Medicines360, MSI Reproductive Choices and MSK Announce Launch of Avibela® Hormonal Intrauterine Device in Kenya

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.”

Click here to learn more about AVIBELA® and the AVIBELA Project.

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.

About Medicines360

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/


About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with global and US partners. Medicines360, through its subsidiary Impact RH360, launched the Avibela Project to expand access to hormonal IUDs in low- and middle-income countries. For more information, visit medicines360.org

Share This

AVIBELA can be made available in the following 88 countries

  1. Algeria
  2. Angola
  3. Bangladesh
  4. Belize
  5. Benin
  6. Bhutan
  7. Botswana
  8. Burkina Faso
  9. Burundi
  10. Cambodia
  11. Cameroon
  12. Cape Verde
  13. Central African Republic
  14. Chad
  15. Comoros
  16. Costa Rica
  17. Cuba
  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
  27. Gabon
  28. Ghana
  29. Grenada
  30. Guatemala
  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
  46. Malaysia
  47. Maldives
  48. Mali
  49. Mauritania
  50. Mauritius
  51. Mayotte
  52. Morocco
  53. Mozambique
  54. Myanmar
  55. Namibia
  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.