Kurvelo - Drug Monograph

Introduction

Kurvelo (levonorgestrel and ethinyl estradiol) is a combination oral contraceptive pill containing synthetic forms of the hormones progesterone and estrogen. It is FDA-approved for pregnancy prevention and is also used for other gynecological indications. This monograph provides comprehensive clinical information about Kurvelo for healthcare professionals.

Mechanism of Action

Kurvelo works through multiple mechanisms to prevent pregnancy. The primary mechanism is suppression of gonadotropins through negative feedback on the hypothalamic-pituitary axis, which inhibits ovulation. Additionally, levonorgestrel alters cervical mucus consistency, creating a barrier to sperm penetration, and causes endometrial changes that reduce the likelihood of implantation.

Indications

• Prevention of pregnancy
• Treatment of moderate acne vulgaris in females ≥15 years who desire oral contraception, have no contraindications to oral contraceptive therapy, and have achieved menarche
• Management of heavy menstrual bleeding (off-label)
• Treatment of dysmenorrhea (off-label)

Dosage and Administration

• 21 active tablets followed by 7 inert tablets
• 24 active tablets followed by 4 inert tablets

• Start on first day of menstrual period or first Sunday after period begins
• Take at approximately the same time each day
• If vomiting or diarrhea occurs within 3-4 hours of ingestion, consider it a missed pill

• Renal impairment: Use with caution
• Hepatic impairment: Contraindicated in hepatic disease
• Pediatrics: Not indicated before menarche
• Geriatrics: Not indicated in postmenopausal women

Pharmacokinetics

• Levonorgestrel: Protein binding ~98% (SHBG and albumin)
• Ethinyl estradiol: Highly protein bound (~98%) to albumin

• Levonorgestrel: Elimination half-life ~24-36 hours
• Ethinyl estradiol: Elimination half-life ~6-20 hours
• Both components excreted in urine and feces

Contraindications

• Current or history of thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease
• Known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas
• Known or suspected pregnancy
• Hypersensitivity to any component
• Heavy smoking (≥15 cigarettes/day) in women over 35 years

Warnings and Precautions

• Increased risk of venous thromboembolism, myocardial infarction, and stroke
• Elevated blood pressure; monitor regularly
• Increased risk of liver tumors
• Possible slight increase in breast cancer risk
• Carbohydrate and lipid metabolic effects
• Headaches including migraines; evaluate new onset headaches
• Bleeding irregularities
• Depression
• Possible reduced efficacy with body weight ≥90 kg

Drug Interactions

Adverse Effects

• Nausea (15%)
• Headache (15%)
• Breast tenderness (8%)
• Irregular uterine bleeding (30%)
• Weight changes
• Mood changes

• Venous thromboembolism
• Arterial thromboembolism
• Hepatic adenomas
• Hypertension
• Gallbladder disease

Monitoring Parameters

• Blood pressure at baseline and periodically
• BMI and weight
• Signs and symptoms of thromboembolism
• Headache patterns
• Visual changes
• Depression symptoms
• Liver function (if indicated)
• Lipid profile (if indicated)
• Cervical cytology (as per screening guidelines)

Patient Education

• Take pill at same time daily for maximum effectiveness
• Use backup contraception if missing pills or during antibiotic therapy
• Report severe abdominal pain, chest pain, headaches, eye problems, or leg pain immediately
• Do not smoke while taking oral contraceptives
• This medication does not protect against HIV or other sexually transmitted infections
• May take several cycles for menstrual patterns to regulate
• Contact healthcare provider for pregnancy suspicion
• Inform all healthcare providers of oral contraceptive use

References

1. FDA Prescribing Information: Kurvelo (levonorgestrel and ethinyl estradiol tablets). 2021 2. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-104 3. Practice Bulletin No. 152: Emergency Contraception. Obstet Gynecol. 2015;126(3):e1-e11 4. Stegeman BH, de Bastos M, Rosendaal FR, et al. Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis. BMJ. 2013;347:f5298 5. Gallo MF, Nanda K, Grimes DA, Lopez LM, Schulz KF. 20 μg versus >20 μg estrogen combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2013;(8):CD003989