Skyla

Name: Skyla

Side effects

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

  • Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Intrauterine Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
  • Pelvic Inflammatory Disease [see WARNINGS AND PRECAUTIONS]
  • Bleeding Pattern Alterations [see WARNINGS AND PRECAUTIONS]
  • Perforation [see WARNINGS AND PRECAUTIONS]
  • Expulsion [see WARNINGS AND PRECAUTIONS]
  • Ovarian Cysts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to Skyla in 1,672 patients in two contraception studies, including 1,383 exposed for one year and 993 who completed the three year studies. The population was generally healthy, 18 to 40-year old females requesting contraception and predominately Caucasian (82.6%). The data cover more than 40,000 cycles of exposure. The frequencies of reported adverse drug reactions represent crude incidences.

Most common adverse reactions (occurring in ≥ 5% users) were increased bleeding (7.8%), vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%) and nausea (5.5%).

In the contraception studies, 18% discontinued prematurely due to an adverse reaction. The most common adverse reactions leading to discontinuation (in >1% of users) were uterine bleeding complaints (4.6%), device expulsion (3.2%), acne/seborrhea (2.9%), abdominal pain (2.5%) dysmenorrhea/uterine spasms (2.0%) and pelvic pain (1.8%).

Other common adverse reactions (occurring in ≥ 1% users) by System Organ Class (SOC): The frequencies of adverse reactions observed in clinical trials are summarized in Table 3 by SOC (presented as crude incidences).

Table 3: Adverse reactions that occurred in at least 1% of Skyla users in clinical trials by SOC

System Organ Class Adverse Reaction Incidence (%)
(N=1,672)
Reproductive System and Breast Disorders Vulvovaginitis 20.2
Ovarian cysta 13.2
Dysmenorrhoea 8.6
Increased bleeding b 7.8
Breast pain/discomfort 5.3/3.3
Genital discharge 4.2
Device expulsion (complete and partial) 3.2
Upper genital tract infection 1.4
Gastrointestinal Disorders Abdominal pain/pelvic pain 12.7/6.2
Nausea 5.5
Skin and Subcutaneous Tissue Disorders Acne/Seborrhoea 13.6/1.4
Alopecia 1.2
Nervous System Disorders Headache 12.4
Migraine 2.3
Psychiatric Disorders Depression/ Depressed mood 3.8/0.5
a Ovarian cysts were reported as AEs if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination
b Not all bleeding alterations were captured as adverse reactions [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post approval use of a LNG-releasing IUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke
  • Hypersensitivity including rash, urticaria, and angioedema
  • Device breakage

Read the entire FDA prescribing information for Skyla (Levonorgestrel-Releasing Intrauterine System)

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Skyla Overdose

If Skyla is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system?

An intrauterine device can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about your personal risk.

Do not use this IUD during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if left in place during pregnancy. Tell your doctor right away if you become pregnant. If you choose to continue a pregnancy that occurs while using a levonorgestrel intrauterine system, watch for signs of infection such as fever, chills, flu symptoms, cramps, vaginal bleeding or discharge.

You should not use this device if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

  • abnormal vaginal bleeding that has not been checked by a doctor;

  • an untreated or uncontrolled pelvic infection (vaginal, cervical uterine, or bladder);

  • endometriosis or a serious pelvic infection following a pregnancy or abortion within the past 3 months;

  • a history of pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection was treated and cleared;

  • uterine fibroid tumors or other conditions that affect the shape of the uterus;

  • past or present breast cancer, known or suspected cervical or uterine cancer;

  • liver disease or liver tumor (benign or malignant);

  • a recent abnormal Pap smear that has not yet been diagnosed or treated;

  • a disease or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse; or

  • if you have another intrauterine device (IUD) in place.

To make sure levonorgestrel is safe for you, tell your doctor if you have ever had:

  • high blood pressure, heart disease or a heart valve disorder;

  • a heart attack or stroke;

  • a bleeding or blood-clotting disorder;

  • migraine headaches; or

  • a vaginal infection, pelvic infection, or sexually transmitted disease.

You should not use this IUD if you are breast-feeding a baby younger than 6 weeks old. This IUD may be more likely to form a hole or get embedded in the wall of your uterus if you have the device inserted while you are breast-feeding.

How is levonorgestrel intrauterine system used?

Levonorgestrel intrauterine system is a T-shaped plastic device that is inserted through the vagina and placed into the uterus by a doctor. The device is usually inserted within 7 days after the start of a menstrual period.

You may feel pain or dizziness during insertion of the IUD. You may also have minor vaginal bleeding. Tell your doctor if you still have these symptoms longer than 30 minutes.

The levonorgestrel device should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications.

After each menstrual period, make sure you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You should be able to feel the strings at the opening of your cervix. Call your doctor at once if you cannot feel the strings, or if you think the device has slipped lower in your uterus or out of your uterus. A sudden increase in menstrual flow may be a sign that the device has slipped out of place.

If you think the device is not properly in place, use a non-hormone method of birth control (condom, or diaphragm with spermicide) to prevent pregnancy until your doctor is able to replace the IUD.

Your doctor will need to see you within a few weeks after insertion of the device to make sure it is still in place correctly. You will also need regular annual pelvic exams and Pap smears.

You may have irregular periods during the first 3 to 6 months of use. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Call your doctor if you miss a period or think you might be pregnant.

If you need to have an MRI (magnetic resonance imaging), tell your caregivers ahead of time that you have an IUD in place.

Your device may be removed at any time you decide to stop using birth control. The Mirena or Kyleena intrauterine system must be removed at the end of the 5-year wearing time. The Skyla or Liletta device must be removed after 3 years. Your doctor can insert a new device at that time if you wish to continue using this form of birth control. Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

If you wish to continue preventing pregnancy, you may need to start using another birth control method a week before your levonorgestrel intrauterine system is removed.

Precautions While Using Skyla

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.

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 Mirena® IUD 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). 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 medicine may also increase your risk of having ovarian cysts or breast cancer. Talk to your doctor if this concerns you.

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.

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.

What are some things I need to know or do while I take Skyla?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Follow up with the doctor as you have been told.
  • Based on when Skyla is put in, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about when to have this medicine put in and using a non-hormone type of birth control.
  • This medicine is not for use as emergency birth control. Talk with the doctor.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • If you are having an MRI, talk with your doctor.
  • Life-threatening infection can happen within a few days after Skyla was put in. Call your doctor right away if you have fever or pain where this medicine was placed.
  • Very bad health problems and the need for surgery can happen if Skyla goes through the uterus. This medicine may also not prevent pregnancy if this happens. Talk with the doctor.
  • This medicine may raise the chance of a health problem called pelvic inflammatory disease (PID). The chance may be higher if you or your partner have sex with other partners. PID can lead to other health problems like not being able to get pregnant, surgery, or rarely death. Talk with your doctor.
  • Vaginal bleeding, spotting, or cramps may happen for 3 to 6 months after this medicine has been put in. If these signs do not go away or are very bad, call your doctor right away.
  • If you think Skyla has come out, call your doctor. You may get pregnant if this medicine comes out. Use another kind of birth control like a condom until you see your doctor.
  • This medicine is not approved for use in women who are going through or have been through the change of life (menopause). Talk with your doctor.
  • Periods may stop in some women after 1 year of using Skyla (levonorgestrel (IUD)). Periods will go back to normal when this medicine is taken out. If you do not have a period for 6 weeks when Skyla is in place, call your doctor.
  • If you think you may be pregnant while this medicine is in place, call your doctor right away. Very bad and sometimes deadly health problems can happen when Skyla is removed or if it is left in place during pregnancy. This includes loss of fertility, infections, and loss of the unborn baby. Talk with your doctor about the risks of getting pregnant while this medicine is in place.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Skyla?

  • If you need to store Skyla at home, talk with your doctor, nurse, or pharmacist about how to store it.

For Healthcare Professionals

Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant

General

The most commonly reported adverse effects are alterations of menstrual bleeding patterns, nausea, abdominal/pelvic pain, headache/migraine, dizziness, fatigue, amenorrhea, ovarian cysts, genital discharge, acne/seborrhea, breast tenderness, and vulvovaginitis.[Ref]

Genitourinary

Very common (10% or more): Irregular menstrual bleeding (67%), infrequent menstrual bleeding (up to 57%), ovarian cyst (31.2%), menstrual changes (up to 31.9%), decreased uterine bleeding (23.4%), prolonged menstrual bleeding (22%), vulvovaginitis (20.2%), amenorrhea (18.4%), genital discharge (up to 14.9%), heavier menstrual bleeding (13.8%),vaginal infections (13.6%), vulvovaginal infections (13.3%), lighter menstrual bleeding (12.5%), increased scheduled uterine bleeding (11.9%), breast tenderness (10.7%)
Common (1% to 10%): Dysmenorrhea, breast pain/discomfort, upper genital tract infection, genital tract bleeding, pelvic inflammatory disease, endometritis, dyspareunia, pelvic discomfort/pain, delay of menses more than 7 days, vaginal discharge, bleeding not related to menses
Uncommon (0.1% to 1%): Uterine spasm, cervicitis/Papanicolaou smear normal class II, change in vaginal secretion
Rare (less than 0.1%): Uterine perforation
Frequency not reported: Breast enlargement, vaginal candidiasis, changes in cervical erosion, changes in cervical secretion, ectopic pregnancy
Postmarketing reports: Oligomenorrhea, irregular menstruation[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23.1%), abdominal/pelvic pain (up to 22.6%)
Common (1% to 10%): Diarrhea, vomiting
Uncommon (0.1% to 1%): Abdominal distension
Frequency not reported: Bloating, abdominal cramps[Ref]

Other

Very common (10% or more): Fatigue (16.9%)
Common (1% to 10%): Partial/complete IUS expulsion, weight increased
Uncommon (0.1% to 1%): Edema, change in body weight
Very rare (less than 0.01%): Face edema
Frequency not reported: Decreased weight, sepsis, group A streptococcal sepsis
Postmarketing reports: IUS breakage, procedural bleeding[Ref]

Nervous system

Very common (10% or more): Headache (up to 16.8%), dizziness (11.2%)
Common (1% to 10%): Migraine
Postmarketing reports: Stroke, syncope, IUS insertion related vasovagal reaction or seizure[Ref]

Psychiatric

Common (1% to 10%): Depression/depressed mood, mood changes, mood swings, decreased libido, nervousness
Frequency not reported: Changes in libido[Ref]

Dermatologic

Very common (10% or more): Acne/seborrhea (15%)
Common (1% to 10%): Alopecia, hirsutism
Uncommon (0.1% to 1%): Pruritus, eczema, pigmentation changes/hyperpigmentation
Rare (less than 0.1%): Rash, urticaria
Frequency not reported: Chloasma, melasma
Postmarketing reports: Angioedema[Ref]

Cardiovascular

Postmarketing reports: Increased blood pressure, arterial/venous thrombotic events, pulmonary emboli, deep vein thrombosis, stroke[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Oncologic

Frequency not reported: Benign/malignant liver tumors
Postmarketing reports: Breast cancer[Ref]

Ocular

Frequency not reported: Contact lens intolerance[Ref]

Metabolic

Frequency not reported: Diabetes mellitus[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions[Ref]

Some side effects of Skyla may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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