Generic Name

Kyleena

Mechanism

• Local progestin effect: Continuous release of levonorgestrel thickens cervical mucus, inhibits sperm motility, and reduces endometrial proliferation.
• Endometrial changes: Creates a sterile, low‑persistence environment (progestin‑induced atrophy) that leads to irregular bleeding and eventual amenorrhea in many users.
• Minimal systemic exposure: Serum levonorgestrel concentrations remain low (<0.1 ng/mL), limiting systemic hormonal side‑effects.

Pharmacokinetics

Indications

• Contraception: Effective ≤5 years, success rate <1 %/year.
• Menstrual regulation: Reduces dysmenorrhea, menorrhagia, and intermenstrual spotting.
• Gynecologic: Anemia correction, non‑iatrogenic surgical planning, and adjunct to hormonal therapy in uterine fibroids (limited evidence).

Contraindications

Absolute
• Suspected or known pregnancy
• Uterine abnormalities (e.g., fibroids >4 cm, uterine septum, cervical incompetence)
• Active pelvic infection or untreated PID
• Known or suspected uterine, cervical, or endometrial malignancy

Relative
• History of thromboembolic disease or hypercoagulable states
• Undiagnosed vaginal discharge/bleeding
• Breastfeeding mothers (no evidence of risk, but monitor)

Warnings
• Rare expulsions (≈3 % in first year)
• Perforation (1/10,000) – careful insertion technique required
• Adverse hormonal profile (weight gain, mood changes) – typically mild and transient

Dosing

• Insertion: Under sterile conditions; device length 2.1 cm, width 1.25 cm, flange diameter 2.4 cm. Place device tip within uterine cavity; remove inserter.
• Removal: Performed by trained provider; can be removed at any time up to 5 years.
• Re‑insertion interval: 60 days after removal or replacement.

Adverse Effects

Monitoring

• Baseline: Gynecologic exam, pregnancy test, ultrasound if indicated.
• Follow‑up: 4–8 weeks (check for expulsion, perforation symptoms); 6–12 months (bleeding patterns, uterine cavity review if abnormal bleeding).
• Annual review: Discuss continuation, removal options, and alternative contraception.
• Laboratory: Usually not required; consider CBC & pregnancy test if abnormal bleeding occurs.

Clinical Pearls

• Insertion technique matters: Use ultrasound guidance in nulliparous women to reduce perforation risk.
• Expulsion vs. displacement: Expulsion is typically symptomatic; displacement may present with spotting; remove for definitive diagnosis.
• Amenorrhea management: If a user experiences amenorrhea for >6 months, evaluate for atrophic endometrium; reassurance often sufficient.
• Adolescent use: Kyleena is FDA‑approved for 12 + years but ensure counseling on device maintenance and return visits.
• Fibroids: For fibroids ≤4 cm, Kyleena may reduce bleeding; larger fibroids limit device placement accuracy.
• Smoking & age: Women aged >35 who smoke have a higher risk of thromboembolism; review contraindications.
• Hormone‑related mood: Document baseline mood; if changes occur, assess for adjustment vs. hormone withdrawal.
• Post‑insertion bleeding: Common; educate patients that most spotting resolves within 3 months.

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• References

1. *FDA approval package insert*, Kyleena, 2023.

2. Bianchi, R., et al. “Clinical Outcomes with Levonorgestrel IUS: A Meta‑analysis.” *Am J Obstet Gynecol*, 2022.

3. Roberge, P.J., et al. “Adverse Events Associated with IUD Insertion.” *J Womens Health*, 2021.

*(All references are illustrative; consult up‑to‑date clinical guidelines for accurate data.)*