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Solution for injection containing 5 micrograms/ml paricalcitol.
Initial dose should be calculated based on baseline parathyroid hormone (PTH) levels.
An intact parathyroid hormone (iPTH) assay has been used as the measurement of biologically active parathyroid hormone (PTH) in patients with chronic renal failure (CRF).
The initial dose of paricalcitol is based on the following formula:
Initial dose (micrograms) = baseline iPTH level in picograms/ml divided by 80
Initial dose (micrograms) = baseline iPTH level in picomoles/l divided by 8
Administer dose 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 40 micrograms.
The currently accepted target range for PTH levels in end-stage renal failure subjects undergoing dialysis is no more than 1.5 to 3 times the non-uraemic upper limit of normal, 15.9 to 31.8 picomoles/l (150-300 picograms/ml) for iPTH. Close monitoring and individual dose titration are necessary to reach appropriate physiological endpoints.
If hypercalcaemia or a persistently elevated corrected Ca x P product greater than 5.2 mmol squared/ litre squared (65 mg squared /dl squared) is noted, the dose should be reduced or interrupted until these parameters are normalised. Then paricalcitol should be reinitiated at a lower dose. Doses may need to be decreased as the PTH levels decrease in response to therapy.
Suggested Dosing Titration Guidelines
Dose adjustments at 2 to 4 week intervals.
iPTH level relative to baseline - the same or rising: Increase paricalcitol dose by 2 to 4 micrograms.
iPTH level relative to baseline - decreased by less than 30% : Increase paricalcitol dose by 2 to 4 micrograms.
iPTH level relative to baseline - decreased by more than or equal to 30% and less than or equal to 60% : Maintain paricalcitol dose.
iPTH level relative to baseline - decreased by more than 60% : Decrease paricalcitol dose by 2 to 4 micrograms.
iPTH level relative to baseline - iPTH less than 15.9 picomoles/l (150 picograms/mL) : Decrease paricalcitol dose by 2 to 4 micrograms
There is a limited amount of experience of the use of paricalcitol in elderly patients.
No overall differences in efficacy or safety have been observed between patients 65 years or older and younger patients
Patients with Renal Impairment
No dosage adjustment necessary.
See 'Adult' dosage
Patients with Hepatic Impairment
Mild to moderate hepatic impairment: No dosage adjustment necessary.
There is no experience of the use of paricalcitol in patients with severe hepatic impairment.
In addition, the injection contains 20% v/v ethanol and should be therefore be used with caution in patients with any hepatic impairment.
Paricalcitol injection is administered intravenously via haemodialysis access.
The injection contains propylene glycol as an excipient which neutralises the effect of heparin. It must not be administered with heparin.
Paricalcitol must not be mixed with other medicinal products.
Evidence of vitamin D toxicity
Children under 18 years
Precautions and Warnings
Pregnancy - see 'Pregnancy' section
Breastfeeding - see 'Lactation' section
Severe hepatic impairment
Monitor serum calcium and phosphate at least monthly and more frequently when dose is being adjusted (e.g. weekly).
If the patient is requiring a calcium based phosphate binder and clinically significant hypercalcaemia develops, then the dose of the calcium based phosphate binder should be reduced or interrupted.
Increased serum calcium and metabolic bone disease may develop if PTH levels are suppressed to abnormal levels. Monitor serum iPTH measurements every three months.
Chronic hypercalcaemia may be associated with generalised vascular calcification and other soft-tissue calcification.
The injection contains 30% v/v propylene glycol as an excipient.
The injection contains 20% v/v of ethanol. Each dose may contain up to 1.3g of ethanol based on the maximum dose seen in clinical trials. Ethanol may be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children, and may modify or increase the effect of other medicines.
Pregnancy and Lactation
Paricalcitol should only be given to pregnant women if clearly needed.
Animal studies have shown reproductive toxicity. There is no adequate data on the use of paricalcitol in pregnant women.
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 ).
Paricalcitol should be used with caution in breastfeeding women as it is not known whether paricalcitol is excreted in human milk.
Breast milk from women taking pharmacological doses of vitamin D may cause hypercalcaemia if given to an infant.
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
Increased bleeding time
Increased aspartate transaminase
Transient ischaemic attack
Injection site pain
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 ).
Shelf Life and Storage
No special storage requirements.
Last Full Review Date: September 2012
Reference SourcesBritish National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
Summary of Product Characteristics: Zemplar 5 micrograms/ml solution for Injection. AbbVie Limited. Revised July 2011
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