Kyleena 5 years official prescribing information?

Kyleena® (levonorgestrel 13.5 µg/day) – 5‑Year Use (Summarized Official Prescribing Information)
Note: This summary is provided for educational purposes only. It is not a substitute for the full prescribing information or professional medical advice. Always consult the full package insert or a qualified healthcare provider before using or prescribing Kyleena.

1. Product Description

• Device: Copper‑free levonorgestrel‑releasing intrauterine system (IUS).
• Release: 0.7 µg/day levonorgestrel.
• Packaging: Sterile, pre‑filled with a 2.0 mm × 4.4 mm polymer tube and a copper‑free plastic shaft.

2. Indications & Usage

• Indicated for:
  • Long‑acting reversible contraception (LARC) for women 15 years and older who desire reversible, effective contraception for up to 5 years.
• Duration: Up to 5 years from insertion.
• Contraindications:
  • Known hypersensitivity to levonorgestrel or any component.
  • Active pelvic infection or untreated pelvic inflammatory disease (PID).
  • Endometrial or cervical cancer.
  • Current pregnancy (do not insert in a pregnant patient).
  • History of systemic conditions that preclude levonorgestrel use (e.g., thrombotic disorders, estrogen‑sensitive cancers, or liver disease with impaired hormone metabolism).

3. Warnings & Precautions

4. Dosage & Administration

• Insertion:
  • Performed by a trained clinician in a sterile setting.
  • No pre‑procedure antibiotic prophylaxis required unless clinically indicated.
  • Follow standard IUS insertion protocol (e.g., ultrasound guidance if indicated).
• Removal:
  • Performed by the prescribing clinician.
  • Do not attempt self‑removal.
• Post‑Insertion:
  • No routine follow‑up required unless symptoms arise.
  • Women should be advised about signs of expulsion, perforation, or infection.

5. Adverse Reactions (Clinical Trial Data)

• Common (≥5 % incidence):
  • Menstrual changes (increased bleeding or spotting, especially in first 3 months).
  • Headache.
  • Breast tenderness.
  • Nausea.
  • Abdominal pain.
• Serious:
  • Expulsion (most common cause of discontinuation).
  • Uterine perforation (rare).
  • Pelvic infection/PID (rare if inserted per protocol).
  • Thromboembolic events (very rare; risk higher in predisposed individuals).

6. Pharmacology

• Mechanism of Action:
  • Levonorgestrel inhibits ovulation, thickens cervical mucus, and creates a hostile uterine environment for implantation.
• Absorption & Metabolism:
  • Local uterine release; minimal systemic absorption (~0.5 µg/L in plasma).
  • Metabolized primarily by hepatic CYP3A4.
• Pharmacokinetics:
  • Steady‑state achieved within 3 months.
  • Elimination half‑life ~18 h for levonorgestrel; device remains effective for 5 years.

7. Use in Special Populations

8. Contraindications

• Known hypersensitivity to levonorgestrel, any component, or prior adverse reaction to other intrauterine devices.
• Suspected or confirmed pregnancy.
• Active pelvic infection or untreated PID.
• Cervical stenosis preventing insertion.
• History of uterine anomaly or malformation.

9. Drug Interactions

• Rifampin, phenobarbital, carbamazepine, and other strong CYP3A4 inducers – May reduce levonorgestrel levels, decreasing contraceptive efficacy.
• Hormonal Contraceptive Withdrawal – No major interaction.
• Other IUDs – No additive effect; avoid simultaneous use.

10. Expiration and Storage

• Storage: Store at 25 °C (77 °F) ± 10 °C, protected from moisture.
• Shelf life: 5 years from date of manufacture.

11. Clinical Trial Highlights (5‑Year Data)

• Efficacy: Pearl Index < 0.2 per 100 woman‑years; < 1 % pregnancy rate over 5 years.
• Retention: ~90 % of devices remain in place after 5 years; expulsion rates ~1 % cumulative.
• Safety: Adverse event profile similar to that of the 3‑year data; no new safety signals.

12. Patient Counseling Points

• Effectiveness: Discuss high efficacy and reversible nature.
• Bleeding: Inform that bleeding patterns may change and usually improve after 6–12 months.
• Symptoms of Complications: Urge immediate reporting of fever, severe abdominal pain, heavy bleeding, or inability to feel the IUS string.
• Removal: Clarify that removal can be performed by a clinician at any time if the patient wishes to discontinue.

Disclaimer: This summary is based on the official prescribing information available as of the last update and may not include all details or the most recent updates. For complete and detailed information, please refer to the full prescribing information, which is available on the manufacturer’s website or through a licensed healthcare professional.