Questions & Answers
Sino-implant (II) is a safe, highly effective, long-acting, reversible hormonal contraceptive implant made up of 2 rods that are inserted into a woman’s upper arm. The rods contain a hormone called levonorgestrel, which is slowly and continuously released over time. Shanghai Dahua Pharmaceutical Co., Ltd., (Dahua) has been manufacturing Sino-implant (II) since 1996. The product has been registered by more than 20 drug regulatory authorities, and more than 11 million units have been distributed worldwide.
Dahua augmented the Sino-implant (II) product specifications and test methods and changed the levonorgestrel supplier in pursuit of World Health Organiza- tion (WHO) prequalification. This product is now sold under the global brand Levoplant.
WHO prequalified Sino-implant (II)/Levoplant on June 30, 2017, after reviewing the product dossier, including new clinical trial data, and inspecting Dahua’s manufacturing facility to ensure it complies with WHO Good Manufacturing Practices. Levoplant is prequalified for 3 years of use.
WHO prequalification recognizes that Levoplant meets international quality standards for manufacturing and clinical performance. WHO evaluated data from a rigorously conducted clinical trial that compared Levoplant to Jadelle and found the product to be safe and highly effective during 3 years of use. The United Nations Population Fund had approved Levoplant for purchase by its country programs through the WHO Expert Review Panel process in November 2016. WHO prequalification will now allow additional donors and procurers to purchase the product for country programs.
Levoplant is labeled for 3 years of use and has a shelf life of 4 years.
Levoplant is one of the most effective family planning methods available. Each year, fewer than 1 pregnancy per 100 users is expected.
Building on existing national approvals for Sino-implant (II), registration of Levoplant at the country level is ongoing. For information about the regulatory status in a particular country, please contact: firstname.lastname@example.org
In FP2020 countries, the product is available for US$6.90 per unit. This pricing structure applies to approved procurers, donors and governments.
Almost all women of childbearing age can use Levoplant: women of any age (with or without children), women in the immediate postpartum period, breastfeeding mothers, HIV-positive women, women who smoke and women who have had a miscarriage or an abortion. Levoplant is ideal for women with limited access to health services because it does not require regular resupply from a provider.
Levoplant works by inhibiting or altering ovulation and thickening the cervical mucus, making it difficult for sperm to unite with an egg. Fertility returns immediately after removal of the implants.
Both insertion and removal are minor surgical procedures that take a few minutes and can be done in a health provider’s office. The implants are inserted into the inner side of either upper arm and are removed by making a small incision and using forceps to gently pull out the rods. To minimize the risk of breakage, Dahua’s recom- mendations for removal of Sino-implant (II)/Levoplant differ slightly from the recom- mendations for removing another 2-rod implant, Jadelle .
Quality assurance: Dahua is designated by the National Health and Family Planning
Commission of the People’s Republic of China (NHFPC) and the China Food and
Drug Administration (CFDA) as an approved manufacturer of contraceptive prod-
ucts. Dahua continually evaluates the quality of the final product by testing each lot
prior to distribution. Since 2008, an independent quality evaluation has been
conducted annually by FHI 360. The findings show Dahua demonstrates the ability to
produce a contraceptive implant that meets international quality standards
Earlier clinical trials: Chinese clinical data from the early 1990s from 4 randomized trials among over 15,000 women support 4-year duration of use of Sino-implant (II), with annual pregnancy rates below 1 percent.2 With funding from the Bill & Melinda Gates Foundation and the U.S. Agency for International Development, FHI 360 and partners have since completed prospective cohort studies in Bangladesh, Kenya, Madagascar and Pakistan, following over 2,000 Sino-implant (II) users for 12 months. The results show Sino-implant (II) is a safe, highly effective method. In Bangladesh and Madagascar, no post-insertion pregnancies were reported; in Kenya and Pakistan, the combined annual pregnancy rate was below 1 percent.