SEYSARA Film-coated tablet (2020)

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Almirall, LLC

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1. 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 ...

2. Dosage and 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 ...

3. Dosage Forms and Strengths

SEYSARA (sarecycline) tablets: 60 mg: capsule-shaped, yellow, film-coated tablets debossed with S60 on one side and blank on the other side. 100 mg: capsule-shaped, yellow, film-coated tablets debossed ...

4. Contraindications

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

5. Warnings and Precautions

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 ...

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 ...

7. Drug Interactions

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 ...

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 ...

8.2. Lactation

Risk Summary 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 ...

8.3. Females and Males of Reproductive Potential

Infertility 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 ...

8.4. Pediatric Use

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 ...

8.5. Geriatric Use

Clinical studies of SEYSARA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10. Overdosage

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. ...

11. Description

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 ...

12.1. Mechanism of Action

The mechanism of action of SEYSARA in treating acne vulgaris is not known.

12.2. Pharmacodynamics

The pharmacodynamics of SEYSARA for the treatment of acne vulgaris are unknown. Cardiac Electrophysiology At approximately 3 times the maximum recommended dose, SEYSARA did not prolong the QT interval ...

12.3. Pharmacokinetics

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 ...

12.4. Microbiology

Antimicrobial Activity Sarecycline is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown. Resistance P. acnes strains displayed ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

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 ...

14. Clinical Studies

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 ...

16.1. How Supplied

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: ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking SEYSARA should receive the following information and instructions: SEYSARA should not be used by pregnant ...