Merck (known as MSD outside the United States and Canada), a global healthcare leader, has launched Nexplanon (etonogestrel implant) 68 mg, a long-acting, progestin-only single-rod hormonal contraceptive, in the United States. Nexplanon is approved by the FDA for the prevention of pregnancy in women for up to three years. It must be removed by the end of the third year and may be replaced by a new Nexplanon, if continued contraceptive protection is desired.
About the size of a matchstick, Nexplanon is made of a soft, flexible, medical polymer and is inserted just under the skin of a woman's upper arm in a minor surgical in-office procedure. All healthcare providers performing insertions and/or removals of Nexplanon should receive instructions and training prior to inserting or removing the implant. Training on the insertion and removal of Nexplanon is offered by Merck.
Nexplanon is effective, when inserted correctly, with less than 1 pregnancy per 100 women who used Nexplanon for 1 year. Nexplanon may be less effective in women who are very overweight and in women who are taking medications that induce liver enzymes. Nexplanon is a progestin-only contraceptive that does not contain estrogen. Nexplanon does not depend on daily, weekly, monthly, or quarterly administration. Etonogestrel, the progestin in Nexplanon, prevents pregnancy in three ways: inhibiting ovulation, thickening of the cervical mucus, and alterations in the endometrium.
“Merck is committed to providing women with a range of birth control options. We are excited to add Nexplanon to Merck's growing Women's Health portfolio,” said Terrie Curran, senior vice president and general manager, Women's Health at Merck.
Nexplanon is indicated for use by women to prevent pregnancy. It is radiopaque, which means physicians can verify presence of the implant after insertion and can locate it prior to removal using two-dimensional X-ray, computed tomography (CT scan), ultrasound scanning (USS), or magnetic resonance imaging (MRI). After insertion and prior to removal, physicians should always verify the presence of the implant in the woman's arm by palpation. If the implant cannot be palpated, the physician can use one of the four available methods to verify presence of the implant. Until the presence of the implant has been verified, women using Nexplanon should be advised to use a non-hormonal contraceptive method, such as condoms.
Removal of Nexplanon can occur at any time during the three years at the request of the user. In clinical trials, pregnancies were observed to occur as early as seven to fourteen days after removal of Nexplanon. If pregnancy is not desired after removal of Nexplanon, another method of birth control must be started immediately.
Nexplanon should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumours, 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; or allergic reaction to any of the components of Nexplanon.