Dosing and uses of Teflaro (ceftaroline)
Adult dosage forms and strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
600 mg IV q12hr; infuse over 5-60 minutes for 5-7 days
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections, including MRSA
600 mg IV q12hr; infuse over 5-60 minutes for 5-14 days
Dosage modifications
Renal impairment
- CrCl 31-50 mL/min: 400 mg IV q12hr
- CrCl 15-30 mL/min: 300 mg IV q12hr
- ESRD (including hemodialysis): 200 mg IV q12hr
Pediatric dosage forms and strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
Indicated in children aged ≥2 months for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr; infuse over 5-60 minutes for 5-7 days
Skin & Skin Structure Infections
Indicated in children aged ≥2 months for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr; infuse over 5-60 minutes for 5-14 days
Teflaro (ceftaroline) adverse (side) effects
1-10%
Diarrhea (5%)
Nausea (4%)
Rash (3%)
Constipation (2%)
Vomiting (2%)
Increased transaminases (2%)
Hypokalemia (2%)
Phlebitis (2%)
Pyrexia (3%)
Pruritus (<3%)
Postmarketing reports
Agranulocytosis
Leukopenia
Warnings
Contraindications
Hypersensitivity
Cautions
Clostridium difficile–associated diarrhea has been reported (evaluate diarrhea if it occurs)
Discontinue therapy if hypersensitivity occurs
Direct Coombs test seroconversion reported and may be indicative of drug-induced hemolytic anemia
Pregnancy and lactation
Pregnancy category: B
Lactation: unknown whether distributed in breast milk, caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Teflaro (ceftaroline)
Mechanism of action
Beta-lactam cephalosporin with activity against aerobic and anaerobic gram-positive and aerobic gram-negative bacteria
Demonstrates activity in vivo against resistant methicillin-resistant Staphylococcus aureus (MRSA) strains and in vitro against vancomycin-resistant and linezolid-resistant S aureus
Pharmacokinetics
Half-Life: 2.6 hr
Peak Plasma Concentration: 21.3 mcg/mL
Peak Plasma Time: 1 hr
Vd: 20.3 L
Protein Bound: 20%
Metabolism: Ceftaroline fosamil converted to bioactive ceftaroline in plasma by phosphatase enzyme; undergoes hydrolysis
Clearance: 9.6 L/hr
Excretion: urine (88%)
Administration
IV Compatibilities
Solution: 0.9% NaCl; D5W; 2.5% dextrose/0.45% NaCl; Lactated Ringer’s solution
IV Preparation
Reconstitute vial by adding 20 mL sterile water for injection, 0.9% NaCl, D5W, or lactated ringer’s injection; mix gently and check to ensure all powder has dissolved completely
Resulting approximate concentrations: 400 mg vial (20 mg/mL); 600 mg vial (30 mg/mL)
Color of solution ranges from clear to light-to-dark yellow depending on concentration and storage conditions
Dilution of the constituted solution
- Withdraw total volume from vial and add to 50-250 mL of 0.9% NaCl, D5W, 2.5% dextrose/0.45% NaCl, or lactated ringer’s solution; use the same diluent that was used for reconstituting (unless sterile water for injection was used)
Dilution of the constituted solution in 50 mL infusion bags
- Preparation of 600 mg dose in 50 mL infusion bag (for adult patients): withdraw 20 mL from bag before adding constituted drug; resulting concentration ~12 mg/mL
- Preparation of 400 mg dose in 50 mL infusion bag (for adult and pediatric patients weighing >33 kg): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~8 mg/mL
Preparation for children weighing ≤33 kg
- Preparation of dose in infusion bag for pediatric patients weighing ≤33 kg: Amount of solution withdrawn from the constituted vial for dilution in the infusion bag will vary according to the weight and age of the child; infusion solution concentration should not exceed 12 mg/mL ceftaroline
IV Administration
Administer IV injection via volumetric infusion pump
Infuse over 5-60 minutes
Storage
Unreconstituted vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Stability of diluted drug in infusion bag or 50-mL bag
- Room temperature: 6 hr
- Refrigerated 2-8°C (36-46°F): 24 hr
