Fablyn - lasofoxifene

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Fablyn?

Fablyn is a medicine that contains the active substance lasofoxifene. It is found in tablets (500 micrograms) peach-colored with a triangular shape.

What is Fablyn used for?

Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in post-menopausal women (women who have passed the menopause period) who are at risk of bone fractures. Fablyn has been shown to reduce fractures of the spine and other parts of the body, but not of the hip.

To decide whether to prescribe Fablyn or other therapies, doctors must see if the patient has the symptoms of menopause and consider the possible effects of the treatment on the uterus, breast, heart and blood vessels.

The medicine can only be obtained with a prescription.

How is Fablyn used?

The recommended dose of Fablyn is one tablet once a day. The tablet can be taken at any time of the day, regardless of food and drink intake. Generally calcium and vitamin D supplements are recommended if dietary intake is inadequate. Fablyn is indicated for long-term use.

Fablyn should be used with caution in women with severe liver or kidney problems.

How does Fablyn work?

Osteoporosis arises when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to fractures. Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone decrease: estrogen slows bone degradation and makes it less prone to fracture.

The active ingredient of Fablyn, lasofoxifene, is a selective estrogen receptor modulator (SERM). Lasofoxifene acts as an "agonist" of the estrogen receptor (ie from a substance that stimulates the estrogen receptor) in some tissues of the body. Lasofoxifene has the same effect as estrogen on bones.

How has Fablyn been studied?

The effects of Fablyn were first tested in experimental models before being studied in humans.

In one main study, conducted on approximately 9, 000 post-menopausal women suffering from osteoporosis and aged between 60 and 80 years, two doses of Fablyn (250 and 500 micrograms once a day) were compared with placebo (a dummy treatment) . The main measure of effectiveness was the number of women who reported a new fracture of the spine highlighted by radiography. The study also examined the worsening of existing vertebral fractures, the onset of new fractures in other parts of the body and bone density throughout the body.

What benefit has Fablyn shown during the studies?

Fablyn was more effective than placebo in reducing the number of new fractures. Over five years, 6% of women treated with Fablyn 500 micrograms suffered a new vertebral fracture (155 out of 2, 748), compared with 9% of those treated with placebo (255 out of 2, 744). Furthermore, the results obtained with the 250 micrograms dose indicate that the 500 micrograms dose is more effective. Fewer women treated with the higher dose reported a non-vertebral fracture and more showed an increase in bone density. Fablyn did not reduce the number of hip fractures significantly to patients.

What is the risk associated with Fablyn?

The most common side effect of Fablyn (seen in more than 1 patient in 10) is muscle cramps. For the full list of all side effects reported with Fablyn, see the Package Leaflet.

Fablyn should not be used in people who may be hypersensitive (allergic) to lasofoxifene or any of the other substances. It must not be used in patients who have had problems with venous thromboembolism, such as deep vein thrombosis (DVT), pulmonary embolism (blood clot in the lungs) and retinal venous thrombosis (blood clot in the back of the eye). It must not be used in women with unexplained uterine bleeding. Fablyn can only be used in women who have passed menopause and should not be used in women who may still be pregnant or in women who are pregnant or breastfeeding.

Why has Fablyn been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Fablyn's benefits are greater than its risks for the treatment of osteoporosis in post-menopausal women with an increased risk of fractures. The committee recommended that Fablyn be given marketing authorization.

What measures are being taken to ensure the safe use of Fablyn?

The company that makes Fablyn will ensure that an information program is available in all Member States for all health professionals who will prescribe Fablyn or order pelvic ultrasound for women taking the medicine. This program will include information on the risk of venous thromboembolism, on uterine changes that may occur during treatment and on the need to analyze any unexplained uterine bleeding.