Paricalcitol oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Capsules containing paricalcitol
Drugs List
Therapeutic Indications
Uses
Secondary hyperparathyroidism in stage 3 to 5 chronic kidney disease
Prevention and treatment of secondary hyperparathyroidism in patients with the following stages of chronic renal impairment:
Chronic kidney disease stage 3 (eGFR = 30-59 ml/minute/1.73 square metres body surface area) OR
Chronic kidney disease stage 4 (eGFR = 15-29 ml/minute/1.73 square metres body surface area) OR
Chronic kidney disease stage 5 (eGFR less than 15 ml/minute/1.73 square metres body surface area) undergoing haemodialysis or peritoneal dialysis.
Dosage
Adults
Chronic kidney disease stage 3 (eGFR = 30-59 ml/minute/1.73 square metres) or stage 4 (eGFR = 15-29 ml/minute/1.73 square metres body surface area)
Paricalcitol may be taken daily, OR three times per week (no more frequently than every other day).
Initial Dose
Initial dose is based on baseline intact parathyroid hormone (iPTH) levels.
iPTH 500 picogram/ml (56 picomol/litre) or less: 1 microgram daily OR 2 micrograms three times per week.
iPTH over 500 picogram/ml (56 picomol/litre): 2 micrograms daily OR 4 micrograms three times per week.
Titration Dose
Dosing must be based on serum or plasma iPTH levels; dose adjustments should be made at 2 to 4 week intervals.
iPTH level decreased by less than 30%, the same or higher than the baseline level
If the patient is on a daily dosage regime, increase the daily dose by 1 microgram. If the patient is on a three times per week dosage regime, increase each dose by 2 micrograms.
iPTH level decreased by 30 to 60% from baseline level
Maintain the existing dosage.
iPTH level decreased by more than 60% from baseline level or if iPTH level less than 60 picogram/litre (7 picomol/litre)
If the patient is on a daily dosage regime, decrease the daily dose by 1 microgram. If the patient is on a three times per week dosage regime, decrease each dose by 2 micrograms. If the patient is receiving the lowest dose, the dosing frequency may be reduced.
Chronic kidney disease stage 5 (eGFR less than 15 ml/minute/1.73 square metres)
Paricalcitol should be taken three times per week (every other day).
Initial Dose
Initial dose of paricalcitol in micrograms is based on baseline iPTH level in picogram/ml divided by 60 (OR picomol/litre divided by 7).
The maximum initial dose is 32 micrograms.
Titration Dose
Dosing must be based on iPTH levels, serum calcium and phosphorus levels.
A suggested dose titration (microgram of paricalcitol) is based on most recent iPTH level in picogram/ml divided by 60 (OR picomol/litre divided by 7).
If serum calcium exceeds 11 mg/dl OR Ca x P is greater than 70 mg squared /dl squared OR iPTH is 150 picogram/ml or less, the dose should be decreased by 2 to 4 micrograms with respect to the dose calculated using the formula above. If further adjustments are required, paricalcitol dosage should be reduced or interrupted until these parameters are normalised.
As iPTH approaches the target range of 150 to 300 picogram/ml, small dose adjustments may be required to achieve a stable iPTH.
Where iPTH, calcium or phosphorus monitoring occurs less frequently then once weekly, the initial dose and dose titrations should be smaller.
Elderly
See Dosage; Adult
Additional Dosage Information
If hypercalcaemia or persistently increased calcium-phosphorus levels greater than 55mg squared /dL squared are observed, the dose of any calcium-based phosphate binders should be reduced or withheld OR the dose of paricalcitol may be reduced or interrupted temporarily. If the dose of paricalcitol is interrupted, treatment should be re-started at a lower dose once serum calcium and calcium-phosphorus levels are in the target range.
Contraindications
Children under 18 years
Hypervitaminosis D
Hypercalcaemia
Precautions and Warnings
Alcoholism
Breastfeeding
Epileptic disorder
Pregnancy
Severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains alcohol
Monitor parathyroid hormone levels before and during treatment
Monitor parathyroid hormone levels
Monitor serum calcium levels
Monitor serum phosphate levels
Vitamin D analogues may increase serum creatinine without changing GFR
Not licensed for use in children under 18 years
The capsules contain small amounts of ethanol, which may be harmful to patients suffering from alcohol dependence. The ethanol content (less than 100 mg/capsule) should be considered when treating children, patients with hepatic disease or epilepsy, pregnant patients or breast-feeding patients.
Pregnancy and Lactation
Pregnancy
At the time of writing, no reports of the use of paricalcitol in pregnant women have been located.
Human pregnancy experience with vitamin D and calcitriol indicates that recommended doses are safe in pregnancy, there is no evidence that recommended doses of paricalcitol would be any different. However, if the mother is taking paricalcitol, she should not take vitamin D supplements or pharmacological doses of vitamin D or its derivatives.
Animal studies with high doses did cause toxicity but this was considered secondary to hypercalcaemia.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
At the time of writing, no reports of the use of paricalcitol during breastfeeding have been located.
It is not known whether paricalcitol is excreted in human milk. Animal studies have shown the excretion of paricalcitol or its metabolites into breast milk and the small molecular weight and long elimination half life suggest the same for humans. However the extensive metabolism and plasma protein binding should limit the amount in milk.
If paricalcitol is used by a nursing mother, she should be advised to avoid vitamin D supplements. The serum calcium level of the infant should be monitored.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal discomfort
Acne
Alterations in hepatic enzymes
Breast tenderness
Constipation
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Gastroesophageal reflux disease
Hypercalcaemia
Hypocalcaemia
Muscle spasm
Pruritus
Rash
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2013
Reference Sources
British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Zemplar soft capsules 1, 2 and 4 mcg capsules. Abbott Laboratories Ltd. Revised January 2012.
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