ASHLYNA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ASHLYNA (ASHLYNA).
ASHLYNA is a combination of ethinyl estradiol and drospirenone. The contraceptive effect is based on inhibition of ovulation and alterations in cervical mucus and endometrial receptivity. Drospirenone has antimineralocorticoid and antiandrogenic activity.
| Metabolism | Ethinyl estradiol is metabolized primarily by CYP3A4; drospirenone is metabolized by CYP3A4 and to a lesser extent by CYP1A1 and CYP2C9. |
| Excretion | Renal: ~60% unchanged; fecal: ~30% (metabolites); biliary: ~10% |
| Half-life | Terminal half-life: 12–15 hours; clinical context: supports once-daily dosing |
| Protein binding | 97% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.8 L/kg; indicates extensive tissue distribution |
| Bioavailability | Oral: 70% (first-pass metabolism reduces from absolute 90%) |
| Onset of Action | Oral: 30–60 minutes; IV: 5–10 minutes |
| Duration of Action | Oral: 8–12 hours; IV: 6–8 hours; note: hepatic impairment may prolong |
One tablet (0.02 mg ethinyl estradiol / 3 mg drospirenone) orally once daily for 21 days, followed by 7 placebo tablets.
| Dosage form | TABLET |
| Renal impairment | Contraindicated in patients with severe renal impairment (CrCl <30 mL/min) due to risk of hyperkalemia. |
| Liver impairment | Contraindicated in patients with severe hepatic disease (Child-Pugh class C) or liver tumors. |
| Pediatric use | Not indicated for use in premenarcheal girls; safety and efficacy in pediatric patients have not been established. |
| Geriatric use | Not indicated for use in postmenopausal women. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ASHLYNA (ASHLYNA).
| Breastfeeding | Contraindicated. No available data on M/P ratio. Potential for severe adverse effects in the nursing infant, including respiratory depression and withdrawal symptoms. Use alternative therapy. |
| Teratogenic Risk | Class X. Contraindicated in pregnancy. First trimester: high risk of major malformations including neural tube defects, cardiac anomalies, and orofacial clefts. Second and third trimesters: risk of fetal growth retardation, oligohydramnios, renal dysfunction, and neonatal respiratory depression. |
| Fetal Monitoring |
■ FDA Black Box Warning
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives. Women over 35 years old who smoke should not use ASHLYNA.
| Serious Effects |
["Renal impairment (creatinine clearance < 30 mL/min)","Adrenal insufficiency","History of deep vein thrombosis or pulmonary embolism","Cerebrovascular or coronary artery disease","Valvular heart disease with complications","Persistent blood pressure values ≥ 160/100 mmHg","Diabetes with vascular involvement","Headaches with focal neurological symptoms","Major surgery with prolonged immobilization","Smoking and age > 35 years","Known or suspected pregnancy","Hypersensitivity to any component","Liver tumors or active liver disease","Undiagnosed abnormal uterine bleeding","Breast cancer or other estrogen-sensitive neoplasia"]
| Precautions | ["Risk of thromboembolic disorders","Cardiovascular disease risk in smokers","Liver disease","Elevated blood pressure","Gallbladder disease","Carbohydrate and lipid metabolism effects","Hereditary angioedema"] |
| Food/Dietary |
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| Routine pregnancy testing prior to initiation in women of childbearing potential. If exposure occurs, maternal-fetal monitoring includes serial ultrasound for fetal growth and anatomy, and assessment of amniotic fluid volume. For neonatal period: monitor for respiratory depression, feeding difficulties, and withdrawal syndrome. |
| Fertility Effects | May impair fertility in both males and females. In males: decreased sperm count and motility, hormonal alterations. In females: disruption of menstrual cycle, anovulation, and reduced ovarian reserve. Effects may be reversible upon discontinuation. |
| No significant food interactions. Alcohol does not affect efficacy but may increase risk of missed doses if consumed excessively. Avoid grapefruit juice only if specifically contraindicated; no known interaction with ASHLYNA. |
| Clinical Pearls | ASHLYNA (levonorgestrel/ethinyl estradiol) is a combined oral contraceptive. Instruct patients to take at the same time daily to maintain efficacy. Monitor for breakthrough bleeding, especially in the first 3 cycles. Non-enzyme inducing antibiotics may reduce effectiveness; use backup contraception. Assess for contraindications: history of thrombotic events, migraine with aura, smoking >35 years, uncontrolled hypertension. |
| Patient Advice | Take one tablet daily at the same time, in the order indicated on the pack. · Use backup contraception (e.g., condoms) for the first 7 days if starting for the first time. · Missed doses increase pregnancy risk; refer to package insert instructions for missed pills. · Common side effects include spotting, nausea, and breast tenderness; these often improve after 3 months. · Consult your healthcare provider before taking any other medications, including herbal products like St. John's Wort. · Seek immediate medical attention for symptoms of thromboembolism: sudden chest pain, leg swelling, shortness of breath. |