Nexplanon (Etonogestrel implant) is a flexible and very thin implant that is placed under the skin of the non-dominant arm. It is indicated for the long term prevention of pregnancy. The Nexplanon Etonogestrel implant is kept in place for up to three years after which it should be removed.

Nexplanon (Etonogestrel implant) Uses:

• Contraception:

  • It is indicated for the long term prevention of pregnancy.

Nexplanon (Etonogestrel implant) Dose in Adults

Nexplanon (Etonogestrel implant) Use for Contraception in females:

• Subdermal:
  • Insert 1 implant in the inner side of the upper, non-dominant arm.
  • Remove no later than 3 years after the date of insertion; may be replaced with a new implant at the time of removal if continued contraceptive protection is desired.
  • After ruling out pregnancy, the timing of insertion is based on the patient's contraceptive history:
    • No hormonal contraceptives within the past month:
      • Insert between days 1 through 5 of menstruation, even if the woman is still bleeding

• Switching from combination hormonal contraceptive:

  • Oral tablet:
    • Put it on the day after the last active tablet (at the latest, insert on the day following the usual tablet-free or placebo interval)
  • Transdermal system or vaginal ring:
    • Put it  on the day of the removal of the transdermal system or vaginal ring (at the latest, Put on the day following the transdermal-free or ring-free interval)

  • Switching from a progestin-only contraceptive:

    • Oral tablet:
      • Any day within the month; do not forget or skip days between the last tablet and implant insertion
    • Implant or intrauterine device (IUD):
      • Put it on the same day as the removal of the implant or IUD.
    • Injection:
      • Put it on the day next injection is due
  • First-trimester abortion or miscarriage:
    • Put within the first 5 days following first-trimester abortion or miscarriage.
  • Second-trimester abortion or miscarriage:
    • Put it within  21 and 28 days following second-trimester abortion or miscarriage.
  • Postpartum:
    • If not breastfeeding, Put it within 21 to 28 days postpartum.
    • If breastfeeding, insert after the fourth postpartum week and use a second non-hormonal form of contraception for the first weak of insertion.
  • Note:
    • If following any of the above insertion schedules, no back-up contraception required (except in postpartum women who are breastfeeding).
    • If deviating, use a back-up non-hormonal contraceptive method for a weak postinsertion. If intercourse has already occurred, pregnancy should be excluded.

• Additional dosing considerations:

  • Initiation of therapy:
    • Once determined that the woman is not pregnant then it may be started at any time in the menstrual cycle.
    • Back-up contraception is not needed if started within 5 days of onset of menstruation.
    • If started more than 5 days after the onset of menstruation or at any time in a woman experiencing amenorrhea (not postpartum), back-up contraception should be used for a weak (7 days).
  • Switching from a different contraceptive to an implant:
    • Once determined that the woman is not pregnant it may be started at any time.
    • Unless the woman abstains from sexual intercourse, a back-up method of contraception is required if it has been more than 5 days since menstrual bleeding has begun.
    • When an additional method of contraception is required, consider continuing the woman's previous method a weak after inserting the implant.
  • Switching from an IUD to an implant:
    • Continue the IUD for at least 7 days(weak) after the implant is inserted or advise the woman to abstain from sexual intercourse or use a barrier contraceptive for a weak before removing the IUD.
    • Alternately, an emergency contraceptive may be used at the time of IUD removal.

Nexplanon (Etonogestrel implant) Dose in Childrens

Note: Implanon has been discontinued in the US for more than 1 year.

Nexplanon (Etonogestrel implant) Use for Contraception:

• Adolescents (females):

  • Refer to adult dosing. Not for use prior to menarche.

Nexplanon (Etonogestrel implant) Pregnancy Risk Category: X

• Pregnant women should not use it.
• Combination hormonal contraceptives used inadvertently early in pregnancy have not been shown to cause teratogenic effects.
• Before prescribing, it is important to evaluate your pregnancy status. If you are pregnant, the implant should be removed.
• There is no evidence to suggest that etonogestrel has a higher risk.
• The manufacturer recommends that you wait at least 21 days after delivery to avoid the risk of thromboembolism.
• According to available guidelines, progestin-only implant may be placed at any time provided that the woman is not pregnant. This includes immediately after birth or after an abortion.
• Administration immediately postpartum (prior hospital discharge) can be provided regardless of breastfeeding status. This may help to prevent unintended or rapid pregnancies.
• The serum concentrations of Etonogestrel decrease 7 days after the implant is removed. Pregnancies can be reported as soon as 7 to 14 business days after the implant has been removed.
• If you wish to continue contraception, it is important that you immediately start contraception after the removal.

Etonogestrel implant use during breastfeeding:

• Breast milk contains Etonogestrel.
• According to the manufacturer, the relative infant dose for etonogestrel is 2.2 percent of its weight-adjusted maternal dosage.
• When the RID of medication falls below 10 percent, breastfeeding is generally acceptable.
• According to the manufacturer, the RID of etonogestrel was calculated from the milk concentrations of 38 women who were breastfeeding at 4-8 weeks after the start date for treatment.
• A 4-month study showed that milk concentrations increased after the implant was inserted and decreased when the maternal serum concentrations dropped.
• However, etonogestrel did not affect the quantity or quality of breast milk.
• The theory is that progestin implants could prevent lactogenesis from arising.
• Breastfed babies of mothers who used an etonogestrel intrauterine device were found not to show differences in growth (body length and biparietal head circumference), or adverse physical or psychological development, as compared to infants who received a nonhormonal contraceptive intrauterine implant (mean breastfeeding duration was 421 months). Infants evaluated over 36 month.
• According to the manufacturer, when deciding whether to breastfeed, you should consider the risks to infants, the benefits to the infant and the mother's benefits.
• The manufacturer doesn't recommend that the implant be placed before 4 weeks after delivery, but guidelines state progestin-only implants can be placed at any time provided it is reasonable to assume the woman isn't pregnant. This includes breastfeeding mothers.

Dose in Kidney Disease:

Manufacturer's labeling doesn't provide any dose adjustments (has not been studied

Dose in Liver disease:

Its use is contraindicated.

Common Side Effects of Nexplanon (Etonogestrel implant):

• Central Nervous System:

  • Headache

• Dermatologic:

  • Acne Vulgaris

• Endocrine & Metabolic:

  • Amenorrhea
  • Weight Gain
  • Menstrual Disease

• Gastrointestinal:

  • Abdominal Pain

• Genitourinary:

  • Mastalgia
  • Vaginitis

• Respiratory:

  • Pharyngitis

Less Common Side Effects Of Nexplanon (Etonogestrel implant):

• Central Nervous System:

  • Nervousness
  • Pain
  • Dizziness
  • Emotional Lability
  • Depression

• Dermatologic:

  • Localized Erythema

• Endocrine & Metabolic:

  • Dysmenorrhea

• Gastrointestinal:

  • Nausea

• Genitourinary:

  • Leukorrhea

• Hypersensitivity:

  • Hypersensitivity Reaction

• Local:

  • Hematoma At Injection Site
  • Bruising At Injection Site
  • Application Site Reaction
  • Local Pain

• Neuromuscular & Skeletal:

  • Back Pain

• Respiratory:

  • Flu-Like Symptoms

Contraindications to Nexplanon (Etonogestrel implant):

• Hypersensitivity to etonogestrel and any component of the formulation
• Breast cancer (known, suspected or personal history);
• Progestin-sensitive cancer (current or past)
• Hpatic tumors (benign and malignant) or active liver disease.
• Pregnancy (known or suspected);
• thrombosis and thromboembolic conditions (current or historical);
• Undiagnosed abnormal Genital Bleeding.

Warnings and precautions

• Breast cancer

  • Women with breast cancer history or who have had it are advised not to use it.
  • Breast cancer is a hormone sensitive tumor. Women with a history of breast cancer or current symptoms may have a worse prognosis if they use progestin-only contraceptives.

• Ectopic pregnancy

  • Rarely, ectopic pregnancy may be more common than for women who use no contraception.

• Ovarian cysts

  • Follicular growth can occur and may increase in size beyond that which may be expected in a normal cycle.
  • Ovarian cysts usually resolve themselves without any intervention. However, it is possible to have surgery.

• Retinal vascular embolism:

  • If you experience an undiagnosed loss of vision, diplopia or papilledema, or retinal vessels lesions, discontinue use immediately and get checked for retinal vein embolism.

• Thromboembolism

  • Progestin-only contraceptives are expected to have a lower risk of DVT/PE than those using combination hormonal contraceptives.
  • Women with thrombosis (current or past) or thromboembolic conditions (current or past) are not advised to use etonogestrel.
  • Combining hormonal contraceptives can increase the risk for thromboembolism as well as other vascular events (eg deep vein thrombosis [DVT], infarction, or pulmonary embolism [PE]).
  • Combination hormonal contraceptives can increase the risk of venous embolism in women with inherited thrombophilias, such as protein C or S deficiencies.

• Vaginal bleeding

  • It is possible for bleeding patterns to change.
  • A diagnosis of persistent, undiagnosed or recurrent abnormal vaginal bleeding is necessary to rule out malignancy.

• Weight loss

  • Common use results in a weight gain of approximately 2.8 pounds after one year and 3.7 after two years.

• Cardiovascular disease

  • Use with caution in patients with risk factors for cardiovascular disease (eg, morbid obesity, diabetes, hypertension, hypercholesterolemia, women who smoke).

• Diabetes:

  • This may cause impaired glucose tolerance. Be cautious with prediabetes and diabetes cases in women.

• Fluid retention can lead to more severe diseases

  • Patients with fluid retention-related diseases should be cautious.

• Gallbladder disease

  • Combination hormonal contraceptives can increase the risk of gallbladder disease. It is not known if this risk is greater with progestin-only products.

• Hepatic adenomas and carcinomas

  • Preexisting hepatic cancers are contraindicated by Etonogestrel.
  • Rarely, combination hormonal contraceptives can cause hepatic tumors.
  • It is unknown what the risk of progestin-only contraceptives.

• Hepatic impairment

  • Hepatic disease is a contraindication to its use.
  • Women with impaired hepatic function may not be able to properly metabolize the drug.
  • If jaundice occurs during treatment or if the liver function is abnormal, discontinue use.

• Hyperlipidemia:

  • Patients with hyperlipidemia should be cautious. Progestins can increase low-density lipoprotein LDL levels.

• Hypertension:

  • Women with hypertension can use progestin-only implant. Other risk factors for heart disease, such as smoking and diabetes, should also be taken into consideration when prescribing.
  • According to the manufacturer, it is recommended that women who have a history of hypertension-related conditions should use non-hormonal contraceptives.
  • Women with well-controlled hypertension may consider using it. Keep an eye on your blood pressure.
  • Remove the implant if you experience persistent hypertension or a severe increase in blood pressure that does not respond to antihypertensive therapy.

• Renal impairment

  • Women suffering from renal disease should be encouraged not to use hormonal contraception.

Etonogestrel implant: Drug Interaction

Monitoring parameters:

• Assessment of pregnancy status (prior to therapy);
• weight (optional;
• body mass index [BMI] at baseline may be helpful to monitor changes during therapy);
• assess potential health status changes at routine visits.
• Monitor patient for vision changes;
• blood pressure;
• signs and symptoms of thromboembolic disorders;
• signs or symptoms of depression;
• glycemic control in patients with diabetes;
• lipid profiles in patients being treated for hyperlipidemias.
• Bleeding irregularities including amenorrhea;
• adequate diagnostic measures should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.

How to Insert and remove Nexplanon (Etonogestrel implant)?

Subdermal:

• For subdermal insertion by health care providers trained in the insertion and removal procedure.
• Put implant subdermally just under the skin at the inner side of the non-dominant upper arm overlying the triceps muscle ~8 to 10 cm (3 to 4 inches) from the medial epicondyle of the humerus and 3 to 5 cm (1.25 to 2 inches) posterior to the sulcus between the biceps and triceps muscles.
• If it is not possible to insert at this location (eg, in women with thin arms), insert as far posterior from the sulcus as possible.
• To ensure proper placement just under the skin, view the advancement of the needle from the side, not from above the patient.

The implant must be palpable after insertion.

• X-ray, CT scan, ultrasound scanning, or MRI may also be used to confirm the location of the implant if it is not palpable.
• Deeply placed implants should be localized and removed as soon as possible.
• Removal of deeply placed implants, implants that are not palpable, or implants that cannot be grasped during removal should be performed by health care providers trained in complex removal procedures.
• Use of a non-hormonal contraceptive (eg, condom) is required until the presence of the implant can be verified.
• Perform removal under aseptic conditions. Inject local anesthetic under (not over) the implant.
• Confirm that the entire implant has been removed by measuring its length of 4 cm. Remove all pieces if the implant has broken.
• A new implant may be inserted in the same arm through the same incision as long as the site is in the correct location.
• Refer to the manufacturer's product labeling for complete insertion, removal, and reinsertion instructions.
• A User Card (to give to the patient), consent form (to keep on file), and patient product information are provided with the device.
• Materials related to the insertion and removal of etonogestrel implant (including videos demonstrating insertion and removal) are available from the manufacturer (877-888-4231); www.nexplanontraining.com.

Mechanism of action of Nexplanon (Etonogestrel implant):

• Etonogestrel is the active metabolite of desogestrel. It inhibits endometrial growth and suppresses ovulation.

Duration:

• Each implant maintains etonogestrel levels sufficient to inhibit ovulation for 3 years

Protein binding:

• Albumin (66%) and sex hormone-binding globulin (~32%)

Metabolism:

• Hepatic via CYP3A4; forms metabolites (activity not known)

Bioavailability:

• Implant: 100%

Half-life, elimination:

• ~25 hours

Excretion:

• Urine (primarily);
• feces

Pharmacokinetics note:

• The rod releases etonogestrel at a rate of 60 to 70 mcg/day in week 5 to 6, decreasing to ~35 to 45 mcg/day at the end of the first year, ~30 to 40 mcg/day at the end of the second year, and ~25 to 30 mcg/day at the end of the third year.
• Following removal of the rod, levels decrease rapidly and are less than the level of detection within 1 week

International Brand Names of Etonogestrel implant:

• Implanon NKST
• Implanon NXT
• Nexplanon
• Implanon

Etonogestrel implant Brand Names in Pakistan:

No Brands are Available in Pakistan.