×
Min. Age:
Max. Age:
Gender:
Reason:
Duration:

Nexplanon

Generic Name: Etonogestrel Implant
Drug Category: Progestin
Litigation Alert Level: High
This drug has been approved for use by females over the age of 18 years old and under the age of 65 years old for a maximum duration of 3 years.

Approved Uses

Indicated for use by women to prevent pregnancy.

Insert one NEXPLANON subdermally just under the skin at the inner side of the non-dominant upper arm. 

NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur.

NEXPLANON isa long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

Nexplanon is contraindicated in patients with the following conditions:

  • Known or suspected pregnancy
  • Current or past history of thrombosis or thromboembolic disorders
  • Liver tumors, benign or malignant, or active liver disease
  • Undiagnosed abnormal genital bleeding
  • Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past

There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis.

Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

The progestin in NEXPLANON may be poorly metabolized in women with liver impairment. Use of NEXPLANON in women with active liver disease or liver cancer is contraindicated.

In clinical studies, mean weight gain in U.S. non-radiopaque etonogestrel implant (IMPLANON) users was 2.8 pounds after one year and 3.7 pounds after two years.

The effectiveness of the etonogestrel implant in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials.

Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

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 a normal cycle.

Women with a history of hypertension-related diseases or renal disease should be discouraged from using hormonal contraception.

Use of NEXPLANON may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance.

Women who are being treated for hyperlipidemia should be followed closely if they elect to use NEXPLANON. Some progestins may elevate LDL levels and may render the control of hyperlipidemia more difficult.

Hormonal contraceptives may cause some degree of fluid retention.

Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a backup method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel.

Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors (decrease: nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir) or (increase: indinavir and atazanavir/ritonavir/HCV protease inhibitors) or (decrease: boceprevir and telaprevir) or with non-nucleoside reverse transcriptase inhibitors (decrease:nevirapine, efavirenz) or (increase etravirine).

Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, Nexplanon should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.

NEXPLANON should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary.

Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource  

• Endometriosis. GoToSource 

• Primary dysmenorrhea. GoToSource

• Premenstrual syndrome. GoToSource

Adverse Events

Acne, headache, weight gain, emotional lability, depression and bleeding irregularities. GoToSource 

Pseudotumor cerebri (increased pressure around the brain). GoToSource 

Increased risk of breast cancer. GoToSource

Thrombotic stroke and myocardial infarction. GoToSource

Litigation

Lawsuits filed for blood clots. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

 iOSAndroidAppOrchard - EPIC EHR

Site Last Updated March 29, 2024