Miudella
Copper · Intrauterine Device · Intrauterine
Uses
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.( 1 )
Dosage and administration
Insert a single Miudella at the fundus of the uterine cavity. Miudella must be removed or replaced after 3 years. ( 2.1 ) Insert Miudella only if you are a trained healthcare provider using clean technique. Follow insertion instructions exactly as described. ( 2.1 ) See the Full Prescribing Information for recommended timing of insertion, preparation instructions, insertion procedures, postplacement management, and instructions on removing Miudella. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Patient can be re-examined as clinically indicated. 2.1 Important Dosage and Administration Instructions Miudella is supplied sterile in a sealed package with a sterile single use inserter for placement. Do not open the package until required for insertion. Do not use if the seal of the sterile package is broken or appears compromised. Before considering use of Miudella, make sure that the patient is an appropriate candidate for Miudella. Exclude pregnancy (consider the possibility of ovulation and conception) prior to use [see Contraindications (4) and Warnings and Precautions (5) ]. Only a healthcare provider should insert Miudella. Healthcare providers should be thoroughly familiar with the product, product educational materials, product insertion instructions, and prescribing information before inserting Miudella. The IUS is provided preloaded in the inserter (see Figure A ). Remove Miudella on or before 3 years from the date of insertion. Replace Miudella at the time of removal with a new Miudella if continued contraceptive protection is desired. Figure A: Miudella Intrauterine System (IUS) Preloaded Inserter Figure B: Detailed diagram of Miudella Figure A Figure B 2.2 Timing of Insertion Miudella can be inserted at any time during the menstrual cycle. If switching to Miudella from another contraceptive, discontinue the previous method (see Table 1 ).
• Table 1: Recommended Timing of Miudella Insertion Clinical Scenario Recommended Timing of Miudella Insertion 1. Start Miudella in females not currently using contraception At any time during the menstrual cycle. 2. Switch to Miudella from an oral, transdermal, or vaginal form of hormonal contraception or an injectable progestin contraceptive At any time during the menstrual cycle; discontinue the previous method. 3. Switch to Miudella from a contraceptive implant or other intrauterine system Same day the implant or IUS is removed (insert at any time during the menstrual cycle). 2.3 Preparation for Insertion a. Ensure use of clean technique during the procedure. b. Perform a bimanual exam to establish the size, shape, and position of the uterus and to rule out abnormalities that would preclude safe placement of Miudella. c. Gently insert a speculum to visualize the cervix. d. Thoroughly cleanse the cervix with chlorhexidine or povidone-iodine. e. Apply a sterile tenaculum to the cervix. Apply traction with the tenaculum. Gently advance a sterile uterine sound to the fundus. Note any uterine anomaly and the depth in centimeters. 2.4 Insertion Procedure Step 1 – Open the Sterile Package a. Remove the sterile packaging containing Miudella from the box. b. Inspect the packaging to confirm a sterile barrier is maintained. Do not use if the packaging is not intact or there are concerns of compromised sterility. c. Peel back the paper lid ¾ of the way up the package to expose the inserter handle and flange. c.
• Step 2 – Setting the Flange a. Grasp the handle while maintaining your thumb or forefinger on the slider to restrict its movement. Gently lift the handle from the package, taking care not to bend or kink the insertion tube. Use the paper lid to hold the flange in the notch of the package, slowly pull the handle back, while keeping the flange in the notch, until the flange is set to the desired depth measured during sounding. Alternately, set the flange with sterile gloves after you have lifted the inserter out of the packaging. b. After setting the flange, remove the inserter from the package. a. c. Inspect the end of the inserter to confirm that Miudella is positioned as shown. c.
• Step 3 – Inserter Placement a. Continue applying upward pressure with the thumb/forefinger on the slider to avoid early deployment of the IUS. Maintain traction with the tenaculum and gently advance the inserter through the cervical canal. Progress slowly towards the fundus until the flange is at the level of the external cervical os and the tip of the inserter is at the fundus. CAUTION: Do not advance the flange beyond the external os, as this may result in fundal perforation. NOTE: Do not force the inserter into the external or internal cervical os. If necessary, consider use of an os finder or a small cervical dilator . a. Step 4 -Miudella Placement a. Once the flange is at the level of the external os, gently withdraw the inserter back towards you 1–2 cm. a. b. With the inserter tip 1-2 cm from the fundus (i.e., with the flange 1-2 cm from the os), move the slider to position ①. b. c. Holding the slider securely in position ①, slowly re-advance the inserter until you feel the fundus. c. d. With the IUS at the fundus, hold the inserter steady and move the slider to position ②. d. e. Release Miudella from the inserter: i. Hold the inserter handle steady with one hand and grasp the end cap with the other hand. ii. While holding the inserter steady with one hand, twist the green end cap (labeled ③ ) ½ - ¾ turn to the left with the other hand. iii. Remove end cap. One end of the white release thread is attached to the end cap as shown in the diagram and removing the end cap initiates removal of the release thread. iii. iv. Completely remove the white release thread from the inserter until you see the free end of the thread Do not cut the white release thread. The length of the release thread is approximately twice the length of the inserter. iv. f. Slowly remove the inserter from the cervix and vaginal cavity and properly dispose of the inserter and end cap with release thread.
Dosage forms and strengths
Intrauterine system: 175 mm 2 exposed copper surface area. Miudella has a nitinol frame with copper sleeves and monofilament polymer retrieval thread, preloaded in a sterile inserter.( 3 , 16 ) Intrauterine system: 175 mm 2 exposed copper surface area. Miudella is a copper-containing IUS that has a flexible nitinol frame with copper sleeves and monofilament polymer retrieval thread, preloaded in a sterile inserter with a tapered rounded tip and packaged in a sealed tray with lid.
Contraindications
The use of Miudella is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] Congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions (5.6) ] Postpartum endometritis or postabortal endometritis in the past 3 months. [see Warnings and Precautions (5.6) ] 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 [see Warnings and Precautions (5.6) ] Wilson's disease [see Warnings and Precautions (5.9) ] 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 [see Adverse Reactions (6) and Description (11) ] . 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. ( 4 ) Uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement. ( 4 ) Acute pelvic inflammatory disease (PID) ( 4 ) Postpartum endometritis or postabortal endometritis in past 3 months. ( 4 ) Known or suspected uterine or cervical malignancy ( 4 ) For use as post-coital contraception (emergency contraception) ( 4 ) Uterine bleeding of unknown etiology ( 4 ) Untreated acute cervicitis or vaginitis or other lower genital tract infection ( 4 ) Conditions associated with increased susceptibility to pelvic infections ( 4 ) Wilson's disease ( 4 ) A previously placed IUS that has not been removed ( 4 ) Hypersensitivity to any component of Miudella including copper, nitinol or any trace elements present in the copper components of Miudella ( 4 )
Warnings and precautions
Risk of Ectopic Pregnancy : Promptly evaluate females who become pregnant for ectopic pregnancy while using Miudella. ( 5.3 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove Miudella if pregnancy occurs with Miudella in place. ( 5.4 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion. ( 5.5 ) Pelvic Inflammatory Disease (PID) : Promptly evaluate patients with complaints of fever or abdominal pain after insertion of Miudella. ( 5.6 ) Perforation resulting in embedment or translocation : May reduce contraceptive effectiveness and require surgery. Risk is increased if inserted in postpartum and lactating females and may be increased if inserted in females with fixed, retroverted uteri or noninvoluted uteri. ( 5.7 ) Expulsion : Partial or complete expulsion may occur. Remove a partially expelled Miudella. ( 5.8 ) Bleeding patterns : May be altered and result in heavier and longer bleeding with spotting. ( 5.10 ) MRI Safety Information : Patients using Miudella can be safely scanned with MRI only under certain conditions. ( 5.11 ) 5.1 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 [see Warnings and Precautions (5.2) ]. 5.2 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 [see Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.2) ]. 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. 5.3 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). 5.4 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. 5.5 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. 5.6 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 [see Contraindications (4) ] . 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.
Side effects
The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions (5.3) ] Intrauterine pregnancy [see Warnings and Precautions (5.4) ] Sepsis [see Warnings and Precautions (5.5) ] Pelvic Infection [see Warnings and Precautions (5.6) ] Perforation [see Warnings and Precautions (5.7) ] Expulsion [see Warnings and Precautions (5.8) ] Wilson's Diseas e [see Warnings and Precautions (5.9) ] Bleeding Pattern Alteration [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5%) are: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 3.2 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 0.3 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.
Use in specific populations
8.1 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 [see Contraindications (4) and Warnings and Precautions (5.3 , 5.4) ] . 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. 8.2 Lactation Risk Summary No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, such as Miudella. There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Miudella and any potential adverse effects on the breastfed child from Miudella. 8.3 Females and Males of Reproductive Potential Return to Fertility After Discontinuing Miudella In Study 1 (NCT03633799), return to fertility was investigated in a total of 63 women who desired pregnancy after study discontinuation and provided follow-up information. The probability to conceive within 12 months after removal of Miudella was 74.1% [see Clinical Studies (14) ]. 8.4 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. 8.5 Geriatric Use Miudella has not been studied in women over 65 years of age and is not indicated in this population.
Pregnancy
8.1 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 [see Contraindications (4) and Warnings and Precautions (5.3 , 5.4) ] . 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
8.4 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.
Geriatric use
8.5 Geriatric Use Miudella has not been studied in women over 65 years of age and is not indicated in this population.
Description
11.1 Miudella Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem. Miudella has a total exposed copper surface area of 175 mm 2 and is provided sterile and preloaded in an inserter. Figure C: Diagram of Miudella Figure C 11.2 Inserter The inserter device provided with Miudella is a single use, disposable, sterile insertion system (insertion tube with a tapered rounded tip, depth markings and flange, and handle with slider and endcap); preloaded with the IUS for intrauterine administration. Once Miudella has been inserted, the inserter is discarded. Figure D: Diagram of Inserter Figure D
Mechanism of action
12.1 Mechanism of Action Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Miudella. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg.
How supplied
Miudella (copper intrauterine system) is a copper-containing sterile IUS preloaded in a single use inserter. Each single-use unit is packaged in a sealed tray with lid (NDC-78206-210-01). The IUS is comprised of a nitinol frame with 10 copper sleeves attached to provide a total copper surface area of 175mm 2 , and a monofilament polymer retrieval thread tied to the vertical arm. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Before inserting Miudella, counsel patients on the following: Sexually Transmitted Infections : Advise patients that Miudella does not protect against HIV infection and other sexually transmitted infections. Ectopic Pregnancy : Advise patients to report pregnancies and be evaluated immediately, as a pregnancy with Miudella in place is more likely to be an ectopic pregnancy, and the risks of ectopic pregnancy include the loss of fertility [See Warnings and Precautions (5.3) ]. Intrauterine Pregnancy : Advise the patient to contact her healthcare provider if she thinks she might be pregnant. Inform the patient about the risks of intrauterine pregnancy while using Miudella, including the risks of leaving Miudella in place and the risks of removing Miudella or probing of the uterus. An intrauterine pregnancy with Miudella in place may result in septic abortion, with septicemia, septic shock, and possible death. 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. If Miudella cannot be removed in a pregnant patient and remains in the uterus during a pregnancy, there is an increased risk of miscarriage, sepsis, premature labor and premature delivery. Advise patients that a pregnancy must be followed closely and advise patients to report immediately any symptom, such as flu- like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leaking of fluid, or any other symptom that suggests complications of the pregnancy. [See Warnings and Precautions (5.4) and Use in Special Populations (8.1) ]. Sepsis : Advise the patient that severe infection or sepsis, including Group A streptococcal sepsis (GAS), can occur within the first few days after Miudella is inserted. Instruct her to contact a healthcare provider immediately if she develops severe pain or fever shortly after Miudella is inserted, as untreated sepsis can result in death [See Warnings and Precautions (5.5) ]. Pelvic Infection : Advise the patient about the possibility of pelvic infections, including PID, after insertion of Miudella and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. Teach patients to recognize and report to their healthcare provider promptly any symptoms of pelvic infection. These symptoms include development of menstrual disorders (spotting or prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever. [See Warnings and Precautions (5.6) ]. Perforation and Expulsion : Advise the patient that the IUS may be expelled from or perforate the uterus and instruct her on how she can check that the thread ends still protrude from the cervix. Inform her that excessive pain or vaginal bleeding during Miudella placement, worsening pain or bleeding after placement, or the inability to feel Miudella strings may occur with Miudella perforation and expulsion. Caution her not to pull on the thread ends and displace Miudella. Inform her that there is no contraceptive protection if Miudella is displaced (for example, expelled or perforated through the uterus). If perforation resulting in displacement occurs, Miudella will have to be located and removed; surgery may be required. Instruct the patient to contact her healthcare provider if she cannot feel the thread ends and to avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide) until the location of Miudella has been confirmed [See Warnings and Precautions (5.7 , 5.8) ]. Bleeding Pattern Alterations : Advise patients that heavier or longer periods and spotting between periods may occur. Instruct patients to report continued or severe symptoms to their healthcare provider [See Warnings and Precautions (5.10) ]. Magnetic Resonance Imaging (MRI) Safety Information : Inform patients that Miudella can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their healthcare provider that they have Miudella. [See Warnings and Precautions (5.11) ]. Medical Diathermy : Instruct patients to tell their healthcare provider that they have Miudella prior to undergoing medical diathermy [see Warnings and Precautions (5.12) ]. Clinical Considerations for Use and Removal: Advise patients to contact their healthcare provider if any of the following occur: Pelvic pain or pain during sex Unusual vaginal discharge or genital sores Possible exposure to STIs Very heavy or prolonged vaginal bleeding Missed period Advise patients that they may use tampons or pads while using Miudella. Advise patients that menstrual cups or discs are not recommended for use with Miudella. Use may cause Miudella to become displaced or expelled.
Label text from the FDA structured product label by Organon LLC (revised Jul 2, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Copper in 1 product
Miudella NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 78206-210 | Copper 175 mm/1 Intrauterine Device | Organon LLC | NDA |
Frequently asked questions
What is Miudella used for?
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.( 1 )
What are the side effects of Miudella?
The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions (5.3) ] Intrauterine pregnancy [see Warnings and Precautions (5.4) ] Sepsis [see Warnings and Precautions (5.5) ] Pelvic Infection [see Warnings and Precautions (5.6) ] Perforation [see Warnings and Precautions (5.7) ] Expulsion [see Warnings and Precautions (5.8) ]… See the full label for the complete list.
Who makes Miudella?
Miudella is listed by 1 labeler in the FDA NDC directory, including Organon LLC.