PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
Characteristics of the medicinal product
Preotact is composed of a white powder and a solvent, contained in a cartridge, to be reduced to an injectable solution by means of a special pen. The active ingredient of Preotact is the parathyroid hormone.
Therapeutic indications
Preotact is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women at high risk of fractures. Preotact has been shown to significantly reduce fractures of the spine, but not those of the hips. The medicine can only be obtained with a prescription.
Method of use
The recommended dose is 100 micrograms of Preotact, administered once a day by subcutaneous injection (under the skin) in the abdomen. When the cartridge is inserted into the special injection pen and screwed, the powder and solvent mix and form the solution for injection. Once the necessary instructions have been received to perform the injection correctly (a user manual is provided with the pen), patients can self-inject the solution. Patients may also need to take calcium and vitamin D supplements if they do not take these items sufficiently through diet. Preotact can be used for up to 24 months, after which patients can be treated with a bisphosphonate (a drug that reduces bone loss).
Mechanisms of action
Osteoporosis occurs when there is not enough new bone to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to breakage (fractures). Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone precipitate. Preotact contains the parathyroid hormone, which stimulates the formation of bone tissue, acting on the osteoblasts (the cells used for the formation of bone tissue). Furthermore, this substance increases the absorption of calcium present in food and prevents an excessive amount of calcium from being lost in the urine. The active substance in Preotact, the parathyroid hormone, is identical to the human parathyroid hormone and is produced by a method known as "recombinant DNA technology"; this hormone is obtained starting from a bacterium in which a gene (DNA) has been introduced that allows it to produce it.
Studies carried out
In the main study of this substance, which included 2, 532 women with postmenopausal osteoporosis, Preotact was compared with placebo (a dummy treatment). The rate of vertebral fractures after 18 months of treatment was the main measure of effectiveness. About two-thirds of women continued to take Preotact for up to 2 years and were subjected to a bone density measurement. Bone density was the main measure of effectiveness in another study, which examined the use of Preotact alone or in combination with alendronate (a bisphosphonate).
Benefits found following the studies
After 18 months, 42 vertebral fractures (3.37%) occurred in the placebo group and 17 (1.32%) in the Preotact group. These data show that, compared to placebo, Preotact significantly reduces in women who take it the risk of running into a vertebral fracture. The risk reduction was more marked in women who had previously had a vertebral fracture and in those who had a vertebral bone density score already low at the beginning of the study, indicating a more fragile vertebral column. Increases in bone density were also observed during the study. The combined use study of Preotact and alendronate showed that by administering alendronate after Preotact it is possible to further increase bone density.
Associated risks
The most common side effects are hypercalcemia (increased level of calcium in the blood), hypercalcinuria (increased level of calcium in the urine) and nausea. For the complete list of side effects reported with the use of Preotact, see the package leaflet.
Preotact should not be used in people who may be hypersensitive (allergic) to the parathyroid hormone or to any of the other ingredients. Furthermore, it should not be used in patients who:
• were subjected to radiotherapy to the bones,
• are affected by any disorder that affects the balance of calcium in the body,
• are affected by a bone disease other than osteoporosis,
• have inexplicably high levels of alkaline phosphatase (an enzyme),
• are suffering from severe kidney or liver disease.
Grounds for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Preotact outweigh its risks in the treatment of osteoporosis in postmenopausal women at high risk of fractures. Therefore, the committee recommended to grant Preotact the authorization to enter
trade.
Further information
On 24 April 2006, the European Commission granted a marketing authorization for Preotact, valid throughout the European Union, to Nycomed Danmark ApS.
For the full version of the evaluation (EPAR) of Preotact, click here.
Last update of this summary: March 2006.
