IMPORTANT SAFETY INFORMATIONPRESCRIBING INFORMATION PATIENT SITE
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TREATMENT CONSIDERATIONS

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When prescribing systemic antibiotics, bacterial resistance is an important consideration.1

  • The development of Propionibacterium acnes resistance can affect a patient’s clinical response to treatment2

Awareness of antibiotic resistance is high among patients and caregivers.3

  • In a large survey of over 1000 patients and caregivers, the majority (over 80%) were familiar with the principles of antibiotic resistance3
Doxycycline was approved in 1967 and minocycline was approved in 1971
as broad-spectrum antibiotics for multiple indications.4
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There is limited clinical evidence supporting efficacy in treating truncal acne for tetracycline-class oral antibiotics.

  • About 50% of patients with facial acne present with concomitant truncal acne9

References:

    1. Acne clinical guideline. American Academy of Dermatology. Accessed June 12, 2020. https://www.aad.org/member/clinical-quality/guidelines/acne.
    2. Leyden JJ, McGinley KJ, Cavalieri S, Webster GF, Mills OH, Kligman AM. Propionibacterium acnes resistance to antibiotics in acne patients. J Am Acad Dermatol. 1983;8(1):41‐45. 
    3. Del Rosso JQ, Rosen T, Palceski D, Rueda MJ. Patient awareness of antimicrobial resistance and antibiotic use in acne vulgaris. J Clin Aesthet Dermatol. 2019;12(6):30-41. 
    4. Moore AY, Charles JEM, Moore S. Sarecycline: a narrow spectrum tetracycline for the treatment of moderate-to-severe acne vulgaris. Future Microbiol. 2019;14(14):1235-1242.  
    5. Margolis DJ, Fanelli M, Hoffstad O, Lewis JD. Potential association between the oral tetracycline class of antimicrobials used to treat acne and inflammatory bowel disease. Am J Gastroenterol. 2010;105(12):2610‐2616.  
    6. Lee TW, Russell L, Deng M, Gibson PR. Association of doxycycline use with the development of gastroenteritis, irritable bowel syndrome and inflammatory bowel disease in Australians deployed abroad. Intern Med J. 2013;43(8):919‐926.  
    7. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33.
    8. SOLODYN [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC. 2017. 
    9. Bikowski J. A review of the safety and efficacy of benzoyl peroxide (5.3%) emollient foam in the management of truncal acne vulgaris. J Clin Aesthet Dermatol. 2010;3(11):26‐29. 

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

  • Like other tetracyclines, SEYSARA can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy, or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately.
  • 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).
  • Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. 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.
  • Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA.
  • Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated.
  • As with other antibiotic preparations, use of SEYSARA may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted.

ADVERSE REACTIONS

Most common adverse reaction (incidence ≥ 1%) was nausea: SEYSARA (3.1%) versus placebo (2.0%).1

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email:
Medical Affairs and Customer Relations
Phone: 1-866-665-2782
Fax: 510-595-8183
Email: almirallmc@eversana.com