SONDELBAY

Posology The recommended dose of Sondelbay is 20 micrograms administered once daily. 4). The 24-month course of Sondelbay should not be repeated over a patient’s lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.

Following cessation of Sondelbay therapy, patients may be continued on other osteoporosis therapies. 2). ). In patients with moderate renal impairment, Sondelbay should be used with caution. No special caution is required for patients with mild renal impairment.

3). Therefore, Sondelbay should be used with caution. Paediatric population and young adults with open epiphyses The safety and efficacy of teriparatide in children and adolescents less than 18 years has not been established. Sondelbay should not be used in paediatric patients (less than 18 years), or young adults (>18 to 29 years) with open epiphyses.

Method of administration Sondelbay should be administered once daily by subcutaneous injection in the thigh or abdomen. 6). A user manual is also available to instruct patients on the correct use of the pen.

Summary of the safety profile The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness. 5% of the placebo patients reported at least 1 adverse event. The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post-marketing exposure are summarised in the table below.

The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000). 25 mmol/L Psychiatric disorders Depression Nervous system disorders Dizziness, headache, sciatica, syncope Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Tachycardia Vascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Emphysema Gastrointestinal disorders Nausea, vomiting, hiatus hernia, gastro-oesophageal reflux disease Haemorrhoids Skin and subcutaneous tissue disorders Sweating increased Musculoskeletal and connective tissue disorders Pain in limb Muscle cramps Myalgia, arthralgia, back cramp/pain* Renal and urinary disorders Urinary incontinence, polyuria, micturition urgency, nephrolithiasis Renal failure/impairment General disorders and administration site condition Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site Injection site erythema, injection site reaction Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral) Investigations Weight increased, cardiac murmur, alkaline phosphatase increase *Serious cases of back cramp or pain have been reported within minutes of the injection.

Description of selected adverse reactions In clinical trials the following reactions were reported at a ≥1 % difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea. Teriparatide increases serum uric acid concentrations.

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 studies 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. 1). 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. 3). Until further clinical data become available, the recmmended treatment time of 24 months should not be exceeded. Excipient This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.

1. 6) • Pre-existing hypercalcaemia • Severe renal impairment • Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis. • Unexplained elevations of alkaline phosphatase • Prior external beam or implant radiation therapy to the skeleton • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.