Forsteo ® (teriparatid)

För fullständig produktresumé för Forsteo® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Forsteo® (teriparatide): Risk för Osteonekros i käkbenet (ONJ)

Baserat på tillgänglig information så verkar teriparatid inte ha ettt kausalt samband med Osteonekros i käkbenet (ONJ).

Background information

Osteonecrosis of the jaw does not belong to the known adverse drug reactions of Forsteo and is not listed in the summary of product characteristics.1

Teriparatide has an anabolic effect on bone, which is different than the mechanism of action of antiresorptive therapies, such as bisphosphonates.2

Among the pivotal Lilly-sponsored teriparatide clinical trials for the treatment of osteoporosis, ONJ was not reported as a treatment-emergent adverse event (TEAE).3

In the Lilly teriparatide spontaneous reporting database, which contains data as of September 12, 2019, both “osteonecrosis” and “osteonecrosis of the jaw” have been very rarely reported.3

To date, there have been no published case reports of the development of ONJ during treatment with teriparatide.

Based on of the available information, teriparatide does not appear to be causally associated with osteonecrosis of the jaw.

References

1. Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Canalis E, Giustina A, Bilezikian JP. Mechanisms of anabolic therapies for osteoporosis. N Engl J Med. 2007;357(9):905-916. http://dx.doi.org/10.1056/NEJMra067395

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Datum fӧr senaste ӧversyn 2020 M03 05


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