Jaimiess - Drug Monograph

Introduction

Jaimiess is a combination oral contraceptive medication containing ethinyl estradiol and levonorgestrel. It is a multiphasic extended-cycle regimen designed to provide contraception with fewer withdrawal bleeding episodes. This monograph provides comprehensive clinical information about Jaimiess for healthcare professionals.

Mechanism of Action

Jaimiess combines estrogen (ethinyl estradiol 30 mcg) and progestin (levonorgestrel 150 mcg) components that work synergistically to prevent ovulation through negative feedback on the hypothalamic-pituitary axis. The primary mechanisms include:

• Suppression of gonadotropin-releasing hormone (GnRH) secretion
• Inhibition of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release
• Thickening of cervical mucus, creating a barrier to sperm penetration
• Alteration of endometrial lining, reducing implantation potential

Indications

• Prevention of pregnancy
• Management of heavy menstrual bleeding (when used for contraception)
• Treatment of dysmenorrhea (when used for contraception)

Dosage and Administration

• 84 active tablets (yellow): ethinyl estradiol 30 mcg/levonorgestrel 150 mcg
• 7 hormone-free tablets (white)
• One tablet daily at approximately the same time each day
• Begin on first day of menstrual period or first Sunday after period begins

• Renal impairment: Use with caution; no specific dosage adjustment recommended
• Hepatic impairment: Contraindicated in hepatic disease
• Geriatric patients: Not indicated in postmenopausal women
• Adolescents: Safety and efficacy established for women who have reached menarche

Pharmacokinetics

• Ethinyl estradiol: Peak concentration reached in 1-2 hours; bioavailability ~43%
• Levonorgestrel: Peak concentration reached in 1-2 hours; bioavailability nearly 100%

• Ethinyl estradiol: Highly protein bound (~98%), primarily to albumin
• Levonorgestrel: Sex hormone-binding globulin (SHBG) bound (~50%) and albumin bound (~47%)

• Hepatic metabolism via cytochrome P450 system (primarily CYP3A4)
• Ethinyl estradiol: Extensive first-pass metabolism, hydroxylation and conjugation
• Levonorgestrel: Reduction followed by conjugation

• Ethinyl estradiol: Terminal half-life ~24 hours; excreted in urine and feces
• Levonorgestrel: Terminal half-life ~36 hours; excreted in urine and feces

Contraindications

• Current or history of thrombophlebitis or thromboembolic disorders
• Known or suspected carcinoma of the breast
• Known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Current or history of cerebrovascular or coronary artery disease
• Liver dysfunction or disease
• Known or suspected pregnancy
• Hypersensitivity to any component of Jaimiess

Warnings and Precautions

• Cigarette smoking increases risk of serious cardiovascular side effects; women over 35 years who smoke should not use combined oral contraceptives

• Increased risk of venous thromboembolism, myocardial infarction, and stroke
• Elevated blood pressure; monitor regularly
• Increased risk of liver tumors and gallbladder disease
• Carbohydrate and lipid metabolic effects
• Headache including migraine; evaluate new, persistent, or severe headaches
• Bleeding irregularities; rule out organic pathology if persistent
• Depression; monitor patients with history of depression
• Possible reduced efficacy with body mass index ≥30 kg/m²

Drug Interactions

• Rifampin, carbamazepine, phenytoin, St. John's wort: May reduce contraceptive efficacy

• Broad-spectrum antibiotics (e.g., penicillins, tetracyclines): May reduce contraceptive efficacy

• Protease inhibitors and non-nucleoside reverse transcriptase inhibitors: May alter contraceptive levels

• Anticoagulants: Potential altered anticoagulant effect
• Lamotrigine: May decrease lamotrigine levels
• Thyroid hormones: May increase thyroid-binding globulin
• Cyclosporine: Increased cyclosporine levels

Adverse Effects

• Headache (15-20%)
• Nausea (10-15%)
• Breast tenderness (8-12%)
• Irregular bleeding/spotting (30-40% in initial cycles)
• Mood changes (5-8%)

• Venous thromboembolism
• Myocardial infarction
• Stroke
• Hepatic adenomas
• Gallbladder disease
• Hypertension
• Glucose intolerance

Monitoring Parameters

• Blood pressure
• Body mass index
• Personal and family medical history
• Smoking status
• Lipid profile and glucose in high-risk patients

• Blood pressure every 6-12 months
• Annual comprehensive history and physical examination
• Symptom assessment for adverse effects
• Evaluation of persistent bleeding irregularities
• Assessment of visual changes or neurological symptoms

• Liver function tests if symptoms suggest hepatic dysfunction
• Lipid studies in women with hyperlipidemias
• Glucose tolerance testing in predisposed women

Patient Education

• Take tablet at same time daily to maintain effectiveness
• Use backup contraception during first 7 days of initial cycle
• Report severe abdominal pain, chest pain, headaches, eye problems, or leg pain immediately
• Understand signs and symptoms of thromboembolism
• Inform healthcare providers about Jaimiess use before any medical procedures
• Recognize potential drug interactions with other medications
• Understand that extended-cycle regimen results in fewer menstrual periods
• Report persistent spotting or bleeding after initial adjustment period
• Understand that Jaimiess does not protect against HIV or other sexually transmitted infections

• One tablet missed: Take as soon as remembered and next tablet at regular time
• Two consecutive tablets missed: Take two tablets as soon as remembered, then two tablets next day; use backup contraception for 7 days
• Three or more consecutive tablets missed: Discard pack, begin new pack on Sunday; use backup contraception for 7 days

References

1. FDA Prescribing Information: Jaimiess (ethinyl estradiol and levonorgestrel) tablets. 2019. 2. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-103. 3. Teal S, Edelman A. Contraception Selection, Effectiveness, and Adverse Effects: A Review. JAMA. 2021;326(24):2507-2518. 4. Practice Bulletin No. 206: Use of Hormonal Contraception in Women with Coexisting Medical Conditions. Obstet Gynecol. 2019;133(2):e128-e150. 5. Steinkampf MP, Hammond KR, Nichols JE, et al. Extended-cycle oral contraceptive use: a systematic review. Obstet Gynecol Surv. 2015;70(4):279-287. 6. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397-404. 7. Lidegaard Ø, Nielsen LH, Skovlund CW, et al. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011;343:d6423.