Movymia - Teriparatide
What is Movymia - Teriparatide and what is it used for?
Movymia is a medicine used to treat osteoporosis (a disease that makes bones fragile) in the following groups:
- postmenopausal women. In these patients, Movymia has been shown to significantly reduce vertebral (spine) and non-vertebral (broken bone) fractures, but not hip fractures;
- 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).
Movymia contains the active substance teriparatide.
Movymia is a 'biosimilar medicine'. This means that it should have been similar to a biological medicine (the 'reference medicine') that is already authorized in the European Union (EU). The reference medicine for Movymia is Forsteo. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Movymia used?
Movymia 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 Movymia administered once daily by subcutaneous injection into the thigh or abdomen ( belly). Patients can inject themselves after training.
Supplementation with calcium and vitamin D is recommended in patients whose dietary intake of these substances is inadequate. Movymia can be used for a maximum duration of two years.The two-year treatment with Movymia should only be given once in a patient's life.
The medicine can only be obtained with a prescription.
How does Movymia - Teriparatide work?
Osteoporosis is a condition in which the new bone produced is not enough to replace the one that deteriorates naturally. Bones become progressively less dense and more prone to fractures. Osteoporosis becomes more common in women after menopause, when the levels of the female hormone estrogen decrease. Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.
Teriparatide, the active ingredient in Movymia, is identical to part of the human parathyroid hormone. Like the human hormone, it stimulates bone formation by acting on osteoblasts (cells responsible for bone formation). In addition, this substance increases absorption. calcium present in food and prevents excessive dispersion through the urine.
What benefit has Movymia - Teriparatide shown during the studies?
Laboratory studies that compared Movymia and Forsteo have shown that the active ingredient of Movymia is very similar to that of Forsteo in terms of structure, purity and biological activity.
Since Movymia is a biosimilar medicine, the studies performed with Forsteo regarding the efficacy and safety of teriparatide need not be repeated for Movymia. A study in 54 healthy women showed that the same dosages of the two medicines given by subcutaneous injection resulted in similar levels of the active substance teriparatide in the body. Additionally, Movymia and Forsteo produced similar effects on blood calcium levels.
What are the risks associated with Movymia - Teriparatide?
The most common side effect with Movymia (which may affect more than 1 in 10 patients) is pain in the arms or legs. For the full list of side effects reported with Movymia, see the package leaflet.
Movymia should not be used in patients with other bone dysfunctions such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), or in patients who have undergone radiation therapy to the skeleton, or have hypercalcaemia (high levels blood calcium), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease. Movymia must not be taken during pregnancy or breastfeeding. For the full list of restrictions, see the package leaflet.
Why has Movymia - Teriparatide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered the evidence showing that Movymia has very similar structure, purity and biological activity to Forsteo and that it is distributed in the body in a similar way. This was considered sufficient to conclude that Movymia behaves in the same way in terms of efficacy and safety. Therefore, as in the case of Forsteo, the benefits outweigh the identified risks and the committee recommended that Movymia be given a marketing authorization.
What measures are being taken to ensure the safe and effective use of Movymia - Teriparatide?
The recommendations and precautions that healthcare professionals and patients need to observe in order for Movymia to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
Other information about Movymia - Teriparatide
For the complete version of the EPAR and the summary of Movymia's risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Movymia therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Movymia - Teriparatide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.