IBSA announces licensed availability of Lubion (Progesterone) PFS for Luteal Support in ART in Ireland

IBSA UK & Ireland has announced the licensed availability of Lubion® PFS (progesterone 25 mg, solution for subcutaneous injection) in the Republic of Ireland, marking the company’s first directly supplied fertility medicine in the country. Lubion® PFS is indicated for luteal support as part of Assisted Reproductive Technology (ART) in women who cannot use or tolerate vaginal progesterone preparations,1 and its licensed introduction provides Irish IVF clinics with a formal, supported access route for the first time.

Supporting progesterone needs in ART
Progesterone plays a vital role in the luteal phase during ART, and subcutaneous administration offers an alternative method of delivering progesterone for patients who are unable to use or tolerate vaginal formulations. Lubion® PFS provides a licensed option for these women, in line with its approved indication.

A ready-to-use formulation designed for patient convenience
Lubion® is a ready-to-use progesterone solution delivered in a pre-filled syringe for once-daily subcutaneous injection. Key features include:

• First2 and only licensed aqueous progesterone for subcutaneous injection in Ireland.
• Supplied in a pre-filled syringe (PFS) and suitable for self-injection after professional instruction or administration by a healthcare professional (HCP).
• Simple, single-use format that reduces handling complexity and packaging waste.

Structured, licensed availability for Irish clinics
Irish fertility clinic prescribers and patients are already familiar with subcutaneous progesterone 25mg, which was previously available via EU parallel-import under European branding (Prolutex and Lubion). With this launch, prescribers can now access licensed Lubion® 25mg PFS as a GMS reimbursable item under the HSE primary care reimbursement service. This launch provides the Irish fertility healthcare service with consistency of supply and distribution plus enhanced direct medical information and support.

Dedicated support for patients and HCPs
With licensed distribution in place, IBSA can provide tailored patient support materials, including leaflets, videos and injection guidance, to help ensure clear administration information is available at clinic and patient level. Healthcare professionals will also have access to information resources and a direct IBSA contact for medical and product enquiries.

For this reason, an educational and support website – IBSA Fertility – is available for all professional and patients.

“We have incorporated Lubion® into IVF treatment plans in Ireland for many years and having IBSA’s support now gives us strong reassurance and confidence in its continued supply and availability for our patients,” said Melissa Mark, Nurse Manager at Therapie Fertility, Ireland. “Lubion® provides an essential, convenient progesterone option for women who cannot tolerate vaginal preparations, and its subcutaneous formulation facilitates comfortable administration” she continued.

This launch signals IBSA’s longer-term commitment to reproductive medicine in Ireland and around the world. It is the first step in a broader fertility portfolio strategy planned for the coming years, supporting both clinics and patients across the ART pathway.

References

1. Cometti B. Pharmaceutical and clinical development of a novel progesterone formulation. Acta Obstet Gynecol Scand. 2015;94 Suppl 161:28-37. DOI:10.1111/aogs.12765
2. Lubion Summary of Product Characteristics

Administration guidance can be found in the Lubion SMPC here: lubion-pfs-smpc

https://ie.ibsafertility.com/