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What is Seysara?
It is not known if Seysara is safe and effective for use for longer than 12 weeks.
It is not known if Seysara is safe and effective in children under 9 years of age.
What are the possible side effects of Seysara?
Seysara may cause serious side effects, including:
The most common side effect of Seysara is nausea.
Seysara may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of Seysara.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Almirall at 1-866-665-2782.
SEYSARA (sarecycline) tablets are a tetracycline class drug for oral administration. Sarecycline hydrochloride is chemically described as (4S,4aS,5aR,12aS)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-[(methoxy- (methyl)-amino)- methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide monohydrochloride with an empirical formula of C24H29N3O8.HCl and a molecular weight of 523.96.
The structural formula is represented below:
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SEYSARA tablets contain 64.5 mg, 107.5 mg, and 161.2 mg of sarecycline hydrochloride equivalent to 60 mg, 100 mg, and 150 mg sarecycline respectively. Inactive ingredients in the tablet formulations are: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminium lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titatnium dioxide.
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.
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 [see Clinical Studies].
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 [see WARNINGS AND PRECAUTIONS].
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.
SEYSARA (sarecycline) tablets:
Store at 20°C -25°C (68°F -77°F); excursions permitted to 15°C -30°C (59°F -86°F) [See USP Controlled Room Temperature].
Protect from moisture and excessive heat.
Distributed by Almirall, LLC Exton, PA 19341, USA. Revised: Jun 2020
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%).
Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin [see WARNINGS AND PRECAUTIONS]. Avoid coadministration of SEYSARA with oral retinoids.
Coadministration with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations may impair absorption of SEYSARA, similar to other tetracyclines, which may decrease its efficacy. Separate dosing of SEYSARA from antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations.
Similar to other tetracyclines, SEYSARA may interfere with the bactericidal action of penicillin. Avoid coadministration of SEYSARA with penicillin.
Similar to other tetracyclines, SEYSARA may depress plasma prothrombin activity, which may increase the risk of bleeding in patients who are on anticoagulant therapy. Decrease anticoagulant dosage when coadministered with SEYSARA as appropriate.
Concomitant use of SEYSARA may increase concentrations of concomitantly administered P-gp substrates (e.g. digoxin). Monitor for toxicities of drugs that are P-gp substrates and may require dosage reduction when given concurrently with SEYSARA [see CLINICAL PHARMACOLOGY].
There is no clinically significant effect of SEYSARA on the efficacy of oral contraceptives containing ethinyl estradiol and norethindrone acetate [see CLINICAL PHARMACOLOGY].
Included as part of the "PRECAUTIONS" Section
Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to potential overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile should be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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. Women of childbearing age who are overweight have a greater risk for developing intracranial hypertension. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension [see DRUG INTERACTIONS]. If visual disturbance occurs during treatment, patients should be checked for papilledema.
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. If patients need to be outdoors while using SEYSARA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.
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 nonsusceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Patients taking SEYSARA should receive the following information and instructions:
In a 2-year oral mouse carcinogenicity study and a 2-year oral rat carcinogenicity study, no drug-related neoplasms were observed in male mice at oral doses of sarecycline up to 100 mg/kg/day (approximately equal to the MRHD based on AUC comparison) or in female mice at doses up to 60 mg/kg/day (approximately equal to the MRHD based on AUC comparison), or in rats at doses up to 200/100 mg/kg/day (dose reduced from 200 to 100 mg/kg/day due to increased mortality; 8 times the MRHD based on AUC comparison).
Sarecycline was not mutagenic or clastogenic in a series of in vitro and in vivo genotoxicity studies, including a bacteria reverse mutation (Ames) assay, an in vitro chromosomal aberration assay in CHO cells, the L5178Y/TK+/-Mouse Lymphoma Assay, and an in vivo micronucleus assay in rats.
In a fertility and early embryonic development study in rats, sarecycline was administered to both male and female rats at oral doses up to 400 mg/kg/day prior to pairing and through the mating and postmating period. Female fertility was not affected at doses up to 400 mg/kg/day (8 times the MRHD based on AUC comparison). In sperm evaluation, decreased sperm motility, decreased sperm count and concentration, and an increase in percent abnormal sperm occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison). Male fertility was not affected at doses up to 150 mg/kg/day (4 times the MRHD based on AUC comparison).
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 and Pediatric Use]. 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]. The potential risk to the fetus outweighs the potential benefit to the mother from SEYSARA use during pregnancy; therefore, pregnant patients should discontinue SEYSARA as soon as pregnancy is recognized.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Animal Data
In an embryofetal developmental study in rats, sarecycline was administered to pregnant rats at oral doses up to 500 mg/kg/day during the period of organogenesis. Decreases in maternal body weight, fetal body weight and litter size and increases in the number of resorption and postimplantation loss occurred at 500 mg/kg/day (7 times the MRHD based on AUC comparison). Skeletal malformations (bent forelimb, hindlimb, and scapula) occurred at all dose levels (≥ 50 mg/kg/day, 1.4 times the MRHD based on AUC comparison).
In an embryofetal developmental study in rabbits, sarecycline was administered to pregnant rabbits at oral doses up to 150 mg/kg/day during the period of organogenesis. Excessive maternal toxicity (mortality/moribundity/abortion) occurred at 150 mg/kg/day (5 times the MRHD based on AUC comparison) and this dose group was terminated early. Maternal moribundity also occurred at 100 mg/kg/day (0.6 times the MRHD based on AUC comparison). No significant embryofetal toxicity or malformations were observed at doses up to 100 mg/kg/day (0.6 times the MRHD based on AUC comparison).
In a pre-and post-natal developmental study in rats, sarecycline was administered to maternal rats at oral doses up to 400 mg/kg/day during the period of organogenesis through lactation. Excessive litter toxicity (litter loss and stillbirth) occurred at 400 mg/kg/day (8 times the MRHD based on AUC comparison), which led to early termination of dams at parturition. Decreases in body weight and food consumption of dams during the lactation period occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison). Decreases in offspring survival and offspring body weight during the preweaning and growth period, and decreases in implantation sites and viable embryos in female offspring occurred at 150 mg/kg/day (3 times the MRHD based on AUC comparison). No significant maternal or developmental toxicity was observed at 50 mg/kg/day (1.4 times the MRHD based on AUC comparison).
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions on bone and tooth development in nursing infants from tetracycline-class antibiotics, advise a woman that breastfeeding is not recommended with SEYSARA therapy [see WARNINGS AND PRECAUTIONS].
Avoid using SEYSARA in males who are attempting to conceive a child. In a fertility study in rats, sarecycline adversely affected spermatogenesis when orally administered to male rats at a dose 8 times the MRHD (based on AUC comparison) [see Nonclinical Toxicology].
The safety and effectiveness of SEYSARA have been established in pediatric patients 9 years of age and older for the treatment of moderate to severe inflammatory lesions of non-nodular acne vulgaris [see Pharmacokinetics and Clinical Studies].
Safety and effectiveness of SEYSARA in pediatric patients below the age of 9 years has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see WARNINGS AND PRECAUTIONS].
Clinical studies of SEYSARA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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.
SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
The mechanism of action of SEYSARA in treating acne vulgaris is not known.
The pharmacodynamics of SEYSARA for the treatment of acne vulgaris are unknown.
At approximately 3 times the maximum recommended dose, SEYSARA did not prolong the QT interval to a clinically relevant extent.
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 Cmax and AUCtau. A mean accumulation ratio of sarecycline ranges from 1.5 to 1.6 fold with repeated dosing. Steady-state of sarecycline was reached by Day 7.
The median time to peak plasma concentration (Tmax) of sarecycline is 1.5 to 2.0 hours.
Coadministration with a high-fat (approximately 50% of total caloric content of the meal), high-calorie (800 to 1000 Kcal) meal that included milk delayed Tmax by approximately 0.53 hour and decreased sarecycline Cmax by 31% and AUC by 27%.
Protein binding of sarecycline is 62.5% to 74.7% in vitro. The mean apparent volume of distribution of sarecycline at steady-state ranges from 91.4 L to 97.0 L.
The mean apparent oral clearance (CL/F) of sarecycline at steady state is approximately 3 L/h. The mean elimination half-life of sarecycline is 21 to 22 hours.
Metabolism of sarecycline by enzymes in human liver microsomes is minimal (< 15%) in vitro. Minor metabolites resulting from non-enzymic epimerization, O-/N-demethylation, hydroxylation, and desaturation have been found.
After a single 100 mg oral dose of radiolabeled sarecycline, 42.6% of the dose was recovered in feces (14.9% as unchanged) and 44.1% in urine (24.7% as unchanged).
No clinically significant differences in the pharmacokinetics of sarecycline were observed based on age (11 to 73 years), weight (42 to 133 kg), sex, renal impairment, or mild to moderate hepatic impairment (Child Pugh A to B). The effect of end-stage renal disease (ESRD) or severe hepatic impairment (Child-Pugh C) on sarecycline pharmacokinetics has not been assessed.
Coadministration of SEYSARA with a combination oral contraceptive, ethinyl estradiol (EE) 20 mcg plus norethindrone (NE) acetate 1 mg, increased EE Cmax by 14% and AUCtau by 11%, and increased NE Cmax by 18% and AUCtau by 23%.
Coadministration of a single dose of SEYSARA 150 mg resulted in a 26% increase in Cmax of digoxin, a P-gp substrate.
Sarecycline is not a substrate for P-gp, BCRP, OATP1B1, or OATP1B3.
Sarecycline is a P-gp inhibitor. Sarecycline does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 isozymes, and does not inhibit OATP1B1, OATP1B3, OCT2, OAT1, OAT3, or BCRP.
Sarecycline does not induce CYP1A2, CYP2B6, or CYP3A4/5 isozymes.
Sarecycline is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.
P. acnes strains displayed a low propensity for the development of resistance to sarecycline, with spontaneous mutation frequencies being 10−10 at 4 – 8 × MIC.
The safety and efficacy of once daily SEYSARA was assessed in two 12-week multicenter, randomized, double-blind, placebo-controlled studies (Study 1 [NCT02320149] and Study 2 [NCT02322866]). Efficacy was assessed in a total of 2002 subjects 9 years of age and older. Overall, 57% were female, 78% were Caucasian, 15% were Black or African American and 51% were adults (18 to 45 years of age). Subjects were randomized to receive either SEYSARA or placebo once daily.
The two co-primary efficacy endpoints were:
The results at Week 12 are presented in the following table.
Table 2: Clinical Efficacy of SEYSARA at Week 12
| Study 1 | Study 2 | |||
| SEYSARA (N=483) | Placebo (N=485) | SEYSARA (N=519) | Placebo (N=515) | |
| Investigator’s Global Assessment | ||||
| IGA Success | 21.9% | 10.5% | 22.6% | 15.3% |
| Inflammatory Lesions | ||||
| Mean absolute reduction | 15.3 | 10.2 | 15.5 | 11.1 |
| Mean percent reduction | 52.2% | 35.2% | 50.8% | 36.4% |
Mean absolute and percent reduction in inflammatory lesions was also greater with SEYSARA compared to placebo at Weeks 3, 6, and 9 for both studies.
SEYSARA®
(SAY' sara)
(sarecycline) tablets
What is SEYSARA?
It is not known if SEYSARA is safe and effective for use for longer than 12 weeks.
It is not known if SEYSARA is safe and effective in children under 9 years of age.
Do not take SEYSARA:
What should I tell my healthcare provider before taking SEYSARA?
Before taking SEYSARA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEYSARA and other medicines can affect each other causing serious side effects.
Especially tell your healthcare provider if you take:
How should I take SEYSARA?
What should I avoid during treatment with SEYSARA?
What are the possible side effects of SEYSARA?
SEYSARA may cause serious side effects, including:
The most common side effect of SEYSARA is nausea.
SEYSARA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of SEYSARA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Almirall at 1-866-665-2782.
How should I store SEYSARA?
Keep SEYSARA and all medicines out of the reach of children.
General information about the safe and effective use of SEYSARA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SEYSARA for a condition for which it was not prescribed. Do not give SEYSARA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SEYSARA that is written for health professionals.
What are the ingredients in SEYSARA?
Active ingredient: sarecycline hydrochloride
Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titanium dioxide.
This Patient Information has been approved by the U.S Food and Drug Administration
