Invanz

Contraindications

Hypersensitivity to ertapenem, beta-lactams, or other drugs in this class

IM administration: Hypersensitivity to amide local anesthetics (eg, lidocaine)

Cautions

Use with caution in CNS disorders (eg., history of seizures); adjust dose in renal impairment to avoid risk of seizures; carbapenem use has been associated with seizures

Do not coinfuse with other medications or use dextrose diluent

Prolonged use increases risk of superinfections

Use caution in renal impairment; adjust dose in moderate to severe renal dysfunction

Carbapenem use may decrease serum levels of divalproex sodium or valproic acid

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• nausea
• diarrhea
• dizziness

Ertapenem is an antibiotic that fights bacteria.

Ertapenem is used to treat severe infections of the skin, lungs, stomach, pelvis, and urinary tract. It is also used to prevent infection in people having certain types of surgery.

Ertapenem may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to certain antibiotics. You should not inject ertapenem into a muscle if you are allergic to a numbing medicine such as lidocaine or Novocain.

You should not use this medicine if you are allergic to ertapenem or to certain antibiotics, especially:

• meropenem (Merrem);
• imipenem (Primaxin);
• a cephalosporin such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others; or
• an antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

You should not inject ertapenem into a muscle if you are allergic to a numbing medicine such as lidocaine or Novocain.

To make sure ertapenem is safe for you, tell your doctor if you have:

• kidney disease;
• epilepsy or other seizure disorder; or
• a history of head injury or brain tumor.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ertapenem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 3 months old.

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• tremors, twitching, or rigid (very stiff) muscles;
• a seizure (convulsions); or
• unusual changes in your mood or behavior.

Common side effects include:

• nausea, vomiting;
• diarrhea;
• headache; or
• pain, redness, or mild swelling where the injection was given.

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.

Invanz is a prescription medication used to treat serious bacterial infections of the abdomen, skin, urinary tract, kidney, pelvis, and pneumonia. Invanz treats diabetic foot infections and certain gynecological infections. It is also used to prevent infection following colorectal surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ertapenem is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

Ertapenem is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Shake the mixture well just before you measure a dose.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ertapenem will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Your doctor will need to check your progress while you are using ertapenem.

Store ertapenem powder at room temperature away from moisture and heat.

You may store the mixture for up to 6 hours at room temperature, or up to 24 hours in a refrigerator. Use the mixed medicine within 4 hours after removing it from a refrigerator. Do not freeze.

Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion or IM injection.1

Administered once daily in adolescents ≥13 years of age and adults.c Administered twice daily in children 3 months to 12 years of age.c

IM route may be used as an alternative to the IV route in treatment of those infections for which IM therapy is appropriate.1 Duration of IM therapy should be ≤7 days.1 Solutions reconstituted for IM administration should not be given IV.1

IV Infusion

Reconstitute 1-g vial with 10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection.1 Shake well to ensure complete dissolution of the drug.1 The appropriate dose should be withdrawn from the vial and diluted in 0.9% sodium chloride to provide a solution containing ≤20 mg/mL.c For a 1-g dose, dilute in 50 mL of 0.9% sodium chloride.1

Administer by IV infusion over 30 minutes.1

IM Administration

Inject IM deeply into a large muscle mass, such as the gluteus or lateral part of the thigh.1 Use caution to avoid inadvertent injection into a blood vessel.1

Reconstitute 1-g vial with 3.2 mL of 1% lidocaine injection (without epinephrine) and shake thoroughly to ensure dissolution.1 Administer within 1 hour of reconstitution.c

Dosage

Available as ertapenem sodium; dosage expressed in terms of ertapenem.1

Duration of therapy depends on the type and severity of infection.1 IV route may be continued for ≤14 days; IM route may be continued for ≤7 days.1

Pediatric Patients

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 3–10 days.c

Adolescents ≥13 years of age: 1 g once daily for 3–10 days.c

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 5–14 days.c

Adolescents ≥13 years of age: 1 g once daily for 5–14 days.c

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.c

Adolescents ≥13 years of age: 1 g once daily.c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.c

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 7–14 days.c

Adolescents ≥13 years of age: 1 g once daily for 7–14 days.c

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.c

Adolescents ≥13 years of age: 1 g once daily.c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.c

Adults

1 g once daily for 3–10 days.1

1 g once daily for 5–14 days.1

1 g once daily.1 Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.1

1 g once daily for 7–14 days.1 In adults with diabetic foot infections, anti-infective therapy (parenteral or parenteral followed by oral) has been given for up to 28 days.c

1 g once daily.1 Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.1

Special Populations

Hepatic Impairment

Dosage recommendations not available; pharmacokinetics have not been studied.1

Renal Impairment

Dosage adjustments recommended in patients with Clcr ≤30 mL/minute.1

Adults with Clcr ≤30 mL/minute, including those with end-stage renal disease (Clcr ≤10 mL/minute) and those undergoing hemodialysis, should receive 500 mg once daily.1 If the dose is given within 6 hours prior to hemodialysis, a supplementary dose of 150 mg should be given after the hemodialysis session; supplemental dose not necessary if daily dose is given ≥6 hours prior to hemodialysis.1 Data not available in pediatric patients undergoing dialysis.c

Geriatric Patients

No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Absorption

Bioavailability

Following IM injection, mean bioavailability is approximately 90%;1 peak plasma concentrations attained in approximately 2.3 hours.1

Exhibits nonlinear pharmacokinetics because of concentration-dependent plasma protein binding.1

Distribution

Extent

Distributed into blister fluid.1

Therapeutic concentrations not achieved in CNS.c

Crosses the placenta in rats; not known whether crosses the placenta in humans.1 Distributed into milk.1

Plasma Protein Binding

Highly bound to plasma protein, principally albumin.1 95% bound at plasma concentration <100 mcg/mL and 85% bound at 300 mcg/mL.1

Elimination

Metabolism

Does not appear to undergo hepatic metabolism.1 The major metabolite is an inactive ring-opened derivative formed by hydrolysis of the β-lactam ring.1

Elimination Route

Eliminated principally in urine.1

Approximately 80% of an IV dose eliminated in urine (38% as unchanged drug and 37% as the ring-opened metabolite) and 10% eliminated in feces.1

Half-life

Healthy young adults: 4 hours.1

Pediatric patients 13–17 years of age: 4 hours.c

Pediatric patients 3 months to 12 years of age: 2.5 hours.c

Special Populations

Pharmacokinetics in patients with hepatic impairment not established.1

In patients with severe renal impairment (Clcr 5–30 mL/minute per 1.73 m2) or end-stage renal disease, the extent of exposure to unbound drug is increased 4.4- or 7.6-fold, respectively.1

Storage

Parenteral

≤25°C.1

Reconstituted and diluted IV solutions may be stored at room temperature, but the infusion should be completed within 6 hours.1 These solutions may be refrigerated at 5°C for up to 24 hours, but the infusion should be completed within 4 hours after removal from refrigeration.1 Do not freeze.1

IM solutions should be used within 1 hour of reconstitution.c

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Reconstitute with sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection, then dilute in 0.9% sodium chloride.1

Do not reconstitute or dilute with dextrose-containing solutions or admix with other medications.1

Parenteral

Incompatible by conventional standards, but recommended for dilution with use in shorter time periods. (See Storage under Stability.)

• Importance of informing clinicians of other medical conditions, including history of seizures.1

• Importance of discontinuing therapy and informing clinician if an allergic or hypersensitivity reaction occurs.1

• Importance of reporting persistent or worsening symptoms of infection.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)

Ertapenem is used alone or in combination with other antibiotics to treat infections caused by bacteria in many different parts of the body. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. Ertapenem is also used to prevent infections after having surgery of the colon and rectum .

This medicine is available only with your doctor's prescription.

Use INVanz as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Headache.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

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.

Probenecid

Probenecid interferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem [see Clinical Pharmacology (12.3)]. 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 (5.3)].

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 9th Edition; CLSI Document M7-A9. CLSI, Wayne, PA, 2012.
2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests. 11th Edition; CLSI Document M2-A11. CLSI, Wayne, PA, 2012.
3. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – 7th Edition; CLSI Document M11-A7. CLSI, Wayne, PA, 2007.
4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 22nd Informational Supplement. CLSI Document M100-S22. CLSI, Wayne, PA, 2012.
5. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS). Performance Standards for Antimicrobial Susceptibility of Anaerobic Bacteria; Informational Supplement. CLSI Document M11-S1. CLSI, Wayne, PA, 2010.

Applies to ertapenem: injectable powder for injection

General

In general, the most common side effects associated with ertapenem (the active ingredient contained in Invanz) have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).[Ref]

Gastrointestinal

Small intestinal obstruction, C difficile infection or colitis, dry mouth, and hematochezia were reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Very common (10% or more): Diarrhea (up to 10.3%)
Common (1% to 10%): Nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), small intestinal obstruction (2.1%)
Uncommon (0.1% to 1%): Greater than 0.5%: Clostridium difficile infection or colitis, dry mouth, hematochezia; Greater than 0.1%: Gastrointestinal hemorrhage, acid regurgitation, dyspepsia, oral candidiasis, anorexia, flatulence, C difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, taste perversion[Ref]

Hepatic

Common (1% to 10%): Increased ALT (up to 8.8%), increased AST (up to 8.4%), increased serum alkaline phosphatase (up to 6.6%)
Uncommon (0.1% to 1%): Increased direct and indirect serum bilirubin (greater than 0.1%)[Ref]

Local

Common (1% to 10%): Infused vein complication (up to 7.1%)
Uncommon (0.1% to 1%): Greater than 0.1%: Injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis
Frequency not reported: Tenderness, ecchymosis[Ref]

Nervous system

Common (1% to 10%): Headache (up to 6.8%), altered mental status (includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor; up to 5.1%), insomnia (3.2%), dizziness (up to 2.1%)
Uncommon (0.1% to 1%): Cerebrovascular accident (greater than 0.5%); Greater than 0.1%: Syncope, seizure, tremor, hypesthesia, spasm, paresthesia, vertigo
Postmarketing reports: Coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor[Ref]

Cerebrovascular accident was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

In clinical trials, seizures were reported in 0.5% of patients, most often in patients with CNS disorders (e.g., brain lesions or seizure history) and/or renal dysfunction. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem.[Ref]

Hematologic

Common (1% to 10%): Increased platelet count (up to 6.5%), anemia (5.7%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%)
Uncommon (0.1% to 1%): Greater than 0.1%: Decreased segmented neutrophils, increased prothrombin time, increased PTT, decreased platelet count, decreased WBC
Frequency not reported: Increased monocytes, increased white blood cell count[Ref]

Anemia was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Other

Postoperative infection, wound infection, anastomotic leak, seroma, wound complication, wound dehiscence, wound secretion, crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication were reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

In patients with complicated intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem and 2.6% of patients receiving comparator drug; however, these deaths were considered not drug-related.[Ref]

Common (1% to 10%): Wound infection (6.5%), fever (up to 5%), edema/swelling (up to 3.4%), wound complication (2.9%), death (up to 2.5%), postoperative infection (2.3%)
Uncommon (0.1% to 1%): Greater than 0.5%: Crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion; Greater than 0.1%: Abdominal distention, pain, chills, septicemia, septic shock, malaise, asthenia/fatigue, necrosis, candidiasis, facial edema, flank pain, flushing[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (3.8%), vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), increased urine WBCs (up to 2.5%)
Uncommon (0.1% to 1%): Greater than 0.5%: Dysuria, pollakiuria; Greater than 0.1%: Oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis
Frequency not reported: Presence of urine protein, increased urine epithelial cells[Ref]

Urinary tract infection, dysuria, and pollakiuria were reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Respiratory

Common (1% to 10%): Atelectasis (3.4%), dyspnea (up to 2.6%), pneumonia (2.1%)
Uncommon (0.1% to 1%): Greater than 0.5%: Lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing; Greater than 0.1%: Cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance[Ref]

Pneumonia, atelectasis, lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing were reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Dermatologic

Common (1% to 10%): Rash (up to 2.5%), pruritus (up to 2%)
Uncommon (0.1% to 1%): Cellulitis (greater than 0.5%); Greater than 0.1%: Erythema, sweating, dermatitis, desquamation, urticaria
Postmarketing reports: Drug rash with eosinophilia and systemic symptoms (DRESS syndrome)[Ref]

Cellulitis was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Cardiovascular

Common (1% to 10%): Hypotension (up to 2%)
Uncommon (0.1% to 1%): Greater than 0.1%: Heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage[Ref]

Musculoskeletal

Muscle spasms were reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.[Ref]

Uncommon (0.1% to 1%): Muscle spasms (greater than 0.5%), gout (greater than 0.1%), leg pain (greater than 0.1%)
Postmarketing reports: Muscular weakness[Ref]

Renal

Uncommon (0.1% to 1%): Greater than 0.1%: Renal impairment, increased serum creatinine, increased BUN[Ref]

Metabolic

Uncommon (0.1% to 1%): Greater than 0.1%: Dehydration, weight loss, decreased serum potassium, decreased serum albumin, increased serum glucose, increased serum potassium, increased serum sodium
Frequency not reported: Decreased serum bicarbonate[Ref]

Psychiatric

Uncommon (0.1% to 1%): Greater than 0.1%: Anxiety, nervousness, depression, aggressive behavior
Postmarketing reports: Altered mental status (including aggression, delirium), hallucinations

Hypersensitivity

Postmarketing reports: Anaphylaxis (including anaphylactoid reactions)[Ref]

Some side effects of Invanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.