Pronunciation:

lee-voe-nor-JES-trel

Brand Names:

• Jadelle

Classifications:

Pharmacologic—

Progestin

Uses of This Medicine:

Levonorgestrel implant is used to prevent pregnancy for up to 5 years. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is to be given only by or under the direct supervision of a trained healthcare professional.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levonorgestrel implants in teenage females. This medicine may be used for birth control in teenage females but is not recommended before the start of menstruation.

Older adults—

Appropriate studies on the relationship of age to the effects of levonorgestrel implant have not been performed in the geriatric population. This medicine is not recommended for use in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Enasidenib
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Repotrectinib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Perampanel
• Selegiline
• Tacrine
• Temazepam
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism) or
• Breast cancer, known or suspected, or a history of or
• Liver disease, including tumors—Should not be used in patients with these conditions.

• Bleeding problems or
• Depression, history of or
• Diabetes or
• Heart attack, history of or
• Heart disease or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure), severe or history of or
• Kidney disease or
• Migraine headaches, severe or
• Ovarian cysts or
• Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Jadelle® is a set of 2 hormone-releasing birth control implants that are surgically placed and removed under the skin of the upper arm by a trained healthcare provider. The implants are placed in the upper arm for up to 5 years.

The implants are usually inserted by your doctor within the first 7 days of your regular menstrual period. Your doctor also needs to do a pregnancy test before inserting the implants.

After the implants are inserted, your doctor should feel your arm to check that the implants are in the right place. If you cannot feel the implants in your arm, you will need to use a non-hormonal birth control (such as condoms, spermicide) until your doctor confirms that the implants are in place.

Your doctor will cover the insertion site with a gauze bandage. Keep it dry and avoid heavy lifting for 2 to 3 days. The gauze may be removed after 1 to 3 days.

Do not try to remove the implants by yourself. Call your doctor if you wish to remove your implants.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

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.

Infection at the insertion site may occur following insertion and removal of the implants. It is important to tell your doctor if you feel any pain, numbness, or tingling in your upper arm.

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 if you get pregnant while your implants are in place. An ectopic pregnancy 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.

You could have less bleeding or even stop having periods by the end of the first year. Call your doctor if you have a change from the regular bleeding pattern after you have had your implants for awhile, such as more bleeding or if you miss a period (and you were having periods even with your implants).

This device will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Absent, missed, or irregular menstrual periods

bloating

breast pain

clear or bloody discharge from the nipple

dimpling of the breast skin

increased clear or white vaginal discharge

inverted nipple longer or heavier menstrual periods

lump in the breast or under the arm

pain in the pelvis

persistent crusting or scaling of the nipple

redness or swelling of the breast

sore on the skin of the breast that does not heal

stomach or pelvic discomfort, aching, or heaviness

stopping of menstrual bleeding

Incidence not known

Abdominal or stomach pain

anxiety

blurred vision

change in vaginal discharge

chest pain

chills

clay-colored stools

confusion

cough

dark urine

diarrhea

difficulty with swallowing

dizziness or lightheadedness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast heartbeat

fever

headache

hives, itching, or rash

loss of appetite

nausea

pain or feeling of pressure in the pelvis

pain, redness, or swelling in the arm or leg

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sudden shortness of breath or troubled breathing

sweating

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

tightness in the chest

trouble breathing

unpleasant breath odor

unusual tiredness or weakness

vaginal bleeding

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blemishes on the skin

blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, or scaly skin

hair loss or thinning of the hair

itching of the vagina or genital area

pain at the insertion site

pain during sexual intercourse

pimples

thick, white vaginal discharge with no odor or with a mild odor

weight gain

Less common

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

trouble concentrating

trouble sleeping

weight loss

Incidence not known

Changes in menstrual or bleeding patterns

white or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.