Etonogestrel

What is Etonogestrel?

• Etonogestrel (Nexplanon and Implanon), is a progestin indicated for use by women to prevent pregnancy.

Etonogestrel

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Etonogestrel molecule ball

What are the uses of this medicine?

• Etonogestrel (Nexplanon and Implanon), is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years.
• The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel.
• It contains a small amount of barium sulfate (15 mg), so that the implant can be seen by X-ray, an ethylene vinyl acetate (EVA) copolymer (28% vinyl acetate, 43 mg) core, and magnesium stearate (0.1 mg).
• Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm.
• You can use a single Etonogestrel implant for up to 3 years.
• It does not contain estrogen.

How does this medicine work?

• Nexplanon prevents pregnancy in several ways.
• The most important way is by stopping the release of an egg from your ovary.
• Nexplanon also thickens the mucus in your cervix and this change may keep sperm from reaching the egg.
• Nexplanon also changes the lining of your uterus.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Are pregnant or think you may be pregnant
• Have, or have had blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)
• Have liver disease or a liver tumor
• Have unexplained vaginal bleeding
• Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
• Are allergic to anything in Nexplanon

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• aprepitant
• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate
• HIV medicines
• Hepatitis C Virus medicines

• If you are taking medicines or herbal products that might make Nexplanon less effective, you and your healthcare provider may decide to leave Nexplanon in place; in that case, an additional non-hormonal contraceptive should be used.

Is this medicine FDA approved?

• Etonogestrel was patented in 1972 and introduced for medical use in 1998.
• It became available in the United States in 2006.

How should this medicine be used?

Recommended dosage:

• Insert one Nexplanon subdermally just under the skin at the inner side of the non-dominant upper arm. Nexplanon must be removed no later than by the end of the third year.

Administration:

• Your healthcare provider will place and remove the Nexplanon implant in a minor surgical procedure in his or her office. The implant is placed just under the skin on the inner side of your non-dominant upper arm.

The timing of insertion is important. Your healthcare provider may:

• Perform a pregnancy test before inserting Nexplanon.
• Schedule the insertion at a specific time of your menstrual cycle (for example, within the first 5 days of your regular menstrual bleeding). If the implant is placed after the fifth day of menses, then you should use an additional contraceptive method (such as a condom) for the first 7 days after insertion.
• Your healthcare provider will cover the site where Nexplanon was placed with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3 to 5 days.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel, pre-loaded in the needle of a disposable applicator.

This medicine is available in fallowing brand namesː

• Nexplanon and Implanon

What side effects can this medication cause?

The most common side effects of this medicine include:

• change in your normal menstrual bleeding pattern
• Mood swings
• Weight gain
• Headache
• Acne
• Depressed mood

Other common side effects include:

• Headache
• Vaginitis (inflammation of the vagina)
• Weight gain
• Acne
• Breast pain
• Viral infections such as sore throats or flu-like symptoms
• Stomach pain
• Painful periods
• Mood swings, nervousness, or depressed mood
• Back pain
• Nausea
• Dizziness
• Pain
• Pain at the site of insertion

Less common,but serious side effects may include:

• Implants have been reported to be found in a blood vessel, including a blood vessel in the lung which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.
• Problems with Insertion and Removal
• Ovarian Cysts
• Ectopic Pregnancy
• Breast Cancer
• Serious Blood Clots
• Broken or Bent Implant

What special precautions should I follow?

• Counsel women about the insertion and removal procedure of the Nexplanon implant. Provide the woman with a copy of the Patient Labeling and ensure that she understands the information in the Patient Labeling before insertion and removal. A USER CARD and consent form are included in the packaging. Have the woman complete a consent form and retain it in your records. The USER CARD should be filled out and given to the woman after insertion of the Nexplanon implant so that she will have a record of the location of the implant in the upper arm and when it should be removed.
• Counsel women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.
• Counsel women that Nexplanon does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
• Counsel women that the use of Nexplanon may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.
• If you become pregnant while using Nexplanon, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.
• Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.
• It is not known whether Nexplanon use changes a woman's risk for [[]]breast cancer. If you have breast cancer now, or have had it in the past, do not use Nexplanon because some breast cancers are sensitive to hormones.
• Nexplanon may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.
• A few women who use birth control that contains hormones may get:
• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors
• Breakage or bending of the implant may occur due to external forces (e.g., manipulation of the implant or contact sports). A broken implant may move from the insertion site. If you feel that the implant may have broken or bent while in your arm, contact your healthcare provider.
• If you are breastfeeding your child, you may use Nexplanon if 4 weeks have passed since you had your baby. A small amount of the hormone contained in Nexplanon passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use Nexplanon, talk with your healthcare provider for more information.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Overdosage may result if more than one implant is inserted.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of suspected overdose, the implant should be removed.

Can this medicine be used in pregnancy?

• Nexplanon is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant

Can this medicine be used in children?

• Safety and efficacy of Nexplanon have been established in women of reproductive age.
• Safety and efficacy of Nexplanon are expected to be the same for postpubertal adolescents.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• etonogestrel

Inactive Ingredients:

• barium sulfate
• magnesium stearate
• ethylene-vinyl acetate copolymer

Who manufactures and distributes this medicine?

Manufactured for:

• Organon USA LLC, a subsidiary of
• ORGANON & Co.,
• Jersey City, NJ, USA

Manufactured by:

• N.V. Organon, Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ, USA

What should I know about storage and disposal of this medication?

• Store Nexplanon (etonogestrel implant) Radiopaque at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF).
• Avoid storing Nexplanon at temperatures above 30ºC (86ºF).

• Dailymed label info on Etonogestrel
• FDA Etonogestrel

Etonogestrel Resources
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