Etonogestrel, Implant

________________________________________________________________________

KEY POINTS

• This medicine is under the skin of your upper arm to prevent pregnancy for up to 3 years.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: contraceptive (birth control)

Generic and brand names: etonogestrel, implant; Implanon; Nexplanon

What is this medicine used for?

This birth control device slowly releases medicine that will prevent pregnancy for up to 3 years.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before using this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any hormones or medicines
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, brain, or eyes
• Asthma
• Breast lumps or an abnormal mammogram
• Cancer of the breast, uterus, cervix, or vagina
• Depression
• Diabetes
• Heart attack, or other heart disease
• High blood pressure
• High cholesterol or high triglycerides
• Gallbladder or kidney disease
• Liver disease or liver tumor
• Migraines or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• Seizures
• Unexplained vaginal bleeding or irregular menstrual periods

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Tell your healthcare provider if you have recently had or are scheduled to have a long period of bed rest after major surgery or a broken bone in a cast. Also, tell your provider if you have recently had a baby, miscarriage, or abortion.

Females of childbearing age: Do not have the rod inserted in your arm if you know or suspect that you are pregnant. If you become pregnant contact your healthcare provider right away. If you are breast-feeding and want to use this medicine, talk with your healthcare provider. It will not be inserted if you are breast-feeding unless you delivered your baby more than 4 weeks ago.

How do I use it?

Your healthcare provider will place a flexible plastic rod the size of a matchstick under the skin of your upper arm. The rod slowly releases medicine into your bloodstream.

It is important to have this medicine inserted at the right time of your menstrual cycle. You may need to use a backup method of birth control (such as condoms) for 7 days after the rod is put in. Talk with your healthcare provider about this. After this medicine is inserted, check that it is in place by gently pressing your fingertips over the skin in your arm where this medicine was inserted. You should be able to feel the small rod. This medicine must be removed at the end of 3 years. This medicine can be removed sooner if you want.

If you cannot feel the small rod, or you think it may have broken or bent while in your arm, contact your healthcare provider right away. Use a backup non-hormonal birth control method (such as condoms) until your healthcare provider confirms that the implant is in place.

You must sign a Patient Consent Form before you receive this medicine. Make sure you understand what is on the form before you sign it. If you have any questions ask your healthcare provider. You will also receive a User Card to keep at home. The card will have information about the insertion and removal dates. Keep track of the removal date and keep all appointments.

What should I watch out for?

The most common side effect of this medicine is a change in your menstrual periods. Expect your period to be irregular while you are using this medicine. You may have more bleeding, less bleeding, or no bleeding. The time between periods may vary, and you may have spotting between periods. Talk with your healthcare provider about this.

After the rod is inserted, keep the incision clean and protected to avoid infection and keep the incision from opening. Keep the top bandage on for 24 hours and the small bandage dry, clean, and in place for 3 to 5 days. If the area becomes red and sore or the incision opens and the rod comes out, contact your healthcare provider right away.

You need to see your healthcare provider at least once a year for checkups while using this medicine. Do not use this medicine for longer than 1 year without a complete physical exam.

This form of birth control does not protect against sexually transmitted diseases, AIDS, or HIV.

If you become pregnant while using this medicine, you may be at risk for an ectopic pregnancy (baby growing outside the uterus). Call your healthcare provider right away if you think you are pregnant or have unexplained pain in the lower belly.

This medicine may increase your risk of ovarian cysts, strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, and liver tumors. Talk with your healthcare provider about these risks.

The rod may be removed at any time for medical or personal reasons, but it must be removed after 3 years. A new rod may then be implanted.

This medicine may increase your HDL cholesterol levels, decrease your LDL levels, and increase your blood triglyceride levels. Talk to your healthcare provider about this.

If you wear contact lenses and notice a change in your vision or it becomes difficult to wear your lenses, contact your healthcare provider.

If you are scheduled to have surgery or will be on bedrest, talk to your healthcare provider. You may need to stop taking hormones at least 4 to 6 weeks before the surgery and bedrest. If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. You may have a greater risk of blood clots.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.):

• Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• Sharp chest pain or pressure, coughing blood, or sudden shortness of breath
• Pain in the calf or leg pain that does not go away
• Sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking

Serious (Report these to your healthcare provider right away.): Unusual bleeding; irregular or heavy periods; discharge from your breasts; severe nausea or vomiting; sudden dizziness or fainting; unexplained swelling; yellowing of your skin or eyes; dark urine; light colored bowel movements; severe stomach pain; suicidal thoughts; depression; breast lumps; severe or ongoing pain, redness, bleeding, or irritation at the insertion site.

Other: Mild headache, nervousness, mild nausea, mild dizziness, weight gain, acne, mild mood changes, breast pain, back pain, mild insertion site pain or irritation, sore throat, vaginal itching or discharge.

What products might interact with this medicine?

Some other medicines may make this medicine less effective at preventing pregnancy. Before using this medicine, talk with your healthcare provider if you are taking:

• Acitretin (Soriatane)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), oxazepam, and temazepam (Restoril)
• Antibiotics such as rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antifungal medicines such as griseofulvin (Grifulvin V, Gris-PEG), itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), ethotoin (Peganone), felbamate (Felbatol), fosphenytoin (Cerebyx), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as bexarotene (Targretin), dabrafenib (Tafinlar), enzalutamide (Xtandi), mitotane (Lysodren), and tretinoin (Atralin, Renova, Retin-A)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and mycophenolate (CellCept, Myfortic)
• Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, rivaroxaban (Xarelto), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as black cohosh, chasteberry, dong quai, evening primrose oil, ginseng, red clover, soy, St. John's wort, topical progesterone, and wild yam
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.