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Etonogestrel (Intradermal route)

Pronunciation:

e-toe-noe-JES-trel

Brand Names:

  • Implanon
  • Nexplanon

Dosage Forms:

  • Implant

Classifications:

Therapeutic—

Contraceptive, Progestin

Pharmacologic—

Progestin

Uses of This Medicine:

Etonogestrel implant is a medicine that is used in women to prevent pregnancy. It is a form of birth control. This medicine contains a hormone in a flexible plastic rod about the size of a matchstick. It is effective for three years when inserted just beneath the skin of your upper arm.

Etonogestrel implant will not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Older adults—

Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the geriatric population. This medicine should not be used in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aripiprazole
  • Carbamazepine
  • Dabrafenib
  • Eliglustat
  • Fentanyl
  • Isotretinoin
  • Theophylline

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Colesevelam
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Efavirenz
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Modafinil
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Voriconazole
  • Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding (non-menstrual) or
  • Breast cancer, now or in the past or if suspected or
  • Cancer (progestin-sensitive), now or in the past or
  • Liver disease, active or
  • Liver tumors, benign or malignant—Should not be used in patients with these conditions.
  • Blood clots, now or in the past—Should not be used in patients with blood clots in the brain, legs, lungs, eyes, or heart.
  • Depression, or history of or
  • Diabetes or
  • Fluid retention (body swelling) or
  • Gallbladder disease or
  • Heart disease or
  • Hypertension (high blood pressure) or
  • Hyperlipidemia (high cholesterol or fats in the blood)—Use with caution. May make these conditions worse.
  • Obesity—This condition may cause the medicine to not work as well.

Proper Use of This Medicine:

It is very important that you tell your doctor if you think you might be pregnant or if you missed a period before you receive this medicine. Tests will be done to make sure you are not pregnant before this medicine is inserted.

This medicine comes with patient instructions. After reading the instructions, you will be asked to sign a USER CARD and a Patient Consent Form before you receive this medicine. The Consent Form tells you about some possible risks when using this medicine, and when it must be removed. Make sure you understand what is in the patient instructions and the Consent Form before you sign it. Keep the USER CARD in a safe place at home with your health records. If you have any questions, ask your doctor to answer them.

After this medicine is inserted, you should check that it is in place. Gently press your fingertips over the skin in your arm where this medicine was inserted. You should be able to feel the small rod.

You may have to use another form of birth control (e.g., condoms, diaphragms, or spermicides) until the implant has been in place for 7 days. Talk with your doctor about this.

Your doctor must remove this medicine after 3 years. If you would like to stop using this medicine, your doctor can remove it at any time.

If you still want to prevent pregnancy after this medicine is removed, you should start using another form of birth control (e.g., condoms, diaphragms, or spermicides) right away. If you still want to continue using this medicine, your doctor can insert a new implant under your skin after taking the old one out.

Precautions While Using This Medicine:

If you will be using the etonogestrel implant for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

If you become pregnant while using this medicine, you have a slightly higher chance of having an ectopic pregnancy (occurs outside the womb). Ectopic pregnancies can cause serious internal bleeding. Contact your doctor immediately to have the implant removed.

Tell your doctor if you are breastfeeding or planning to breastfeed. You may start using this medicine if you had a baby more than 4 weeks ago.

Etonogestrel implant will not protect you against HIV/AIDS or other sexually transmitted diseases. The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.

Tell your doctor if you have had an allergic reaction to numbing medicines (anesthetics) or skin cleansers (antiseptics). These medicines will be used when etonogestrel implant is inserted into your arm.

This medicine may cause several problems related to insertion and removal, such as pain, irritation, swelling, bruising, scarring, or other complications. Talk to your doctor about these possible risks.

Using this medicine may increase your risk of blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), brain (stroke), heart (heart attack), or eyes (blindness). Make sure your doctor knows at least 4 weeks before if you are going to have a surgery or will need to be on bed rest. Your risk of these serious medical problems is greater during surgery or bed rest, or if you smoke cigarettes.

This medicine may also increase your risk of having irregular monthly periods, ovarian cysts, high blood pressure, gallbladder problems, or liver tumors.

Call your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

If you wear contact lenses and you have blurred vision, difficulty in reading, or any other change in vision while using this medicine, check with your doctor right away. Your doctor may want you to get your eyes checked by an eye doctor (ophthalmologist).

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using etonogestrel implant. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
Breast pain
chills
cough
diarrhea
fever
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pain
nausea
runny nose
shivering
sore throat
sweating
trouble sleeping
unusual tiredness or weakness
vomiting
Less common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
bloating
blurred vision or other changes in vision
breast discharge
breast enlargement
burning while urinating
difficult or painful urination
difficulty with breathing
difficulty with swallowing
dizziness
fast heartbeat
headache, severe and throbbing
hives
itching
lumps in the breasts
nervousness
noisy breathing
painful or tender cysts in the breasts
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash
slow or fast heartbeat
stomach or pelvic discomfort, aching, or heaviness
swelling of the hands, ankles, feet, or lower legs
tightness in the chest
wheezing
Rare
Collection of blood under the skin at the injection site
deep, dark purple bruise at the injection site

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Back pain
blemishes on the skin, pimples
body aches or pain
crying
depersonalization
discouragement
dysphoria
ear congestion
euphoria
feeling sad or empty
hoarseness
increased clear or white vaginal discharge
increased weight
irregular bleeding cycle
irritability
itching of the vagina or genital area
light vaginal bleeding between regular menstrual periods
loss of interest or pleasure
loss of voice
mental depression
nasal congestion
pain, cramps, or heavy menstrual bleeding
pain during sexual intercourse
pain or tenderness around the eyes and cheekbones
paranoia
quick to react or overreact emotionally
rapidly changing moods
stomach pain
tender, swollen glands in the neck
thick, white vaginal discharge with no odor or with a mild odor
trouble concentrating
voice changes
Less common
Abdominal or stomach bloating and cramping
abnormal ejaculation
abnormal or decreased touch sensation
acid or sour stomach
belching
bone pain
burning feeling in the chest or stomach
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
difficulty with moving
dull ache or feeling of pressure or heaviness in the legs
earache, redness, or swelling in the ear
excess air or gas in the stomach or intestines
feeling of vaginal pressure
feeling of warmth
hair loss or thinning of the hair
heartburn
inability to have or keep an erection
increased appetite
increased hair growth on the forehead, back, arms, and legs
indigestion
itching skin near damaged veins
lack or loss of strength
loss in sexual ability, desire, drive, or performance
muscle cramping or stiffness
passing gas
pelvic pain
redness of the face, neck, arms, and occasionally upper chest
sleepiness or unusual drowsiness
sleeplessness
sneezing
stomach upset or pain
stuffy nose
swollen joints
tenderness in the stomach area
unable to sleep
vaginal burning or pain
weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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