Generic Name: levonorgestrel (Intrauterine route)

lee-voe-nor-JES-trel

Commonly used brand name(s)

In the U.S.

  • Mirena
  • Skyla

Available Dosage Forms:

  • Insert, Extended Release

Therapeutic Class: Contraceptive, Local

Pharmacologic Class: Progestin

Uses For Mirena

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 (TM) or up to 5 years for Mirena(R). 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.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Levonorgestrel-releasing intrauterine system is also used to treat heavy menstrual bleeding in women. It works best in women who have had at least one child.

This medicine is available only with your doctor's prescription.

Before Using Mirena

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.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

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.

Interactions with Medicines

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.

  • 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.

  • Carbamazepine
  • Ceritinib
  • Dabrafenib
  • Fentanyl
  • Isotretinoin
  • Mitotane
  • Piperaquine
  • Siltuximab
  • Theophylline
  • Tizanidine

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
  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Colesevelam
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Eslicarbazepine Acetate
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Modafinil
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Perampanel
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Tacrine
  • Telaprevir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Voriconazole
  • Warfarin

Interactions with Food/Tobacco/Alcohol

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 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, vaginitis), acute and untreated, or
  • Infection (eg, leukemia, pneumonia, HIV/AIDS) or
  • Liver disease, including tumors or cancer or
  • Pelvic infection (active or untreated), history of or
  • Pelvic inflammatory disease (a serious pelvic infection), or history of—Should not be used in patients with these conditions.
  • Bleeding problems or
  • Blood clots or
  • Diabetes 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
  • Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of levonorgestrel

This section provides information on the proper use of a number of products that contain levonorgestrel. It may not be specific to Mirena. Please read with care.

Your doctor will give you this medicine in a hospital or clinic. The intrauterine device (IUD) is inserted into your uterus.

This medicine comes with a patient information insert. Read and follow the 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 or immediately after a miscarriage or an abortion in the first trimester of your pregnancy. 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 12 weeks of having your IUD placed and then once a year.

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 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.

You will need to have your levonorgestrel-releasing IUD replaced every 3 years for Skyla(TM), or 5 years for Mirena(R), or sooner if it comes out of your uterus.

Precautions While Using Mirena

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 every 4 to 12 weeks after insertion, but some doctors require them more often.

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 if you get pregnant while your IUD is in place. An ectopic pregnancy 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 of 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 can happen at any time. Regularly checking the string of your IUD can tell you if your IUD 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.

An IUD increases your risk of a serious infection of the female organs called pelvic inflammatory disease (PID). PID 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 device will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin 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.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

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.

Mirena 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
  • Abdominal or pelvic pain
  • absent, missed, or irregular menstrual periods
  • longer or heavier menstrual periods
  • mild bloating
  • 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
  • itching of the vagina or genitals
  • 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
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • white or brownish vaginal discharge
Rare
  • Chills
  • confusion
  • dizziness, lightheadedness, or 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 abdominal or stomach pain
  • foul-smelling vaginal discharge
  • 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 on urination
  • persistent crusting or scaling of the nipple
  • redness or swelling of the breast
  • severe abdominal or stomach pain or cramping
  • sharp pain on insertion
  • shivering fever
  • sore on the skin of the breast that does not heal
  • unexpected, heavy vaginal bleeding

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
  • depression
  • pimples
Less common
  • Back pain
  • breast tenderness or pain
  • decreased interest in sexual intercourse
  • full or bloated feeling
  • hair loss
  • hives or welts
  • increased hair growth, especially on the face
  • increased weight
  • itching
  • loss in sexual ability, desire, drive, or performance
  • nausea
  • pressure in the stomach
  • rash
  • redness of the skin
  • skin rash, encrusted, scaly, and oozing
  • swelling of the abdominal or 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.

See also: Side effects (in more detail)

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