Crestor drug monograph template
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Crestor drug monograph template Crestor drug monograph template Document Transcript

  • Drug Monograph TemplateRevised 7/27/2011 Page 1 of 6Melissa MathurinGeneric Name: RosuvastatinTrade Name: CrestorPharmacological Class: Inhibits HMG CoA ReductaseSimilar Agents on Formulary:Juvisync, Simcor, Triglide, Vytorin, WelcholAdvantages Compared to Similar Formulary Agent(s):Disadvantages Compared to Similar Formulary Agent(s):FDAs up-to-date information about the risk of rhabdomyolysis (serious muscle damage) inpatients taking Crestor and other statin drugs is welcome. The rare adverse effectofstatins is well-known and has been extensively documented and reviewed.As a result of discussions with the FDA., Crestors manufacturer Astra-ZenecaPharmaceuticals revised the package insert for Crestor; recommendations made originallyabout the need for physicians to consider using lower starting doses of the drug in someindividuals to reduce the risk of rhabdomyolysis have been re-emphasised.This is particularly important in treating Asian American patients, since trial data suggeststhat they may be at greater risk of muscle injury due to Crestor (along with patients oncyclosporine or patients with severe renal insufficiency) as they may have higher druglevels.Kidney failure has also been reported in patients treated with Crestor, as well asotherstatins. But patients who are likely to benefit from statin therapy (e.g., patientswithdiabetes, hypertension, atherosclerosis, and/or heart failure) may be at higher risk forkidney failure before taking these drugs. FDA cannot confirm that recommended doses ofstatins, including Crestor, can cause or worsen kidney failure.Indications for Use1. FDA Approved:CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, andtriglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemiaand to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lowerTotal-C and LDL-C to target levelsCRESTOR is indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularizationprocedures in patients without clinically evident coronary heart disease but with an increased risk of
  • Drug Monograph TemplateRevised 7/27/2011 Page 2 of 6cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactiveprotein (hsCRP) ≥2 mg/L, and the presence of at least one additional CVD risk factor, such ashypertension, low HDL-C, smoking, or a family history of premature coronary heart disease2. Non FDA Approved:Pharmacology:Crestor is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of actionsimilar to that of other statins.[3]Its approximate elimination half life is 19 h and its time to peak plasmaconcentration is reached in 3–5 h following oral administration.Putative beneficial effects of rosuvastatin therapy on chronic heart failure may be negated by increases incollagen turnover markers as well as a reduction in plasma coenzyme Q10 levels in patients with chronicheart failure.Pharmacokinetics:Absorption: In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin werereached 3 to 5 hours following oral dosing. Both Cmax and AUC increased in approximate proportion toCRESTOR®(rosuvastatin calcium) dose. The absolute bioavailability of rosuvastatin is approximately 20%.Administration of CRESTOR with food did not affect the AUC of rosuvastatin. The AUC of rosuvastatin doesnot differ following evening or morning drug administration1Distribution: Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters.Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent ofplasma concentrations1Metabolism: Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose isrecovered as metabolite. The major metabolite is N-desmethylrosuvastatin, which is formed principally bycytochrome P450 2C9, and in vitro studies have demonstrated that N-desmethylrosuvastatin hasapproximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound.Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by theparent compound1Excretion: Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces(90%). The elimination half-life (t1/2) of rosuvastatin is approximately 19 hours. After an intravenous dose,approximately 28% of total body clearance was via the renal route, and 72% by the hepatic routeReview of Clinical Trials:
  • Drug Monograph TemplateRevised 7/27/2011 Page 3 of 6Primary Prevention of CVD IndicationSafety Profile1. Look Alike Products on Formulary:2. Sound Alike Products on Formulary:3. Precautions/Warnings:Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renalfailure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and asclinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemiaor jaundice occurs; do not restart if alternate etiology not found. History of liver disease or heavy alcoholingestion.Severe renal insufficiency. Hypothyroidism (if undertreated). Elderly.4. Adverse Effect Profile:Serious Reactionsmyopathyrhabdomyolysisacute renal failurehepatotoxicitypancreatitishypersensitivity rxnsangioedemavesiculobullous rashleukopeniathrombocytopeniaphotosensitivitydiabetes mellitusCommon Reactions View slide
  • Drug Monograph TemplateRevised 7/27/2011 Page 4 of 6pharyngitisheadachediarrheadyspepsianauseamyalgiaastheniaback painflu syndromeUTIrhinitis/sinusitisconstipationabdominal painarthralgia/arthritisrashparesthesiaperipheral edemaCK elevated5. High Risk Medication Classification (yes/no):NoIf yes, explain based on Steps in medication use processa. Prescribing:b. Preparation: noc. Distribution/Storage: nod. Administration: noe. Monitoring: nof. Disposition:6. Standard Concentration (if parenteral infusion route used): Noa. Infusion:b. Direct Injection:Dosage&Administration:hypercholesterolemia[5-40 mg PO qd]Start: 10-20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day: Info: consider 5 mg start in Asianpts; see Drug Interactions for dose adjustments based on concurrent txmixed dyslipidemia[5-40 mg PO qd]Start: 10-20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day: Info: consider 5 mg start in Asianpts; see Drug Interactions for dose adjustments based on concurrent tx View slide
  • Drug Monograph TemplateRevised 7/27/2011 Page 5 of 6hypertriglyceridemia, type IV[5-40 mg PO qd]Start: 10-20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day: Info: consider 5 mg start in Asianpts; see Drug Interactions for dose adjustments based on concurrent txdysbetalipoproteinemia[5-40 mg PO qd]Start: 10-20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day: Info: consider 5 mg start in Asianpts; see Drug Interactions for dose adjustments based on concurrent txfamilial hypercholesterolemia, homozygous[20-40 mg PO qd]Start: 20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day; Info: consider 5 mg start in Asian pts;see Drug Interactions for dose adjustments based on concurrent txcardiovascular event prevention[20 mg PO qd]Start: 20 mg PO qd, may adjust q2-4wk; Max: 40 mg/day; Info: consider 5 mg start in Asian pts;see Drug Interactions for dose adjustments based on concurrent txCAD[40 mg PO qd]Start: 10-20 mg PO qd, then incr. q2-4wk; Max: 40 mg/day; Info: consider 5 mg start in Asian pts;see Drug Interactions for dose adjustments based on concurrent txrenal dosing[adjust dose amount]CrCl<30, not on HD: start 5 mg qd, max 10 mg qd; HD: not definedhepatic dosing[see below]active hepatic dz or unexplained elev. LFTs: contraindicatedInpatient (yes/no): Outpatient (yes/no): Transitional Care (yes/no):Available Dosage Forms and Strengths:Tabs 5mg, 10mg, 20mg—90; 40mg—30Anticipated Annual Use:Unit Cost/Dosage Form:Cost per Treatment (per day/dose/procedure):Comparative Cost per Treatment with Similar Formulary Agents:Reimbursement per Treatment (outpatient only):Overall Analysis:
  • Drug Monograph TemplateRevised 7/27/2011 Page 6 of 6Recommendationa. Approve (yes/no): yes1. Restrictions (describe if applicable):2. Pharmacy Auto Substitution (describe if applicable):b. Deny (yes/no):c. Delete a Formulary Alternative (list if applicable):d. Tabled Pending Further Analysis (yes/no): Noe. Stocked in the Pharmacy (yes/no):Yesf. Used as a Sample in Outpatients (yes/no):yesg. Scheduled Review of Efficacy and Safety Data in Literature (6 months):h. Scheduled Review of Adverse Events (6 months):References:http://www.empr.com/cardiovascular-system/hyperlipoproteinemias/pnote/147/https://online.epocrates.com/noFrame/showPage.do?method=drugs&MonographId=3476&ActiveSectionId=1http://www1.astrazeneca-us.com/pi/crestor.pdfReviewed by:MelissaMathurinReview Date:7/25/2012Final Disposition:________________________________________________________Risk Management Plan