Slynd® Important Safety Information


Indication

SLYND (drospirenone) tablets are a progestin, indicated for females of reproductive potential to prevent pregnancy.

Contraindications

SLYND is contraindicated in females with renal impairment, adrenal insufficiency, a presence or history of cervical cancer or progestin sensitive cancers, liver tumors (benign or malignant) or hepatic impairment, and undiagnosed abnormal uterine bleeding.

Warnings and Precautions

Hyperkalemia: SLYND has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females. Check serum potassium levels prior to starting treatment and during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Monitor females taking SLYND who later develop conditions and/or begin medication that put them at an increased risk for hyperkalemia.

Thromboembolic Disorders: Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism. Consider the increased risk of thromboembolism inherent in the postpartum period and in females with a history of thromboembolism. Discontinue SLYND if a thromboembolic event occurs and consider discontinuing SLYND in case of prolonged immobilization due to surgery or illness.

Bone Loss: Treatment with SLYND leads to decreased estradiol serum levels. It is unknown if this may cause a clinically relevant loss of bone mineral density.

Liver Disease: Discontinue SLYND if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and SLYND causation has been excluded.

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: Females with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring. Progestins, including SLYND, may decrease insulin sensitivity.

Bleeding Irregularities and Amenorrhea: Females may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. If bleeding persists, occurs after previously regular cycles, or if scheduled bleeding does not occur, evaluate for possible causes such as pregnancy or malignancy.

Depression: Carefully observe females with a history of depression and discontinue SLYND if depression recurs to a serious degree. Data on the association of progestin-only contraceptive products with onset of depression and exacerbation of depression are limited.

The most common adverse reactions (>1%) are: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, decreased libido, breast tenderness, irregular menstruation.

Drug Interactions

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 non-hormonal method of contraception when enzyme inducers are used with SLYND and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer. Drugs or products that inhibit CYP3A4 may increase SLYND systemic exposure.