospital, or you may use the medication at home. If you will be using ertapenem injection at home, use it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or other healthcare provider to explain any part you do not understand. Use ertapenem injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be using ertapenem injection at home, your health care provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing ertapenem injection.

You should begin to feel better during the first few days of treatment with ertapenem injection. If your symptoms do not improve or if they get worse, call your doctor.

Use ertapenem injection until you finish the prescription, even if you feel better. If you stop using ertapenem injection too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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. W hen 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.

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].

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].

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.

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.

Dosage Forms And Strengths

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.

INVANZ is a lyophilized powder in an ADD-Vantage® vial containing 1.046 g ertapenem sodium equivalent to 1 g ertapenem for intravenous infusion.

INVANZ is supplied as a sterile lyophilized powder in single dose vials containing ertapenem for intravenous infusion or for intramuscular injection as follows:

No. 3843 - 1 g ertapenem equivalent

NDC 0006-3843-71 in trays of 10 vials.

INVANZ is supplied as a sterile lyophilized powder in single dose ADD-Vantage® vials containing ertapenem for intravenous infusion as follows:

No. 3845 - 1 g ertapenem equivalent

NDC 0006-3845-71 in trays of 10 ADD-Vantage® vials.

Storage And Handling

Do not store lyophilized powder above 25°C (77°F).

The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection [see DOSAGE AND ADMINISTRATION], may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.

REFERENCES

1Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976
2Refer to the prescribing information for lidocaine HCl.

Manuf for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. By: Laboratoires Merck Sharp & Dohme-Chibret. Revised: Sep 2014

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Your pharmacist can provide more information about ertapenem.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.03. Revision date: 5/14/2012.

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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.

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

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.

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

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.

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

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

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

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.

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.

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

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)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ertapenem, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ertapenem or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ertapenem in infants and children 3 months to 17 years of age. Use in infants younger than 3 months of age is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ertapenem in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution or adjustment of dosage in patients receiving ertapenem .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ertapenem, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ertapenem with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Valproic Acid

Using ertapenem with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Probenecid
• Tacrolimus

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of ertapenem. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or
• Diarrhea or
• Seizures, history of—Use with caution. May make these conditions worse .

• Kidney disease—The effects of ertapenem may be increased because of slower removal of the medicine from the body .

Before using ertapenem, tell your doctor or pharmacist if you are allergic to it; or to penicillins or cephalosporins; or if you have any other allergies. Before getting ertapenem by injection into a muscle, also tell your doctor or pharmacist if you are allergic to any amide-type local anesthetics (such as lidocaine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as seizures, head injury, tumor), kidney disease, stomach/intestinal diseases (such as colitis).

Ertapenem may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood count, kidney function tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised December 2016. Copyright(c) 2016 First Databank, Inc.