Product Expands Access to High-Quality Contraception for Women in Africa
SAN FRANCISCO and LONDON and NAIROBI– August 2, 2021 – Medicines360, MSI Reproductive Choices (MSI) and Marie Stopes Kenya (MSK) today announced the launch of AVIBELA (levonorgestrel-releasing intrauterine system) 52 mg in Kenya. This is the third launch of Medicines360’s hormonal intrauterine device (IUD) in Africa, following Madagascar and Zambia.
“Through our partnership with MSI and MSK, women in Kenya will gain increased access to an affordable and effective long-acting reversible contraceptive. We are committed to closing gaps in women’s health, and AVIBELA will help us reach a population of women who don’t have access to the full range of contraceptive methods,” said Tina Raine-Bennett, MD, MPH, FACOG, Chief Executive Officer, Medicines360. “Research has shown that making more methods of contraception widely available in a country better meets the needs of women and couples, resulting in an increase in overall contraceptive use.”
Together, Medicines360, MSI and MSK are dedicated to increasing access to the full range of contraceptive options in Kenya and across the globe. In collaboration with Medicines360, MSK will offer the product to women in Kenya at a lower price than previously available in the country, enabling the product to be distributed broadly throughout their networks. MSK and MSI will market and distribute the contraceptive while training qualified healthcare providers in health clinics and hospitals across Kenya, including virtual trainings on device insertion and removal techniques from Medicines360’s master trainers. Ongoing client and consumer research from MSK will also help ensure relevant strategies, promotional and educational materials reach women and providers in the area.
“Only 6% of Kenyan women currently use an IUD, but almost all of this use is copper IUDs, as hormonal IUDs have only been available in limited quantities at unaffordable prices,” said Dr. Helen Blackholly, Vice President & Technical Services Director, MSI Reproductive Choices. “AVIBELA is an attractive option because it combines pregnancy prevention with other lifestyle and health benefits that so many women want. We are delighted to have collaborated with Medicines360 to bring this product to market.”
Kenya is among the leading nations in family planning in Africa, with the first official nationwide family planning program in sub-Saharan Africa that launched in 1967. In addition, the Kenyan government aims to increase the contraceptive prevalence rate to 66% by 2030, after reaching 61% in 2018. “However, increases in contraceptive prevalence have stagnated in the past several years. Most contraception users rely on one of two methods, injectables and implants, which may indicate a lack of choice,” said Dr. Job Makoyo, Programmes and Operations Director, Marie Stopes Kenya. “Making this highly effective and affordable method available in Kenya will give women a new choice that may better meet their needs.”
AVIBELA® Important Safety Information
Who is not appropriate for AVIBELA
Contraindications to use of AVIBELA include: pregnancy; use for post-coital contraception (emergency contraception); acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy; infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor (benign or malignant); conditions associated with increased susceptibility to pelvic infections; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct IUS placement; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; a previously inserted IUS that has not been removed; a history of hypersensitivity reaction to any component of AVIBELA (reactions may include rash, urticaria, and angioedema).
Clinical considerations for use of AVIBELA
Use AVIBELA with caution after careful assessment in patients with coagulopathy or who are taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removal of the IUS if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use.
IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of AVIBELA insertion, while the remainder were diagnosed more than six months after insertion. PID is often associated with sexually transmitted infection (STI), and AVIBELA does not protect against STIs. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae.
Pregnancy related risks with AVIBELA
In the case of pregnancy with AVIBELA in place, advise the woman of the increased risks for pregnancy complications, including miscarriage, premature delivery, infection and sepsis. Ectopic pregnancy should be excluded, and removal of the system should be considered. Removal of AVIBELA or probing of the uterus may result in spontaneous abortion. When a woman becomes pregnant with AVIBELA in place, the relative likelihood of ectopic pregnancy is increased. Ectopic pregnancy may require surgery and may result in loss of fertility. Women with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy.
Be aware of other serious complications and most common adverse reactions
Some serious complications with IUSs like AVIBELA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of AVIBELA is essential in order to minimize serious infections such as GAS.
Perforation (total or partial, including penetration/embedment of AVIBELA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation is suspected, the IUS should be removed as soon as possible. Delayed detection or removal of AVIBELA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera.
Partial or complete expulsion of AVIBELA may occur, resulting in the loss of contraceptive protection.
Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts.
In a large clinical trial of 1751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include procedural bleeding, vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne.
AVIBELA is a registered trademark of Medicines360 in Algeria, Benin, Botswana, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Cote D’Ivoire, Democratic Republic of Congo, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, India, Kenya, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Mali, Mauritania, Morocco, Namibia, Niger, Nigeria, Pakistan, Philippines, Rwanda, Sao Tome and Principe, Senegal, Swaziland, Tanzania (mainland), Togo, Uganda, Vietnam, Zambia, and Zimbabwe.
Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical organization with a mission to remove cost as a barrier to health by developing and providing affordable Women’s Health products. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org
About MSI Reproductive Choices
MSI is a global organisation providing contraception and safe abortion services to women and girls in 37 countries. We believe that every woman and girl must determine her own future, and the high-quality services we provide give a woman the power to pursue her dreams for herself and her family. For more information, visit https://www.msichoices.org/
About Marie Stopes Kenya
Since 1985, Marie Stopes Kenya (MSK) has increased access to high quality affordable sexual and reproductive health (SRH) services for all people across Kenya to support its vision of a world in which every birth is wanted and a mission of children by choice, not chance. As one of the leading specialised SRH providers in Kenya, MSK works with the Government of Kenya and other stakeholders to ensure the poorest and hardest to reach clients can access affordable SRH services that meet their needs. MSK implements a service delivery approach that is free from stigma, judgement, and discrimination, regardless of age, location, background, marital, or economic status. For more information, visit https://www.mariestopes.or.ke/