etonogestrel 68 mg subdermal implant

Generic name:
Etonogestrel - implant

Pronunciation
(e-TOE-noe-JES-trel)

Brand name(s)
Implanon , Nexplanon

This product is a small, thin plastic rod that is inserted under the skin to prevent pregnancy. The rod slowly releases etonogestrel into the body over a 3-year period. Etonogestrel is similar to a natural hormone made in your body. This product does not contain any estrogen.

This medication may not work as well in women who are very overweight or those taking certain drugs. (See also Drug Interactions section.) Discuss your birth control options with your doctor.

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Read the Patient Information Leaflet provided by your pharmacist or health care provider before the rod is placed. If you have any questions, ask your doctor or pharmacist.

Ask your doctor about the best time to schedule your appointment to have the rod placed. Your doctor may want you to have a pregnancy test first. The medication usually starts working right away when the rod is inserted during the first 5 days of your period. If your appointment is at another time in your menstrual cycle, you may need to use a non-hormonal form of birth control (such as condoms, diaphragm, spermicide) for the first 7 days after the rod is placed. Ask your doctor about whether you need backup birth control.

The rod will be inserted under the skin in your upper arm by a health care professional. Usually it will be placed in the arm that you do not write with. Be sure you can feel the rod underneath your skin after it has been placed. If at any time you cannot feel the rod underneath the skin or feel that the rod has been bent or broken, tell your doctor right away.

There will be 2 bandages covering the area where the rod is placed. Leave the top bandage on for 24 hours. Keep the smaller bandage on as directed by your doctor, usually for 3 to 5 days. Keep the bandage clean and dry.

The rod must be removed after 3 years and can be replaced if continued birth control is desired. The rod can be removed at any time by a trained health care professional if birth control is no longer desired or if there are side effects.

Nausea, stomach cramping/bloating, dizziness, headache, breast tenderness, acne, hair loss, weight gain, and vaginal irritation/discharge may occur. Pain, bruising, numbness, infection, and scarring may occur at the site where the rod is placed. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row, contact your doctor for a pregnancy test.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as new/worsening depression)
• lump in the breast
• unwanted facial/body hair
• severe stomach/abdominal/pelvic pain
• unusual tiredness
• dark urine
• yellowing eyes/skin
• coughing up blood

Rarely, people using this medication have had very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs, legs, or eyes). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using etonogestrel, tell your doctor or pharmacist if you are allergic to it; or to other progestins (such as norethindrone, desogestrel); or to any anesthetics or antiseptics that might be used in the procedure; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots (for example in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• abnormal breast exam
• personal or family history of cancer (especially breast or cervical cancer)
• high cholesterol or triglyceride (blood fat) levels
• depression
• diabetes
• gall bladder problems
• severe headaches/migraine
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• kidney disease
• liver disease (including tumors)
• smoking
• stroke
• swelling (edema)
• unexplained vaginal bleeding

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This product must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. A certain serious pregnancy problem (ectopic pregnancy) may be more likely if you become pregnant while using this product.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain lab tests (such as sex-hormone-binding globulin, thyroid), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This implant may be harmful if swallowed. If someone has swallowed it and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are using this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Not applicable. This product is inserted in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.