Dose increases may be necessary for lopinavirr to 3 tablets bid, atazanavirr 400100mg, rifabutin 450 mg, methadone 2030% and maraviroc 600 mg bid if no boosted pi is given. Maraviroc hiv treatment fda label tablet film coated aidsinfo. Direct oral anticoagulants and renal dosing college of. Manufacturers renal dosing recommendations for medications are based on cockcroftgault estimates of renal function, so this formula is also recommended when estimating creatinine clearance for the purpose of calculating drug doses that vary according to renal function. Maraviroc hiv treatment dosage, side effects aidsinfo. As maraviroc is a substrate for cyp3a4 and pgp, the dose of maraviroc should be halved when. On may 27, 2010, fda approved changes to the labeling for selzentry maraviroc 150 mg and 300 mg tablets to expand the patient population to include dosing recommendations for patients with renal impairment, add a contraindication for patients with severe renal impairment or endstage renal disease, add a warning regarding postural hypotension for renal impaired patients, and add new.
Maraviroc was approved for use in the united states in 2007 but has had limited use. An open randomized two period crossover study in 2 cohorts to investigate the effect of steady state tmc125 and the combination of tmc125drvr on the steady state pharmacokinetics of oral maraviroc in healthy subjects abstract p 4. The first of a new class of antiretroviral agents clinical. Renal impairment in patients taking noninteracting concomitant medications. Prices represent cost per unit specified and are representative of average wholesale price awp. The guide includes a brief overview of drug disposition and dialysis principles followed by 80 pages of drug dosing tables and 70 pages of drugspecific references. In contrast, drugs that are inhibitors of renal transporters, such as cotrimoxazole and tenofovir, do not affect the. Maraviroc concentrations increased but dose adjustment not recommended. Adults with mild or moderate renal impairment clcr. Dosing of antiretroviral drugs in adults with chronic kidney disease. Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. For renally excreted drugs with a narrow therapeutic index, the total daily maintenance dose may be reduced either by decreasing the dose or by increasing the dosing interval, or sometimes by a combination of both. As maraviroc is a substrate for cyp3a4 and renal clearance.
The information on dosage adjustments in renal impairment given in this book is based on cockcroftgault creatinine clearance and not egfr, since the majority. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdrs drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Selzentry maraviroc labeling changes for patients with. The recommended dose is 150 to 600 mg twice daily in combination with. Noninteracting concomitant medications include all agents that are not potent cyp450 3a inhibitors or inducers. Renal dosage adjustment guidelines for antimicrobials the. Maraviroc selzentry is a lowmolecularweight ccr5 antagonist used for treatment of. Drug dosing adjustments in patients with chronic kidney disease myrna y. The population was 89% male and 84% white, with mean age of 46 years range 1775 years. Maraviroc is always used in combination with other hiv medicines. Food and drug administration fda for the treatment of hiv infection in people 2 years of age and older weighing at least 22 lb 10 kg. Maraviroc is a p450 substrate and the dose may need to be adjusted if taken with drugs that induce or inhibit hepatic p450 enzymes. Aidsinfo provides the following drug label solely as an example of the labels available for maraviroc.
Bennetts drug prescribing in renal failure has been the best pocket book for drug prescribing in patients with renal insufficiency and dialysis since the first edition in 1987. The adjustments listed in the dosing guidelines will be made unless the. In combination with other antiretroviral agents, for the treatment of only ccr5tropic hiv1 infection. Welcome to the fifth edition of the renal drug handbook.
Prescribing in renal disease australian prescriber. In a single 300 mg dose study in patients with severe renal impairment crcl maraviroc adult dose to 600 mg twice daily when used with strong cyp3a4 inducers. Tivicay dolutegravir dosing, indications, interactions. Effect of maraviroc on the pharmacokinetics of midazolam.
Renal failure or kidney failure formerly called renal insufficiency describes a medical condition in which the kidneys fail to adequately filter toxins and waste products from the blood. Dosage of maraviroc oral solution or tablets in pediatric patients. No dosage change required ie, may continue on maraviroc 300 mg bid, unless postural hypotension experienced, then reduce dose to 150 mg bid. National institute of diabetes and digestive and kidney diseases, bethesda md. General renal dosing guidelines agents not listed below click here for a specialized list of other renal medication dosing not listed in the alphabetical main section simple renal dosing guidelines. The fourth edition of drug prescribing in renal failure. Drug information on maraviroc hiv treatment tablet film coated for health care professionals.
Oat3, organic cation transporter oct2, novel organic cation transporter octn1, and. Awp prices were obtained and gathered by lakshmi vasist pharm d using the red book, manufacturers information, and the mckesson database. Several fdaapproved drug labels may be available for maraviroc. Dosing guidelines for adults is the product of a new editorial team and represents a major update from the previous edition published in 1994.
Raltegravir tablets, dosage adjustment for chronic kidney disease does not. Maraviroc is a chemokine coreceptor 5 ccr5 antagonist, the first of a new class. A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in subjects with severe renal impairment clcr dlp renal dosing protocol drug usual dose crcl adjusted mlmin dose hemodialysis peritoneal dialysis comments acyclovir iv 5 20 mgkg q 8h 25 50 100% of dose q12 h manufacturer suggest 1 l of fluid per gram of drug urine output should be maintained at. Dosing guidelines for varying degrees of renal impairment are stated accordingly. Renal failure 3vignan pharmacy college,vadlamudi,gunturdist. Renal failure is described as a decrease in glomerular filtration rate gfr. Direct oral anticoagulants doacs are nonvitamin k antagonists that have now been approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation nvaf, the acute and extended treatment of venous thromboembolism, and the prevention of venous thromboembolism after total knee or hip. Efavirenz capsules and tablets, no data on patients with renal impairment, but. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Maraviroc should only be used in people whose strain of hiv uses the ccr5 coreceptor. No dose adjustment is necessary for renal or hepatic impairment 12.
Maraviroc has been associated with liver toxicity, which is often preceded by evidence of a systemic allergic reaction e. Selzentry maraviroc dosing, indications, interactions. Effect of concomitant drugs on the pharmacokinetics of. The fifth edition of 2007 has been significantly expanded by dosage tables for children. The renal drug handbook the st georges hospital, adult critical. Prograf tacrolimus dose, indications, adverse effects. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Maraviroc is a prescription medicine approved by the u.
Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Maraviroc is a chemokine coreceptor 5 ccr5 antagonist, the first of a new class of agents active against the human immunodeficiency virus hiv and the acquired immunodeficiency syndrome aids. Efavirenz is a frequently used and very effective nnrti. Abacavir abacavir lamivudine abacavir lamivudine zidovudine acarbose acebutolol acetaminophen acetazolamide acetohexamide acetohydroxamic acid acetylsalicylic acid aspirin acrivastine acyclovir adefovir adenosine albuterol inhaled albuterol oral alfentanil alfentanil allopurinol alprazolam alteplase tissuetype plasminogen activator. The information on dosage adjustments in renal impairment given in this book is. Manufacturer advises caution in impairment and in patients with chronic hepatitis increased risk of hepatic sideeffects. Consequently, dosing recommendations for many older drugs are based on flimsy data, including sparse case reports, common usage, and pharmacokinetic extrapolations from studies in subjects with normal renal function. Drug dosing adjustments in patients with chronic kidney. This does not apply to patients also receiving strong cyp3a4 inhibitors. Munar, pharmd, bcps, and harleen singh, pharmd oregon state university college of pharmacy, portland, oregon. Selzentry is contraindicated in patients with severe renal impairment. Maraviroc has not been studied in pediatric patients with renal impairment. Recommended dose should be based on body weight and should not exceed the recommended adult dose.
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