Indicated for use by women to prevent pregnancy for up to 5 years.

The two implants should be inserted during the first 7 days following the onset of menses by a healthcare professional familiar with JADELLE insertion technique. JADELLE implants provide up to 5 years of contraception.

Use of this product before menarche is not indicated.

JADELLE is contraindicated in patients who have:

• Known or suspected pregnancy
• Current thrombophlebitis or thromboembolic disorders
• Liver tumors, benign or malignant, or active liver disease
• Undiagnosed abnormal uterine bleeding
• Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past

Steroid hormones may be poorly metabolized in patients with impaired liver function. Use of JADELLE in women with acute liver disease is contraindicated.

Infection (including cellulitis), ulcerations, excessive scarring/keloid, phlebitis and hyperpigmentation have been reported with JADELLE implants. If infection is present, ensure that it is resolved before another implant is inserted. Protection against pregnancy is likely to be inadequate if only a single implant is in place.

Thromboembolic disorders (e.g., pulmonary embolism and deep vein thrombosis) have been reported with JADELLE implants; stroke and cardiovascular problems (e.g., myocardial infarction) have been reported with levonorgestrel implant use. Evaluate patients for retinal thrombosis immediately if there is a unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

Discourage women with a history of hypertension-related diseases or renal disease from using hormonal contraception.

Idiopathic intracranial hypertension has been reported on rare occasions in users of levonorgestrel implants. Consider this diagnosis if persistent headache and/or visual disturbances occur in a woman with JADELLE, particularly if the patient is obese or has recently gained weight. Remove JADELLE if idiopathic intracranial hypertension is diagnosed.

If follicular development occurs with JADELLE implants, atresia of the follicle may be delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle.

Most women using JADELLE implants can expect some variation in menstrual bleeding patterns. Irregular menstrual bleeding, prolonged episodes of bleeding and spotting, heavy bleeding, intermenstrual spotting and amenorrhea occur in some women.

Carefully observe women with a history of depression and consider removal of JADELLE if depression recurs to a serious degree. Consider removing JADELLE implants in women who become significantly depressed, because depression may be drug-related.

Follow women who are being treated for hyperlipidemias closely if they elect to use JADELLE implants, as serum lipoprotein levels may be altered. Changes in carbohydrate tolerance and insulin sensitivity following oral glucose loads have been reported in some studies among healthy users of JADELLE implants.

Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased. The dose of replacement thyroid hormone therapy may need to be decreased.

Sex hormone-binding globulin and thyroid-binding globulin concentrations are decreased by JADELLE
use. Thyroxine concentrations may be slightly decreased and triiodothyronine uptake increased. The dose of replacement thyroid hormone therapy may need to be decreased.

Some drugs or herbal products that may decrease the effectiveness of HCs include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a backup method when enzyme inducers are used with HCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including levonorgestrel.

When co-administered with sex hormones, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of the progestin (decrease (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos) amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir, nevirapine, efavirenz) or increase (e.g., indinavir and atazanavir/ritonavir, etravirene).

Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

GoToSource

• Menorrhagia. GoToSource

• Chronic pelvic pain associated with adenomyosis. GoToSource

• Complex endometrial hyperplasia. GoToSource

• Use in pre-menarche and postmenopausal patients. GoToSource

Infection and pain at implant site, leukorrhea (vaginal discharge), mastalgia (breast pain), nausea, pelvic pain, urinary tract infections, vaginitis (inflammation of vagina), acne, hair loss, ovarian cyst or follicle enlargement, ectopic pregnancy, irregular menstrual bleeding, prolonged episodes of bleeding and removal complications. GoToSource

Thrombotic thrombocytopenic purpura (blood disorder causing blood clots to form in small blood vessels). GoToSource

Intracranial hypertension (increased pressure around the brain). GoToSource

Gallbladder disease, hypertension (high blood pressure), upper limb neuropathies, dizziness, nervousness, malaise, visual disturbances, arthropathies (disease of the joints), weight gain, anxiety and non-clinical depression. GoToSource

Lawsuits filed for intracranial hypertension.