Paricalcitol

INDICATION: secondary hyperparathyroidism in chronic kidney disease - the indication this page carries and the one the SPC posology is written around; the SPC doses by CKD stage rather than by a separate diagnosis label. || TITRATION, CKD STAGES 3 AND 4 (UK SPC §4.2, Table 2, adjustments at 2-4 week intervals): if iPTH is the same, increased, or decreased by less than 30% relative to baseline - increase by 1 microgram (daily regimen) or 2 micrograms (three-times-a-week regimen); if decreased by 30% to 60% - maintain; if decreased by more than 60%, or iPTH is below 60 pg/ml (7 pmol/l) - decrease by 1 microgram (daily) or 2 micrograms (three times a week). 'If a patient is taking the lowest dose on the daily or three times a week regimen, and a dose reduction is needed, dosing frequency can be decreased.' || TITRATION, CKD STAGE 5: 'If serum calcium > 11.0 mg/dl (2.8 mmol/l) or Ca x P > 70 mg2/dl2 (5.6 mmol2/l2) or iPTH <= 150 pg/ml, the dose should be decreased by 2 to 4 micrograms with respect to that calculated by the most recent iPTH/60 (pg/ml) [iPTH/7 (pmol/l)]. If further adjustment is required, the dose of paricalcitol capsules should be reduced or interrupted until these parameters are normalised. As iPTH approaches the target range (150-300 pg/ml), small, individualised dose adjustments may be necessary in order to achieve a stable iPTH.' 'In situations where monitoring of iPTH, Ca or P occurs less frequently than once per week, a more modest initial and dose titration ratio may be warranted.' || HYPERCALCAEMIA HANDLING (§4.2): 'If hypercalcaemia or a persistently elevated calcium-phosphate product greater than 55 mg2/dl2 (4.4 mmol2/l2) is observed, the dose of calcium based phosphate binders should be reduced or withheld. Alternatively, the dose of Zemplar may be reduced or temporarily interrupted. If interrupted, the drug should be restarted at a lower dose, when serum calcium and calcium-phosphate product are in the target range.' || RENAL TRANSPLANT (§4.2): post-transplant patients with CKD stages 3 and 4 'were not studied in phase 3 clinical trials', but 'Based on the published literature, the initial dose and dose-titration algorithm... is the same as for patients with native CKD Stages 3 and 4 and secondary hyperparathyroidism.' || ELDERLY (§4.2): 'No overall differences in safety and effectiveness were observed between elderly patients (65-75 years) with regard to younger patients, but greater sensitivity of some older individuals cannot be ruled out.' No dose adjustment is given for age. || Nothing in either fetched label doses paricalcitol by body weight - dosing is by baseline iPTH and CKD stage.

FIXED MICROGRAM DOSE TITRATED TO iPTH, NOT PER-KG - dosePerKg is deliberately null; nothing in this bundle doses paricalcitol by body weight. UK SPC §4.2, 'Paediatric population', CKD Stages 3 and 4, ages 10 to 16 years, verbatim: 'The recommended starting dose of paricalcitol capsules is 1 microgram administered three times a week, no more frequently than every other day.' Titration: 'Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels to maintain an iPTH level between 35 and 69 pg/ml (Stage 3) or 70 and 110 pg/ml (Stage 4). Paricalcitol dose may be increased in 1 microgram increments every 4 weeks, maintaining the three times per week regimen. At any time, the dose may be decreased by 1 microgram or may be held if the patient is receiving a 1 microgram dose. Paricalcitol may be stopped if the patient requires reduction while receiving 1 microgram three times per week, resuming when appropriate.' AGE AND STAGE LIMITS: 'The safety and efficacy of Zemplar capsules in children under the age of 10 years have not yet been established' and, for CKD Stage 5, 'The efficacy of Zemplar in children with CKD Stage 5 has not been established.' The US cross-check label carries no paediatric dosing at all - it states that the 10-to-16-year information 'is approved for AbbVie Inc.'s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.' SAFETY: 'In children 10 years of age and older, the nature of the safety profile is similar to that seen in adults.'