Invanz (ertapenem)

Invanz may cause serious side effects including:

• severe stomach pain,
• diarrhea that is watery or bloody,
• tremors,
• twitching,
• rigid (very stiff) muscles,
• seizures, and
• unusual changes in your mood or behavior

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Invanz include:

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

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Invanz. For more information, ask your doctor or pharmacist.

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

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.

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

Prophylactic Regimen In Adults

• Table 2 presents prophylaxis guidelines for Invanz.

Table 2 : Prophylaxis Guidelines for Adults

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 ≤10mL/min/1.73m²)should receive 500mg 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 isneeded.
• 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.

Probenecid

• Probenecid interferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem. 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.

• Available data from a small number of post-marketing cases with Invanz use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
•  Ertapenem is present in human milk. There are no data on the effects on the breastfed infant or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Invanz and any potential adverse effects on the breastfed infant from Invanz or from the underlying maternal condition.