IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
Jasmiel is an estrogen/progestin combined oral contraceptive indicated for use by women to:
- Prevent pregnancy
- Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception
- Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control
Consult the Package Insert for Complete Prescribing Information
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases
- Undiagnosed abnormal uterine bleeding
- Breast cancer or other estrogen- or progestin-sensitive cancer
- Liver tumors or liver disease
- Co-administration with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir
WARNINGS AND PRECAUTIONS
- Vascular risks—Stop Jasmiel if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating Jasmiel in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
- Hyperkalemia—DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
- Liver disease—Discontinue Jasmiel if jaundice occurs.
- High blood pressure—Do not prescribe Jasmiel for women with uncontrolled hypertension or hypertension with vascular disease.
- Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Jasmiel. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
- Headache—Evaluate significant change in headaches and discontinue Jasmiel if indicated.
- Uterine bleeding—Evaluate irregular bleeding or amenorrhea
The most frequent adverse reactions (≥2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%), and mood changes (2.2%).
The most frequent adverse reactions (≥2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
Patients should be counseled that Jasmiel does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Jasmiel™ [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; September 2018.
Please see full Prescribing Information .
To report SUSPECTED ADVERSE REACTIONS, call
report via the FDA MedWatch Program at www.fda.gov/medwatch