Miudella Drug Information
Generic name: COPPER
Copper-containing Intrauterine Device [EPC]
Uses of Miudella
Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Miudella is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
Dosage & Administration of Miudella
| At any time during the menstrual cycle. |
|---|---|
| At any time during the menstrual cycle; discontinue the previous method. |
| Same day the implant or IUS is removed (insert at any time during the menstrual cycle). |
Side Effects of Miudella
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure of 1,904 healthy 17- to 45-year-old women (mean age 27.5 ± 5.72 years) to Miudella. These data come from two multi-center contraceptive trials with a 3-year duration and a single, multi-center comparative bioavailability study with a 3 year duration, all conducted in the United States, enrolling generally healthy, postmenarcheal females to 45 years old.
In total 1,904 subjects were exposed to Miudella for one year and 916 completed three years. The data in these trials cover approximately 51,692 cycles of exposure. The following adverse reactions have been observed in ≥5% of users in clinical trials with Miudella: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, and dyspareunia.
Table 2 shows discontinuation rates from the 3 multi-center clinical studies by adverse reaction and year. Table 2: Summary of Rates Rates were calculated by weighting the annual rates by the number of subjects starting each year. (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation Year 1 2 3 Number of Women at Start of Year 1,904 1,463 1,118 Bleeding/Pain Bleeding/Pain includes the preferred terms (PTs) Abdominal pain, Abdominal pain lower, Post procedural discomfort, Procedural pain, Coital bleeding, Dysmenorrhea, Dyspareunia, Heavy menstrual bleeding, Intermenstrual bleeding, Menometrorrhagia, Pelvic discomfort, Pelvic pain, Polymenorrhea, Uterine hemorrhage, Uterine spasm 8.5 5.1
Expulsion 1.9 1.0 0.9 Other Medical Event Includes PTs embedded device (n=6)
and uterine perforation (n=1) 0.2 0.1
According to the safety analyses of these three studies, it was determined
the incidence of expulsion of Miudella did not vary significantly by body mass index (BMI). There was no statistically significant difference in the incidence of expulsion of Miudella in normal weight versus obese females.
Warnings & Cautions for Miudella
Risk of Complications Due to Improper Insertion Improper insertion of intrauterine systems
including Miudella, increases the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss (if pregnancy occurs with IUS in situ), and expulsion. 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 REMS.
Miudella
REMS Miudella is only available through a restricted program under a REMS called Miudella REMS Program to ensure healthcare providers are trained prior to first use. Notable requirements include the following: Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion of Miudella prior to first use. Pharmacies and healthcare settings that dispense Miudella must be certified by enrolling in the REMS and must only dispense Miudella to certified healthcare providers.
Further information is available at miudellarems.com and 1-855-337-0772.
Risk of Ectopic Pregnancy Evaluate for possible ectopic pregnancy in any female
who becomes pregnant while using Miudella because a pregnancy that occurs with Miudella in place is more likely to be ectopic than a pregnancy in the general population. However, because Miudella prevents most pregnancies, females who use Miudella have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception. The incidence of ectopic pregnancy in the clinical trials with Miudella was approximately 0.3%. Ectopic pregnancy may require surgery and may result in loss of fertility.
Patients who use Miudella should be informed about recognizing the signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professional, and about the associated risks of ectopic pregnancy (e.g., loss of fertility).
Risks with Intrauterine Pregnancy
If intrauterine pregnancy occurs with Miudella in place and the thread ends are visible or can be retrieved from the cervical canal, remove Miudella. Leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Miudella may also result in spontaneous abortion.
In the event of an intrauterine pregnancy with Miudella, consider the following: Septic Abortion In females becoming pregnant with an intrauterine system (IUS), including Miudella in place, septic abortion, with septicemia, septic shock, and death, may occur. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination.
A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility. Continuation of Pregnancy If a female becomes pregnant with Miudella in place and if Miudella cannot be removed or the female chooses not to have it removed, warn her that failure to remove Miudella increases the risk of miscarriage, sepsis, premature labor, and premature delivery. Prenatal care should include counseling about these risks and that she should report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.
Sepsis Severe infection or sepsis, including Group
A streptococcal sepsis (GAS), have been reported following insertion of IUSs. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections.
Aseptic technique during insertion of Miudella is essential to minimize serious infections such as GAS.
Pelvic Infection Promptly examine users with complaints of lower abdominal or pelvic
pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Miudella in cases of recurrent pelvic inflammatory disease or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. Pelvic Inflammatory Disease (PID) Miudella is contraindicated in the presence of known or suspected PID or endometritis . IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion.
Females at increased risk for PID PID is often associated with a sexually transmitted infection (STI), and Miudella does not protect against STI. The risk of PID is greater for females who have multiple sexual partners, and also for females whose sexual partner(s) have multiple sexual partners. Females who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the female is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome, intravenous drug abuse). Subclinical PID PID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PID Following a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of Miudella after initiation of antibiotic therapy is appropriate in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. Actinomycosis Actinomycosis has been associated with IUS use.
Symptomatic patients with known actinomycosis infection should have Miudella removed and receive antibiotics. Actinomycetes can be found in the genital tract cultures in healthy patients without IUSs. The significance of actinomyces-like organisms on Pap test in an asymptomatic IUS user is unknown, and so this finding alone does not always require Miudella removal and treatment.
When possible, confirm a Pap test diagnosis with cultures.
Perforation Partial or total perforation of the uterine wall or cervix may
occur during insertions, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy.
The incidence of perforation during or following Miudella insertion in clinical trials was 0.1% (2 out of 1904). A post-marketing safety study conducted in Europe (EURAS IUS) with IUSs, including copper IUSs, demonstrated an increased risk of perforation in postpartum and lactating women. The risk of perforation may be increased if an IUS, such as Miudella, is inserted when the uterus is fixed, retroverted or not completely involuted during the postpartum period. If perforation is suspected or if known perforation occurs during placement, the IUS should be removed as soon as possible.
Surgery may be required. Preoperative imaging followed by laparoscopy or laparotomy may be required to remove the IUS from the peritoneal cavity. Delayed detection or removal of Miudella in cases of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses and/or damage to adjacent organs.
Expulsion Partial or complete expulsion of Miudella has been reported, resulting in
the loss of contraceptive protection. The incidence of expulsion in the clinical trials with Miudella was 3.6% through 3 years of use. Consider further diagnostic imaging, such as x-ray, to confirm expulsion if the IUS is not found in the uterus on ultrasound.
Miudella should be placed no earlier than 4 weeks post-pregnancy to mitigate the risk of expulsion that may be increased when the uterus is not completely involuted at the time of insertion. Remove a partially expelled Miudella and do not attempt to push a partially expelled Miudella into the uterus. If expulsion has occurred, a new Miudella may be inserted when there is reasonable certainty the patient is not pregnant.
Wilson's Disease Miudella may exacerbate Wilson's disease, a rare genetic disease affecting
copper excretion; therefore, the use of Miudella is contraindicated in females with Wilson's disease . 5.10 Bleeding Pattern Alterations Miudella can alter the bleeding pattern and result in heavier and longer menstrual cycles with intermenstrual spotting. In three clinical trials with Miudella , menstrual changes were the most common medical reason for discontinuation. Discontinuation rates for pain and bleeding combined were highest in the first year of use and diminished thereafter.
The percentage of females who discontinued Miudella because of bleeding problems or pain during this study ranged from 8.5% in the first year to 3.2% in Year 3. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue Miudella . 5.11 Magnetic Resonance Imaging (MRI) Safety Information MRI Safety Information MR Conditional The Miudella Intrauterine Device (IUD) is MR Conditional. A patient with Miudella may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.
Nominal Values of Static Magnetic Field (T) 1.5-Tesla or 3.0-Tesla Maximum Spatial Field Gradient 40 T/m (4,000 gauss/cm) Type of RF Excitation Circularly Polarized (CP) (i.e., Quadrature-Transmission) Transmit RF Coil Information There are no transmit RF coil restrictions. Accordingly, the following may be used: body transmit RF coil and all other RF coil combinations (i.e., body RF coil combined with any receive-only RF coil, transmit/receive head RF coil, transmit/receive knee RF coil, etc.) Operating Mode Normal Operating Mode Maximum Whole-Body Averaged SAR 2 W/kg (Normal Operating Mode) Limits on Scan Duration 2 W/kg whole body average SAR for 60 minutes of continuous RF exposure (a sequence or back to back sequences/series without breaks) MR Image Artifact The presence of this implant produces an imaging artifact. In testing with gradient-echo sequencing, the shape of the image artifact follows the approximate contour of the device and extends radially up to 0.7 cm from the device.
Image 5.12 Medical Diathermy Medical equipment that contains high levels of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in females with a metal-containing IUS including Miudella. Avoid using high medical RF transmitter devices in females with Miudella.
Pregnancy Safety for Miudella
Pregnancy Risk Summary Use of Miudella is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Miudella may cause adverse pregnancy outcomes. If a female becomes pregnant with Miudella in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery . Advise the female of the potential risks if pregnancy occurs with Miudella in place. Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus.
Studies on Miudella and birth defects have not been conducted.
Pediatric Use of Miudella
Pediatric Use The safety and effectiveness of Miudella have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age. Miudella is not indicated in females before menarche.
Contraindications for Miudella
The use of Miudella is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy Congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) Postpartum endometritis or postabortal endometritis in the past 3 months. Known or suspected uterine or cervical malignancy For use as post-coital contraception (emergency contraception) 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 Hypersensitivity to any component of Miudella including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any of the trace elements present in the copper component of Miudella . Persons with allergic reactions to these components may suffer an allergic reaction to this intrauterine system. Prior to placement, patients should be counseled on the materials contained in the IUS, as well as potential for allergy/hypersensitivity to these materials.
Pregnancy or suspicion of pregnancy. Uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement. Acute pelvic inflammatory disease (PID) Postpartum endometritis or postabortal endometritis in past 3 months.
Known or suspected uterine or cervical malignancy For use as post-coital contraception (emergency contraception) 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 Hypersensitivity to any component of Miudella including copper, nitinol or any trace elements present in the copper components of Miudella
Clinical Studies of Miudella
The efficacy of Miudella for the prevention of pregnancy in women of reproductive potential for up to 3 years was demonstrated in Study 1 (NCT03633799), a multi-center, single-arm, open-label study conducted in the U.S. Women were excluded if they were less than six weeks postpartum, had a history of previous IUS complications, were known to be HIV positive, or were otherwise at high risk for sexually transmitted infections. There were no exclusions based on BMI. Study 1 included 1601 generally healthy women aged 17 to 45 years who had Miudella successfully placed. Of these 60% (960/1601) were nulliparous.
Successful placement of Miudella with first attempt occurred in 96% of the subjects and 99% with two insertion attempts by healthcare providers who received training on proper insertion prior to first use. The median age was 27 years, the mean weight was 75.3 kg (range 40.6 kg to 170.1 kg); mean BMI was 27.9 kg/m 2 (range 15.8 kg/m 2 to 63.5 kg/m 2 ); 74% were White, 15% were Black, 5% were Asian, and 6% were Other; 19% were Hispanic. The primary endpoint for Study 1 was the contraceptive efficacy of Miudella through 3 years of use as measured by the Pearl Index (PI) in women 17 to 35 years of age.
The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which no intercourse occurred, or back-up contraception was used unless a pregnancy occurred in that cycle. Women enrolled in the study provided 12,493 evaluable 28-day cycle equivalents in the first year and 27,115 evaluable cycles over the three-year treatment period. The PI for Year 1 was based on 9 pregnancies and the cumulative 3-year pregnancy rate was based on 22 pregnancies that occurred after the onset of treatment and within 7 days after Miudella removal or expulsion.
Table 4 shows the calculated annual pregnancy rates and cumulative 3-year pregnancy rate estimated by Pearl Index. Table 4: Pearl Indices by Year and 3-Year Cumulative Pregnancy Rate Of the 22 pregnancies, 2 occurred within 7 days of in-clinic removal of Miudella. Miudella Clinical Trial Pearl Index Cumulative 3-Year Pearl Index Year 1 Year 2 Year 3 Number of Evaluable 28- day Cycles of Exposure 12,493 8,150 6,472 27,115 Pregnancy Rate (95% Confidence Interval) 0.94 1.60 0.60 1.05 Of 54 subjects who desired pregnancy after study discontinuation and provided follow-up information, approximately 74.1% conceived within 12 months after removal of Miudella.
The majority of these subjects conceived within 4 months of removal and as early as the first week post-removal, demonstrating the reversibility of Miudella.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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