Us dod 2007

Dialysis of Drugs
Curtis A. Johnson, PharmD
Nephrology Pharmacy Associates
Verona, Wisconsin
Professor (Emeritus) of Pharmacy and MedicineUniversity of Wisconsin-MadisonMadison, Wisconsin SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK 2007 Dialysis of Drugs
DISCLAIMER—These Dialysis of Drugs guidelinesare offered as a general summary of informationfor pharmacists and other medical professionals.
Inappropriate administration of drugs may involveserious medical risks to the patient that can onlybe identified by medical professionals. Dependingon the circumstances, the risks can be serious andcan include severe injury, including death. Theseguidelines cannot identify medical risks specificto an individual patient or recommend patienttreatment. These guidelines are not to be used asa substitute for professional training. The absenceof typographical errors is not guaranteed. Use ofthese guidelines indicates acknowledgment thatneither Nephrology Pharmacy Associates, Inc.
nor Genzyme will be responsible for any loss orinjury, including death, sustained in connectionwith or as a result of the use of these guidelines.
Readers should consult the complete informationavailable in the package insert for each agentindicated before prescribing medications. Guides such as this one can only draw frominformation available as of the date ofpublication. Neither Nephrology PharmacyAssociates, Inc. nor Genzyme is under anyobligation to update information containedherein. Future medical advances or productinformation may affect or change the informationprovided. Pharmacists and other medicalprofessionals using these guidelines areresponsible for monitoring ongoing medicaladvances relating to dialysis. Copyright 2007, Nephrology PharmacyAssociates, Inc. Printed in the U.S.A. All rightsreserved. This material may not be published,rewritten or redistributed. SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK Drug removal during dialysis is frequently of interest to those caring for patients receivinghemodialysis or peritoneal dialysis. The extentof drug dialyzability determines whether sup-plemental dosing is necessary during or fol-lowing dialysis. The accompanying table isa reference regarding the effect of either formof dialysis on drug clearance. This table shouldbe used as a general guideline.
The drugs included in the table are parentdrugs. In some cases, these drugs are con-verted to pharmacologically active or toxicmetabolites for which little dialysis informationis known. Therefore, for a few drugs, a primarymetabolite is also included in the table. Whenavailable, serum drug measurements may beappropriate for dosing individual patients. Inall cases, patients should be monitored forclinical efficacy and toxicity.
What Determines
Drug Dialyzability?
The extent to which a drug is affected by
dialysis is determined primarily by several
physicochemical characteristics of the drug
that are briefly described in the text that fol-
lows. These include molecular size, protein
binding, volume of distribution, water solubil-
ity, and plasma clearance. In addition to these
properties of the drug, technical aspects of
the dialysis procedure also may determine the
extent to which a drug is removed by dialysis.
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Molecular Weight
Dialysis is dependent upon the use of a dialytic
membrane: either a synthetic membrane with
fixed pore size, as in hemodialysis, or a natu-
rally occurring peritoneal membrane, as in
peritoneal dialysis. The movement of drugs or
other solutes is largely determined by the size
of these molecules in relation to the pore size
of the membrane. As a general rule, smaller
molecular weight substances will pass through
the membrane more easily than larger molecu-
lar weight substances. A common assumption
is that pore size of the peritoneal membrane is
somewhat larger than that of the hemodialysis
membrane. This would explain the observation
that larger molecular weight substances appear
to cross the peritoneal membrane to a greater
extent than the hemodialysis membrane.
Protein Binding
Another important factor determining drug
dialyzability is the concentration gradient
of unbound (free) drug across the dialysis
membrane. Drugs with a high degree of
protein binding will have a low plasma
concentration of unbound drug available for
dialysis. Uremia may have an effect on protein
binding for some drugs. Through mechanisms
not completely understood, protein binding
may decrease in uremic serum. Should this
change in binding be substantial, increased
dialyzability of free drug may occur.
SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK Because the primary binding proteins for most large molecular size, the drug-protein complex is often unable to cross the dialysis membrane,especially the hemodialysis membrane. Sincethe peritoneal membrane does permit thepassage of some proteins, there may be somelimited drug-protein removal with peritonealdialysis. Increased protein concentrationsoften occur in peritoneal effluent duringepisodes of peritonitis.
Volume of Distribution
A drug with a large volume of distribution is
distributed widely throughout tissues and is
present in relatively small amounts in the
blood. Factors that contribute to a large vol-
ume of distribution include a high degree of
lipid solubility and low plasma protein bind-
ing. Drugs with a large volume of distribution
are likely to be dialyzed minimally.
Water Solubility
The dialysate used for either hemodialysis or
peritoneal dialysis is an aqueous solution. In
general, drugs with high water solubility will
be dialyzed to a greater extent than those with
high lipid solubility. Highly lipid-soluble drugs
tend to be distributed throughout tissues, and
therefore only a small fraction of the drug is
present in plasma and accessible for dialysis.
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Plasma Clearance
The inherent metabolic clearance—the sum of
renal and nonrenal clearance—is often termed
the “plasma clearance” of a drug. In dialysis
patients, renal clearance is largely replaced
by dialysis clearance. If nonrenal clearance
is large compared to renal clearance, the
contribution of dialysis to total drug removal
is low. However, if renal (dialysis) clearance
increases plasma clearance by 30% or more,
dialysis clearance is considered to be clinically
important.
Dialysis Membrane
As mentioned previously, the characteristics
of the dialysis membrane determine to a
large extent the dialysis of drugs. Pore size,
surface area, and geometry are the primary
determinants of the performance of a given
membrane. The technology of hemodialysis
has evolved, and new membranes have been
introduced for clinical use. Interpretation of
published literature should be tempered with
the understanding that newer hemodialysis
membranes may have different drug dialysis
characteristics. Little can be done to alter the
characteristics of the peritoneal membrane.
SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK Blood and Dialysate
Flow Rates
The hemodialysis prescription includes thedesired blood and dialysate flow rates. Asdrugs normally move from blood to dialysate,the flow rates of these two substances mayhave a pronounced effect on dialyzability.
In general, increased blood flow rates duringhemodialysis will deliver greater amounts ofdrug to the dialysis membrane. As the drugconcentration increases in the dialysate, theflow rate of the dialysis solution also becomesimportant in overall drug removal. Greaterdialysis can be achieved with faster dialysateflow rates that keep the dialysate drugconcentration at a minimum.
During peritoneal dialysis, little can be doneto alter blood flow rates to the peritoneum.
However, dialysate flow rates are determinedby the volume and frequency of dialysateexchange in the peritoneum. At low exchangerates, drug concentrations in the dialysatewill increase during the time in which thedialysate resides in the peritoneum, thusslowing additional movement of drug acrossthe membrane. More frequent exchanges willfavor increased drug dialyzability, provided thedrug’s physicochemical characteristics permitits movement across the peritoneal membrane.
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Special Considerations
HIGH PERMEABILITY DIALYSIS
Much of the information contained in thisguide has been obtained from studiesconducted under conditions of standardhemodialysis that employed conventionaldialysis membranes. Changes in dialysistechnology have led to more permeabledialysis membranes and the opportunity toemploy higher blood and dialysate flow rates.
These new technologies are often referred toas “high permeability,” “high-efficiency,” and“high-flux” dialysis. The United States Foodand Drug Administration has classified highpermeability dialysis membranes as thosewhose in vitro ultrafiltration coefficient(KUf) is greater than 8 mL/hour/mm Hg.
Commonly included in this group of dialysismembranes are polysulfone, polyacrylonitrile,and high-efficiency cuprammonium rayondialyzers. Changes in dialysis membranes andchanges in blood and dialysis flow rates mayhave clinically important effects on drugremoval through the membrane.
There are an increasing number of studiesthat examine the effects of high permeabilitydialysis on drug dialyzability. Results of thesestudies confirm predictions that drug removalfrom plasma is often enhanced as comparedwith more traditional dialysis membranes.
Studies with high permeability dialysis alsodemonstrate that removal of drug from plasma SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK often exceeds the transfer of drug from tissues to plasma. As a result, a rebound of plasma drug concentrations following the conclusion of dialysis may occur as blood-tissue drug equilibration occurs. Patients receiving high permeability dialysis may require more drug and physiological variables, individualized therapeutic drug monitoring may be necessary.
The reader is referred to the primary literaturefor further details.
CONTINUOUS RENAL
REPLACEMENT THERAPY
Another therapeutic development that willaffect drug dialyzability is continuous renalreplacement therapy (CRRT), known in itsvarious forms as continuous arteriovenoushemofiltration (CAVH), continuous venovenoushemofiltration (CVVH), continuousarteriovenous hemodialysis (CAVHD),continuous venovenous hemodialysis(CVVHD), continuous venovenoushemodiafiltration (CVVHDF), continuousarteriovenous hemodiafiltration (CAVHDF),slow continuous ultrafiltration (SCUF),continuous arteriovenous high-fluxhemodialysis (CAVHFD), and continuousvenovenous high-flux hemodialysis (CVVHFD).
These various techniques are used in themanagement of acute renal failure in criticallyill patients.
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Continuous renal replacement therapies differconsiderably from intermittent hemodialysis.
Relying heavily upon continuous ultrafiltrationof plasma water, CRRT has the potential forthe removal of large quantities of ultrafilterabledrugs contained in plasma. Unfortunately, fewin vivo studies have been published, andvery few drugs have been studied pharmaco-kinetically in intensive care patients. Therefore,many guidelines for drug dosing during CRRTare extrapolated from experiences with chronichemodialysis or from theoretical considerationsbased upon general principles of drug removalderived from the physicochemical characteriticsof the drug and the CRRT technique employed.
Molecular weight of a drug has been animportant determinant of drug dialyzabilityin conventional hemodialysis. This drugcharacteristic becomes less importantduring CRRT because of the use of high-fluxhemofilters that permit passage of largermolecules up to 5000 Da. As is true withconventional hemodialysis, drugs witha large volume of distribution are unlikelyto be removed to a great extent during CRRT.
Most of the body stores of such drugs areoutside the vascular compartment and notaccessible to the hemofilter for removal.
Similarly, drugs that are highly bound toplasma proteins are not subject to significantremoval during CRRT because the molecularweight of drug-protein complexes usuallyhinders passage of the complex across thefilter. The fraction of unbound drug maychange during renal failure, however, thus SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK altering the likelihood of drug removal. If the unbound fraction increases, more drug clear- becomes less, there is likely to be less drug A useful tool to predict the likelihood of a drug to cross the hemofilter membrane is the sieving coefficient. This term is defined as the ratio of drug concentration in the ultrafiltrate to the pre- filter plasma water concentration of the drug. Ifthe sieving coefficient is close to 1.0, the drughas relatively free passage across the filter. Thefollowing table presents sieving coefficientdata from in vitro and in vivo evaluations.
SIEVING COEFFICIENT
Drug Name
Predicted Measured Condition Filter
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SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK The above table was published in the following article: Joy MS,Matzke, GR, Armstrong DK, Marx MA, Zarowitz BJ. A primer oncontinuous renal replacement therapy for critically ill patients.
Ann Pharmacother. 1998;32:362-75. Reprinted with permission.
Harvey Whitney Books Company.
The specific CRRT technique employed willinfluence the ultrafiltration rate and hence,the potential rate of drug removal. WhenCRRT relies solely on spontaneous blood flowwithout extracorporeal blood pumping, anultrafiltration rate of 10-15 mL/min isanticipated. The addition of blood pumpsand continuous dialysis may increase theultrafiltration rate to 50 mL/min. Higher ratesof ultrafiltration may lead to greater drugremoval with a need for more frequentreplacement doses. Drug removal can bedetermined by collection of the total volumeof dialysate/ultrafiltrate and measurement ofthe concentration of drug in the effluent. Because of the multiple techniques employedin CRRT, the variability in individual patientcircumstances, and the lack of in vivo data, the SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK 2007 Dialysis of Drugs
tables in this guide do not contain informationon drug removal during CRRT. Once again, thereader is referred to the primary literature forassistance with the dosing of specific drugs.
PLASMAPHERESIS
Plasmapheresis is another specialconsideration in which drug removal fromplasma may be of concern. This technique isused for the treatment of certain immunologic,infectious, and metabolic diseases, as wellas for the removal of toxins that cannot beremoved by hemodialysis or peritonealdialysis. Plasmapheresis removes plasma fromthe patient with replacement by crystalloid orcolloid solutions. Solutes such as drug mole-cules that are present in the plasma may beremoved from the patient. Unfortunately, littleis known about the specific pharmacokineticeffects of plasmapheresis. The procedure maybe most likely to remove substances that arelipophilic, that are highly protein-bound, andthat have a small volume of distribution. Thereader is referred to reference 5.
Drug dialyzability is determined by a complexinteraction of many factors, including thecharacteristics of the drug and the technicalaspects of the dialysis system. Publishedstudies on drug dialyzability should specifythe conditions that pertain during dialysis.
Results from these studies should be appliedwith caution to other dialysis conditions. SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK About This Guide
extensive, easy-to-read information regarding the dialyzability of drugs. Numerous literature guidelines. For many drugs, including newly- approved medications, no studies have beendone to determine the effect of dialysis ondrug removal. In some cases, the availabledata may conflict. Conditions of dialysis usedin published studies may not necessarily reflectcurrent dialysis procedures and technology.
Variations in the duration of dialysis, flow rates,dialysis membranes, and whether peritonealdialysis is continuous or intermittent will allaffect drug removal. This educational reviewwill distinguish between conventionalhemodialysis and high permeability (oftencalled high-flux) hemodialysis where such dataare available. However, the review does notcontain information on drug dialyzability withCRRT (See “Special Considerations,” page 9) orwith plasmapheresis. For additional informationon specific drugs, the reader should consult theprimary literature.
A designation of “Yes” in the Hemodialysisand Peritoneal Dialysis columns indicates thatdialysis enhances plasma clearance by 30%or more. Supplemental dosing may be requiredor dosing after dialysis should be considered.
“No” indicates that dialysis does not have aclinically important effect on plasma clearance.
Supplemental dosing is usually not required.
As a general principle, usual methods of SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK 2007 Dialysis of Drugs
continuous ambulatory peritoneal dialysis(CAPD) provide relatively low drug clearancesduring any given dialysate exchange. However,cumulative drug removal may require dosagesupplementation at appropriate intervals.
Relatively little research has examined peri-toneal drug clearance in PD techniques thatutilize automated systems employing largevolumes of short dwells at night, often accom-panied by one or more longer daytime dwells(APD). Similarly, little data exists on the effectsof tidal peritoneal dialysis on drug clearance.
A few studies have confirmed that clearanceof some drugs is increased by APD due to theincreased drug concentration gradient betweenblood and dialysate. Increased drug dialyza-bility may occur with increased peritonealdialysate flow rates or in the presence of peri-tonitis. A designation of “U” indicates that nodialysis studies have been published, but thatthe authors of this guide have concluded thatsignificant drug removal during dialysis isunlikely based upon the physicochemicalcharacteristics of the drug, which are primarilya high degree of protein binding, a largemolecular weight, or a large volume ofdistribution. A designation of “L” indicatesthat no published data exist on the removalof the drug during high permeability dialysis.
However, the authors have extrapolated datafrom studies using conventional dialysis toconclude that significant drug removal islikely to occur during high permeability dialy-sis. A designation of “ND” indicates that nodata are available on drug dialyzability. Insome cases, the literature reports the use SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK of a high permeability, or high-flux, dialysis membrane, however the type of membrane is not specified. A designation of “NS” indicates Yes Indicates that dialysis enhances plasma clearance
by 30% or more. Supplemental dosing may be re-quired or dosing after dialysis should be considered.
No Indicates that dialysis does not have a clinically
important effect on plasma clearance.
Supplemental dosing is usually not required. Indicates significant drug removal is unlikely basedon physicochemical characteristics of the drugsuch as protein binding, molecular size or volumeof distribution Indicates no published data exist, but informationextrapolated from studies using conventional dialy-sis techniques suggests significant drug removal islikely during high permeability dialysis ND Indicates there are no data on drug dialyzability
NS Indicates the type of membrane was not specified
Note: In these tables, conventional hemodialysis is
defined as the use of a dialysis membrane whose in
vitro coefficient of ultrafiltration (KUf) ≤8 mL/hour/mm
Hg. Data also are placed in the conventional column
if the literature does not specify the type of dialysis
membrane employed. High permeability hemodialysis
is defined as the use of a dialysis membrane whose
KUf >8 mL/hour/mm Hg. In the tables, the KUf of the
membrane(s) used is included in parentheses.
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HEMODIALYSIS
PERITONEAL
CONVENTIONAL
PERMEABILITY
DIALYSIS
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PERITONEAL
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PERMEABILITY
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HEMODIALYSIS
PERITONEAL
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DIALYSIS
Anisoylated plasminogen streptokinase activator complex SEE DISCLAIMER REGARDING USE OF THIS POCKET BOOK HEMODIALYSIS
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PERMEABILITY
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References
1. Aronoff GR, Berns JS, Brier ME, Golper TA, Morrison G, Singer I, Swan SK, Bennett WM. Drug prescribing inrenal failure, 4th ed. Philadelphia: American Collegeof Physicians; 1999.
2. Böhler J, Donauer J, Keller F. Pharmacokinetic principles during continuous renal replacement therapy: drugs anddosage. Kidney Int. 1999;56 (Suppl 72):S-24-S-28.
3. Bressolle F, Kinowski JM, de la Coussaye JE, Wynn N, Eledjam JJ, Galtier M. Clinical pharmacokinetics duringcontinuous haemofiltration. Clin Pharmacokinet.
1994;26:457-471.
4. Joy MS, Matzke GR, Armstrong DK, Marx MA, Zarowitz BJ. A primer on continuous renal replacementtherapy for critically ill patients. Ann Pharmacother.
1998;32:362-375.
5. Kale-Pradham PB, Woo MH. A review of the effects of plasmapheresis on drug clearance. Pharmacotherapy.
1997;17:684-695.
6. Keller E, Reetze P, Schollmeyer P. Drug therapy in patients undergoing continuous ambulatory peritonealdialysis: Clinical pharmacokinetic considerations.
Clin Pharmacokinet. 1990;18:104-117.
7. Keller F, Böhler J, Czock D, Zellner D, Mertz AKH.
Individualized drug dosage in patients treated withcontinuous hemofiltration. Kidney Int. 1999;56 (Suppl 72):S-29- S31.
8. Bugge JF. Pharmacokinetics and drug dosing adjust- ments during continuous venovenous hemofiltrationor hemodiafiltration in critically ill patients. Acta Anaesthesiol Scand. 2001; 45:929-934.
9. Olyaei AJ, DeMattos A, Bennett WM. Principles of drug usage in dialysis patients, in Nissenson AR,Fine RN (eds). Dialysis therapy. Philadelphia: Hanley & Belfus; 2002.
10. Taylor CA, Abdel-Rahman E, Zimmerman SW, Johnson CA. Clinical pharmacokinetics duringcontinuous ambulatory peritoneal dialysis.
Clin Pharmacokinet. 1996;31:293-308.
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