Invanz

Invanz Manufacturers

• Merck Sharp & Dohme Corp.
  

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  Invanz | Merck Sharp & Dohme Corp.

  

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  2.1 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.

  2.2 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 * defined as creatinine clearance >90 mL/min/1.73 m 2 † due to the designated pathogens [see Indications and Usage (1)] ‡ not to exceed 1 g/day § INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14.1)]. ¶ adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral switch therapy) # duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. 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 2.3 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 2.4 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.

  2.5 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 formula1 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)

  1

  Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976

  2.6 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)].

  2.7 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 injection2 (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®3 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.

  2

  Refer to the prescribing information for lidocaine HCl.

  3

  Registered trademark of Hospira Laboratories, Inc.

  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.

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