Sarecycline

The Basics

What is Sarecycline?

Used to treat moderate to severe acne.

Brand names for Sarecycline

Seysara

How Sarecycline is classified

Anti-Infective Agents, Antibacterial Agents, Tetracyclines

Sarecycline During Pregnancy

Sarecycline pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Sarecycline while pregnant

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) . 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. Data 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 (‚â• 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). Lactation

Taking Sarecycline While Breastfeeding

What are recommendations for lactation if you're taking Sarecycline?

No information is available on the use of sarecycline during breastfeeding. The manufacturer states that breastfeeding is not recommended during treatment. However, based on the excretion of other tetracycline antibiotics, amounts in milk are expected to be low and probably poorly absorbed orally by the breastfed infant. If an infant is breastfed, monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. As a theoretical precaution, avoid prolonged or repeat courses during nursing.

Maternal / infant drug levels

No information is available on the use of sarecycline during breastfeeding. The manufacturer states that breastfeeding is not recommended during treatment. However, based on the excretion of other tetracycline antibiotics, amounts in milk are expected to be low and probably poorly absorbed orally by the breastfed infant. If an infant is breastfed, monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. As a theoretical precaution, avoid prolonged or repeat courses during nursing.

Possible effects of Sarecycline on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Sarecycline