WARNINGS AND PRECAUTIONS

• Risk of Complications Due to Improper Insertion: Improper insertion of IUSs, 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 www.miudellarems.com and 1-855-337-0772.
• Ectopic Pregnancy: Promptly evaluate females who become pregnant for ectopic pregnancy while using MIUDELLA. Ectopic pregnancy may require surgery and may result in loss of fertility.
• 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 and the thread ends are visible or can be retrieved from the cervical canal.
• Sepsis: Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other IUSs; strict aseptic technique is essential during insertion.
• Pelvic Infection: Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores after insertion of MIUDELLA. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Remove MIUDELLA in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment.

  Subclinical PID: PID may be asymptomatic but still result in tubal damage and its sequelae.

• 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. 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. If perforation is suspected or if known perforation occurs during placement, the IUS should be removed as soon as possible. Surgery may be required. 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. 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.
• 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.
• Bleeding Pattern Alterations: Menstrual bleeding may be altered and result in heavier and longer bleeding with spotting. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue MIUDELLA.
• Magnetic Resonance Imaging (MRI) Safety Information: Patients using MIUDELLA can be safely scanned with MRI only under certain conditions.
• 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.