Human medicines European public assessment report (EPAR): Sondelbay, teriparatide, Date of authorisation: 24/03/2022, Revision: 1, Status: Authorised
The safety of Sondelbay has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Forsteo.
The most common side effect with teriparatide (which may affect more than 1 in 10 people) is pain in the arms or legs; nausea (feeling sick), headache and dizziness are also common. For the full list of side effects of Sondelbay, see the package leaflet.
Sondelbay must not be used in patients who have other bone diseases such as Paget’s disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme that can be a sign of bone disease) or severe kidney disease. Sondelbay must not be used during pregnancy or breastfeeding. For the full list of restrictions, see the package leaflet.
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