Seysara

SEYSARA- sarecycline hydrochloride tablet, coated
Almirall, LLC

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 UseEfficacy 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)].

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 (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.

3 DOSAGE FORMS AND STRENGTHS

SEYSARA (sarecycline) tablets:

  1. 60 mg: capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side.
  2. 100 mg: capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side.
  3. 150 mg: capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Teratogenic Effects

  1. 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.
  2. 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.
  3. 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.

6 ADVERSE REACTIONS

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%).

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 (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.

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