Jadelle (Levonorgestrel Implants) – Complete Information

• JADELLE is a set of 2 birth control implants (flexible, plastic rod-shaped almost the size of a matchstick) used by women to prevent pregnancy for up to 5 years. It releases a progestin hormone called levonorgestrel. JADELLE does not contain estrogen.

• Your doctor will insert the implants under the skin of the inner side of your upper arm.

JADELLE prevents pregnancy in different ways. JADELLE stops the release of an egg from your ovary. JADELLE also thickens the mucus in your cervix, and this stops the sperm from reaching the egg. It also thins the lining of the uterus.

• are pregnant or may be pregnant

• have unexplained vaginal bleeding

• have serious blood clots such as blood clots in your legs (deep vein thrombosis), eyes (total or partial blindness) lungs (pulmonary embolism), heart (heart attack), or brain (stroke).

• have liver disease

• are allergic to levonorgestrel or any of the ingredients in JADELLE.

• The JADELLE implants are placed by your doctor during an in-office visit. The implants are inserted just under the skin on the inner side of your upper arm.

• The timing of the insertion of the JADELLE implants should be important.
  • before inserting the JADELLE implants, your doctor will do a pregnancy test
  • Your doctor will schedule the JADELLE implant insertion at a specific time of your menstrual cycle (for example, within the first 7 days of your regular menstrual bleeding).

• Right after the JADELLE implants are inserted, your doctor should feel your arm to check that the implants are in the right place.

• If you and your doctor cannot feel the JADELLE implants, you should use birth control such as condoms and spermicide until your doctor confirms that the implants are in place. You may need special tests to check that the implants are in place or to help find the implant when it is time to take them out.

• Your doctor will cover the site where JADELLE was placed with a gauze bandage. The insertion site should be dry and avoid heavy lifting for 2 to 3 days. You may remove the gauze bandage after 1 day. You may remove the skin closure strip as soon as the insertion area has healed, usually in 3 days.

• You should also remember the date when the JADELLE implants are to be removed. Schedule an appointment with your doctor to remove the JADELLE implants on or before the removal date.

• have had a heart attack, blood clot, or stroke

• planning to have surgery

• have high blood pressure

• have an allergy to anesthetics or medicines used to clean your skin (antiseptics). These medicines will be used when JADELLE is placed in or removed from your arm.

• have or have had depression

• have diabetes

• have severe migraine headaches

• have any other medical conditions.

• Tell your doctor about all the medicines you take, including prescription and over-the-counter, vitamins, medicines, and herbal supplements.

• Switching from a Combined Oral Contraceptive, Vaginal Ring, Transdermal Patch:
  • Preferably, insert JADELLE the day after the last active tablet of the previous combined oral contraceptive but at the latest on the day after the last day of the tablet-free interval or placebo tablet.
  • If a vaginal ring or transdermal patch has been used, it is preferable to insert JADELLE on the day of removal of the last ring, but at the latest when the next application would have been due.

• No Preceding Hormonal Contraceptive Use in the Past Month:
  • JADELLE implants may be inserted at any time during the cycle provided that the possibility of ovulation and conception has been considered, pregnancy has been excluded, and a nonhormonal contraceptive method is used for at least 7 days after the insertion. If possible, insert JADELLE within 7 days after the onset of menstrual bleeding.
  • If JADELLE is inserted within 7 days after the onset of menstrual bleeding, backup contraception is not needed.

• Changing from Another Progestin-releasing Intrauterine System (IUS) or from a Progestin-only Method (Minipill, Injection, or Implant) The woman may switch:
  • Any day when switching from the minipill,
  • on the day of removal of another implant or the IUS, or
  • on the day when the next injection of an injectable contraceptive would have been due.

• Following Delivery:
  • JADELLE should be inserted immediately after delivery and no additional contraceptive measures are needed.
  • If inserted later than 21 days after delivery, exclude pregnancy and instruct the woman to use additional non-hormonal contraception for a minimum of 7 days after insertion.

• Following First- or Second-trimester Abortion:
  • • JADELLE may be inserted immediately and no additional contraceptive measures are needed.

• Call your doctor right away if you:

• think you might be pregnant

• have pain in your lower leg that is not going away

• have severe chest pain or heaviness in the chest

• have sudden shortness of breath, sharp chest pain, or coughing up blood

• have weakness or numbness in your arm, leg, or trouble speaking

• have partial or complete blindness

• have very severe migraine headaches

• have yellow skin or whitening of the eyes. These may be signs of liver problems.

• have flu-like symptoms, unexplained fever, or chills

• have severe pain, swelling, or tenderness in the lower stomach area (abdomen)

• feel a lump in your breast

• have lack of energy, problems sleeping, tiredness or have mood changes, like feeling sad

• have heavy vaginal bleeding or bleeding that concerns you

• headache
• nausea
• whitish discharge from the vagina (leukorrhea)
• acne
• ovarian cyst
• pelvic pain
• nervousness
• weight gain, itchy rash
• vaginal discharge, itching
• injection site reaction, pain (vaginitis)
• hair loss, dizziness
• benign breast lump
• breast pain
• tenderness
• weight loss

• Insertion and removal problems: One or more JADELLE implants may fail to be inserted in your arm properly. If this happens, you may become pregnant. Right after JADELLE is inserted, and with help from your doctor, you should be able to feel the JADELLE implants under your skin. If you cannot feel them, tell your doctor. In some cases, removal of the JADELLE implants may be difficult or impossible because the implants might have moved and are not where they should be. Special procedures, including surgery in the hospital, may be needed to remove the implants. Other problems with insertion and removal problems may include:
  • pain
  • bruising
  • swelling
  • infection
  • numbness and tingling
  • abscess
  • breakage of the implants
  • blisters
  • ulcers
  • peeling
  • scarring
  • darkening of the skin
  • nerve injury
  • inflammation of blood vessels making it hard to remove

• Ectopic pregnancy: If you get pregnant while using JADELLE, it means that the pregnancy is not in the uterus. Lower stomach-area pain or unusual vaginal bleeding may be a sign of ectopic pregnancy. Ectopic pregnancy may require surgery. It can cause infertility, internal bleeding, and even death. Call your doctor if you think you are pregnant or have unexplained lower abdominal pain.

• Serious blood clots and heart problems: Serious heart problems (heart attack) and serious blood clots in your eyes (total or partial blindness) or brain (stroke) have happened with implants that contain levonorgestrel. Serious blood clots in your legs (deep vein thrombosis), or lungs (pulmonary embolism) have happened with JADELLE. It is possible to die from problems such as a heart attack or stroke caused by a blood clot.
  • Tell your doctor at least 4 weeks before if you are going to have surgery that will limit your ability to move around or if you will need to be on bed rest. You have an increased chance of getting blood clots when you are not moving around regularly.

• High blood pressure: If you have high blood pressure that is controlled by medicine, your doctor will check your blood pressure while you use JADELLE.

• Changes in menstrual bleeding: You may have changes in menstrual bleeding or your menstrual periods may stop. There may also be bleeding and spotting between menstrual periods. Tell your doctor if you have irregular or heavy bleeding, bleeding, or spotting that goes on for a long time, spotting in between your periods, or if you have not had a menstrual period for at least 6 weeks after having normal periods.

• Cysts on the ovary: Some women may develop a cyst on the ovary while using JADELLE. These cysts usually disappear on their own, but sometimes they can cause pain. Sometimes surgeries are needed to remove a cyst on the ovary.

• Liver problems: Call your doctor right away if you get any of these symptoms of liver problems while using JADELLE: itchy skin, yellowing of the whites of your eyes, nausea or vomiting, feeling tired, or flu-like symptoms.

• Depressed mood: Tell your doctor if you have problems sleeping, lack of energy, tiredness, or feel sad.

• Idiopathic intracranial hypertension (Increased pressure around the brain): Tell your doctor right away if you have vision problems or have headaches that happen often, are severe or do not go away.

• insulin, changes in the level of fats (lipoprotein), and sugar in your blood.

• Effects on the thyroid gland: If you take thyroid hormone replacement, your dose may need to be decreased during treatment with JADELLE.

• Blood and lymphatic system disorders: anemia, coagulopathy, hemoconcentration, leukocytosis, hemoglobin decrease

• Eye disorders: ocular icterus, papilledema, blurred vision, visual impairment

• Endocrine disorders: increased serum prolactin, thyroid disorder

• Gastrointestinal disorders: abdominal discomfort, distension or pain, constipation, diarrhea, flatulence, gastritis, pancreatic cyst, vomiting

• Hepatobiliary disorders: cholelithiasis, cholestatic jaundice

• Immune system disorders: Anaphylactic shock, hypersensitivity, mouth swelling

• Infections: bronchitis, cystitis, influenza, pharyngitis, pneumonia, urinary tract infection, fungal infection, vaginal infection, vulvovaginal mycotic infection

• Implant site skin disorders: abscess, bruising, cellulitis, discharge, hematoma, hemorrhage, hypersensitivity discoloration, discomfort, edema, erosion, erythema, fibrosis, furuncle, hypoesthesia, impaired, healing, induration, infection, inflammation, irritation, pain, pruritus, rash, swelling, urticaria, vesicles, warmth

• Metabolism and nutrition disorders: changes in weight and appetite, changes in glucose, hypoglycemia, increased body temperature, pyrexia

• Musculoskeletal and connective tissue disorders: arthralgia, arthropathy, asthenia, joint swelling, limb, discomfort, muscle atrophy, spasms, tightness or weakness, musculoskeletal pain, musculoskeletal, stiffness, systemic lupus erythematosus

• Psychiatric disorders: altered mood, mood swings, nervousness, anxiety, apathy, depressed mood, fear of eating, hallucination, insomnia, irritability, libido decrease, panic attack, personality change, stress, fearfulness, tension

• Nervous system disorders: hypoesthesia, loss of consciousness, migraine, monoplegia, peripheral neuropathy, paresthesia, peripheral nerve lesion, benign intracranial hypertension, brain edema, burning sensation, cerebrovascular stenosis, dysesthesia, hypersomnia, somnolence, syncope Neoplasms benign, malignant and unspecified: fibroadenoma of breast, melanocytic nevus

• Renal and urinary disorders: dysuria, urine abnormality, urine output decreased

• Reproductive system and breast disorders: alterations in bleeding and menstrual patterns, endometriosis, genital pruritus, suppressed lactation, adnexa uteri, pain, breast discharge, galactorrhea, genital discharge, nipple pain, engorgement, enlargement, swelling or mass, cervical dysplasia, dyspareunia, uterine cyst, vaginal discharge, or odor

• Skin and subcutaneous tissue disorders: nail discoloration, night sweats, pain, palmar-plantar erythema, pruritus, rash, scarring, seborrheic dermatitis, chloasma, dermatitis ecchymosis, eczema, erythema, abnormal hair growth, hirsuitism, discoloration, discomfort, striae, ulcer, urticaria

• Respiratory: dyspnea

• Vascular disorders: pulmonary embolism, intracranial venous sinus thrombosis, hot flush, hypertension, hypotension, deep vein thrombosis, peripheral coldness, varicose vein, thrombosis, vasodilation

Drugs or herbal products like cytochrome P450 3A4 (CYP3A4), may diminish the effectiveness of Hormonal Contraceptives (HCs), increase breakthrough bleeding, or decrease the plasma concentrations of HCs.

Some drugs or herbal products that may decrease the effectiveness of HCs include bosentan, felbamate, griseofulvin, phenytoin, rufinamide, aprepitant, barbiturates, carbamazepine, oxcarbazepine, rifampicin, topiramate, rifabutin, and products containing St. John’s wort.

The doctors would tell you to use an alternative method of contraception or a backup method when enzyme inducers are used with HCs and to continue backup 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 non-nucleoside reverse transcriptase inhibitors and HIV/HCV protease inhibitors can increase or decrease plasma concentrations of the progestin (decrease [e.g., ritonavir, nelfinavir, darunavir/ritonavir, (fos) lopinavir/ritonavir, amprenavir/ritonavir, and tipranavir/ritonavir, nevirapine, efavirenz] or increase [e.g., atazanavir/ritonavir and indinavir, etravirene]). These changes may be clinically relevant in some cases.

Efavirenz, a moderate CYP3A4 inducer, decreased systemic exposure to levonorgestrel. Reports of contraceptive failure with JADELLE in efavirenz-exposed patients have been seen.

Plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). Consult a doctor for more information.

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, glucose tolerance, lipids, and binding proteins.

JADELLE must be removed after 5 years. Your doctor can place a new JADELLE during the same visit if you choose to continue using JADELLE.

Your doctor can remove JADELLE at any time. You might become pregnant as soon as JADELLE is removed.

JADELLE is meant for use for up to 5 years, but you can stop using JADELLE at any time by asking your doctor to remove it. You could become pregnant as soon as JADELLE is removed, so you should use other methods of birth control. Certain birth control methods should be started 7 days before JADELLE is removed to ensure continued birth control.

Call your doctor if you think that you are pregnant. If you get pregnant while using JADELLE, it means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy may require surgery. Ectopic pregnancy can cause infertility, internal bleeding, and even death.

The hormone in JADELLE passes into your breast milk. You can ask your doctor for more information.

Taking ibuprofen or other NSAIDs for 5 days can help stop bleeding while on JADELLE but will only work for some people. You will need to consult your doctor before doing this because you might need high doses of ibuprofen and not everyone can take them safely.

JADELLE may increase the risk of cancer in some individuals.

JADELLE may cause weight gain in some individuals.