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Tigecycline

Tetracycline-class Antibacterial

Route: Intravenous

5 interactions on record⛔ Black Box Warning

Tigecycline has 5 known drug interactions based on U.S. FDA drug labeling data. 4 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Cyclosporine, Tacrolimus, Warfarin. Patients taking Tigecycline should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 5
Major: 4
Moderate: 1

Major (4)

Tigecycline + Cyclosporine— Tigecycline may increase serum trough concentrations of cyclosporine, leading to risk of toxicity. Monitor serum concent…
Tigecycline + Tacrolimus— Tigecycline may increase serum trough concentrations of tacrolimus, leading to risk of toxicity. Monitor serum concentra…
Tigecycline + Warfarin— CYP2C9 inhibitor that increases warfarin effect and INR; requires close INR monitoring
Tigecycline + Warfarin Sodium— CYP2C9 inhibitor that increases warfarin effect and INR; requires closer INR monitoring.

Moderate (1)

Tigecycline + Oral Contraceptives— Concurrent use of tigecycline with oral contraceptives may render oral contraceptives less effective.

Tigecycline + Cyclosporine⚠️Major

Tigecycline may increase serum trough concentrations of cyclosporine, leading to risk of toxicity. Monitor serum concentrations during treatment.

Tigecycline + Tacrolimus⚠️Major

Tigecycline may increase serum trough concentrations of tacrolimus, leading to risk of toxicity. Monitor serum concentrations during treatment.

Tigecycline + Warfarin⚠️Major

CYP2C9 inhibitor that increases warfarin effect and INR; requires close INR monitoring

Tigecycline + Warfarin Sodium⚠️Major

CYP2C9 inhibitor that increases warfarin effect and INR; requires closer INR monitoring.

Tigecycline + Oral Contraceptives🟡Moderate

Concurrent use of tigecycline with oral contraceptives may render oral contraceptives less effective.

⛔ FDA Black Box Warning

WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. 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 [see Indications and Usage (1.4) , Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ]. 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 ).

Contraindications

4 CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ]. • Known hypersensitivity to tigecycline. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary TYGACIL, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.7 , 5.8) , Data , and Use in Specific Populations (8.4) ]. There are no available data on the risk of major birth defects or miscarriage following the use of TYGACIL during pregnancy. Administration of intravenous tigecycline in pregnant rats and rabbits during the period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at the recommended clinical dose in rats and rabbits, respectively. Advise the patient of the potential risk to the fetus if TYGACIL is used during the second or third trimester. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline-class antibacterial drugs, that includes TYGACIL, during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth. This adverse reaction is more common during long-term use of tetracyclines but has been observed following repeated short-term courses. TYGACIL may cause reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. Animal Data In embryo-fetal development studies, tigecycline was administered during the period of organogenesis at doses up to

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.