What is the recommended treatment for moderate to severe acne vulgaris using Seysara (sarecycline)?

From the Guidelines

For moderate to severe acne vulgaris, Seysara (sarecycline) is conditionally recommended as an oral antibiotic option, with a dosing regimen based on patient weight, as part of a comprehensive treatment plan that includes topical therapies to minimize antibiotic resistance and optimize outcomes. The recommended dose of Seysara is 60 mg, 100 mg, or 150 mg once daily, with treatment typically continuing for 8-12 weeks, followed by an evaluation of response [ 1 ]. As a tetracycline-class antibiotic, sarecycline works by inhibiting bacterial protein synthesis and has anti-inflammatory properties that help reduce acne lesions, specifically targeting Cutibacterium acnes while minimizing effects on gut bacteria [ 1 ].

Key Considerations for Seysara Use

• Patients should avoid sun exposure due to the risk of photosensitivity.
• Seysara should not be used during pregnancy or in children under 9 years due to potential effects on bone development and tooth discoloration.
• For optimal results, Seysara should be used alongside topical treatments such as benzoyl peroxide to prevent bacterial resistance, as recommended by guidelines [ 1 ].
• The choice of antibiotic, including sarecycline, should be based on the severity of acne, patient weight, and potential side effects, with a preference for limiting systemic antibiotic use to reduce the development of antibiotic resistance and other complications [ 1 ].

Comprehensive Treatment Approach

• Combining topical therapies with multiple mechanisms of action is recommended as a good practice statement to enhance treatment efficacy [ 1 ].
• Limiting systemic antibiotic use and combining systemic antibiotics with topical therapies are also recommended to minimize resistance and maximize outcomes [ 1 ].
• Intralesional corticosteroid injections may be considered as an adjuvant therapy for larger acne lesions to rapidly improve inflammation and pain, used judiciously to minimize local corticosteroid adverse events [ 1 ].

From the FDA Drug Label

SEYSARA® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. The recommended dosage of SEYSARA is based on body weight described in Table 1. Table 1: Dosing Table for SEYSARA Body Weight (kg) Tablet Strength 33 to 54 kg 60 mg tablet 55 to 84 kg 100 mg tablet 85 to 136 kg 150 mg tablet Take SEYSARA once daily, with or without food

The recommended treatment for moderate to severe acne vulgaris using Seysara (sarecycline) is to take the medication once daily, with or without food, at the following dosages based on body weight:

• 33 to 54 kg: 60 mg tablet
• 55 to 84 kg: 100 mg tablet
• 85 to 136 kg: 150 mg tablet 2

From the Research

Treatment Overview for Moderate to Severe Acne Vulgaris

• Seysara (sarecycline) is a newly approved oral tetracycline antibiotic for the treatment of moderate to severe acne vulgaris 3.
• The recommended dosage of sarecycline is 1.5 mg/kg, taken once daily, which has been shown to be effective in reducing inflammatory lesions 3.

Efficacy of Sarecycline

• In phase 3 clinical trials, sarecycline demonstrated significant reductions in facial inflammatory lesion counts compared to placebo 3.
• The absolute change from baseline in facial inflammatory lesion count at week 12 was -15.3 for the sarecycline arm and -10.1 for placebo (P < 0.01) in one study, and -15.7 for sarecycline and -10.7 for placebo (P < 0.01) in another study 3.
• Sarecycline has been shown to be well-tolerated and has more targeted antimicrobial activity, which may help reduce the risk of developing antibiotic resistance 3.

Comparison to Other Treatments

• Other treatments for moderate to severe acne vulgaris include topical retinoids, benzoyl peroxide, azelaic acid, and oral antibiotics such as doxycycline and minocycline 4.
• Isotretinoin is also an effective treatment for severe recalcitrant nodular acne, but it is often associated with more side effects 4, 5.
• Sarecycline may represent a useful alternative to these treatments, particularly for patients who are intolerant of or unresponsive to other therapies 3.

Safety and Tolerability

• Sarecycline has been shown to be well-tolerated in clinical trials, with a safety profile similar to that of other tetracycline antibiotics 3.
• The most common adverse events associated with sarecycline include nausea, vomiting, and diarrhea, but these are generally mild and self-limiting 3.