Kyleena Iud
It is used to prevent pregnancy.It is used to treat heavy bleeding during monthly periods (menstruation).
Drug Class
Contraceptive, Long-Acting Reversible Contraceptive (LARC)
Pharmacologic Class
Progestin
Pregnancy Category
Contraindicated (if pregnancy occurs with IUD in place, remove if possible)
FDA Approved
Sep 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Kyleena is a small, T-shaped device that a healthcare provider inserts into your uterus to prevent pregnancy. It slowly releases a hormone called levonorgestrel, which works to thicken cervical mucus, thin the uterine lining, and affect sperm movement, making it very effective at preventing pregnancy for up to 5 years. It does not protect against sexually transmitted infections (STIs).
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. This medication will be administered by a doctor, and you should follow up with them as directed. It's essential to verify the medication's placement as instructed by your doctor or by reading the package insert.
Birth Control Considerations
Depending on when this medication is inserted, you may need to use a non-hormonal birth control method, such as condoms, to prevent pregnancy for a certain period. Adhere to your doctor's guidance on when to have the medication inserted and how to use non-hormonal birth control. If the medication is being removed and you wish to avoid pregnancy, consult your doctor. You will need to use an alternative birth control method, like condoms, for one week before removal. Note that this medication is not intended for emergency birth control; discuss any concerns with your doctor.
Using Tampons or Menstrual Cups
You can use tampons or menstrual cups with this medication. However, change them carefully to avoid dislodging the medication's threads. If you suspect you may have pulled the medication out of place, use a non-hormonal birth control method (such as condoms or spermicide) or abstain from sex, and contact your doctor immediately.
Storage and Disposal
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. This medication will be administered by a doctor, and you should follow up with them as directed. It's essential to verify the medication's placement as instructed by your doctor or by reading the package insert.
Birth Control Considerations
Depending on when this medication is inserted, you may need to use a non-hormonal birth control method, such as condoms, to prevent pregnancy for a certain period. Adhere to your doctor's guidance on when to have the medication inserted and how to use non-hormonal birth control. If the medication is being removed and you wish to avoid pregnancy, consult your doctor. You will need to use an alternative birth control method, like condoms, for one week before removal. Note that this medication is not intended for emergency birth control; discuss any concerns with your doctor.
Using Tampons or Menstrual Cups
You can use tampons or menstrual cups with this medication. However, change them carefully to avoid dislodging the medication's threads. If you suspect you may have pulled the medication out of place, use a non-hormonal birth control method (such as condoms or spermicide) or abstain from sex, and contact your doctor immediately.
Storage and Disposal
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Regularly check for the IUD strings after your period or as advised by your doctor.
- Continue routine gynecological exams as recommended by your healthcare provider.
- Kyleena does not protect against STIs; use condoms for STI prevention if needed.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One Kyleena intrauterine delivery system (IUD) inserted into the uterus for up to 5 years of continuous contraception.
Condition-Specific Dosing:
contraception:
One IUD inserted for up to 5 years.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Approved for use in nulliparous and parous women, including adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; systemic exposure is low.
Hepatic Impairment:
Mild:
Use with caution
Moderate:
Use with caution
Severe:
Contraindicated in acute liver disease or liver tumor (benign or malignant).
Pharmacology
Mechanism of Action
Kyleena releases levonorgestrel locally into the uterine cavity. The primary mechanism of action is to prevent pregnancy by causing thickening of the cervical mucus (inhibiting sperm passage), thinning of the endometrial lining (making it unsuitable for implantation), and inhibition of sperm motility and function within the uterus and fallopian tubes. Ovulation may or may not be inhibited.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local delivery system); systemic exposure is low.
Tmax:
Plasma concentrations typically peak within the first week after insertion.
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 1.6 L/kg (systemic levonorgestrel)
ProteinBinding:
Approximately 98% bound to serum proteins, primarily sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Limited (due to low systemic concentrations)
Elimination:
HalfLife:
Approximately 20 hours (systemic levonorgestrel)
Clearance:
Approximately 1.0 L/hr/kg (systemic levonorgestrel)
ExcretionRoute:
Primarily via urine and feces as metabolites.
Unchanged:
Less than 0.1% of the dose is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Immediate upon insertion.
PeakEffect:
Contraceptive efficacy is achieved immediately upon insertion.
DurationOfAction:
Up to 5 years.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred eyesight
Chest pain or pressure
Stomach pain
Pelvic pain
Abnormal vaginal bleeding
Vaginal itching or discharge
Fever or chills
Breast lump or soreness
Painful sex
Yellow skin or eyes (jaundice)
Depression or other mood changes
Genital sores
Some people may experience side effects when the IUD is inserted or removed, such as pain, bleeding, dizziness, or other reactions. If these symptoms are severe, persist for more than 30 minutes after insertion, or occur after removal, contact your doctor right away. Additionally, seek medical attention if you experience seizures, slow heartbeat, or passing out.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or worsen:
Acne or greasy skin
Headache
Upset stomach or vomiting
Painful periods
Back pain
Weight gain
Vaginal bleeding and spotting between menstrual periods (especially during the first 3-6 months)
Cramping (especially during the first few weeks)
If you experience heavy or prolonged bleeding, or if your bleeding pattern changes, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred eyesight
Chest pain or pressure
Stomach pain
Pelvic pain
Abnormal vaginal bleeding
Vaginal itching or discharge
Fever or chills
Breast lump or soreness
Painful sex
Yellow skin or eyes (jaundice)
Depression or other mood changes
Genital sores
Some people may experience side effects when the IUD is inserted or removed, such as pain, bleeding, dizziness, or other reactions. If these symptoms are severe, persist for more than 30 minutes after insertion, or occur after removal, contact your doctor right away. Additionally, seek medical attention if you experience seizures, slow heartbeat, or passing out.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or worsen:
Acne or greasy skin
Headache
Upset stomach or vomiting
Painful periods
Back pain
Weight gain
Vaginal bleeding and spotting between menstrual periods (especially during the first 3-6 months)
Cramping (especially during the first few weeks)
If you experience heavy or prolonged bleeding, or if your bleeding pattern changes, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain or tenderness
- Fever or chills (signs of infection)
- Unusual or foul-smelling vaginal discharge
- Heavy or prolonged bleeding, or severe cramping
- Missing or shortened IUD strings
- Signs of pregnancy (e.g., missed period, breast tenderness)
- Unexplained pain, especially on one side (possible ectopic pregnancy)
- Pain during sex
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you are pregnant or think you may be pregnant, as this medication should not be used during pregnancy.
If you have an intrauterine device (IUD) in place.
Certain health conditions, including:
+ Active liver disease
+ Chlamydia or gonorrhea
+ Endometritis (including postpartum endometritis)
+ Genital tract infection
+ Liver tumor
+ Pelvic infection
+ Uterine or cervical tumor or growth
+ Uterine problems, such as uterine fibroids
+ Untreated cervicitis or vaginitis
If you have had a pelvic infection within the past 3 months, especially if it occurred before, during, or after an abortion or miscarriage.
If you experience unexplained vaginal bleeding.
A history of certain health conditions, including:
+ Breast cancer
+ Cancer that is hormone-sensitive
+ Pelvic inflammatory disease
A weakened immune system, or if you:
+ Use or abuse intravenous (IV) drugs
+ Have a disease that may cause a weakened immune system, such as HIV
If you or your partner have multiple sexual partners.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have or have had in the past.
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety while taking this medication.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you are pregnant or think you may be pregnant, as this medication should not be used during pregnancy.
If you have an intrauterine device (IUD) in place.
Certain health conditions, including:
+ Active liver disease
+ Chlamydia or gonorrhea
+ Endometritis (including postpartum endometritis)
+ Genital tract infection
+ Liver tumor
+ Pelvic infection
+ Uterine or cervical tumor or growth
+ Uterine problems, such as uterine fibroids
+ Untreated cervicitis or vaginitis
If you have had a pelvic infection within the past 3 months, especially if it occurred before, during, or after an abortion or miscarriage.
If you experience unexplained vaginal bleeding.
A history of certain health conditions, including:
+ Breast cancer
+ Cancer that is hormone-sensitive
+ Pelvic inflammatory disease
A weakened immune system, or if you:
+ Use or abuse intravenous (IV) drugs
+ Have a disease that may cause a weakened immune system, such as HIV
If you or your partner have multiple sexual partners.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have or have had in the past.
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety while taking this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Ovarian cysts may form rarely, but they usually resolve on their own within 2 to 3 months. However, in some cases, these cysts can cause pain and may require surgical intervention. If you experience any symptoms, discuss them with your doctor.
If you become pregnant while using this medication, your risk of having an ectopic pregnancy (a pregnancy that develops outside the uterus) may increase. Be sure to talk to your doctor about this potential risk.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, always use a latex or polyurethane condom during sexual activity. If you have any questions or concerns, consult your doctor.
Before undergoing an MRI, inform your doctor that you are using this medication.
There is a risk of life-threatening infection within a few days after the medication is inserted. If you experience fever or pain at the insertion site, contact your doctor immediately.
In rare cases, the medication can perforate the uterus, leading to severe health complications and potentially requiring surgical intervention. This risk is higher when the medication is inserted during breastfeeding. If the medication perforates the uterus, it may not effectively prevent pregnancy. If you have any questions or concerns, discuss them with your doctor.
Using this medication may increase your risk of developing pelvic inflammatory disease (PID), especially if you or your partner have multiple sexual partners. PID can lead to complications such as infertility, surgery, or even death. Talk to your doctor about this potential risk.
If you are unable to feel the medication's string or suspect that it has been dislodged, contact your doctor. The risk of dislodgement is higher if you experience heavy menstrual bleeding or have a higher-than-normal body mass index (BMI). If the medication is dislodged, you may be at risk of becoming pregnant. Use an alternative form of birth control, such as a condom, until you can consult your doctor. If you suspect the medication has been dislodged and you have had sexual intercourse within the past week, contact your doctor, as you may be at risk of pregnancy.
In some individuals, menstrual periods may cease after one year of using this medication. Once the medication is removed, menstrual cycles typically return to normal. If you do not experience a menstrual period for six weeks while using this medication, contact your doctor.
You may need to undergo a pregnancy test before the medication is inserted. If you have any questions or concerns, discuss them with your doctor.
If you suspect you may be pregnant while using this medication, contact your doctor immediately. Severe and potentially life-threatening complications can occur if the medication is removed or left in place during pregnancy, including loss of fertility, infection, and miscarriage.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Ovarian cysts may form rarely, but they usually resolve on their own within 2 to 3 months. However, in some cases, these cysts can cause pain and may require surgical intervention. If you experience any symptoms, discuss them with your doctor.
If you become pregnant while using this medication, your risk of having an ectopic pregnancy (a pregnancy that develops outside the uterus) may increase. Be sure to talk to your doctor about this potential risk.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, always use a latex or polyurethane condom during sexual activity. If you have any questions or concerns, consult your doctor.
Before undergoing an MRI, inform your doctor that you are using this medication.
There is a risk of life-threatening infection within a few days after the medication is inserted. If you experience fever or pain at the insertion site, contact your doctor immediately.
In rare cases, the medication can perforate the uterus, leading to severe health complications and potentially requiring surgical intervention. This risk is higher when the medication is inserted during breastfeeding. If the medication perforates the uterus, it may not effectively prevent pregnancy. If you have any questions or concerns, discuss them with your doctor.
Using this medication may increase your risk of developing pelvic inflammatory disease (PID), especially if you or your partner have multiple sexual partners. PID can lead to complications such as infertility, surgery, or even death. Talk to your doctor about this potential risk.
If you are unable to feel the medication's string or suspect that it has been dislodged, contact your doctor. The risk of dislodgement is higher if you experience heavy menstrual bleeding or have a higher-than-normal body mass index (BMI). If the medication is dislodged, you may be at risk of becoming pregnant. Use an alternative form of birth control, such as a condom, until you can consult your doctor. If you suspect the medication has been dislodged and you have had sexual intercourse within the past week, contact your doctor, as you may be at risk of pregnancy.
In some individuals, menstrual periods may cease after one year of using this medication. Once the medication is removed, menstrual cycles typically return to normal. If you do not experience a menstrual period for six weeks while using this medication, contact your doctor.
You may need to undergo a pregnancy test before the medication is inserted. If you have any questions or concerns, discuss them with your doctor.
If you suspect you may be pregnant while using this medication, contact your doctor immediately. Severe and potentially life-threatening complications can occur if the medication is removed or left in place during pregnancy, including loss of fertility, infection, and miscarriage.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Not applicable for an IUD as it delivers a controlled, local dose. Systemic overdose is highly unlikely.
What to Do:
Not applicable. In case of any severe or unusual symptoms, seek immediate medical attention or call 911. For general concerns, call a poison control center at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Strong CYP3A4 inducers (e.g., barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) - theoretical reduction in systemic levonorgestrel levels, but local action of IUD minimizes impact on efficacy. Clinical significance for IUD efficacy is generally considered low, but not studied.
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To ensure patient is not pregnant prior to insertion.
Timing: Prior to insertion
Pelvic examination
Rationale: To assess uterine size and position, and rule out contraindications.
Timing: Prior to insertion
STI screening
Rationale: To rule out active pelvic infection, which is a contraindication.
Timing: Prior to insertion (if indicated)
Cervical cytology (Pap test)
Rationale: Routine screening for cervical abnormalities.
Timing: Prior to insertion (if indicated)
Routine Monitoring
Follow-up visit
Frequency: 4-6 weeks after insertion
Target: N/A
Action Threshold: To check IUD placement, address any concerns, and ensure patient comfort.
IUD string check (patient self-check)
Frequency: Monthly after menstruation, or as advised
Target: Strings present and of appropriate length
Action Threshold: If strings are missing, shorter, or longer, contact healthcare provider for evaluation of expulsion or perforation.
Annual gynecological examination
Frequency: Annually
Target: N/A
Action Threshold: Routine health maintenance, including IUD check.
Symptom Monitoring
- Severe lower abdominal pain or tenderness
- Fever or chills (signs of infection)
- Unusual vaginal discharge or odor
- Heavy or prolonged vaginal bleeding
- Missing or shortened IUD strings (possible expulsion)
- Signs of pregnancy (e.g., missed period, breast tenderness)
- Pain during intercourse
- Unexplained pain, especially on one side (possible ectopic pregnancy)
Special Patient Groups
Pregnancy
Kyleena is contraindicated in pregnancy. If pregnancy occurs with Kyleena in place, the IUD should be removed if possible. If removal is not possible or desired, the patient should be counseled on the risks of continuing the pregnancy with the IUD in situ (e.g., increased risk of miscarriage, sepsis, premature labor, ectopic pregnancy).
Trimester-Specific Risks:
First Trimester:
Increased risk of miscarriage and septic abortion if IUD remains in place.
Second Trimester:
Increased risk of miscarriage, septic abortion, and premature labor if IUD remains in place.
Third Trimester:
Increased risk of premature labor and delivery if IUD remains in place.
Lactation
Considered compatible with breastfeeding. Low levels of levonorgestrel pass into breast milk, but no adverse effects on infant growth, development, or health have been reported in studies of progestin-only contraceptives during lactation. Initiation can occur immediately postpartum.
Infant Risk:
Low risk to the breastfed infant.
Pediatric Use
Kyleena is approved for use in nulliparous and parous women, including adolescents. Safety and efficacy are expected to be the same as in adult women.
Geriatric Use
Kyleena is not indicated for contraception in post-menopausal women. Safety and efficacy have not been established in women over 65 years of age.
Clinical Information
Clinical Pearls
- Kyleena is a highly effective, long-acting reversible contraceptive (LARC) with a low systemic hormonal load.
- It can be used in nulliparous women and adolescents.
- Patients may experience irregular bleeding and spotting, especially during the first few months after insertion. This often improves over time, with many women experiencing lighter periods or amenorrhea.
- Does not protect against sexually transmitted infections (STIs).
- Insertion should be performed by a trained healthcare professional. Proper counseling on insertion, removal, and potential side effects is crucial.
Alternative Therapies
- Other levonorgestrel-releasing IUDs (e.g., Mirena, Liletta, Skyla)
- Copper IUD (Paragard)
- Contraceptive implant (e.g., Nexplanon)
- Oral contraceptives (combined or progestin-only)
- Contraceptive patch
- Contraceptive vaginal ring
- Contraceptive injection (e.g., Depo-Provera)
- Barrier methods (e.g., condoms, diaphragm)
- Surgical sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Varies widely per device
Insurance Coverage:
Often covered under most health insurance plans, including those mandated by the Affordable Care Act (ACA), typically with no out-of-pocket cost.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is recommended that you consult with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time of ingestion, to facilitate prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is recommended that you consult with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time of ingestion, to facilitate prompt and effective treatment.