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. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. This product does not contain any estrogen.
Read the Patient Information Leaflet provided by your pharmacist or health care provider before the rod is placed. Read and sign the Informed Consent provided by your doctor. You will also be given a User Card with the date and the place on your body where the rod was inserted. Keep the card and use it to remind yourself when to schedule an appointment to have the rod removed. 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 back-up 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.
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 persist or worsen, 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 your doctor has prescribed this medication because he or she 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.
The rod must be removed after 3 years. This is usually a simple procedure done in your doctor's office. Rarely (for example, if the rod has been placed too deeply or can't be felt), the rod may require surgery to remove.
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.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). 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 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.
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), stroke, swelling (edema), unexplained vaginal bleeding.
Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, implant, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.
Tell your doctor at least 4 weeks beforehand if you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight). You may need to have this medication removed for a time or take special precautions.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Etonogestrel may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a 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 immediately. 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 breast-feeding.
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), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable 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 laboratory tests (such as sex-hormone-binding globulin, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
This implant may be harmful if swallowed. If swallowing is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all regular medical and laboratory appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your breasts, and report any lumps immediately. Consult your doctor for more details.
Store at room temperature away from light and moisture until insertion. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.
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