Kauliv

HOS-098917 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limbs, headache and dizziness. Tabulated list of adverse reactions Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event. 5 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), and rare (≥1/10 000 to <1/1 000). Table 1. Adverse reactions MedDRA system organ class Frequency Adverse reactions Blood and lymphatic system disorders Common Anaemia Immune system disorders Rare Anaphylaxis Common Hypercholesterolaemia Hypercalcaemia greater than Uncommon Metabolism and nutrition disorders 2.76 mmol/L, hyperuricaemia Hypercalcaemia greater than Rare 3.25 mmol/L Psychiatric disorders Common Depression Nervous system disorders Common Dizziness, headache, sciatica, syncope Ear and labyrinth disorders Common Vertigo Common Palpitations Cardiac disorders Uncommon Tachycardia Vascular disorders Common Hypotension Respiratory, thoracic and Common Dyspnoea mediastinal disorders Uncommon Emphysema Nausea, vomiting, hiatus hernia, Common gastro-oesophageal reflux disease Gastrointestinal disorders

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HOS-098913 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Pregnancy and breast-feeding (see sections 4.4 and 4.6). • Pre-existing hypercalcaemia. • Severe renal impairment. • Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucocorticoid-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.

HOS-098912 · has-indication-information · PDF-Seite 2

Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non- vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

HOS-098915 · has-interaction-information · PDF-Seite 4

In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases serum calcium, teriparatide should be used with caution in patients taking digitalis. Teriparatide has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide. No clinically significant interactions were noted. 4 Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the effects of teriparatide on serum or urine calcium or on clinical adverse events.

HOS-098916 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential/Contraception in females Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, Kauliv should be discontinued. Pregnancy Kauliv is contraindicated for use during pregnancy (see section 4.3). Breast-feeding Kauliv is contraindicated for use during breast-feeding. It is not known whether teriparatide is excreted in human milk. Fertility Studies in rabbits have shown reproductive toxicity (see section 5.3). The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown.

HOS-098914 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal 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. 3  Urolithiasis Teriparatide has not been studied in patients with active urolithiasis. Teriparatide 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, including premenopausal women, is limited (see section 5.1). 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, teriparatide should be discontinued. Duration of treatment Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3). Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-

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