Etonogestrel

Etonogestrel is a prescription medication used as contraception to prevent pregnancy. 

• Etonogestrel is available under the following different brand names: Implanon, Nexplanon 

Common side effects of Etonogestrel include:

• Changes in the menstrual periods,
• Vaginal itching or discharge,
• Acne,
• Mood changes,
• Weight gain,
• Breakthrough bleeding,
• Menstrual cramps,
• Nausea,
• Stomach pain,
• Breast tenderness,
• Dizziness,
• Flu-like symptoms, and
• Sore throat

Serious side effects of Etonogestrel include:

• Warmth, redness, swelling, or oozing where the implant was inserted,
• Severe pain or cramping in the pelvic area,
• Sudden numbness or weakness (especially on one side of the body),
• Sudden severe headache,
• Slurred speech,
• Problems with vision or balance,
• Sudden vision loss,
• Stabbing chest pain,
• Feeling short of breath,
• Coughing up blood,
• Pain or warmth in one or both legs,
• Chest pain or pressure,
• Pain spreading to the jaw or shoulder,
• Nausea,
• Sweating,
• Severe headache,
• Blurred vision,
• Pounding in the neck or ears,
• Swelling in the hands, ankles, or feet,
• Yellowing of the skin or eyes,
• Breast lump,
• Depression,
• Sleep problems,
• Weakness,
• Tired feeling, and
• Mood changes

Rare side effects of Etonogestrel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Implant

• 68 mg

Contraception

Adult dosage

• Insert 1 implant subdermal
• No preceding hormonal contraceptive use in the past month: Insert between Days 1 through 5
• Switch from a combination of another contraceptive
• OCP: Within 7 days after the last active pill
• Vaginal ring: During 7-day ring-free period etonogestrel/ethinylestradiol
• Transdermal patch: During a 7-day patch-free period of a transdermal contraceptive system
• Switch from progestin-only contraceptive
• Any day of the month when switching from the pill; do not skip any days between the last pill and insertion
• On the same day as contraceptive implant removal
• On the same day as the removal of a progestin-containing IUD
• On the day when the next contraceptive injection would be due

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Etonogestrel has severe interactions with no other drugs.
• Etonogestrel has serious interactions with the following drugs:
  • brigatinib
  • carbamazepine
  • clarithromycin
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • lesinurad
  • lumacaftor/ivacaftor
  • mavacamten
  • rifabutin
  • rifampin
  • St John's Wort
  • sugammadex sodium
• Etonogestrel has moderate interactions with at least 67 other drugs.
• Etonogestrel has minor interactions with the following drugs:
  • eslicarbazepine acetate
  • nefazodone

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past
• Liver tumors, benign or malignant, or active liver disease
• Undiagnosed abnormal vaginal bleeding
• Hypersensitivity to etonogestrel or component of the formulation
• Current/history of thrombophlebitis, thromboembolic disorders

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Etonogestrel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Etonogestrel?”

Cautions

• Caution in the family history of DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (. g, migraine, asthma, epilepsy)
• Women with a family history of breast cancer or who develop breast nodules should be carefully monitored
• Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, the drug should not be used before 21 days postpartum; women with a history of thromboembolic disorders should be made aware of the possibility of recurrence
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, severe depression, increased risk of thromboembolic complications after surgery
• Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist
• Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Use caution in patients on warfarin, and oral anticoagulants (an increase in anticoagulant dose may be warranted)
• Some studies link OCP use with an increased risk of breast cancer, whereas other studies have not shown a change in risk; a woman's risk depends on conditions where naturally high hormone levels persist for long periods including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity
• Increased risk of cervical cancer with OCP use, however, HPV remains the main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Hormonal contraceptives may cause some degree of fluid retention; prescribe with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention; unknown if the drug causes fluid retention
• Disturbances of liver function may necessitate discontinuation of hormonal contraceptive use until markers of liver function return to normal; remove treatment if jaundice develops; the progestin may be poorly metabolized in women with liver impairment; increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• A pregnancy that occurs in a woman may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception; be alert to the possibility of ectopic pregnancy in women receiving therapy who become pregnant or complain of lower abdominal pain
• After starting therapy, women are likely to have a change from their normal menstrual bleeding pattern; these may include changes in bleeding frequency (absent, less, more frequent, or continuous), intensity (reduced or increased), or duration; evaluate abnormal bleeding as needed to exclude pathologic conditions or pregnancy
• The implant should be removed in the event of a thrombosis
• Discourage women with a history of hypertension-related diseases or renal disease from using hormonal contraception; for women with well-controlled hypertension, use can be considered; women with hypertension receiving therapy should be closely monitored; if sustained hypertension develops during therapy, or if a significant increase in blood pressure does not respond adequately to antihypertensive therapy, remove the implant
• Patients receiving therapy should have a yearly visit with the healthcare provider for a blood pressure check and other indicated healthcare
• The implant should be removed if blood pressure rises significantly and becomes uncontrolled
• When the implant is broken or bent, may increase the release rate of etonogestrel; when the implant is removed, remove it in its entirety
• A small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users was reported; not known whether a similar risk exists with progestin-only methods
• Monitor prediabetic and diabetic women receiving therapy; may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance; carefully monitor prediabetic and diabetic women receiving therapy
• Follow closely women being treated for hyperlipidemia, if they elect to receive treatment; some progestins may elevate LDL levels and may render control of hyperlipidemia more difficult
• If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in the normal cycle; generally, enlarged follicles disappear spontaneously; on rare occasions, surgery may be required
• Sex hormone-binding globulin concentrations may be decreased for the first six months after implant insertion followed by gradual recovery; thyroxine concentrations may initially be slightly decreased followed by gradual recovery to baseline
• Re-start contraception immediately after removal of the implant if continued contraceptive protection is desired
• Complications of Insertion
  • Implant removal may be difficult or impossible if the implant is not inserted correctly, inserted too deeply, not palpable, encased in fibrous tissue, or has migrated
  • Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged
  • Migration of implant within arm from the insertion site, which may be related to deep insertion, reported; in cases where the implant has migrated to the pulmonary artery, chest pain and/or respiratory disorders (such as dyspnea, cough, or hemoptysis) reported; others were asymptomatic; endovascular or surgical procedures may be needed for removal
  • If at any time implant cannot be palpated, it should be localized; removal is recommended
  • If inserted deeply (intramuscular or in fascia), a neural or vascular injury may occur; to help reduce the risk of neural or vascular injury insert the product subdermally just under the skin at the inner side of the non-dominant upper arm overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to sulcus (groove) between biceps and triceps muscles; this location avoids large blood vessels and nerves lying within and surrounding the sulcus

Pregnancy and Lactation

• Contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant; epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low-dose CHCs before conception or during early pregnancy
• Lactation
  • Small amounts of contraceptive steroids and/or metabolites, including etonogestrel, are present in human milk; no significant adverse effects were observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants
  • Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers; this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women; when possible, advise nursing mothers about both hormonal and non-hormonal contraceptive options, as steroids may not be the initial choice for these patients; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for hormonal contraceptive and any potential adverse effects on the breastfed child from hormonal contraceptive or underlying maternal condition