The brand name of the drug is Kyleena, and its active ingredient is levonorgestrel in an intrauterine system form. It belongs to the class of progestins. Kyleena is formulated to release approximately 17.5 micrograms per day of levonorgestrel after 24 days.

How should I use this medication?

This device is placed inside the uterus by your care team.

A patient package insert for the product will be given each time it is inserted. Be sure to read this information carefully each time. The sheet may change often.

Talk to your care team about use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. Depending on the brand of device you have inserted, the device will need to be replaced every 3 to 8 years if you wish to continue using this type of birth control.

Where should I keep my medication?

This does not apply.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Pelvic inflammatory disease (PID)—fever, abdominal pain, pelvic pain, pain or trouble passing urine, spotting, bleeding during or after sex
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Vaginal pain, irritation, or sores
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Irregular menstrual cycles or spotting
• Nausea
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal Pap smear
• Cancer of the breast, uterus, or cervix
• Diabetes
• Endometritis
• Genital or pelvic infection now or in the past
• Have more than one sexual partner or your partner has more than one partner
• Heart disease
• History of an ectopic or tubal pregnancy
• Immune system problems
• IUD in place
• Liver disease or tumor
• Problems with blood clots or take blood-thinners
• Seizures
• Use intravenous drugs
• Uterus of unusual shape
• Vaginal bleeding that has not been explained
• An unusual or allergic reaction to levonorgestrel, other hormones, silicone, or polyethylene, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Interactions are not expected. Tell your care team about all the medications you take.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular check-ups. Tell your care team if you or your partner becomes HIV positive or gets a sexually transmitted disease.

Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs).

You can check the placement of the IUD yourself by reaching up to the top of your vagina with clean fingers to feel the threads. Do not pull on the threads. It is a good habit to check placement after each menstrual period. Call your care team right away if you feel more of the IUD than just the threads or if you cannot feel the threads at all.

The IUD may come out by itself. You may become pregnant if the device comes out. If you notice that the IUD has come out use a backup birth control method like condoms and call your care team.

Using tampons will not change the position of the IUD and are okay to use during your period.

This IUD can be safely scanned with magnetic resonance imaging (MRI) only under specific conditions. Before you have an MRI, tell your care team that you have an IUD in place, and which type of IUD you have in place.