Drospirenone

SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.

SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.

Take one tablet taken daily for 28 days, one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days.

SLYND is contraindicated in females with the following conditions: Renal impairment Adrenal insufficiency Presence or history of cervical cancer or progestin sensitive cancers Liver tumors, benign or malignant, or hepatic impairment Undiagnosed abnormal uterine bleeding Renal impairment. Adrenal insufficiency. Presence or history of progestin sensitive cancers. Liver tumors, benign or malignant, or hepatic impairment. Undiagnosed abnormal uterine bleeding

Hyperkalemia: Check serum potassium levels during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions of diseases with medications that may increase serum potassium concentrations. Thromboembolic disorders: Discontinue SLYND if a thromboembolic event occurs. Bone loss: It is unknown if SLYND may cause a clinically relevant loss of bone mineral density. Liver Disease: Discontinue use if jaundice or acute or chronic disturbances of liver function develop. Ectopic pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND. Risk of Hyperglycemia in Patients with Diabetes: Patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring.

The following clinically significant adverse reactions are described elsewhere in other sections of the labeling: Hyperkalemia Bleeding Irregularities and Amenorrhea 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. The data described below reflect the exposure of SLYND in females of reproductive potential desiring to prevent pregnancy based on four clinical studies including Study CF111/303. The mean time of SLYND exposure ranged from 197 to 328 days. The demographic profile for the pooled study data was: mean age 28 years, mean BMI 25 kg/m 2, racial distribution was 83% White, 14% Black, 1% Asian and 2% Other.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of SLYND or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with SLYND.

Store at 25°C (77°F), excursions permitted from 15 to 30°C (59 to 86°F).