ZILXI (minocycline hydrochloride)

In a pharmacokinetic study, male and female subjects 18 years of age or older with inflammatory lesions of rosacea (N=20) applied approximately 2 grams of ZILXI topically to the face once daily for 14 days. The mean ± SD maximum plasma concentration (C max ) and area under the concentration time curve from 0 to 24 hours post dose (AUC 0-24h ) for minocycline on Day 1 were 1.3 ± 0.9 ng/mL and 22.5 ± 16.2 h·ng/mL, respectively. After daily application of ZILXI in subjects with inflammatory lesions...

The safety and efficacy of once daily use of ZILXI was assessed in two 12-week multicenter, randomized, double-blind, vehicle-controlled trials in subjects with inflammatory lesions of rosacea (Trial 1 [NCT02601963] and Trial 2 [NCT03142451]). Efficacy was assessed in a total of 1,522 subjects 18 years of age and older. ZILXI or its vehicle were applied once daily for 12 weeks; no other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. Subjects were required to have an inflammatory lesion count in the range 15-75 l...

The most commonly observed adverse reaction (incidence ≥1%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates ob...

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in ZILXI. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients in ZILXI. ( 4 )

• The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 )
• The use of tetracycline-class of drugs orally during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.2 , 5.3 , 5.4 , 8.4 )
• If Clostridioides difficile associated diarrhea occurs, discontinu...

7 DRUG INTERACTIONS

• Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 )
• Penicillin: avoid coadministration. ( 7.2 ) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Since bact...