SAN FRANCISCO and CAPE TOWN, South Africa, April 22, 2026 (GLOBE NEWSWIRE) -- Medicines360 and Pharma Dynamics have announced the availability of AVIBELA, South Africa’s first generic levonorgestrel 52 mg intrauterine device (IUD), marking a significant step forward in access to long‑acting reversible contraception (LARC) and the treatment of heavy menstrual bleeding (HMB). AVIBELA, developed by Medicines360, is a quality-assured hormonal IUD that is more than 99% effective at preventing pregnancy for up to six years of use (the approved duration of use in South Africa).i
“Building access strategies alongside innovation from the start is essential to closing the decades‑long gap between scientific discovery and real‑world delivery,” said Kelly Dannucci, Senior Director, Global Access at Medicines360. “Our partnership with Pharma Dynamics represents an important step forward in expanding access to our cost‑effective, clinically proven hormonal IUD, giving women in South Africa more choices in their contraceptive and menstrual health care.”
South Africa has made steady progress in contraceptive access, with an estimated nine million women currently using modern contraceptive methods. However, IUD uptake remains low, representing only ~1.9% of the national method mix, while short‑acting methods like pills, injectables, and condoms continue to dominate. Key barriers to IUD use include upfront cost, limited availability, and provider training gaps. With an estimated 64% of pregnancies in South Africa being unplanned, improving access to highly effective, long‑acting contraception is a public health priority.
“While IUDs are among the most cost‑effective methods over time, the initial expense has placed them out of reach for many women,” said Ingrid Singels, Associate Director, Scientific Division at Pharma Dynamics. “By introducing an affordable, clinically equivalent generic IUD, we’re helping remove a long‑standing barrier to access -- so more women can consider the hormonal IUD for contraception and/or treatment of HMB.”
As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to Pharma Dynamics.
From a health‑system perspective, IUDs provide long‑term pregnancy protection with minimal follow‑up, making them among the most cost‑effective contraceptive methods. AVIBELA will address clinical need and affordability in South Africa, providing clinicians with a proven, clinically validated option and expanding patient choice.
About AVIBELA
AVIBELA is a levonorgestrel‑releasing intrauterine system (52 mg) indicated for contraception and the treatment of HMB. AVIBELA is supported by efficacy and safety data from a large U.S. pivotal clinical study conducted by Medicines360. AVIBELA is not available in the U.S.
AVIBELA is a trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean. For more information about AVIBELA, please visit www.avibela.com.
AVIBELA Important Safety Information
Contraindications to use of AVIBELA
- Pregnancy
- For use as 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
Special Warnings & Precautions for Use
Medical examination
- Obtain a complete medical and social history, including partner status, to determine conditions that might influence the selection of an IUS for contraception and/or heavy menstrual bleeding
- Exclude underlying endometrial pathology (e.g., polyps or cancer) prior to the insertion of AVIBELA in women with persistent or uncharacteristic bleeding because irregular bleeding/spotting is common during the first months of AVIBELA use and may preclude adequate assessment after insertion. AVIBELA is contraindicated in women with uterine bleeding of unknown etiology
- Exclude underlying congenital or acquired uterine anomalies, including fibroids, that distort the uterine cavity and would be incompatible with correct IUS placement
- Ensure a previously inserted IUS has been removed prior to insertion of AVIBELA
- Assess whether the woman is at increased risk of infection (e.g., leukemia, acquired immune deficiency syndrome [AIDS], IV drug abuse), or has a history of PID unless there has been a subsequent intrauterine pregnancy. AVIBELA does not protect against HIV/STI transmission
Special Warnings & Precautions for Use
Conditions under which AVIBELA can be used by caution
- Use AVIBELA with caution after careful assessment if any of the following conditions exist, and consider removal of the IUS if any of them arise during use:
- Coagulopathy or use of 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
- Severe arterial disease such as stroke or myocardial infarction
- Consider removing AVIBELA if any of the following conditions arise during use:
- Uterine or cervical malignancy
- Jaundice
Pregnancy related risks with AVIBELA
- In case of an accidental pregnancy with AVIBELA in place, advise a woman of the increased risks for pregnancy complications, including miscarriage, premature labor, 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. Should these procedures not be possible or if the woman wishes to continue the pregnancy, the woman should be informed about these risks, and accordingly, such pregnancies should be closely monitored. Prenatal care should include counseling about these risks and that she should report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.
Adverse reactions to AVIBELA
- Undesirable effects are more common during the first months after the insertion and generally subside during prolonged use
- In a large clinical trial of 1751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne
- Cases of sepsis (including group A streptococcal sepsis) have been reported following insertions with hormonal IUSs
- The following adverse reactions have been reported in connection with the insertion or removal procedure of AVIBELA: pain, bleeding, and insertion-related vasovagal reaction with dizziness or syncope. The procedure may also precipitate a seizure in patients with epilepsy
- The removal threads may be felt by the partner during intercourse
- Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product
- Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system or to the supplier
- Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system or to the supplier
About Medicines360
Medicines360 is a women’s health innovation organization with a mission to be a catalyst for change, fearless in the pursuit of creative approaches to solving consequential women’s health issues. Medicines360 transforms novel ideas into life-changing products that improve the lives of all women, with a focus on ensuring access from day one. For more information about Medicines360 and the 360 Innovation Hub™, visit: www.medicines360.org.
About Pharma Dynamics
Pharma Dynamics was established in 2001 and is headquartered in Cape Town, South Africa. The company is a leading provider of generic medicines with a strong footprint in cardiovascular, neuroscience, anti-infectives, and self-help therapies. Pharma Dynamics is a wholly owned subsidiary of the global pharmaceutical company, Lupin Limited.
Contact:
hglasser@medicines360.org
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i AVIBELA Summary of Product Characteristics & Prescribing Information [South Africa], 2025
