JAYDESS® 13.5mg

JAYDESS® is a levonorgestrel-releasing intrauterine system (IUS) designed for long-acting reversible contraception. It consists of a small, T-shaped polyethylene frame containing 13.5 mg of levonorgestrel, a synthetic progestogen hormone. This hormone is slowly released into the uterus over a period of up to three years, preventing pregnancy through local hormonal effects rather than systemic hormone absorption. JAYDESS works by thickening cervical mucus, inhibiting sperm motility, and altering the endometrial lining, creating an unfavorable environment for fertilization and implantation.

• Duration of Action: Up to 3 years
• Onset: Contraceptive effect begins immediately after insertion
• Reversibility: Rapid return to fertility after removal
• Device Type: Hormonal IUS

JAYDESS must be inserted by a trained healthcare professional using a sterile, preloaded insertion device. Placement should occur during the first 7 days of the menstrual cycle unless otherwise directed.

• Insertion Timing: Within 7 days of menstruation onset
• Placement: Intrauterine (into the uterus)
• Insertion Device: Preloaded sterile applicator
• Removal/Replacement: After 3 years or earlier if desired
• Follow-up: Examination at 4–12 weeks post-insertion, then annually

JAYDESS is indicated for prevention of pregnancy in women of reproductive age who desire a long-acting contraceptive option.

Indications:

• Long-term contraception (up to 3 years)
• Women seeking hormone-based IUS with low systemic exposure

Contraindications:

• Pregnancy
• Active pelvic inflammatory disease (PID)
• Cervical or uterine tumors
• Unexplained uterine bleeding
• Anatomical abnormalities (e.g., fibroids distorting the cavity)
• Liver disease or tumors
• Allergy to levonorgestrel or IUS components

Side Effects:

• Common: Spotting, irregular bleeding, acne, pelvic pain, ovarian cysts
• Less Common: Mood changes, breast tenderness, headache
• Serious (rare): Perforation, expulsion, pelvic infections, ectopic pregnancy

JAYDESS contains both active and inactive pharmaceutical ingredients, carefully formulated for gradual and localized hormone delivery.

• Active Ingredient: Levonorgestrel – 13.5 mg per system
• Matrix Material:
  
  • Dimethylsiloxane/methylvinylsiloxane cross-linked elastomer
  • Membrane of the same elastomer
• Other Components:
  
  • Colloidal anhydrous silica
  • Polyethylene
  • Barium sulfate (for radiopacity)
  • Iron oxide black (CI 77499) (in threads)
  • Silver ring for ultrasound detection

Each unit is packaged in a sterile applicator designed for single use. The device is intended for direct insertion into the uterus by a clinician.

• Contents:
  
  • 1 x JAYDESS® IUS (levonorgestrel 13.5 mg)
  • 1 x sterile insertion device
• Additional Features:
  
  • Two brown removal threads
  • Silver ring in stem visible via ultrasound
• Packaging: Single-use, sterile, tamper-evident pack

Side effects are generally mild and most common during the first 3–6 months of use. Serious complications are rare but must be managed promptly.

• Common:
  
  • Irregular bleeding or spotting
  • Ovarian cysts (usually resolve spontaneously)
  • Headache, acne, mood swings
• Less Common:
  • Pelvic pain
  • Breast tenderness
  • Vaginal infections
• Serious (Rare):
  
  • Perforation of the uterus
  • Expulsion of the device
  • Pelvic inflammatory disease (PID)
  • Ectopic pregnancy
  • Allergic reactions (e.g., rash, facial swelling, anaphylaxis)

Proper storage is essential to maintain sterility and device performance until insertion.

• Storage Temperature: Below 30°C
• Avoid: Moisture, heat, sunlight
• Shelf Life: Refer to expiration date on outer carton
• Safety: Keep out of reach of children
• Packaging: Do not use if damaged or expired