Fablyn - lasofoxifene
PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Fablyn?
Fablyn is a medicine that contains the active substance lasofoxifene. It is available in peach-colored, triangular-shaped tablets (500 micrograms).
What is Fablyn used for?
Fablyn is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who are past the menopausal period) who are at risk for bone fractures. Fablyn has been shown to reduce bone fractures. spine and other parts of the body, but not the hip.
To decide whether to prescribe Fablyn or other therapies, doctors must see if the patient has symptoms of menopause and consider the possible effects of the treatment on the uterus, breasts, 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 day, regardless of food and drink intake. Calcium and vitamin D supplements are generally recommended if dietary intake is inadequate. Fablyn is intended for long-term use.
Fablyn should be used with caution in women with severe liver or kidney problems.
How does Fablyn work?
Osteoporosis occurs when sufficient new bone is not produced to replace what is naturally consumed. Bones become progressively thinner and more fragile and more prone to fractures. Osteoporosis is more common in postmenopausal women, when levels of the female hormone estrogen: Estrogen slows the breakdown of bones and makes them less prone to fracture.
The active substance in Fablyn, lasofoxifene, is a selective estrogen receptor modulator (SERM). Lasofoxifene acts as an "agonist" of the estrogen receptor (ie 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?
Fablyn's effects were first tested in experimental models before being studied in humans.
In one main study involving approximately 9,000 postmenopausal women with osteoporosis aged 60 to 80 years, two doses of Fablyn (250 and 500 micrograms once daily) were compared with placebo (a dummy treatment). . The main measure of effectiveness was the number of women who reported a new spine fracture as evidenced by X-rays. The study also looked at the worsening of existing vertebral fractures, the occurrence of new fractures elsewhere in the body, and the density. bone 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 reported a new vertebral fracture (155 out of 2,748), compared with 9% of those treated with placebo (255 out of 2,744). the 250 microgram dose indicates that the 500 microgram dose is more effective. Fewer women on the higher dose had a non-vertebral fracture and more had increased bone density. Fablyn did not reduce the number. of hip fractures to a significant extent for patients.
What is the risk associated with Fablyn?
The most common side effect with Fablyn (seen in more than 1 in 10 patients) is muscle cramps. For the full list of side effects reported with Fablyn, see the package leaflet.
Fablyn must 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 vein thrombosis (blood clot in the back of the eye). used in women with unexplained uterine bleeding Fablyn can only be used in women who have been through menopause and must not be used in women who may still become 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 postmenopausal women with an increased risk of fractures. "placing on the market for Fablyn.
What measures are being taken to ensure the safe use of Fablyn?
The company that makes Fablyn will ensure that an education program is made available in all Member States for all healthcare professionals who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine. This program will include information on the risk of venous thromboembolism, on uterine changes that may occur during the course of treatment and on the need to investigate any unexplained uterine bleeding.
More information about Fablyn
On February 24, 2009, the European Commission granted Pfizer Limited a "Marketing Authorization" for Fablyn, valid throughout the European Union.
For the full version of Fablyn's EPAR click here.
Last update of this summary: 01-2009
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