MIUDELLA®
HORMONE-FREE PREGNANCY PREVENTION

Full Prescribing Information Important Safety Information

MIUDELLA® is a hormone-free, copper-releasing, long-acting reversible contraceptive. 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

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 insertion.
  • MIUDELLA® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA® REMS program to ensure all 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 distorts the uterine cavity and would be incompatible with correct IUS placement, acute pelvic inflammatory disease, postpartum endometritis or postabortal endometritis in past 3 months, known or suspected uterine or cervical malignancy, uterine bleeding of unknown etiology, 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 to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any trace elements present in the copper components of MIUDELLA®. Do not use MIUDELLA® for post-coital contraception (emergency contraception).
  • 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 painful periods, pelvic discomfort/pain, procedural pain, post procedural bleeding, and pain during sex.
  • 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.

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.

For important risk and use information about MIUDELLA®, please see Full Prescribing Information.

To learn more, call 1-866-246-2133.

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.