Fosavance

What is Fosavance?

Fosavance is a medicine that contains two active substances: alendronate sodium trihydrate and colecalciferol (vitamin D3). It is available as white tablets (capsule-shaped: 70 mg alendronate sodium trihydrate and 2 800 international units [IU] of cholecalciferol; rectangular: 70 mg of alendronate sodium trihydrate and 5 600 IU colecalciferol).

What is Fosavance used for?

Fosavance (containing 2 800 IU or 5 600 IU cholecalciferol) is used in the treatment of osteoporosis (a disease that makes bones fragile) in women who have passed the menopause period and are at risk of vitamin D deficiency. Fosavance 70 mg / 5, 600 IU is indicated in patients not taking vitamin D supplements. Fosavance reduces the risk of vertebrae and hip fractures.

The medicine can only be obtained with a prescription.

How is Fosavance used?

The recommended dose of Fosavance is one tablet per week. The medicine is indicated for long-term therapies.

The tablet should be swallowed with a full glass of water (but not mineral) at least 30 minutes before the ingestion of any food, drink or other medicine (including antacids, calcium supplements and vitamins). To avoid irritating the esophagus, the patient must not lie down before the end of the first meal of the day, which must occur at least 30 minutes after taking the tablet. The tablet should be swallowed whole and should not be crushed, chewed or dissolved in the mouth.

If the normal diet does not ensure sufficient calcium intake, the patient will need to take calcium supplements. For more information, see the package leaflet.

How does Fosavance work?

Osteoporosis occurs when there is an insufficient turnover of the decomposing bone tissue. The bones become progressively thinner and more fragile, so they are more exposed to fractures. Osteoporosis is more common in women who have passed menopause due to lower levels of female hormones, estrogens, which allow bones to be preserved.

Fosavance contains two active ingredients: alendronate and colecalciferol (vitamin D3). Alendronate is a bisphosphonate used in the treatment of osteoporosis since the mid-1990s that acts by inhibiting the action of osteoclasts, the cells that are involved in the decomposition of bone tissue. This inhibitory action reduces the loss of bone tissue. Vitamin D3 is a nutrient contained in some foods but also produced by the skin when exposed to sunlight. Vitamin D3, as well as other forms of vitamin D, is necessary for the absorption of calcium and the normal formation of bone tissue. Given that one of the causes of osteoporosis is the insufficient intake of vitamin D3 produced by exposure to sunlight, Fosavance contains vitamin D3.

How has Fosavance been studied?

Since alendronate and vitamin D3 are already used separately in other medicines authorized in the European Union (EU), the pharmaceutical company has presented data obtained from previous studies and published data in the scientific literature relating to postmenopausal women treated with alendronate and vitamin D in separate tablets.

To support the association of alendronate and vitamin D3 in the same tablet, the pharmaceutical company also conducted a study of 717 patients with osteoporosis, including 682 post-menopausal women suffering from osteoporosis, to demonstrate Fosavance's ability to raise vitamin D levels. Patients were given Fosavance 70 mg / 2 800 IU or only alendronate once a week. The main parameter for assessing efficacy was the decrease in the number of patients with vitamin D deficiency after 15 weeks. This study was extended to 652 patients for an additional 24 weeks to compare the effects on continued therapy with Fosavance 70 mg / 2 800 IU as a single agent (alone) or with the addition of an additional 2 800 IU of vitamin D3 (equivalent to use of Fosavance 70 mg / 5 600 IU).

What benefit has Fosavance shown during the studies?

The information presented by the company from previous studies and from the published literature showed that the dose of alendronate contained in Fosavance is the same as that required to avoid bone loss.

Complementary studies have shown that the addition of vitamin D3 in the same tablet containing alendronate could increase vitamin D levels: after 15 weeks fewer patients reported low levels of vitamin D if treated with Fosavance 70 mg / 2 800 IU ( 11%) compared to those treated only with alendronate (32%). In the extension study, although the same number of patients taking Fosavance 70 mg / 2 800 IU and Fosavance 70 mg / 5 600 IU had low levels of vitamin D, patients taking Fosavance 70 mg / 5 600 IU showed a greater increase of vitamin D levels during the 24-week study duration.

What is the risk associated with Fosavance?

The most common side effects reported with Fosavance (seen in between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (indigestion)), constipation, diarrhea, flatulence, ulcers in the esophagus, dysphagia ( difficulty swallowing), abdominal distension (swollen belly), acid regurgitation and musculoskeletal pain (bones, muscles, joints). For the full list of all side effects reported with Fosavance, see the Package Leaflet.

Fosavance should not be used in patients who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients. Fosavance should also not be used in the presence of abnormalities of the esophagus, in patients with hypocalcemia (calcium deficiency) and in patients unable to stand or sit upright for at least 30 minutes.

Why has Fosavance been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Fosavance outweigh its risks for the treatment of osteoporosis in post-menopausal women with a risk of vitamin D deficiency. The committee recommended the release of the marketing authorization for Fosavance.