MIRENA®

MIRENA® Product Overview

MIRENA® is a levonorgestrel-releasing intrauterine delivery system designed for effective long-term contraception, heavy menstrual bleeding treatment, and endometrial hyperplasia protection during estrogen replacement therapy. The device offers hormonal regulation with localized effects in the uterus.

• Type: Intrauterine delivery system
• Active Ingredient: Levonorgestrel 52 mg
• Usage Duration: Up to 8 years for contraception, 5 years for other indications

MIRENA® Key Features and Benefits

MIRENA® provides reliable, reversible contraception and significant menstrual bleeding reduction. It also offers protection against endometrial hyperplasia in menopausal women.

• Contraception Efficacy: Approximately 99.8% effective
• Menstrual Benefits: Reduces heavy bleeding within 3–6 months
• Local Hormonal Action: Limits systemic side effects

MIRENA® Indications and Treatment Applications

This device addresses several gynecological needs:

• Contraception: Long-term prevention of pregnancy
• Menorrhagia: Reduces idiopathic heavy menstrual bleeding
• Menopause Management: Protects against endometrial hyperplasia during estrogen therapy

MIRENA® Dosage and Administration

Insertion must be performed by a trained healthcare professional using sterile technique. The release of levonorgestrel decreases over time, averaging 15 mcg/day over five years.

• Insertion Timing:
  • Within 7 days of menstruation onset for immediate contraception
  • At least 6 weeks postpartum
  • Immediately post-abortion if no infection is present
• Replacement: Can be swapped with a new device at any cycle stage

MIRENA® Side Effects and Warnings

Common side effects are most noticeable within the first few months. MIRENA® may affect menstrual patterns and has rare but serious risks like uterine perforation or pelvic infections.

• Common Side Effects:
  • Spotting or irregular bleeding
  • Headache, abdominal pain, or acne
  • Mood changes, including depression
• Severe Risks:
  • Uterine perforation during insertion
  • Rare ectopic pregnancies
  • Increased breast cancer risk for postmenopausal estrogen users

MIRENA® Precautions and Contraindications

Before use, women should consult a healthcare provider for a full medical history and necessary tests.

• Contraindications:
  • Current or suspected pregnancy
  • Abnormal uterine anatomy or infections
  • Progestogen-dependent tumors
• Precautions:
  • Not suitable as emergency contraception
  • Close monitoring for users with migraines or cardiovascular risks

MIRENA® Long-Term Considerations

While effective, the device may cause conditions requiring removal or replacement.

• Fertility Restoration: Fertility returns promptly after removal.
• Osteoporosis Risk: No direct link but long-term hormonal therapy warrants monitoring.

MIRENA® Manufacturer and Regulatory Information

MIRENA® is manufactured by Bayer OY in Turku, Finland, and distributed globally. Updated information is accessible via QR code or regulatory websites.

• Manufactured By: Bayer OY, Finland
• Last Revision: July 2023

MIRENA® FAQs

What makes MIRENA® different from other contraceptives?

MIRENA® provides localized hormonal action, minimizing systemic side effects while offering long-term efficacy.

Can I become pregnant after removing MIRENA®?

Yes, fertility typically returns quickly after removal.

Is MIRENA® safe for breastfeeding mothers?

Small hormone amounts may pass into breast milk but are considered safe for nursing.

How often should MIRENA® be checked?

Regular checks are advised at 6 weeks post-insertion, 12 months, and annually thereafter.

What happens if MIRENA® dislodges?

Check the threads regularly, and consult a healthcare provider if the device is misplaced or expelled.