Liletta

Pregnancy Prevention

Liletta is primarily used as a long-term, reversible method of birth control. It is a small, T-shaped plastic device that is inserted into the uterus by a healthcare professional. It is approved to prevent pregnancy for up to 8 years. The device can be removed by a healthcare provider at any time if the user decides they want to become pregnant or switch to a different contraceptive method.

Heavy Menstrual Bleeding

This intrauterine system is also used to treat heavy menstrual bleeding, often referred to as menorrhagia. It is specifically indicated for individuals who choose to use an intrauterine device as their primary method of contraception and also experience heavy periods.

Important Considerations

• Liletta is intended for use by individuals who can become pregnant.
• This device is not used as emergency contraception.
• It does not provide protection against HIV infection (AIDS) or other sexually transmitted infections (STIs).

How Liletta Prevents Pregnancy

Liletta is an intrauterine system (IUS) that releases levonorgestrel, a progestin hormone, directly into the uterus. It works through several different mechanisms to provide long-term contraception.

Primary Mechanisms

• Changes to Cervical Mucus: The hormone thickens the mucus in the cervix, creating a physical barrier that makes it difficult for sperm to pass into the uterus.
• Sperm Inhibition: Liletta affects the movement and survival of sperm within the uterus and fallopian tubes, preventing them from reaching or fertilizing an egg.
• Alteration of the Uterine Lining: The continuous release of levonorgestrel thins the lining of the uterus (the endometrium). This makes the environment less suitable for a fertilized egg to attach.

In some cases, the hormone may also prevent the ovaries from releasing an egg (ovulation), although many individuals using Liletta continue to ovulate regularly. The device is effective primarily because of its local effects within the reproductive system.

Common Side Effects

The most frequently reported side effects associated with Liletta include:

• Changes in menstrual bleeding, such as irregular periods, spotting, heavier bleeding, or the absence of a period
• Pelvic or abdominal pain
• Headaches or migraines
• Acne
• Vaginal discharge or inflammation
• Breast tenderness
• Nausea

Serious Side Effects

Seek medical attention immediately if you experience symptoms of these rare but serious conditions:

• Pelvic inflammatory disease (PID), a serious infection of the reproductive organs
• Perforation, which occurs if the device moves through the wall of the uterus
• Expulsion, where the device is pushed out of the uterus partially or completely
• Ectopic pregnancy, a life-threatening condition where a pregnancy develops outside the uterus
• Ovarian cysts, which may cause pelvic pain
• Severe allergic reactions
• Sepsis, a severe systemic infection

Serious Risks

Ectopic Pregnancy: If a pregnancy occurs while using Liletta, there is a high risk that it will be located outside the uterus (ectopic pregnancy). This is a medical emergency that may require surgery and can affect future fertility.

Sepsis and Infection: Severe, life-threatening infections can occur within the first few days after insertion. Pelvic inflammatory disease (PID) is also a risk, which can lead to infertility or chronic pelvic pain. Symptoms such as severe pain or fever shortly after insertion require immediate medical attention.

Perforation and Expulsion: The device may pierce the wall of the uterus or cervix (perforation), usually during insertion. If this happens, the device may move outside the uterus and must be removed, often through surgery. Liletta may also be pushed out of the uterus (expulsion) by the body, which makes it ineffective for preventing pregnancy.

Contraindications

Liletta should not be used if certain conditions are present, including:

• Pregnancy or suspected pregnancy.
• Current or recurrent pelvic inflammatory disease or a history of PID.
• Known or suspected progestogen-sensitive cancer, such as breast cancer.
• Unexplained vaginal bleeding.
• Uterine abnormalities, such as large fibroids, that distort the uterine cavity and interfere with insertion.
• Acute liver disease or liver tumors.
• Current infection of the cervix or vagina, or a high susceptibility to pelvic infections.

Other Precautions

Bleeding Pattern Changes: Most users will experience changes in their menstrual bleeding. This may include irregular spotting, heavier bleeding, or the complete absence of periods (amenorrhea) over time. These changes are common and do not necessarily indicate pregnancy.

Ovarian Cysts: Some users may develop enlarged follicles on the ovaries, often called ovarian cysts. These usually do not cause symptoms and often disappear on their own within two to three months, but they may occasionally cause pelvic pain and require monitoring.

MRI Safety: Liletta is considered MR-conditional. Healthcare providers should be informed about the device before an MRI scan is performed to ensure the procedure is conducted safely.

Pregnancy

Liletta is used to prevent pregnancy and should not be used if you are already pregnant. If pregnancy occurs while the device is in place, it must be removed promptly by a healthcare professional. Continuing a pregnancy with an intrauterine device (IUD) in place increases the risk of severe complications, including miscarriage, premature birth, and life-threatening infections.

There is also an increased risk of ectopic pregnancy (a pregnancy outside the uterus) if conception occurs while using Liletta. This is a serious condition that requires immediate medical intervention.

Breastfeeding

Levonorgestrel, the hormone in Liletta, is known to pass into breast milk in small amounts. Current evidence suggests that using this system while breastfeeding does not negatively impact the quality or quantity of milk or the health and development of the infant. It is generally recommended to wait at least six weeks after delivery before inserting the device to minimize risks.

Available Forms

Liletta is available as an intrauterine system (IUS). It is a small, T-shaped device made of flexible plastic.

The system includes the following components:

• A drug reservoir located on the vertical stem of the T-shaped frame.
• Removal threads attached to the bottom of the device to allow for monitoring and removal.
• A sterile insertion device used for placement by a healthcare provider.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Liletta in 2015 as a long-acting reversible contraceptive. It is a hormone-releasing system placed in the uterus by a healthcare provider. The FDA has approved Liletta for two primary uses:

• Contraception: To prevent pregnancy for up to 8 years.
• Heavy Menstrual Bleeding: To treat heavy menstrual bleeding for up to 5 years in people who choose intrauterine contraception.

Regulatory History and Extensions

The FDA has updated the regulatory status of Liletta multiple times to extend its approved duration of use. While it was initially approved for 3 years, clinical data supported subsequent extensions to 4, 5, 6, and eventually 8 years for pregnancy prevention. These extensions are based on cumulative safety and efficacy data from ongoing clinical trials.

Safety Requirements

There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements for Liletta. The FDA monitors the device through standard post-marketing surveillance to track reports of serious adverse events, such as pelvic infection, ectopic pregnancy, or device displacement.

Insurance and Coverage

Most private health insurance plans cover the full cost of Liletta as a preventive service under the Affordable Care Act. This coverage typically includes the device itself, the office visit for insertion, and follow-up care. Medicaid and other government-funded programs also frequently cover the cost of this intrauterine system.

Retail Pricing

For individuals without insurance or those whose plans do not cover the device, the retail price for one Liletta device is approximately $984. This price generally covers only the device; additional fees from the healthcare provider for the insertion procedure and any necessary medical exams will likely apply.

Financial Assistance Options

If you do not have insurance or have high out-of-pocket costs, there are options available to help make the device more affordable:

• Patient Assistance Programs: The manufacturer may offer programs to help eligible patients access the device at a reduced cost.
• Community Clinics: Many family planning centers and public health clinics offer services on a sliding fee scale based on income, which can significantly lower the price of the device and the insertion procedure.
• Cost Verification: It is recommended to contact your insurance provider or the healthcare facility in advance to confirm coverage and understand the total expected costs.