sarecycline
Regulatory sources consulted
Approved indications
- Inflammatory lesions of moderate-to-severe nonnodular acne vulgaris in patients aged 9 years and older. It has not been evaluated for treating infections.
Contraindications
Absolute
- Hypersensitivity to any tetracycline.
Clinical warnings
- Major warning · It may cause tooth discoloration and inhibition of bone growth; do not use under age 9. — DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
- Major warning · Avoid oral retinoids because of intracranial-hypertension risk. — DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
- Major warning · It may cause Clostridioides difficile-associated diarrhea, including after completion; stop and treat according to severity. — DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
- It may cause photosensitivity. Limit sun/UV exposure and stop for marked erythema. — DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
Drug interactions
- ModerateAntacids and products containing aluminum, calcium, magnesium, bismuth, or iron
Mechanism: Chelation reduces oral absorption.
Recommendation: Separate doses according to the label and administer with plenty of water.
DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
- HighOral retinoids, anticoagulants, and P-gp substrates
Mechanism: Retinoids increase intracranial hypertension; anticoagulation may be potentiated and P-gp substrate exposure may rise.
Recommendation: Avoid retinoids; monitor INR and toxicity of narrow-index P-gp substrates.
DailyMed, set_id b200957c-3004-4988-be97-9fd619a83649
Adverse events
Common (≥1%)
Nausea
Rare but serious
Intracranial hypertension, anaphylaxis, and ulcerative esophagitis
Pregnancy and lactation
It may cause fetal harm; discontinue sarecycline when pregnancy is recognized. Breastfeeding is not recommended during treatment.
Recent literature (PubMed)
Acne vulgaris commonly affects adults, adolescents, and preadolescents aged 9 years or older. The objective of this study was to provide evidence-based recommendations for the management of acne. A work group conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations. This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl peroxide, topical retinoids, topical antibiotics, and oral doxycycline. Oral isotretinoin is strongly recommended for acne that is severe, causing psychosocial burden or scarring, or failing standard oral or topical therapy. Conditional recommendations are made for topical clascoterone, salicylic acid, and azelaic acid, as well as for oral minocycline, sarecycline, combined oral contraceptive pills, and spironolactone. Combining topical therapies with multiple mechanisms of action, limiting systemic antibiotic use, combining systemic antibiotics with topical therapies, and adding intralesional corticosteroid injections for larger acne lesions are recommended as good practice statements. Analysis is based on the best available evidence at the time of the systematic review. These guidelines provide evidence-based recommendations for the management of acne vulgaris.
Although many treatments are available for acne, these can be limited by lack of effectiveness, patient tolerance and adherence, and accessibility. This review provides a comprehensive summary of the latest developments in acne management, exploring a range of topical, systemic, and procedural treatments. The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed. No information is available on the use of sarecycline during breastfeeding. For acne treatment, it is taken for 12 weeks or longer. Such prolonged courses of tetracyclines are not recommended because if even a small fraction is absorbed by the infant from milk, it could have a cumulative staining effect on the infant’s permanent teeth.
Cutibacterium acnes protects skin homeostasis. The species has three subspecies, and associations between C. acnes subsp. acnes and acne, C. acnes subsp. defendens and prostate cancer, and C. acnes subsp. elongatum and progressive macular hypomelanosis have recently been suggested. Different phylotypes/clonal complexes may cause prosthetic joint and other infections, and virulence factors such as fimbriae, biofilms, multidrug-resistance plasmids, porphyrin, Christie-Atkins-Munch-Petersen factors and cytotoxicity contribute to infections. Isolates are subtyped by multiplex PCR or multi- or single-locus sequence typing; however, these methods could be better synchronized. Resistance of acneic strains to macrolides (25.0-73.0%), clindamycin (10.0-59.0%) and tetracyclines (up to 37.0%) is worrisome, but susceptibility testing is now facilitated by European Committee on Antimicrobial Susceptibility Testing disk diffusion breakpoints. New therapeutic approaches include sarecycline, antimicrobial peptides and bacteriophages. What is this summary about? Cutibacterium acnes is necessary for skin health. However, different subspecies and types may be associated with different diseases. At present, the species has three known subspecies and six known major phylotypes. What were the results? Acne results from a disturbance of the skin bacteria. It has often been linked to C. acnes, whereas associations of other subspecies with prostate cancer, skin disease and various infections have been observed. Strain typing can be performed with different techniques; however, methods should be better synchronized. Resistance of isolates from acne to antibiotics is high. Antibiotic susceptibility testing is necessary and is being facilitated. New treatments with newer antibiotics, antimicrobial peptides and phages are promising. What do the results mean? C. acnes has three subspecies and numerous types that can support skin health or be linked to different diseases. New associations between