- NEXPLANON® is the first single-rod arm implant to be approved by
Health Canada for the prevention of pregnancy.1 - The implant provides Canadians with a new birth control option that can be removed at any point during the three-year period by a healthcare professional.1
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The arm implant contains etonogestrel, a hormone that is continuously released in small amounts into the blood.1 It prevents pregnancy in two ways: by stopping the release of egg cells from the ovaries and by causing changes in the cervical mucus to make it difficult for sperm to enter the uterus.1
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Approximately the size of a matchstick, the implant is a small, soft and flexible plastic rod that is inserted by a healthcare professional just below the skin on the inner side of a patient's upper arm.1 When inserted correctly, NEXPLANON was shown to be effective, with less than one pregnancy per 100 patients who used the birth control implant for one year.1
About NEXPLANON®
NEXPLANON is approved for pregnancy prevention for up to three years.1 By the end of the third year, the implant must be removed and may be replaced with a new implant, if continued contraceptive protection is desired.1 It will not protect patients against sexually transmitted infections (STIs), including HIV/AIDS.1 To prevent STIs, patients should use latex or polyurethane condoms while using the implant.1
The arm implant is radiopaque, meaning 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) and ultrasound scanning (USS), or magnetic resonance imaging (MRI).1 After insertion and prior to removal, physicians should be able to verify the presence of the implant in the patient's arm by palpation.1 If the implant cannot be palpated, the physician can use one of the four available methods to verify presence of the implant.1 Until the presence of the implant can be verified, patients should be advised to use a non-hormonal contraceptive method, such as condoms.1
The approval of the implant is based on results from a multicenter, randomized, double-blind, parallel group bioequivalence study comparing the radiopaque implant to the non-radiopaque etonogestrel subdermal implant (IMPLANON®).1 NEXPLANON and the non-radiopaque etonogestrel subdermal implant met comparative bioavailability standards with respect to rate and extent of absorption of etonogestrel.1 The safety and efficacy of the non-radiopaque implant as a birth control option was demonstrated in adults who were between the ages of 18 and 40 years at the beginning of the clinical trial.1
The clinical trials, which were up to three years in duration, involved 923 subjects, with 1756 woman-years of use with the non-radiopaque etonogestrel implant (IMPLANON). In a subgroup of patients aged 18-35, six pregnancies were reported, resulting in a Pearl Index of 0.38.1 Each conception was likely to have occurred shortly before or within two weeks following removal of the non-radiopaque etonogestrel implant.1 Pregnancies were observed to occur as early as seven to 14 days after removal of the arm implant.1 If pregnancy is not desired after removal of the implant, another method of birth control must be started immediately.1
About
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Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2017 Annual Report on Form 10-K and the company's other filings with the
Please see the product monograph for NEXPLANON® (etonogestrel implant) at:
https://www.merck.ca/static/pdf/NEXPLANON-PM_E.pdf
Reference
1 NEXPLANON® Product Monograph. |
SOURCE
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