MIRENA® 20mg

MIRENA® is a levonorgestrel-releasing intrauterine system (IUS) designed for long-term use inside the uterus. It provides hormonal contraception for up to 8 years, treatment of heavy menstrual bleeding (menorrhagia) for up to 5 years, and endometrial protection during estrogen replacement therapy in menopausal women for up to 5 years.

It works by thinning the uterine lining, thickening cervical mucus to block sperm, and in some cases, inhibiting ovulation. The device releases levonorgestrel gradually, averaging 15 micrograms/day over 5 years. It is T-shaped, made of polyethylene with barium sulfate for X-ray visibility, and includes two threads for checking placement or removal.

MIRENA® must be inserted by a qualified healthcare professional under aseptic conditions. Proper positioning is essential for efficacy and safety.

Key features:

• Releases levonorgestrel locally in the uterus
  
• Provides up to 8 years of contraception
  

Protocol:

• Insert within 7 days of menstruation onset for immediate protection
  
• Insert ≥6 weeks postpartum or immediately after abortion (<3 months)
  
• Use backup contraception for 7 days if timing doesn’t ensure protection
• Replace or remove after 8 years, or earlier if indicated

Indications:

• Contraception for up to 8 years
  
• Idiopathic menorrhagia (heavy menstrual bleeding) for up to 5 years
  
• Endometrial protection during estrogen replacement therapy in menopause for up to 5 years
  

Contraindications:

• Known or suspected pregnancy
  
• History or presence of progestogen-dependent tumors (e.g. breast cancer)
  
• Pelvic infections, cervical or uterine cancer, or abnormal uterine bleeding
  
• Liver disease, uterine abnormalities, or hypersensitivity to ingredients
  

Side effects:

• Common: Headache, acne, mood changes, irregular bleeding
  
• Serious: Uterine perforation, expulsion, ectopic pregnancy, pelvic infection

Active ingredient:

• Levonorgestrel 20 mg (released gradually over time)
  

Other components:

• Polydimethylsiloxane elastomer, anhydrous colloidal silica
  
• Polyethylene frame with barium sulfate (radiopaque)
  
• Polyethylene threads colored with iron oxide
  

Release rate:

• ~19 µg/day initially
  
• Decreases to ~11 µg/day after 5 years
  
• ~7 µg/day after 8 years

Each sterile, sealed package includes:

• 1 MIRENA intrauterine system (preloaded in an inserter)
  
• 1 sterile inserter system
  
• Patient reminder card
  
• Packaging suitable for healthcare professional use only

Yes, MIRENA® can cause side effects, most commonly within the first few months of insertion.

Very common (>1 in 10):

• Headache
  
• Abdominal pain
  
• Irregular bleeding or spotting
  

Common (≤1 in 10):

• Acne, mood changes, breast tenderness
  
• Pelvic infections, back pain, ovarian cysts
  
• Weight changes, loss of libido
  

Uncommon/Rare:

• Uterine perforation
  
• Hair loss, chloasma (pigmentation)
  
• Allergic reactions, blood clots (rare but serious)

Storage requirements:

• Keep in original packaging until use
  
• Protect from moisture and sunlight
  
• Do not use if packaging is damaged
  
• Store below 25°C (77°F)
  
• Only healthcare professionals should open the packaging