Sarecycline

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. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA 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, SEYSARA should be used only as indicated. SEYSARA ® is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Sarecycline is an aminomethylcycline within the tetracycline class of drugs. The mechanism of action of SEYSARA in treating the inflammatory lesions of non-nodular acne vulgaris is not known.

The recommended dosage of SEYSARA is based on body weight described in Table 1. If there is no improvement after 12 weeks, reassess treatment with SEYSARA. 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. To reduce the risk of esophageal irritation and ulceration, administer SEYSARA with adequate amounts of fluid. The recommended dosage of SEYSARA is once daily with or without food: 60 mg for patients who weigh 33-54 kg, 100 mg for patients who weigh 55-84 kg, 150 mg for patients who weigh 85-136 kg.

SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

The use of SEYSARA during tooth development (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). If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. SEYSARA may cause intracranial hypertension. Discontinue SEYSARA if symptoms occur. Photosensitivity can occur with SEYSARA. Patients should minimize or avoid exposure to natural or artificial sunlight.

Most common adverse reaction (incidence ≥ 1%) is nausea.

Oral retinoids: avoid coadministration. Antacids and iron preparations: separate dosing of SEYSARA. Penicillin: avoid coadministration. Anticoagulants: decrease anticoagulant dosage as appropriate. P-glycoprotein substrates: monitor for toxicities of drugs that may require dosage reduction.

Store at 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C - 30°C (59°F - 86°F). Handling Protect from moisture and excessive heat.