Etonogestrel Implant

What is this medicine?

ETONOGESTREL (et oh noe JES trel) is a contraceptive (birth control) device. It is used to prevent pregnancy. It can be used for up to 3 years.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abnormal vaginal bleeding

• blood vessel disease or blood clots

• cancer of the breast, cervix, or liver

• depression

• diabetes

• gallbladder disease

• headaches

• heart disease or recent heart attack

• high blood pressure

• high cholesterol

• kidney disease

• liver disease

• renal disease

• seizures

• tobacco smoker

• an unusual or allergic reaction to etonogestrel, other hormones, anesthetics or antiseptics, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This device is inserted just under the skin on the inner side of your upper arm by a health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amprenavir

• bosentan

• fosamprenavir

This medicine may also interact with the following medications:

• barbiturate medicines for inducing sleep or treating seizures

• certain medicines for fungal infections like ketoconazole and itraconazole

• griseofulvin

• medicines to treat seizures like carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate

• modafinil

• phenylbutazone

• rifampin

• some medicines to treat HIV infection like atazanavir, indinavir, lopinavir, nelfinavir, tipranavir, ritonavir

• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This product does not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

You should be able to feel the implant by pressing your fingertips over the skin where it was inserted. Contact your doctor if you cannot feel the implant, and use a non-hormonal birth control method (such as condoms) until your doctor confirms that the implant is in place. If you feel that the implant may have broken or become bent while in your arm, contact your healthcare provider.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast lumps

• changes in emotions or moods

• depressed mood

• heavy or prolonged menstrual bleeding

• pain, irritation, swelling, or bruising at the insertion site

• scar at site of insertion

• signs of infection at the insertion site such as fever, and skin redness, pain or discharge

• signs of pregnancy

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• unusual vaginal bleeding, discharge

• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• acne

• back pain

• breast pain

• changes in weight

• dizziness

• general ill feeling or flu-like symptoms

• headache

• irregular menstrual bleeding

• nausea

• sore throat

• vaginal irritation or inflammation

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.