Safety

Amzeeq was
well-tolerated by patients

Low adverse events were demonstrated with Amzeeq
Amzeeq adverse events chart
  • *Skin discoloration (2 vs 3) and skin hyperpigmentation (1 vs 0) for Amzeeq vs vehicle respectively. In Amzeeq clinical trials, there were no reported cases of minocycline-induced blue-gray skin hyperpigmentation.
  • In an additional 40-week, open-label, extension safety study (up to total of 52 weeks of treatment), frequency and severity of local tolerability signs and symptoms, as well as adverse events, were comparable at Week 52 to those reported at Week 1212
Important Safety Considerations:
  • AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered: Clostridium difficile associated diarrhea, hepatotoxicity, metabolic effects, central nervous system effects, intracranial hypertension, autoimmune syndromes, photosensitivity, hypersensitivity reactions and tissue hyperpigmentation. Discontinue AMZEEQ immediately if serious adverse reactions occur with AMZEEQ.
  • Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
Amzeeq has proven tolerability: 95% of cutaneous reactions were assessed as none or mild at Week 1210,14†
  • Dermal side effects were uncommon with Amzeeq (most cases mild), with no significant difference between Amzeeq and vehicle
  • Hyperpigmentation was most frequently assessed as characteristic of inflammatory and postinflammatory changes associated with acne
SUBJECTS WITH LOCAL SIGN OF SYMPTOMS
safety results erythema
safety results skin peeling
safety results itching
safety results dryness
safety results hyperpigmentation
  • In clinical trials, Facial Local Tolerability Assessments at Week 12—scale of 0 (none) to 3 (severe).
  • There was no change from baseline.
  • Integrated Safety Population (N=1377)