HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TYGACIL safely and effectively. See full prescribing information for TYGACIL.
TYGACIL® (tigecycline) for injection, for intravenous use
Initial U.S. Approval: 2005
WARNING: ALL-CAUSE MORTALITY
See full prescribing information for complete boxed warning.
All-cause mortality was higher in patients treated with TYGACIL than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable (1.4, 5.1, 5.2, 6.1).
RECENT MAJOR CHANGES
|Dosage and Administration, Monitoring of Blood Coagulation Parameters (2.4)|| 6/2020|
|Warnings and Precautions, Monitoring of Blood Coagulation Parameters (5.6)|| 6/2020|
|Warnings and Precautions, Tooth Discoloration and Enamel Hypoplasia (5.7)|| 1/2020|
|Warnings and Precautions, Inhibition of Bone Growth (5.8)||1/2020|
INDICATIONS AND USAGE
TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for:
- Complicated skin and skin structure infections (1.1)
- Complicated intra-abdominal infections (1.2)
- Community-acquired bacterial pneumonia (1.3)
Limitations of Use: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia (1.4).
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 that are proven or strongly suspected to be caused by bacteria (1.5).
DOSAGE AND ADMINISTRATION
- Initial dose of 100 mg followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1)
- Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. (2.2)
- Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with TYGACIL. (2.4, 5.6)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 mg, lyophilized powder for reconstitution in a single-dose 5 mL vial or 10 mL vial. (3)
- Known hypersensitivity to tigecycline. (4)
WARNINGS AND PRECAUTIONS
- All-Cause Mortality: A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in TYGACIL-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0.0, 1.2)]. The greatest difference in mortality was seen in TYGACIL-treated patients with ventilator-associated pneumonia. (5.1, 5.2)
- Anaphylactic Reactions: have been reported with TYGACIL, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines. (5.3)
- Hepatic Adverse Effects: have been reported with TYGACIL. Patients who develop abnormal liver function tests during TYGACIL therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. (5.4)
- Pancreatitis: including fatalities, has been reported with TYGACIL. If pancreatitis is suspected, then consider stopping TYGACIL. (5.5)
- Monitoring Blood Coagulation Parameters: Hypofibrinogenemia has been reported with TYGACIL. Monitor blood coagulation parameters, including fibrinogen, at baseline and regularly during treatment with TYGACIL. (5.6)
- Tooth Discoloration and Enamel Hypoplasia: The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. (5.7)
- Inhibition of Bone Growth: The use of TYGACIL during the second and third trimester of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. (5.8)
- Clostridioides difficile-Associated Diarrhea (CDAD): evaluate if diarrhea occurs. (5.9)
The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Warfarin: Suitable anticoagulation test should be monitored if TYGACIL is administered to patients receiving warfarin. (7.1)
- Calcineurin Inhibitors: Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with TYGACIL due to risk of toxicity. (7.2)
USE IN SPECIFIC POPULATIONS
- Lactation: Avoid breastfeeding for longer than 3 weeks while taking TYGACIL. A lactating woman may also pump and discard breast milk during treatment and for 9 days after the last dose of TYGACIL (8.2)
- Pediatrics: Use in patients under 18 years of age is not recommended. Pediatric trials were not conducted because of the higher risk of mortality seen in adult trials (8.4)
See 17 for PATIENT COUNSELING INFORMATION.