Medicines360, Population Services International, and Society for Family Health Announce Launch of Avibela® Hormonal Intrauterine Device in Nigeria

Improving Access to Modern Contraception for Women in Nigeria

SAN FRANCISCO, WASHINGTON and ABUJA, Nigeria, March 22, 2022 /PRNewswire/ -- Medicines360, Population Services International (PSI), and Society for Family Health (SFH) announced the launch of Avibela (levonorgestrel-releasing intrauterine system) 52 mg in Nigeria. Nigerian women and girls' contraceptive options have historically been limited. The introduction of Avibela provides women and girls more choices in their reproductive health decisions. This marks the fourth country launch of Medicines360's hormonal intrauterine device (IUD) in Africa, following Madagascar, Zambia and Kenya.

"As a nonprofit pharmaceutical organization, we are committed to helping fill the gaps for women who experience barriers to affordable and effective contraception around the world," said Dr. Tina Raine-Bennett, Chief Executive Officer, Medicines360. "Our partnership with PSI and SFH enables us to increase access to a high quality and cost-effective hormonal IUD at a time when the need for modern contraception is more important than ever. Our partners provide critical on-the-ground services including product awareness, provider training, quality assurance and local capacity building activities to ensure sustainable access to the hormonal IUD."

The hormonal IUD has historically been unaffordable for most women in Nigeria. Only 12% of married women of reproductive age currently use a modern method of contraception, and 19% of married women have an unmet need for contraception.¹ Together, Medicines360, PSI and SFH are paving the way to increase access to the full range of cost-effective contraception options in Nigeria. Impact RH360, a subsidiary of Medicines360, will supply the product and offer clinical training resources and technical assistance to SFH as needed. SFH will distribute the product through their social franchise network, offer provider training and supportive supervision, and build consumer awareness for Avibela, alongside a full range of method options, through community health workers and local media.

"Avibela enables us to offer more affordable contraceptive access to help fit women's needs. When women can see that there are choices that fit their own unique health needs, they view the system as serving them. We have seen first-hand the difference affordable access to modern contraception can make in allowing women in Nigeria more control over their sexual and reproductive health," said Dr. Anthony Nwala, Practice Area Lead – RH/FP Projects Society for Family Health. "In addition, the availability of more contraceptive products contributes to a more robust family planning market for consumers, making the market less vulnerable to disruptions such as stockouts that can occur due to reliance on a single supplier."

A pilot study conducted in Nigeria found that hormonal IUD users had high satisfaction and continuation rates, and that nearly a third of women who chose the hormonal IUD would have left with no method of contraception, had the hormonal IUD not been available that day.² The launch of Avibela in Nigeria will give more women the option to consider whether the hormonal IUD is the right method for them and may contribute to more women and girls opting for, and staying on, modern contraception.

"We know that when women and girls can use their voice, choice and agency, they're equipped to live their potential. But to get there, women and girls need supportive health systems that not only see, but champion, their whole selves," said Kendal Danna, Sexual and Reproductive Health Technical Advisor, PSI. "This is about more than creating markets for health access. It's about establishing opportunities so that we support every woman and girl to make and own their health decisions—that is an essential component of what we at PSI call consumer-powered healthcare. Avibela's expansion into Nigeria is a critical part of that work."

The Avibela Project^® was first launched to expand access to hormonal IUDs in low- and middle-income countries. Through its subsidiary Impact RH360, Medicines360 makes its hormonal IUD available to NGOs and works together with them to support registration, provider training, and product launch. Impact RH360 is a wholly owned, non-profit subsidiary formed to focus on maximizing impact in low- and middle-income countries.

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 IUD 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 IUD 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 IUD if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use.

IUDs 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 IUDs 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 IUDs. 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 IUD 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, São Tomé and Príncipe, Senegal, Swaziland, Tanzania (mainland), Togo, Uganda, Vietnam, and Zambia.

About Medicines360

Headquartered in San Francisco, CA Medicines360 is the first "nonprofit pharma" entity focused on Women's Health in the U.S. and globally. Combining the rigor and expertise of a commercial pharmaceutical company with the pro-social ambitions of a nonprofit, Medicines360's mission is to catalyze equitable access to medicines and devices for women everywhere. For more information, visit www.medicines360.org.

About PSI

With over 50 years of insights, global health NGO Population Services International (PSI) reimagines how to bring quality healthcare closer to those who need it most. PSI brings innovation to scale through our presence in 40+ countries and a network of over 10,000 health clinics and pharmacies. PSI takes a business approach to saving lives, designing effective, scalable, and sustainable solutions to the world's biggest health challenges. Learn more: psi.org

About SFH

Society for Family Health (SFH) is a Nigerian non-governmental organisation (NGO) working in partnership with communities, government, donors and the private sector for universal health coverage and social justice of all Nigerians. We deploy health system strengthening and total market approaches in a bid to unify the private and public health sectors to scale an Essential Package of Health Services (EPHS) offering of good quality to all Nigerians. We leverage on over thirty years of thought leadership in a range of practical community-level interventions and policy engagements to scale population-level impact. SFH connects all Nigerians in an innovative social business model to expand access to essential health commodities while boosting overall national health financing.

SOURCE Medicines360