Preparation and Handling
Each vial of TYGACIL should be reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, to achieve a concentration of 10 mg/mL of tigecycline. (Note: Each vial contains a 6% overage. Thus, 5 mL of reconstituted solution is equivalent to 50 mg of the drug.) Please note that TYGACIL should not be reconstituted with Sterile Water for Injection.	The vial should be gently swirled until the drug dissolves.
Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL IV bag of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the IV bag should be 1 mg/mL. The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration (e.g., green or black) prior to administration.	Once reconstituted, TYGACIL may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the IV bag). Alternatively, TYGACIL may be stored refrigerated at 2° to 8°C (36° to 46°F) for up to 45 hours following immediate transfer of the reconstituted solution into the IV bag.

Administration

TYGACIL may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of TYGACIL with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Injection should be made with an infusion solution compatible with tigecycline and with any other drug(s) administered via this common line.

Y-site compatibility

Administration frequency

Intravenous (IV) infusions of TYGACIL should be administered over approximately 30 to 60 minutes every 12 hours.

Special populations

• No dosage adjustment is warranted in patients with mild-to-moderate hepatic impairment (Child Pugh A and Child Pugh B).¹
  • In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response.¹
• No dosage adjustment of TYGACIL is necessary in patients with renal impairment or in patients undergoing hemodialysis.¹
• No dosage adjustment of TYGACIL is necessary based on age, gender, or race.¹
• The safety and effectiveness of TYGACIL have not been established in patients younger than 18 years; therefore, use of TYGACIL in patients younger than 18 years is not recommended.¹

Duration of Treatment

The recommended duration of treatment with TYGACIL for adults with complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress.

How Supplied

TYGACIL for injection is supplied in a single-dose 5 mL glass vial containing 50 mg tigecycline lyophilized powder for reconstitution.

Storage

Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Once reconstituted, TYGACIL may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the IV bag). Alternatively, TYGACIL may be stored refrigerated at 2° to 8°C (36° to 46°F) for up to 45 hours following immediate transfer of the reconstituted solution into the IV bag. Reconstituted solution must be transferred and further diluted for IV infusion.

For additional information, please see the Prescribing Information for TYGACIL.

Indications and Important Safety Information

Indications

TYGACIL^® (tigecycline) is indicated for the treatment of adults with:

• Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis
• Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Important Safety Information

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria
• Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening
• TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline
• TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics
• Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL
• The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established
• In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5%) and vomiting (19.7%)
• TYGACIL may cause fetal harm when administered to a pregnant woman
• The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis
• Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective
• The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated
• Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin
• Monotherapy should be used with caution in patients with clinically apparent intestinal perforation
• In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response
• The following drugs should not be administered simultaneously through the same Y‑site as TYGACIL: amphotericin B and diazepam

Please see Prescribing Information

Prescribing Information | Pressroom | References | Indications and Important Safety Information