ZEMPLAR

Posology Adults 1) Initial dose should be calculated based on baseline parathyroid hormone (PTH) levels: The initial dose of paricalcitol is based on the following formula: Initial dose (micrograms) = baseline intact PTH level in pmol/l 8 OR = baseline intact PTH level in pg/ml 80 and administered as an intravenous (IV) bolus dose no more frequently then every other day at any time during dialysis.

The maximum dose safely administered in clinical studies was as high as 40 micrograms. 8 pmol/l (150-300 pg/ml), for intact PTH. Close monitoring and individual dose titration are necessary to reach appropriate physiological endpoints.

2 mmol2/l2 (65 mg2/dl2) is noted, the dosage should be reduced or interrupted until these parameters are normalised. Then, paricalcitol administration should be reinitiated at a lower dose. Doses may need to be decreased as the PTH levels decrease in response to therapy.

9 pmol/l (150 pg/ml) Decrease by 2 to 4 micrograms Once dosage has been established, serum calcium and phosphate should be measured at least monthly. Serum intact PTH measurements are recommended every three months. During dose adjustment with paricalcitol, laboratory tests may be required more frequently.

Hepatic impairment Unbound concentrations of paricalcitol in patients with mild to moderate hepatic impairment are similar to healthy subjects and dose adjustment is not necessary in this patient population. There is no experience in patients with severe hepatic impairment.

Paediatric population The safety and efficacy of Zemplar in children have not been established. No data are available on children under 5 years. 1 but no recommendation on a posology can be made. Elderly There is a limited amount of experience with patients 65 years of age or over receiving paricalcitol in the phase III studies.

In these studies, no overall differences in efficacy or safety were observed between patients 65 years or older and younger patients. Method of administration Zemplar solution for injection is administered via haemodialysis access.

Summary of the safety profile Approximately 600 patients were treated with paricalcitol in Phase II/III/IV clinical trials. Overall, 6% of the paricalcitol treated patients reported adverse reactions. 7% of patients. Hypercalcaemia is dependent on the level of PTH oversuppression and can be minimised by proper dose titration.

Tabulated list of adverse reactions Adverse events at least possibly related to paricalcitol, both clinical and laboratory are displayed by MedDRA System Organ Class, Adverse Reaction and frequency. The following frequency groupings are used: very common ( ≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10000), not known (cannot be estimated from the available data).

” Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to metabolic bone disease. Patient monitoring and individualised dose titration is required to reach appropriate physiological endpoints.

If clinically significant hypercalcaemia develops, and the patient is receiving a calcium-based phosphate binder, the dose of the calcium-based phosphate binder should be reduced or interrupted. Chronic hypercalcaemia may be associated with generalised vascular calcification and other soft-tissue calcification.

5). 5). 5). Warning for excipients A dose of 40 micrograms of this medicine administered to an adult weighing 70 kg would result in exposure to approximately 18 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 3 mg/100 ml.

For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

1. Vitamin D toxicity Hypercalcaemia.