2.1 Recommended Dosage in Adult Patients

The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.

The recommended dosage and administration by infection is described in Table 1.

2.2 Recommended Dosage in Pediatric Patients

The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress.

Pediatric Patients 2 Months of Age and Older

• For pediatric patients 2 months of age and older, Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes.
  
• Teflaro dosing regimen is dependent on the type of infection (ABSSSI, CABP). See dosing Table 2 below.

Pediatric Patients Less Than 2 Months of Age

• Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.
  
• Teflaro dosing regimen is only recommended for patients with ABSSSI. See dosing Table 3 below.
  
• Concentrations of Teflaro in the cerebrospinal fluid have not been evaluated [see Use in Specific Populations (8.4)].
  
• There is no information for dosing Teflaro in infants less than 34 weeks gestational age and less than 12 days postnatal age.

*Gestational age 34 weeks and older and postnatal age 12 days and older.

2.3 Dosage Adjustments in Patients with Renal Impairment

Adults: No dosage adjustment is required in adult patients with CrCL > 50 mL/min. The dose in adult patients should be adjusted when creatinine clearance (CrCL) is < 50 mL/min as shown below (see Table 4).

a Creatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.

b End-stage renal disease is defined as CrCl < 15 mL/min.

c Teflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.

Pediatrics: No dosage adjustment is required in pediatric patients with CrCL > 50 mL/min/1.73 m2, estimated using the Schwartz equation. There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m2.

2.4 Preparation of Teflaro for Administration

Constitution of Teflaro Powder for Injection

Aseptic technique must be followed in preparing the infusion solution. The contents of Teflaro vial should be constituted with 20 mL Sterile Water for Injection, USP; or 0.9% of sodium chloride injection; or 5% of dextrose injection; or lactated ringer’s injection. Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. The preparation of Teflaro solutions is summarized in Table 5.

* The recommended dosage of Teflaro is based on the age and weight of the child. See Table 2

Dilution of the Constituted Solution of Teflaro

The constituted solution must be further diluted in a range between 50 mL to 250 mL before intravenous infusion into patients. Use the same diluent used for constitution of the powder for this further dilution, unless sterile water for injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP; or Lactated Ringer’s Injection, USP.

Dilution of the Constituted Solution of Teflaro in the 50 mL Infusion Bags Only

Preparation of 600 mg of Teflaro dose in 50 mL infusion bag (for adult patients): Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 12 mg/mL.

Preparation of 400 mg of Teflaro dose in 50 mL infusion bag (for adult patients or pediatric patients weighing > 33 kg): Withdraw 20 mL of diluent from the infusion bag. Proceed to inject entire content of the Teflaro vial into the bag to provide a total volume of 50 mL. The resultant concentration is approximately 8 mg/mL.

Preparation of Teflaro dose in the infusion bag (for pediatric patients weighing ≤ 33 kg): The amount of solution withdrawn from the constituted Teflaro vial for pediatric patients weighing < 33 kg for dilution in the infusion bag will vary according to the weight and age of the child. The infusion solution concentration for administration should not exceed 12 mg/ml ceftaroline fosamil. Discard unused portion.

The color of Teflaro infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions. When stored as recommended, the product potency is not affected. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.5 Storage of Constituted Solutions

Stability in Baxter® Mini-Bag Plus™: Solutions of Teflaro in concentrations ranging from 4 to 12 mg/mL in Baxter Mini-Bag Plus containers with 0.9% Sodium Chloride Injection may be stored for up to 6 hours at room temperature or for up to 24 hours at 2°C to 8°C (36°F to 46°F). Stability testing in the Baxter Mini-Bag Plus has solely been conducted on 50 mL and 100 mL containers (0.9% Sodium Chloride Injection).

Stability in Infusion Bag: Studies have shown that the constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2 to 8º C (36 to 46º F).

2.6 Drug Compatibilities

The compatibility of Teflaro with other drugs has not been established. Teflaro should not be mixed with or physically added to solutions containing other drugs.