Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 1) SEYSARA (sarecycline) tablets, 60 mg are capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-245-30 2) SEYSARA (sarecycline) tablets, 100 mg are capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-246-30 3) SEYSARA (sarecycline) tablets, 150 mg are capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-247-30 Storage 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]. Handling Protect from moisture and excessive heat.; PRINCIPAL DISPLAY PANEL - NDC: 16110-245-30 - 60 mg 30-count Bottle Label 60 mg 30-count Bottle Label; PRINCIPAL DISPLAY PANEL - NDC: 16110-246-30 - 100 mg 30-count Bottle Label 100 mg 30-count Bottle Label; PRINCIPAL DISPLAY PANEL - NDC: 16110-247-30 - 150 mg 30-count Bottle Label 150 mg 30-count Bottle Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 1) SEYSARA (sarecycline) tablets, 60 mg are capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-245-30 2) SEYSARA (sarecycline) tablets, 100 mg are capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-246-30 3) SEYSARA (sarecycline) tablets, 150 mg are capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side. Bottles of 30 tablets with child-resistant closure: NDC: 16110-247-30 Storage 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]. Handling Protect from moisture and excessive heat.
- PRINCIPAL DISPLAY PANEL - NDC: 16110-245-30 - 60 mg 30-count Bottle Label 60 mg 30-count Bottle Label
- PRINCIPAL DISPLAY PANEL - NDC: 16110-246-30 - 100 mg 30-count Bottle Label 100 mg 30-count Bottle Label
- PRINCIPAL DISPLAY PANEL - NDC: 16110-247-30 - 150 mg 30-count Bottle Label 150 mg 30-count Bottle Label
Overview
SEYSARA (sarecycline) tablets are a tetracycline class drug for oral administration. Sarecycline hydrochloride is chemically described as (4 S ,4a S ,5a R ,12a S )-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 C 24 H 29 N 3 O 8 .HCl and a molecular weight of 523.96. The structural formula is represented below: 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 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titatnium dioxide. Chemical Structure
Indications & 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 [see Clinical Studies ( 14 )] . 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 ( 5.6 )] . 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. ( 1 ) 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 [see Warnings and Precautions ( 5.6 )].
Dosage & Administration
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.
Warnings & Precautions
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. Enamel hypoplasia has also been reported. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated with SEYSARA during pregnancy in association with maternal toxicity [see Use in Specific Populations ( 8.1 )] . 5.2 Clostridium difficile Associated Diarrhea (Antibiotic Associated Colitis) 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. 5.3 Central Nervous System Effects 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. 5.4 Intracranial Hypertension 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 ( 7.1 )] . If visual disturbance occurs during treatment, patients should be checked for papilledema. 5.5 Photosensitivity 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. 5.6 Development of Drug Resistant Bacteria 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. 5.7 Superinfection/Potential for Microbial Overgrowth 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.
Contraindications
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. ( 4 )
Adverse Reactions
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%).
Drug Interactions
Oral retinoids: avoid coadministration. ( 5.4 , 7.1 ) Antacids and iron preparations: separate dosing of SEYSARA. ( 7.1 ) Penicillin: avoid coadministration. ( 7.2 ) Anticoagulants: decrease anticoagulant dosage as appropriate. ( 7.2 ) P-glycoprotein substrates: monitor for toxicities of drugs that may require dosage reduction. ( 7.2 ) 7.1 Effect of Other Drugs on SEYSARA Oral Retinoids Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin [see Warnings and Precautions ( 5.4 )] . Avoid coadministration of SEYSARA with oral retinoids. Antacids and Iron Preparations 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. 7.2 Effect of SEYSARA on Other Drugs Penicillin Similar to other tetracyclines, SEYSARA may interfere with the bactericidal action of penicillin. Avoid coadministration of SEYSARA with penicillin. Anticoagulants 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. P-Glycoprotein (P-gp) Substrates 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 ( 12.3 )] . Oral Hormonal Contraceptives There is no clinically significant effect of SEYSARA on the efficacy of oral contraceptives containing ethinyl estradiol and norethindrone acetate [see Clinical Pharmacology ( 12.3 )] .
Storage & Handling
Storage 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]. Handling Protect from moisture and excessive heat.
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