Kyleena, illustration of medicine carton form (not a photo of the actual pack)

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Kyleena

Levonorgestrel

Prescription required

$241.00

19.5mg · 1 package

BrandBranded medicine· By Bayer

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About Kyleena

Overview

Kyleena is an intrauterine device (IUD) that releases levonorgestrel, a progestin hormone. It is used to prevent pregnancy. Its exact contraceptive mechanism is not fully established, but it may work by thickening cervical mucus to block sperm, affecting sperm function or survival, and changing the lining of the uterus.

What it treats

Prevention of pregnancy for up to 5 years.

Safety information

Side effects

Common side effects include inflammation of the vagina and vulva, ovarian cysts, abdominal or pelvic pain, headache or migraine, acne or oily skin, painful periods or uterine cramps, breast pain or discomfort, and increased bleeding. Bleeding patterns may become irregular, and periods may stop. Contact a doctor if pregnancy occurs with Kyleena in place. Risks include pregnancy outside the uterus (ectopic pregnancy), loss of fertility, pregnancy loss, severe infection associated with miscarriage, shock, death, and premature labor or delivery. Other serious risks requiring medical attention include pelvic inflammatory disease, severe group A streptococcal infection following insertion, and perforation of the uterus, which may require surgery and reduce contraceptive protection. Kyleena may also come out partly or completely without being noticed, leading to loss of contraceptive protection. Persistent enlarged ovarian follicles or ovarian cysts need medical evaluation.

When to call your doctor

• Seek medical attention immediately if you become pregnant while Kyleena is in place, because serious pregnancy complications can occur. • Contact your doctor about abdominal or pelvic pain or increased vaginal bleeding. • Contact your doctor promptly if Kyleena comes partly or completely out, as it may no longer prevent pregnancy.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Kyleena must not be used if you: • Are pregnant or think you may be pregnant, or need emergency contraception after sex. • Have an abnormality of the uterus, including fibroids, that changes the shape of the uterine cavity. • Have active pelvic inflammatory disease (PID), or a history of PID unless you have since had a pregnancy within the uterus. • Have had an infection of the uterine lining after childbirth or an infected abortion within the past 3 months. • Have known or suspected cancer of the uterus or cervix. • Have or have previously had breast cancer or another cancer sensitive to progestins, or such a cancer is suspected. • Have unexplained uterine bleeding. • Have an untreated acute infection of the cervix or vagina, including bacterial vaginosis, or another lower genital tract infection, until it is controlled. • Have acute liver disease or a liver tumour, whether benign or cancerous. • Have a condition that increases your susceptibility to pelvic infections. • Already have an intrauterine device (IUD) that has not been removed. • Are allergic to any component of Kyleena. Pregnancy with Kyleena in place requires prompt medical assessment and removal by a healthcare professional. Risks include pregnancy outside the uterus (ectopic pregnancy), loss of fertility, pregnancy loss, severe infection that may cause shock or death, and premature labour and delivery. The risk of the device piercing the uterine wall is higher during breastfeeding and may also be higher after childbirth or if the uterus is fixed in a backward-tilted position. This can reduce contraceptive protection and may require surgery. Kyleena may also come out partly or completely without being noticed, leading to loss of contraceptive protection. Pelvic infection risks should be assessed before use. Serious group A streptococcal infection has been reported after insertion, so strict sterile technique is essential. Persistent enlarged ovarian follicles or ovarian cysts need assessment. Bleeding may become irregular or stop. MRI scanning is safe only under specific conditions; tell the MRI team that you have Kyleena.

Interactions

No drug interaction studies have been conducted with Kyleena. Tell your doctor about medicines and herbal products you use. Some may affect enzymes that break down levonorgestrel, including CYP3A4, and raise or lower its level in the blood. However, these interactions are unlikely to affect Kyleena’s contraceptive effect because it releases levonorgestrel directly into the uterus.

Using Kyleena

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in the original pack, away from direct light, heat and moisture. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label KYLEENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.] (DailyMed, retrieved 19 September 2026).

Patient information and references

Official and supporting information to read alongside advice from your prescriber or pharmacist.

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