Copper (4 brand names, 2 dosage forms, 1 route)
Available dosage forms: SYSTEM, INTRAUTERINE DEVICE.
Routes of administration: INTRAUTERINE.
Brand Names
- CU-7
- MIUDELLA
- PARAGARD T 380A
- TATUM-T
Boxed Warning
Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1)]. Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1)]. 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 [see Warnings and Precautions (5.2)].
Indications and Usage
Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
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.
Adverse Reactions
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 Disease [see Warnings and Precautions (5.9)] Bleeding Pattern Alteration [see Warnings and Precautions (5.10)]
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.