Sarecycline

Sarecycline is an aminomethylcycline within the tetracycline class of drugs. [see CLINICAL PHARMACOLOGY ( 12.4 )] .

• 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.ICD-10: L70.0

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

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 ( 2 ): 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.

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). ( 5.1 ) If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. ( 5.2 ) 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. ( 5.3 ) SEYSARA may cause intracranial hypertension. Discontinue SEYSARA if symptoms occur. ( 5.4 ) Photosensitivity can occur with SEYSARA. Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.5 ) 5.1 Teratogenic Effects SEYSARA, like other tetracyclines, 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 drugs of the tetracycline-class 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). This adverse reaction is more common during long-term use of these drugs, but has been observed following repeated short-term courses.

Most common adverse reaction (incidence ≥ 1%) is nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1064 subjects and 1069 subjects with moderate to severe acne vulgaris were treated with SEYSARA and placebo, respectively, for 12 weeks in 3 controlled clinical trials. The only adverse drug reaction that was reported in at least 1% of subjects was nausea, SEYSARA (3.1%) versus placebo (2.0%). The following additional adverse drug reactions occurred in less than 1% of female SEYSARA subjects: vulvovaginal mycotic infection (0.8%) and vulvovaginal candidiasis (0.6%).

Sarecycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. ( 5.1 , 8.1 ) The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. ( 5.1 , 8.4 ) Lactation: Breastfeeding is not recommended. ( 8.2 ) 8.1 Pregnancy Risk Summary SEYSARA, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . The limited available human data are not sufficient to inform a drug-associated risk for birth defects or miscarriage. Tetracyclines are known to cross the placental barrier; therefore, SEYSARA may be transmitted from the mother to the developing fetus. In animal reproduction studies, sarecycline induced skeletal malformations in fetuses when orally administered to pregnant rats during the period of organogenesis at a dose 1.4 times the maximum recommended human dose (MRHD) of 150 mg/day (based on AUC comparison). When dosing with sarecycline continued through the period of lactation, decreases in offspring survival, offspring body weight, and implantation sites and viable embryos in offspring females occurred at a dose 3 times the MRHD (based on AUC comparison) [see Data ] .

Metabolism

Increasing the SEYSARA dose from 60 to 150 mg once daily in healthy subjects resulted in a slightly less than proportional increase in sarcyeline steady-state C max and AUC tau . A mean accumulation ratio of sarecycline ranges from 1.5 to 1.6 fold with repeated dosing.

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

• Oct 1, 2018NDANDA209521Almirall

1. 1Headache2011%
2. 2Dizziness137.0%
3. 3Drug Ineffective137.0%
4. 4Vision Blurred115.9%
5. 5Rash94.9%
6. 6Off Label Use73.8%
7. 7Pruritus73.8%
8. 8Anxiety63.2%
9. 9Erythema63.2%
10. 10Fatigue63.2%
11. 11Product Dose Omission Issue63.2%
12. 12Seizure63.2%
13. 13Acne52.7%
14. 14Condition Aggravated52.7%
15. 15Migraine52.7%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Sarecycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
  Recruiting · Phase 4 · Interventional · 30 enrolled · Integrative Skin Science and Research
  NCT07544251updated 2026-04-22
• Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
  Completed · Observational · 300 enrolled · Almirall, S.A.
  NCT04820673updated 2024-10-10
• Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
  Completed · Phase 4 · Interventional · 9 enrolled · The Dermatology Institute of Boston
  NCT06461299updated 2024-06-21
• Sarecycline Truncal Acne Safety and Efficacy Response
  Completed · Observational · 10 enrolled · Angela Moore
  NCT05010538updated 2023-08-01
• Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy
  Unknown · Phase 2 · Interventional · 120 enrolled · Beijing Tiantan Hospital
  NCT05836753updated 2023-07-20
• A Pilot Study on the Use of Seysara for Rosacea
  Completed · Phase 4 · Interventional · 100 enrolled · Derm Research, PLLC
  NCT04555525updated 2021-01-07
• Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
  Completed · Phase 3 · Interventional · 968 enrolled · Almirall, S.A.
  NCT02320149updated 2019-02-15
• Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
  Completed · Phase 2 · Interventional · 285 enrolled · Almirall, S.A.
  NCT01628549updated 2019-02-01
• Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
  Completed · Phase 3 · Interventional · 1,034 enrolled · Almirall, S.A.
  NCT02322866updated 2019-02-01
• A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
  Completed · Phase 3 · Interventional · 490 enrolled · Almirall, S.A.
  NCT02413346updated 2019-02-01

Frequently asked questions

How does Sarecycline work?

Sarecycline is an aminomethylcycline within the tetracycline class of drugs. [see CLINICAL PHARMACOLOGY ( 12.4 )] .

What is Sarecycline used for?

According to FDA labeling, Sarecycline carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sarecycline?

Sarecycline is classified as Tetracyclines, Tetracycline-class Drug, P-Glycoprotein Inhibitors, Protein Synthesis Inhibitors, Decreased Protein Synthesis.

What are the brand names for Sarecycline?

Sarecycline is marketed under brand names including Seysara.

What are the contraindications for Sarecycline?

Sarecycline labeling lists contraindications including: SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.. Always consult the full prescribing information and a clinician.