Liletta

— THERAPEUTIC CATEGORIES —
  • Contraception
  • Menorrhagia
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Liletta Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Levonorgestrel 52mg; intrauterine system (IUD).

    Pharmacological Class

    Progestin IUD.

    How Supplied

    System—1

    Manufacturer

    AbbVie

    Mechanism of Action

    The local mechanism by which continuously released levonorgestrel provides contraception has not been conclusively demonstrated.

    Liletta Indications

    Indications

    Prevention of pregnancy for up to 8yrs.

    Liletta Dosage and Administration

    Adult

    See full labeling. Insert into uterine cavity as directed. Reexamine and evaluate 4–6wks after insertion; then yearly or more if needed. Remove or replace after 8yrs if protection is desired.

    Children

    Pre-menarche: not recommended.

    Liletta Contraindications

    Contraindications

    Post-coital contraception. Congenital or acquired uterine anomaly including leiomyomas. Acute pelvic inflammatory disease (PID). Postpartum endometritis. Infected abortion in past 3 months. Uterine or cervical malignancy. Breast or other hormone-sensitive cancer. Uterine bleeding of unknown etiology. Untreated acute cervicitis or vaginitis. Active liver disease or tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD. Pregnancy.

    Liletta Boxed Warnings

    Not Applicable

    Liletta Warnings/Precautions

    Warnings/Precautions

    History or risk of ectopic pregnancy. Assure suitable uterine anatomy before inserting. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Bleeding pattern alterations: exclude endometrial pathology prior to insertion in women with persistent bleeding. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in lactating women, if inserted in women with fixed retroverted uteri, or during postpartum period; and increased risk of explusion if inserted in women with uteri that is not completely involuted; delay insertion a minimum ≥4wks, or until involution is complete after delivery or a second trimester abortion. Breast cancer. Evaluate and consider patients' clinical conditions prior to use risk (eg, leukemia, AIDS, IV drug abuser). Anticoagulant therapy or coagulopathies. Cervical stenosis. Predisposition to syncope, bradycardia, other vasovagal reactions. Remove device if any of these occur: uterine or cervical perforation, embedment, pregnancy, symptomatic actinomycosis, pelvic infection, endometritis, any sign of expulsion. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe or frequent headache, marked increase in BP, severe arterial disease, uterine/cervical malignancy, or jaundice occurs. Nursing mothers.

    Liletta Pharmacokinetics

    Absorption

    • Mean plasma concentrations (± SD, pg/mL) following Liletta insertion: 252±123 at 7 days; 195±68 at 6 months; 168±51 at 12 months; 150±47 at 24 months; 132±54 at 36 months; 114±52 at 48 months; 101±42 at 60 months; 92±43 at 72 months; 90±38 at 84 months; 88±37 at 96 months.

    Distribution

    • Apparent volume of distribution: 1.8 L/kg.

    • Plasma protein bound: 98.9%.

    Metabolism

    • CYP enzymes (esp. CYP3A4).

    Elimination

    • Renal (45%), fecal (32%). Half-life: ~13.9±3.2 hours.

    Liletta Interactions

    Interactions

    Caution with anticoagulants; consider removal.

    Liletta Adverse Reactions

    Adverse Reactions

    Vaginal and vulvovaginal infections, acne, nausea/vomiting, abdominal discomfort/pain, headache/migraine, breast tenderness/pain, dyspareunia, pelvic discomfort/pain, depression; irregular bleeding, ectopic pregnancy, sepsis, PID, perforation, expulsion, ovarian cysts.

    Liletta Clinical Trials

    See Literature

    Liletta Note

    Not Applicable

    Liletta Patient Counseling

    See Literature

    Liletta Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Levonorgestrel 52mg; intrauterine system (IUD).

    Pharmacological Class

    Progestin IUD.

    How Supplied

    System—1

    Manufacturer

    AbbVie

    Mechanism of Action

    The local mechanism by which continuously released levonorgestrel provides contraception has not been conclusively demonstrated.

    Liletta Indications

    Indications

    Heavy menstrual bleeding for up to 5yrs in patients who choose intrauterine contraception as their method of contraception.

    Liletta Dosage and Administration

    Adult

    See full labeling. Insert into uterine cavity as directed. Reexamine and evaluate 4–6wks after insertion; then yearly or more if needed. Replace after 5yrs if continued treatment is needed.

    Children

    Pre-menarche: not recommended.

    Liletta Contraindications

    Contraindications

    Post-coital contraception. Congenital or acquired uterine anomaly including leiomyomas. Acute pelvic inflammatory disease (PID). Postpartum endometritis. Infected abortion in past 3 months. Uterine or cervical malignancy. Breast or other hormone-sensitive cancer. Uterine bleeding of unknown etiology. Untreated acute cervicitis or vaginitis. Active liver disease or tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD. Pregnancy.

    Liletta Boxed Warnings

    Not Applicable

    Liletta Warnings/Precautions

    Warnings/Precautions

    History or risk of ectopic pregnancy. Assure suitable uterine anatomy before inserting. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Bleeding pattern alterations: exclude endometrial pathology prior to insertion in women with persistent bleeding. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in lactating women, if inserted in women with fixed retroverted uteri, or during postpartum period; and increased risk of explusion if inserted in women with uteri that is not completely involuted; delay insertion a minimum ≥4wks, or until involution is complete after delivery or a second trimester abortion. Breast cancer. Evaluate and consider patients' clinical conditions prior to use risk (eg, leukemia, AIDS, IV drug abuser). Anticoagulant therapy or coagulopathies. Cervical stenosis. Predisposition to syncope, bradycardia, other vasovagal reactions. Remove device if any of these occur: uterine or cervical perforation, embedment, pregnancy, symptomatic actinomycosis, pelvic infection, endometritis, any sign of expulsion. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe or frequent headache, marked increase in BP, severe arterial disease, uterine/cervical malignancy, or jaundice occurs. Nursing mothers.

    Liletta Pharmacokinetics

    Absorption

    • Mean plasma concentrations (± SD, pg/mL) following Liletta insertion: 252±123 at 7 days; 195±68 at 6 months; 168±51 at 12 months; 150±47 at 24 months; 132±54 at 36 months; 114±52 at 48 months; 101±42 at 60 months; 92±43 at 72 months; 90±38 at 84 months; 88±37 at 96 months.

    Distribution

    • Apparent volume of distribution: 1.8 L/kg.

    • Plasma protein bound: 98.9%.

    Metabolism

    • CYP enzymes (esp. CYP3A4).

    Elimination

    • Renal (45%), fecal (32%). Half-life: ~13.9±3.2 hours.

    Liletta Interactions

    Interactions

    Caution with anticoagulants; consider removal.

    Liletta Adverse Reactions

    Adverse Reactions

    Vaginal and vulvovaginal infections, acne, nausea/vomiting, abdominal discomfort/pain, headache/migraine, breast tenderness/pain, dyspareunia, pelvic discomfort/pain, depression; irregular bleeding, ectopic pregnancy, sepsis, PID, perforation, expulsion, ovarian cysts.

    Liletta Clinical Trials

    See Literature

    Liletta Note

    Not Applicable

    Liletta Patient Counseling

    See Literature

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