What is Terrosa - Teriparatide and what is it used for?
Terrosa is a medicine used to treat osteoporosis (a disease that makes bones fragile) in the following groups:
- postmenopausal women. In these patients it has been shown that Terrosa significantly reduces vertebral (spine) and non-vertebral (bone) fractures, but not those of the hip;
- men at increased risk of fractures;
- men and women at increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Terrosa contains the active substance teriparatide.
Terrosa is a "biosimilar medicine". This means that it should have been similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Terrosa is Forsteo. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Terrosa - Teriparatide used?
Terrosa is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended for use with the ServoPen Fix system. The recommended dose is 20 micrograms of Terrosa given once a day by subcutaneous injection in the thigh or abdomen (belly). Patients can be injected themselves after training.
Supplementation with calcium and vitamin D is recommended in patients whose intake of these substances with the diet is inadequate. Terrosa can be used for a maximum of two years. The two-year treatment with Terrosa should only be given once in the patient's life.
The medicine can only be obtained with a prescription
How does Terrosa - Teriparatide work?
Osteoporosis is a condition in which the new bone produced is not enough to replace what naturally deteriorates. The bones become progressively less dense and more prone to fractures. Osteoporosis is more common in postmenopausal women, when levels of estrogen, a female hormone, decrease. Osteoporosis can also occur as an undesirable effect of glucocorticoid treatment in men and women.
Teriparatide, the active ingredient of Terrosa, is identical to a part of the human parathyroid hormone. Similarly to the human hormone, it stimulates bone formation by acting on osteoblasts (cells responsible for bone formation). Furthermore, this substance increases the absorption of calcium present in food and prevents its excessive dispersion by urine.
What benefit has Terrosa - Teriparatide shown during the studies?
Laboratory studies that have compared Terrosa and Forsteo have shown that the active ingredient of Terrosa is very similar to that of Forsteo in terms of structure, purity and biological activity.
Because Terrosa is a biosimilar medicine, it is not necessary that the studies performed on Forsteo regarding the efficacy and safety of teriparatide be repeated for Terrosa. A study of 54 healthy women showed that the same dosages of the two drugs given by subcutaneous injection produced similar levels of the active substance teriparatide in the body. Furthermore, Terrosa and Forsteo have produced similar effects on blood calcium levels.
What are the risks associated with Terrosa - Teriparatide?
The most commonly observed side effect of Terrosa (which may affect more than 1 in 10 patients) is pain in the arms or legs.
For the full list of all side effects reported with Terrosa, see the package leaflet.
Terrosa should not be used in patients suffering from other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bones) or in patients who have undergone skeletal radiotherapy or are still suffering from hypercalcaemia (high levels of calcium in the blood), inexplicably high levels of alkaline phosphatase (an enzyme) or severe kidney disease. Terrosa should not be taken during pregnancy or breastfeeding. For the full list of limitations, see the package leaflet.
Why has Terrosa - Teriparatide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has taken into account elements that confirm the fact that Terrosa has a structure, purity and biological activity very similar to Forsteo and is distributed in the body in the same way. This was considered sufficient to conclude that Terrosa behaves in the same way in terms of efficacy and safety. Therefore, as in the case of Forsteo, the benefits outweigh the risks identified and the committee recommended the granting of the marketing authorization for Terrosa
What measures are being taken to ensure the safe and effective use of Terrosa - Teriparatide?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Terrosa have been included in the summary of product characteristics and the package leaflet.
Other information on Terrosa - Teriparatide
The full EPAR for Terrosa can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Terrosa therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
