MIUDELLA®
HORMONE-FREE PREGNANCY PREVENTION

Full Prescribing Information
Important Safety Information

MIUDELLA® is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. MIUDELLA® is made of nitinol with flexible and super-elastic properties that can conform to different uterine shapes and sizes and contains less than half the copper of the currently available copper IUD.1-3

Clinical Study Information2

  • Data for 3 years is available
  • Phase 3 study is ongoing to evaluate efficacy, safety, and tolerability up to 8 years
  • Prospective, multicenter, single-arm, open-label study to 3 years with extension up to 8 years
  • In the efficacy cohort (n=1,397):
    • First-year Pearl Index was 0.94 (95% CI, 0.43-1.78)
    • Cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)
  • Safety was evaluated in three clinical trials (N=1,904)
    • Most common adverse events were similar to those seen with use of IUDs: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia
    • In the first year, 8.5% of participants across all three safety studies discontinued due to bleeding or pain, with lower numbers discontinuing due to these adverse events in years 2 and 3 (5.1% and 3.2%, respectively)
  • Expulsion rates were low, ranging from 1.9% in year 1 to 0.9% in year 3

INDICATION FOR MIUDELLA®

MIUDELLA is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.

IMPORTANT SAFETY INFORMATION

  • WARNING: Improper insertion of intrauterine systems, including MIUDELLA, increases the risk of complications.
  • Proper training prior to first use of MIUDELLA can minimize the risk of improper MIUDELLA insertion.
  • MIUDELLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA REMS program to ensure healthcare providers are trained on the proper insertion of MIUDELLA prior to first use. Further information is available at miudellarems.com and 1-855-337-0772.

CONTRAINDICATIONS

  • Don’t use MIUDELLA if you are or may be pregnant, have a uterine anomaly that may affect correct placement, acute pelvic inflammatory disease, postpartum endometritis or postabortal endometritis in past 3 months, known or suspected uterine or cervical malignancy, for use as post-coital contraception (emergency contraception), unexplained bleeding, untreated acute cervicitis or vaginitis or other lower genital tract infection, conditions associated with increased susceptibility to pelvic infections, Wilson's disease, a previously placed IUS that has not been removed and/or hypersensitivity to any component of MIUDELLA including copper, nitinol or any trace elements present in the copper components of MIUDELLA.
  • Pregnancy with MIUDELLA is rare but can be life threatening and cause infertility or loss of pregnancy.
  • MIUDELLA may attach to or go through the uterus and cause other problems.
  • Tell your healthcare provider (HCP) if you develop severe pain or fever shortly after placement, miss a period, have abdominal pain, or if MIUDELLA comes out. If it comes out, use backup birth control.
  • At first, periods may be altered and result in heavier and longer bleeding with spotting in between.
  • Tell your HCP you have MIUDELLA before having an MRI or a medical procedure using heat therapy.
  • Additional common side effects include anemia, pain during sex, backache, and vaginal discharge.
  • MIUDELLA does not protect against HIV or STDs.

Only you and your HCP can decide if MIUDELLA is right for you. Available by prescription only.

For additional information or to report suspected adverse reactions, please contact Sebela Women’s Health Inc at 1-866-246-2133.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for the Full Prescribing Information for MIUDELLA

References

1. ClinicalTrials.gov. Evaluation of Efficacy, Safety, and Tolerability of VeraCept IUD. Accessed February 14, 2024. https://clinicaltrials.gov/study/NCT03633799

2. MIUDELLA® [package insert]. Roswell, GA: Sebela Women’s Health Inc.

3. U.S. Food and Drug Administration. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol Guidance for Industry and Food and Drug Administration Staff. Accessed February 14, 2025. https://www.fda.gov/media/123272/download.