MORE ON SAFETY
Zilxi delivers minocycline directly to the skin, and systemic absorption is very low
Zilxi 1.5% topically
(2 g/day)
1.3 ng/mL
PLASMA CONCENTRATION
Single-dose
(1 mg/kg)
850 ng/mL
PLASMA CONCENTRATION
*Clinical significance of lower systemic exposure with Zilxi is unknown.
In clinical trials, Zilxi was shown to have a low incidence of adverse events compared to vehicle12
SUMMARY OF TREATMENT-EMERGENT ADVERSE EVENTS (TEAEs) OF SUBJECTS15
†In Zilxi clinical trials, there were no reported cases of minocycline-induced blue-gray skin hyperpigmentation.
Important Safety Considerations:
Zilxi was well-tolerated on already-sensitive skin in clinical trials10,17‡
FACIAL CUTANEOUS TOLERABILITY SIGNS AND SYMPTOMS§
FACIAL CUTANEOUS TOLERABILITY SIGNS AND SYMPTOMS§
‡All symptoms were evaluated on a 4-point scale consisting of 0=none, 1=mild, 2=moderate, and 3=severe, except for erythema, which was evaluated on a 5-point scale consisting of 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
§Of 1008 subjects, 897 had local tolerability assessments at Week 12.
¶Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with inflammatory lesions of rosacea.
FLUSHING/BLUSHING, TELANGIECTASIA, OR ERYTHEMA17
BURNING/STINGING, DRYNESS/XEROSIS, ITCHING, PEELING/DESQUAMATION, OR HYPERPIGMENTATION17
Contraindications
Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.
Warnings and Precautions
Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
Adverse Reactions
The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.
Indications and Usage
ZILXI (minocycline) topical foam, 1.5% is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.
Please click to access full Prescribing Information.
Contraindications
Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.
Warnings and Precautions
Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
Adverse Reactions
The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.
Indications and Usage
ZILXI (minocycline) topical foam, 1.5% is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.
Please click to access full Prescribing Information.
REFERENCES