Zoledronic Acid Teva Pharma

Posology Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma. This is especially important for the elderly (≥ 65 years) and for patients receiving diuretic therapy. Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.

Osteoporosis For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma administered once a year.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Zoledronic acid Teva Pharma on an individual patient basis, particularly after 5 or more years of use.

1). In patients with a recent low-Medicinal product no longer authorised 3 trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.

Paget’s disease For the treatment of Paget’s disease, Zoledronic acid Teva Pharma should be prescribed only by physicians with experience in the treatment of Paget’s disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.

4).

Re-treatment of Paget’s disease:

After initial treatment with zoledronic acid in Paget’s disease, an extended remission period is observed in responding patients. Re-treatment consists of an additional intravenous infusion of 5 mg Zoledronic acid Teva Pharma after an interval of one year or longer from initial treatment in patients who have relapsed.

1). 4). No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min. 2). Elderly (≥ 65 years) No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.

Paediatric population The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established. No data are available. Method of administration Intravenous use. Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate.

2% after the first, second and third infusion, respectively. 1%). The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid. The majority of these reactions occur within the first three days following zoledronic acid administration.

The majority of these reactions were mild to moderate and resolved within three days of the event onset. 7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used. Tabulated list of adverse reactions Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.

Frequency categories are defined using the following convention: very common (≥1/10);Medicinal product no longer authorised 7 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); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8 Class effects) Renal and urinary disorders Uncommon Blood creatinine increased, pollakiuria,Medicinal product no longer authorised 8 proteinuria Not known** Renal impairment.

8 Class effects) General disorders and administration site conditions Very common Pyrexia Common Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea Investigations Common C-reactive protein increased Uncommon Blood calcium decreased # Observed in patients taking concomitant glucocorticosteroids.

* Common in Paget’s disease only. ** Based on post-marketing reports. Frequency cannot be estimated from available data. † Identified in post-marketing experience. 9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.

Medicinal product no longer authorised 4 Renal function The use of Zoledronic acid Teva Pharma in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.

5), or dehydration occurring after zoledronic acid administration. Renal impairment has been observed in patients after a single administration. Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.

The following precautions should be taken into account to minimise the risk of renal adverse reactions: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic acid Teva Pharma dose.

• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function. • Monitoring of serum creatinine should be considered in at-risk patients. 5). • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.

2). 3). g. diminished parathyroid reserve, intestinal calcium malabsorption). Physicians should consider clinical monitoring for these patients. Elevated bone turnover is a characteristic of Paget’s disease of the bone. 8). Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.

2). Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk. Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.

8). 8). The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth. Medicinal product no longer authorised 5 The following should be considered when evaluating a patient’s risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.

1. 4). 4). 6).