Kyleena

This device is placed inside the uterus by your doctor within 7 days after the start of your period. Your doctor will most likely perform a gynecological examination before the device is inserted to examine your uterus for correct placement and to rule out pregnancy or other gynecological conditions that would make using levonorgestrel undesirable.

The device is inserted during a routine office visit with your doctor and only takes a few minutes. You may have to go back to your doctor's office about 4 to 12 weeks after the device is inserted to ensure it is in the right position, and then once a year thereafter or as directed by your doctor. The device can be left in place for up to 5 years, after which you must decide whether to replace the device with a new one or simply to remove the old device.

It is important Kyleena (Levonorgestrel-intra-uterine) be used exactly as recommended by your doctor. If you miss an appointment to have a new levonorgestrel-releasing intrauterine device removed or inserted, contact your doctor as soon as possible to reschedule your appointment. After 5 years, this device may not prevent pregnancy.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause pimples (acne); it may cause headaches; it may cause stomach ache; it may affect menstruation (irregular or absence of menses); it may cause nausea or, rarely, vomiting; it may cause your breasts to feel swollen and tender. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Kyleena® consists of a small, white, T-shaped body made from soft, flexible plastic. The vertical and horizontal arms of the T-body are about 3 cm long. The vertical arm is surrounded by a narrow, cylindrical drug reservoir that contains levonorgestrel. Nonmedicinal ingredients: barium sulphate, copper phthalocyanine, polydimethylsiloxane elastomer, polyethylene, polypropylene, silica colloidal anhydrous, and silver. Two fine blue plastic threads are attached to the tip of the vertical arm. In addition, the vertical stem contains a silver ring located close to the horizontal arms, which is visible under ultrasound.

Do not take Kyleena (Levonorgestrel-intra-uterine) if you:

• are allergic to levonorgestrel or any ingredients or components of the device
• are or may be pregnant
• have a bacterial infection of the heart valves (Endocarditis)
• have a previously inserted intrauterine device that has not been removed
• have an infection of the genital tract
• have abnormal cells in the cervix
• have abnormalities of the uterus (e.g., fibroids) that distort the shape of the uterus
• have acute liver disease or a liver tumour
• have cancer that responds to progestins (i.e., uterine, cervical, or Breast Cancer)
• have current or recurrent pelvic inflammatory disease or a condition that increases the risk of pelvic inflammatory disease
• have had an abortion complicated by an infection within the past 3 months
• have inflammation of the cervix
• have inflammation of the endometrium (lining of the uterus) after pregnancy within the past 3 months
• have recently had an abnormal growth of cells inside the uterus
• have a tumour related to pregnancy
• have unexplained bleeding of the uterus

There may be an interaction between levonorgestrel intrauterine system and any of the following:

• acitretin
• anticoagulants (e.g., Apixaban, dabigatran, Rivaroxaban)
• Aprepitant
• Bosentan
• Cladribine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Dabrafenib
• diabetes medications (e.g., Canagliflozin, Glyburide, insulin, Linagliptin, Lixisenatide, Metformin, Rosiglitazone)
• Elagolix
• Flibanserin
• Heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, lopinavir, saquinavir, tipranavir)
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor and Ivacaftor
• mifepristone
• Modafinil
• mycophenolate
• Octreotide
• Pomalidomide
• retinoic acid medications (e.g., etretinate, Isotretinoin)
• rifampin
• St. John 's wort
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, Phenytoin, Rufinamide, Topiramate)
• Selegiline
• thalidomide
• Tranexamic acid
• Triazolam
• Ulipristal
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Kyleena (Levonorgestrel-intra-uterine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Kyleena (Levonorgestrel-intra-uterine).

Blood Clots: Kyleena (Levonorgestrel-intra-uterine) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Blood pressure: Levonorgestrel can cause an increase in blood pressure. If you have high blood pressure, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience an increase in your blood pressure after having this device inserted, contact your doctor.

Depression: Hormones, such as progestins, are known to contribute to mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking Kyleena (Levonorgestrel-intra-uterine), contact your doctor as soon as possible.

Diabetes: While low-dose contraceptives, such as this device, often have very little effect on blood sugar control, women with diabetes or those with a family history of diabetes should monitor their blood sugar closely to detect any worsening of blood sugar control.

Ectopic pregnancy: If you have a history of ectopic pregnancy (when a fertilized egg implants itself outside of the uterus), have had surgery on the fallopian tubes, or have had a pelvic infection, you should speak to your doctor or pharmacist before using this device. If you experience lower abdominal pain along with a missed period or unexpected bleeding while using Kyleena (Levonorgestrel-intra-uterine), contact your doctor.

Expulsion of device: Bleeding or pain may indicate that the device has either moved out of position or been expelled from the uterine cavity. A device that is out of position is less effective and should be removed and replaced by a new device.

Eye problems: Some women may experience a change in vision or contact lens tolerance. If this occurs, contact your eye doctor.

Headache: Levonorgestrel, like other hormones, may cause severe headache or migraine. If you have a history of migraine, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you notice increasing numbers or severity of Headaches after the device has been inserted, contact your doctor as soon as possible.

Heart disease: Levonorgestrel may increase the risk of developing blood clots, causing reduced blood flow to organs or the extremities. If you have a history of clotting, you may be at increased risk of experiencing blood-clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Heart valve disorders: Kyleena (Levonorgestrel-intra-uterine) can increase your risk of getting an infection in your heart valves if you were born with or have acquired a heart valve defect. You may need to take antibiotics before the insertion and removal of Kyleena (Levonorgestrel-intra-uterine) to prevent the infection.

Infections: In the first few weeks after this device is inserted, you may be at an increased risk of a serious infection known as pelvic inflammatory disease (PID). This infection can cause the development of pregnancy outside the uterus (ectopic pregnancy) or ongoing pelvic pain. If you experience heavy bleeding, unusual vaginal discharge, pain in the lower stomach area, pain during sexual activity, chills, or fever, contact your doctor as soon as possible.

Liver function: Women who have a history of liver problems, particularly during pregnancy, may also be at an increased risk of developing liver problems when using this device. Your doctor may want to test your liver function regularly with blood tests while you are taking Kyleena (Levonorgestrel-intra-uterine).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Menstrual bleeding: Some women may experience pain and bleeding when the device is inserted or removed. Irregular menstrual bleeding is common for the first few months after the device is inserted. Over time, menstrual bleeding decreases and may stop completely while the device is inserted.

If you develop unusual or unexpected menstrual bleeding after using Kyleena (Levonorgestrel-intra-uterine) for some time, contact your doctor.

Ovarian cysts: Kyleena (Levonorgestrel-intra-uterine) can cause the development of ovarian cysts. Most of these don't have any symptoms and disappear on their own within 2 to 3 months. However, if you experience pain in the pelvic area, contact your doctor.

Perforation: The chance of the device puncturing the cervix or uterus is very rare (between 1 in 1,000 and 1 in 10,000). If it were to occur, it would most likely be when the device is being inserted. If this happens, the device should be removed as soon as possible.

Removal of the device: If you experience any of the following, check with your doctor to see if you should have your device removed:

• confirmed or suspected breast or endometrial cancer
• migraines or severe headaches
• recurrent inflammation of the lining of the uterus
• recurrent pelvic infections
• significantly elevated blood pressure
• stroke or heart attack

Sexually transmitted infections (STIs): This device does not protect against STIs, including HIV/AIDS. For protection against STIs, use latex condoms.

Pregnancy: This device should not be used during pregnancy. If you become pregnant, have this device removed as soon as possible. The effects of levonorgestrel on a developing infant are not well known, and the risk of harm to the baby cannot be completely ruled out. Removal of this device or probing of the uterus may result in spontaneous abortion, but an intrauterine system that is left in place during pregnancy increases chances of having a miscarriage or premature delivery. Talk to your doctor about the risks to you and your unborn child.

Breast-feeding: Hormonal birth control, such as this device, is not the first choice of birth control for women who are breast-feeding. Kyleena (Levonorgestrel-intra-uterine) passes into breast milk. If you are a breast-feeding mother and are using levonorgestrel, it may affect your baby. Some women using Kyleena (Levonorgestrel-intra-uterine) have reported decreased milk production. Talk to your doctor about whether you should continue breast-feeding.

Children: The levonorgestrel-releasing intrauterine system is not intended to be used by girls who have not had their first menstrual period. The safety and effectiveness of using Kyleena (Levonorgestrel-intra-uterine) have not been established for adolescents less than 18 years old.

The intra-uterine device must be inserted by a doctor.