Sondelbay Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Serum and urine calcium: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required.
Teriparatide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
Urolithiasis: Teriparatide has not been studied in patients with active urolithiasis. Sondelbay should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Orthostatic hypotension: In short-term clinical trials with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
Renal impairment: Caution should be exercised in patients with moderate renal impairment.
Younger adult population: Experience in the younger adult population (>18 to 29 years), including premenopausal women, is limited. Treatment should only be initiated if the benefit clearly outweighs risks in this population.
Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, Sondelbay should be discontinued.
Duration of treatment: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide. Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded.
Excipient: This medicinal product contains less than 1 mmol sodium (23 mg) per dose unit, that is to say essentially "sodium-free".
Effects on ability to drive and use machines: Teriparatide has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided.