Drospirenone

1 INDICATIONS AND USAGE SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in other sections of the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Bleeding Irregularities and Amenorrhea [see Warnings and Precautions (5.8) ] 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 [see Clinical Studies (14) ] . The mean time of SLYND exposure ranged from 197 to 328 days.

8.1 Pregnancy Risk Summary Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy ( See Data ). Discontinue SLYND if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

5 WARNINGS AND PRECAUTIONS 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. ( 5.1 ) Thromboembolic disorders: Discontinue SLYND if a thromboembolic event occurs. ( 5.2 ) Bone loss: It is unknown if SLYND may cause a clinically relevant loss of bone mineral density. ( 5.3 ) Liver Disease: Discontinue use if jaundice or acute or chronic disturbances of liver function develop. ( 5.5 ) Ectopic pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND. 4 CONTRAINDICATIONS SLYND is contraindicated in females with the following conditions: Renal impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] Adrenal insufficiency [see Warnings and Precautions (5.1) ] Presence or history of cervical cancer or progestin sensitive cancers [see Warnings and Precautions (5.4) ] Liver tumors, benign or malignant, or hepatic impair...