Description
Levonorgestrel-releasing intrauterine system is a device that contains the female hormone, levonorgestrel. It is placed in the uterus (womb) where it slowly releases the hormone to prevent pregnancy for up to 3 years for Skyla®, up to 5 years for Kyleena®, or up to 8 years for Liletta® and Mirena®. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
Levonorgestrel-releasing intrauterine system is also used to treat heavy menstrual bleeding for up to 5 years in women who choose this device as their method for birth control.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Insert, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levonorgestrel in teenage females. This medicine may be used for birth control in teenage females but is not recommended before the start of menstruation.
Geriatric
Appropriate studies on the relationship of age to the effects of levonorgestrel have not been performed in the geriatric population. This medicine is not recommended for use in elderly women.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dasabuvir
- Fezolinetant
- Ombitasvir
- Paritaprevir
- Ritonavir
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Bacampicillin
- Belzutifan
- Betamethasone
- Bexarotene
- Bosentan
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Chlortetracycline
- Clobazam
- Cloxacillin
- Colesevelam
- Cyclacillin
- Cyclosporine
- Dabrafenib
- Darunavir
- Demeclocycline
- Dexamethasone
- Dicloxacillin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acitretin
- Amitriptyline
- Atazanavir
- Clomipramine
- Diazepam
- Doxepin
- Imipramine
- Lamotrigine
- Leflunomide
- Licorice
- Lorazepam
- Perampanel
- Selegiline
- Tacrine
- Temazepam
- Teriflunomide
- Triazolam
- Voriconazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Abnormally-shaped uterus or uterine fibroids or
- Breast cancer, known or suspected, or a history of or
- Cancer of the uterus or cervix, known or suspected or
- Genital tract infections (eg, bacterial vaginosis, cervicitis, endometritis, vaginitis), acute and untreated or
- Infection (eg, leukemia, pneumonia, HIV/AIDS) or
- IUD that has not been removed, previous or
- Liver disease, including tumors or cancer or
- Pelvic infection (active or untreated), history of or
- Pelvic inflammatory disease (a serious pelvic infection) or endometritis, or history of—Should not be used in patients with these conditions.
- Bleeding problems or
- Blood clots or
- Bradycardia (slow heartbeat) or
- Diabetes or
- Fainting, history of or
- Heart attack, history of or
- Heart disease or other heart problems (eg, congenital heart disease, heart valve problems) or
- Hypertension (high blood pressure), severe or
- Migraine headaches, severe or
- Ovarian cysts or
- Seizures or
- Stroke, history of—Use with caution. May make these conditions worse.
- Ectopic pregnancy (pregnancy outside the uterus), history of or
- Pelvic infection or
- Tubal surgery, history of—May increase the risk of having ectopic pregnancy.
Proper Use
Your doctor will give you this medicine in a hospital or clinic. This intrauterine device (IUD) is inserted into your uterus.
This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor may want to do tests to make sure you do not have an infection before putting in an IUD. The IUD is usually inserted during your monthly period, immediately after a miscarriage or an abortion in the first trimester of your pregnancy, at least 4 to 6 weeks after a miscarriage or an abortion in the second trimester of your pregnancy, or at least 4 to 6 weeks after giving birth. Putting an IUD in during a monthly period also helps to make sure that you are not pregnant. You will also need to see your doctor within 4 to 6 weeks of having your IUD inserted and then once a year. Use another form of birth control or refrain from having sex if the IUD is not inserted during the first 7 days of your menstrual cycle.
Levonorgestrel IUD has a string or "tail" which is made of plastic thread. About one or two inches of this string hangs into your vagina. You cannot see this string, and it will not cause problems when you have sex. Check your IUD string every few days during the first few months that you have your IUD. After that, check the string after each monthly period. You may not be protected against pregnancy if you cannot feel the string or if you feel the plastic. Do the following to check the placement of your IUD:
- Wash your hands with soap and warm water. Dry them with a clean towel.
- Bend your knees and squat low to the ground.
- Gently put your index (pointing) finger high inside your vagina. The cervix is at the top of the vagina and feels like the tip of your nose. Find the IUD string coming from your cervix. Never pull on the string. You should not be able to feel the firm plastic of the IUD itself.
- Wash your hands after you are finished checking your IUD.
If you are using levonorgestrel-releasing IUD to prevent pregnancy, you will need to have your device replaced every 3 years for Skyla®, 5 years for Kyleena®, or 8 years for Liletta® and Mirena®, or sooner if it comes out of your uterus unexpectedly.
If you are using Liletta® or Mirena® treat heavy menstrual bleeding, you will need to have it replaced every 5 years, or sooner if it comes out of your uterus unexpectedly.
If you are using Kyleena®, Liletta®, Mirena®, or Skyla®, and want to stop, your doctor can remove it at any time. However, you may become pregnant as soon as Kyleena®, Liletta®, Mirena®, or Skyla® is removed, or if you have intercourse the week before Liletta® is removed. Use another form of birth control (eg, condoms, spermicides) or have a new IUD inserted at the same day of removal to keep from getting pregnant.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be 4 to 6 weeks after insertion and then once a year, but some doctors would require them more often.
There is a small chance that you could get pregnant when using an IUD, just as there is with any birth control. If you get pregnant, your doctor may remove your IUD to lower the risk of miscarriage or other problems.
Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy (occurs outside the womb) if you get pregnant while your IUD is in place. This can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.
An IUD can slip partly or all the way out of your uterus without you knowing it. If this happens, you will have no protection against getting pregnant or you may have an increased risk for serious problems. This is more likely during the first year that you have your IUD, but it can happen at any time. Regularly checking the string of your IUD can tell you if it is still in place.
You may have some blood spotting and cramping during the first few weeks after the IUD has been inserted. These symptoms should go away within a few months. Rarely, the IUD may make a hole in the wall of your uterus when it is inserted. If this happens, check with your doctor right away.
Using Kyleena®, Liletta®, Mirena®, or Skyla® can increase your risk for severe infections, including sepsis. This is a rare and life-threatening condition that requires immediate medical attention. Talk to your doctor if you have concerns about this risk.
An IUD can increase your risk of having a serious infection of the female organs, called pelvic inflammatory disease (PID) or endometritis (pregnancy-related), which can be serious, even life threatening. This infection could cause scarring of the female organs, which may make it hard for you to become pregnant in the future, and can increase your risk of ectopic pregnancy.
Call your doctor right away if you have flu-like symptoms, fever, chills, cramps, pain, bleeding, or fluid leaking from your vagina. These may be signs that you have an infection.
This medicine may increase your risk of having ovarian cysts or cancer of the breast, uterus, or cervix. It may also cause yellowing of the skin or the whites of the eyes (jaundice). Talk to your doctor if these concern you.
This medicine may also increase your risk of having high blood pressure (hypertension), clotting problems, or serious heart and blood vessel problems including heart attack or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, problems with vision, speech, or walking, or unusual bleeding, bruising, or weakness.
This device will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begins to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.
It is important to tell your doctor that you are using this medicine before you have a medical procedure, such as magnetic resonance imaging or MRI.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Absent, missed, or irregular menstrual periods
- longer or heavier menstrual periods
- mild bloating
- stomach or pelvic pain or spasm
- stopping of menstrual bleeding
- unusually heavy or unexpected menstrual bleeding
- uterine bleeding between menstrual periods
- vaginal bleeding or spotting
Less common
- Blurred vision
- cramps
- dizziness
- headache
- heavy bleeding
- itching of the vagina or genital area
- nervousness
- pain
- pain during sexual intercourse
- pale skin
- pounding in the ears
- slow or fast heartbeat
- swelling
- thick, white vaginal discharge with mild or no odor
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- white or brownish vaginal discharge
Rare
- Chills
- confusion
- dizziness, lightheadedness, fainting
- fast heartbeat
- fast, weak pulse
- fever
- pale, cold, clammy skin
- rapid, shallow breathing
- sudden increase in stomach or shoulder pain
- sweating
- unusual or large amount of vaginal bleeding
Incidence not known
- Clear or bloody discharge from the nipple
- dimpling of the breast skin
- dull or aching stomach pain
- foul-smelling vaginal discharge
- increased blood pressure
- increased urge to urinate
- inverted nipple
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lump in the breast or under the arm
- pain during urination
- persistent crusting or scaling of the nipple
- redness or swelling of the breast
- severe stomach pain or cramping
- sharp pain on insertion
- shivering fever
- sores on the skin of the breast that does not heal
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Blemishes on the skin
- breast pain or discomfort
- dandruff
- depression
- nausea or vomiting
- oily skin
- pimples
Less common
- Back pain
- breast tenderness
- decreased interest in sexual intercourse
- full or bloated feeling
- hair loss
- hives or welts, itching, or rash
- increased hair growth, especially on the face
- increased weight
- loss in sexual ability, desire, drive, or performance
- pressure in the stomach
- redness of the skin
- skin rash, encrusted, scaly, and oozing
- swelling of the stomach area
- thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20073437
