All Indications, IV Route. Results: The serum voriconazole concentration did not decrease <1.0 mg/L at any time point, and the mean was 4.3 ± 2.6 mg/L and the median (range) 3.6 (9.0) mg/L. During voriconazole load and in severely ill patients, IV therapy is preferred. Pharmacy for alternate dosing* Vancomycin 15mg/kg q12h Consult pharmacy for dosing in renal insufficiency Voriconazole (IV/PO) 6mg/kg q12h x 1 day, then 4mg/kg q12h <50: Consider oral tablets due to accumulation of IV maint. In a two-way crossover study, the pharmacokinetics of voriconazole were evaluated in eight obese (BMI ≥ 35 kg/m 2) healthy volunteers given oral maintenance doses of either 200 mg or 300 mg BID, both after receiving a 400-mg PO BID loading dose [27•]. See full prescribing information for VFEND. Max: 6 months. Tacrolimus Dosing in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients Receiving Concomitant Voriconazole. dose to 3 mg/kg/dose IV q12h if 4 mg/kg/dose IV q12h not tolerable; may switch to 100-150 mg PO q12h after 7 days of IV … Vfend® Paediatric Dosing Recommendations • From previous analysis of voriconazole paediatric data 4mg/kg q12h IV comparable to 3mg/kg q12h IV in adults – Higher IV maintenance dose due to higher elimination capacity in Administer diluted voriconazole for injection I.V. prophylaxis with posaconazole or voriconazole. See TABLE 1 for the mechanisms of these agents. The dosing and duration of voriconazole was as follows: iv dosing on Day 1 every 12 hours at 6mg/kg body weight and from Day 2 to a maximum of Day 28 at 3mg/kg body weight. for Injection requires reconstitution to 10 mg/mL and subsequent dilution to 5 mg/mL or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 2 hours. Highly variable and non-linear pharmacokinetics of voriconazole are mainly caused by CYP2C19 polymorphisms. Invasive aspergillosis (IA) is a life-threatening infection and is almost exclusively seen in the severely immunocompromised host. The median initial levels were 1.5, 3.5, and 1.7 mcg/mL with 62% (73/119), 55% (6/11), and 60% (72/120) within the therapeutic range, respectively. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. Polyene Antibiotic (Amphotericin B): Amphotericin B (AmB) is a polyene (containing multiple double bonds) macrolide antibiotic originally isolated from a Streptomyces species.4It binds to ergosterol, a component of the fungal cell membrane.Binding to ergosterol destroys fungal membrane integrity, resulting inleakage of cellular content and then cell death. Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i.e. Steven Trifilio , Steven Trifilio * Minimum 2 … Dosing recommendations for voriconazole based on CYP2C19 phenotype for pediatric patients (children and adolescents <18 years old) Supplement to: Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Voriconazole Therapy (December 2016) 1 Marquette General Pharmacy – DLP Renal Dosing Protocol Drug Usual Dose CrCl Adjusted (ml/min) Dose Hemodialysis/ Peritoneal Dialysis/ Comments Acyclovir (IV) 5 -20 mg/kg q 8h 25 50 100% of dose q12 h Manufacturer suggest 1 L of fluid Treatment Recommendations. IV or oral voriconazole is the primary therapy for most patients with invasive aspergillosis. 2 Parenteral voriconazole should be administered at a dosage of 6 mg/kg IV for day 1, followed by 4 mg/kg IV every 12 hours. 2 Oral voriconazole may be administered at a dosage of 200 mg every 12 hours. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. 6mg/kg IV Q12h x 2 doses, then 4mg/kg IV Q12hr. The sieving coefficient of the drug did not exceed 0.30 in children are at significant risk of invasive fungal infections (IFIs). by intravenous infusion over 1 to 2 hours only. No dose adjustment in hemodialysis. Usual Dosing (Adults) (IV): 6 mg/kg IV q12h x 2 doses, then 4 mg/kg q12h. Voriconazole use was categorized as: new start, new start with loading dose, or continuation of home therapy. Voriconazole for injection I.V. Voriconazole is hemodialyzed with clearance of 121 mL/min. Generally, intraperitoneal (IP) medication administration results in high IP drug VFEND Tablets or Oral Suspension should be taken at least one hour before, or one hour following, a meal. solution. Switch to IV fluconazole 200 mg IV q24h 1 Vincristine, tyrosine-kinase inhibitors, clofarabine, doxorubicin, or if mandated by clinical trial protocol (e.g., quizartinib). 7 mg/kg IV q24h Use traditional dosing or contact pharmacy for assistance Traditional dosing: patients who do not qualify for high-dose extended interval dosing 1.6 mg/kg IV q8h 1.5 mg/kg IV q12h 1.5 mg/kg IV q12-24h 2 mg/kg Background Incorporation of the solubilizing excipient, sulfobutylether-β-cyclodextrin (SBECD), in the intravenous (IV) formulation of voriconazole has resulted in the recommendation that this formulation be used with caution in patients with creatinine clearances (Clcr) < 50 mL/min. VFEND I.V. Micafungin should be utilized Only patients who were unable to swallow oral tablets of voriconazole (mostly due to mucositis) continued to receive the iv regimen. The dosage for oral and iv therapy was the same: two doses of 6 mg/kg of body weight on day 1, then from day 2 through 7 twice daily 4 mg/kg, followed by 200 mg twice daily. Consider switch to oral if patient clinically responding, able to tolerate and absorb oral medication. Paediatric patients need higher loading and maintenance dosing of voriconazole [both intravenous (IV) or orally (PO) administered], due to enhanced hepatic clearance and first-pass effect 11. For intravenous infusion, manufacturer advises reconstitute each 200 mg with 19 mL Water for Injections or Sodium Chloride 0.9% to produce a 10 mg/mL solution; dilute dose to concentration of 0.5–5 mg/mL with Glucose 5% or Sodium Chloride 0.9% and give intermittently at a rate not exceeding 3 mg/kg/hour. Dosing regimens should be tailored based on presumed source of infection, MIC data (when available), and residual renal function. The median initial levels were 1.5, 3.5, and 1.7 mcg/mL with 62% (73/119), 55% (6/11), and 60% (72/120) within the therapeutic range, respectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VFEND safely and effectively. Do not administer as an IV bolus injection. All Indications, PO Route. This study aimed to develop a mechanistic population pharmacokinetic model including the CYP2C19 phenotype, and to assess the appropriateness of various dosing regimens based on the therapeutic target. Ciprofloxacin (IV/PO)1– 4,22,29 CrCl > 50 CrCl 30 – 50 CrCl < 30 General infections 400 mg IV q12h 500 mg PO q12h Same 400 mg IV q24h 500 mg PO q24h Pseudomonas, severe 400 mg IV q8h 750 mg PO q12h 400 mg IV Dose: 4 mg/kg/dose IV q12h; Start: 6 mg/kg/dose IV q12h x2 doses; Info: for infections due to S. apiospermum or Fusarium spp; may decr. VORICONAZOLE IV 6mg/kg every 12 hours for 2 doses then 4mg/kg every 12 hours. Hence, caution must be exercised when using IV voriconazole in patients with renal failure/dysfunction who are not on any form of renal replacement therapy. requires reconstitution to 10 mg/mL and subsequent dilution to 5 mg/mL or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 2 hours. Oral (tablets or suspension) 9 mg/kg twice daily (maximum dose 350 mg twice daily) Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years. Administer diluted VFEND I.V. by intravenous infusion over 1 to 2 hours only. Antimicrobial Dosing Recommendations: Peritoneal Dialysis (PD)-related Infections Background: Peritonitis is a common and serious complication of PD. Fluconazole 100-200 mg IV/PO q24h (Prophylaxis Dosing) CVVHD > 2 to < 6 L/hr 100-200 mg IV/PO q24h CVVHD < 2 L/hr 100 mg IV/PO q24h 400-800 mg IV/PO q24h (Treatment Dosing) CVVHD > 2 to < 6 L/hr 400-800 mg Dosing & Administration. Prospective TDM: voriconazole dose will be adjusted based on per protocol obtained TDM levels, and Standard dosing: standard doses of voriconazole will be used. Cite this protocol as: Molinelli A.R., Rose C.H. It typically occurs in patients treated for haematological malignancies (5–20% in high-risk groups) especially during prolonged neutropenia, after allogeneic stem cell transplantation and in the context of graft versus host disease.1 Recently, treatment options for IA have improved with the availability of voriconazole, a broad-spectrum triazole, with a better efficacy and safety profile than … After iv therapy, oral dosing at 200mg To optimize voriconazole dosing in pediatric hematopoietic cell transplantation (HCT), we conducted a phase I study with a modified 3 + 3 dose-escalation followed by … Official Protocol Title: NCT number: NCT02180165 Document Date: 27-Apr-2017 A Randomized, Comparative, Open-label Study to Assess the Safety and Efficacy of MK-5592 Compared with Voriconazole in Japanese Subjects with KEY POINTS Voriconazole (VFend) is an “azole” antifungal drug that interferes with ergosterol synthesis, which leads to inhibition of fungal cell membrane formation Widely considered the drug of choice for Aspergillus infections, but has activity versus many fungi, including a number of Candida species Available as IV or PO Commonly weight-based dosing, rounded to nearest 50mg … 1st line: Voriconazole 6 mg/kg IV every 12 hours for 2 doses then 4mg/kg IV every 12 hours (reduce to 3mg/kg IV BD if not tolerated). 400mg PO Q12h x doses, then 200mg PO Q12. Needs to be diluted to <5mg/mL prior to infusion (2-5mg/mL recommended) Should be administered at rate of 2-3mg/kg/h (so the 4-6mg/kg dose goes in over 2h) * Continue at 4mg/kg PO q12 or switch to fluconazole when transition to oral meds. In the prospective TDM arm, voriconazole TDM will be performed in real time at each site and results will be reported to treating physicians for dose adjustment. (Oral): >40kg: 200mg (up to 300mg) po q12h. In obese patients consider a weight-based PO regimen (4mg/kg q12H ADJ BW), Consult ID or ASP for assistance. Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral voriconazole therapy (see DOSAGE and ADMINISTRATION). VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. VFEND I.V. is intended for administration by intravenous infusion. [3] There is no point in reducing the intravenous dose of voriconazole in compromised renal function as it … Being highly insolub… (2016) Quantification of the Triazole Antifungal Compounds Voriconazole and Posaconazole in Human Serum or Plasma Using Liquid Chromatography Electrospray Tandem Mass Spectrometry (HPLC-ESI-MS/MS). VFEND I.V. A voriconazole dose modification guideline was introduced in July 2014 based on a retrospective analysis. Objective: The primary objective was to evaluate the voriconazole dose modification guideline. Dosing Recommendations for Patients Receiving Renal Replacement Therapy Drug IHD PD (IV or PO) SLED¥ <24 hrs/day Acyclovir (IV) 2.5 – 5 mg/kg IV Q24 2.5 – 5 mg/kg IV Q24 £5 – 10 mg/kg IV Q12-24 … to … 1. Voriconazole Review. Pharmacokinetic Studies Voriconazole pharmacokinetic data in obesity are sparse. DOSAGE AND ADMINISTRATION: Administration. In patients aged 2–11 years, the package leaflet recommends a weight-based dose of 9 mg kg –1 IV or PO twice daily and a maximum dose of 350 mg. Dogs: Loading dose 6mg/kg IV q12h x2 doses, then 4mg/kg IV q12h. Using the voriconazole dose modification guideline, 80% were within goal by the second dose adjustment. Preferred alternative in patients intolerant to voriconazole (see comments): Isavuconazole 372 mg q8h /IV x48 hours, then 372 mg PO/IV daily Voriconazole drug substance is a white to light-colored powder. After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days). Directions for administration. Posaconazole prophylaxis dosing Oral route Intravenous route Tablets: Loading dose 300mg BD for 1 st day, then … stomach). Voriconazole is a triazole antifungal with broad-spectrum activity against yeasts and moulds.1 Do not a… <40 kg: 100 mg (up to 150mg) po q12h. Bioavailability of oral voriconazole is 96%.
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