Etonogestrel (implant)

Etonogestrel (implant)

Etonogestrel (implant)

What is an etonogestrel implant?

The etonogestrel implant may also be used for purposes not listed in this medication guide.

Side effects of etonogestrel implants

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Etonogestrel can cause serious side effects. Call your doctor immediately if you have:

• warmth, redness, swelling or oozing at the site where the implant was inserted;

• severe pain or cramps in the pelvic area (possibly only on one side);

• Signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• Signs of a blood clot - sudden loss of vision, stabbing chest pain, shortness of breath, coughing up blood, pain or warmth in one or both legs;

• Heart attack symptoms – chest pain or feeling of pressure, pain spreading to the jaw or shoulder, nausea, sweating;

• increased blood pressure – severe headache, blurred vision, throbbing in the neck or ears;

• swelling of your hands, ankles, or feet;

• jaundice (yellowing of the skin or eyes);

• a lump in the breast; or

• Symptoms of depression: sleep problems, weakness, fatigue, mood swings.

Common side effects of etonogestrel may include:

• pain at the site where the implant was inserted;

• changes in your menstruation;

• vaginal itching or discharge;

• acne, mood swings, weight gain;

• back pain, menstrual cramps;

• nausea, stomach pain;

• chest pain;

• headache, dizziness; or

• flu-like symptoms, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

Do not use if you are pregnant or have recently had a child.

You should not use an etonogestrel implant if you:undiagnosed vaginal bleeding, liver disease or liver cancer, if you are having major surgery or if you have ever had a heart attack, stroke, blood clot or breast, uterine/cervical or vaginal cancer.

Using an etonogestrel implant may increase your risk of blood clots, stroke, or heart attack.

Smoking can significantly increase your risk of blood clots, strokes or heart attacks.You should not smoke while using an etonogestrel implant.

Before you take this medicine

Using an etonogestrel implant may increase your risk of blood clots, stroke, or heart attack. You are at even greater risk if you have high blood pressure, diabetes, high cholesterol or are overweight. Your risk of a stroke or blood clot is highest in the first year of using etonogestrel.

Smoking can significantly increase your risk of blood clots, strokes or heart attacks.Your risk increases the older you are and the more you smoke.

Do not use if pregnant.If you become pregnant, the etonogestrel implant should be removed if you plan to continue the pregnancy.

A negative pregnancy test may be required prior to implantation.

You should not use hormonal contraception if you have:

• a history of heart attack, stroke, or blood clots;

• a history of hormone-related cancer or cancer of the breast, uterus/cervix, or vagina;

• unusual vaginal bleeding that has not been checked by a doctor; or

• Liver disease or liver cancer.

Tell your doctor if you have ever had:

• Diabetes;

• high cholesterol or triglyceride levels;

• high blood pressure;

• Headache;

• Gallbladder disease;

• kidney disease;

• Depression; or

• an allergy to anesthetic medications.

An etonogestrel implant may not be as effective in overweight women.

The etonogestrel implant should not be used in girls under 18 years of age.

Etonogestrel can pass into breast milk, but there are no known effects on the breast-fed infant. Tell your doctor if you are breast-feeding.

How is the etonogestrel implant used?

The timing of when you receive this implant depends on whether you have previously used contraception and what type it is.

The etonogestrel implant is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. After the implant is inserted, your arm will be covered with 2 bandages. Remove the top dressing after 24 hours, but leave the smaller dressing on for 3 to 5 days. Keep the area clean and dry.

You should be able to feel the implant under your skin. Tell your doctor if you cannot feel the implant at any time during implantation.

The etonogestrel implant can remain in place for up to 3 years. If the implant is correctly placed, you will not need to use additional contraception. Follow your doctor's instructions.

You may experience irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your period is very heavy, long-lasting, or if you miss your period (you may be pregnant).

If you need major surgery, need bed rest for a long time or need medical testsYour etonogestrel implant may need to be removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

Have regular physical exams and mammograms, and self-examine your breasts for lumps monthly while using this medication.

The etonogestrel implant must be removed by the end of the third year after insertion, at which time it can be replaced with a new implant. After the implant is removed, your ability to become pregnant will be restored quickly. If the implant is not replaced with a new one, start using another method of contraception immediately if you want to prevent pregnancy.

Call your doctor immediately if you think the implant may be bent or broken while it is in your arm.

Etonogestrel dosage information

Usual adult dose for contraception:

A 68 mg implant subdermally just under the skin on the inside of the non-dominant upper arm
– Remove at the end of the third year at the latest

Comments:
-The implant can be replaced with a new implant at the time of removal.
-If a hormonal contraceptive has not been used in the last month: Insert between days 1 and 5 of the menstrual cycle, even if bleeding still occurs.
-Switching from a combined hormonal contraceptive: Take the dose on the day after the last active tablet of the oral contraceptive or on the day the vaginal ring or patch is removed.
-Switching from a progestogen-only injectable contraceptive: implant on the day the next injection is due.
-Switching from the progestogen-only minipill: Switch any day of the month within 24 hours of the last tablet.
-Conversion from a progestin-only implant or intrauterine device: Insertion occurs on the same day that the previous contraception is removed.
-After a first trimester abortion or miscarriage: Insert within 5 days of the abortion/miscarriage.
-After second trimester abortion or miscarriage: Insert between 21 and 28 days of abortion/miscarriage.
-After birth, not while breastfeeding: Introduce between 21 and 28 days after birth.
-After birth, breastfeeding: Insertion after the fourth week after birth, the use of a barrier contraception method is recommended until 7 days after implantation.
-If introduced as recommended above, additional contraception is not necessary. If there are deviations from the above recommendations, a barrier contraceptive is recommended until 7 days after insertion.

What happens if I miss a dose?

Because etonogestrel is administered as an implant by a healthcare professional, you do not need to follow frequent dosages. Make sure to see your doctor to have the implant removed by the end of the third year.

What happens if I overdose?

If the implant is inserted correctly, an overdose of etonogestrel is highly unlikely.

What should I avoid while taking etonogestrel implants?

You should not smoke while using an etonogestrel implant.

The etonogestrel implant does not protect you from sexually transmitted diseases – including HIV and AIDS. The only way to protect yourself from these diseases is to use a condom.

What other drugs affect the etonogestrel implant?

Certain other medicines or herbal products may make etonogestrel less effective, which could result in pregnancy. You may need to use a non-hormonal form of additional contraception (e.g. condoms containing spermicide) while you are taking certain medicines and for up to 28 days after stopping the medicine.

Tell your doctor about all other medicines you are taking, especially:

• aprepitant;

• bosentan;

• griseofulvin;

• rifampin;

• St. John's wort;

• topiramate;

• medicines to treat hepatitis C, HIV or AIDS;

• a barbiturate – butabarbital, secobarbital, phenobarbital; or

• Seizure medications – carbamazepine, felbamate, oxcarbazepine, phenytoin.

This list is not complete. Other medications can affect etonogestrel, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible drug interactions are listed here.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.