Pharmacy & Therapeutics - February 2008 - (Page 116)

Pharmaceutical Approval Update nebivolol dose may need to be reduced. lmpaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. This agent has not been studied in patients receiving dialysis. lmpaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. This drug has not been studied in patients with severe hepatic impairment, and it is thus contraindicated in these patients. Dosage and Administration: The dose should be titrated to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at two-week inter vals, up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial. Renal lmpairment: In patients with severe renal impairment (i.e., a creatinine clearance [CICr] of less than 30 mL/ minute), the recommended initial dose is 2.5 mg once daily; upward titration should be performed cautiously if needed. Nebivolol has not been studied in dialysis patients. Hepatic lmpairment: In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; upward titration should be performed cautiously if needed. Nebivolol has not been studied in patients with severe hepatic impairment and is thus not recommended in this population. Contraindications: Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first-degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment, and hypersensitivity to any component of the product. Commentar y: Nebivolol represents the 19th beta blocker on the U.S. market, according to Forest. It appears to be well tolerated and has “placebo-like” rates of beta-blocker side effects (such as fatigue and sexual dysfunction), which means that it may lead to better compliance, according to a health blog reproduced in The Wall Street Journal on December 18, 2007. (The adverse effects are milder than those from other drugs of the same class.) With a lower rate of adverse events, nebivolol affords an advantage over other beta blockers. The drug was marketed in other countries for several years before the FDA approved it in the U.S. Its cost is expected to be higher than that of many other generic beta blockers. Source: www.frx.com Uniqueness of Product: This product expands the volume of blood plasma (the liquid portion of the blood) and thus draws fluid into capillaries. Warnings and Precautions: • Anaphylactoid and hypersensitivity reactions can occur. • Fluid overload should be avoided, and the dosage should be adjusted for patients with cardiac or renal dysfunction. • In cases of severe dehydration, a crystalloid solution should be given first. • Caution should be used in patients with severe liver disease or bleeding disorders. • Kidney function, fluid balance, and serum electrolytes should be monitored. • Serum amylase values may become elevated and interfere with the diagnosis of pancreatitis. • High dosages may cause dilution of blood components. Dosage and Administration: Voluven is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics, and on the hemodilution (dilution effect). The product can be given repetitively over several days. The initial 10 to 20 mL should be infused slowly, and the patient should remain under close observation in case of possible anaphylactoid reactions. Adults: Up to 50 mL/kg of Voluven of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight) is recommended. This dose is equivalent to 3,500 mL of the product for a 70-kg patient. Pediatric Patients: Clinical data on the use of Voluven in children are limited. In 41 children, including newborns to infants younger than two years of age, a mean dose of 16 ± 9 mL/kg was administered. The dosage in children should be adapted to the individual patient colloid needs, with the disease state, as well as the hemodynamic and hydration status, taken into account. The safety and efficacy of the product have not been established in children two to 12 years of age. The use of Voluven in children older than 12 years is supported by evidence from adequate and well-controlled studies in adults and by data from children younger than two years of age. Contraindications: Voluven is not indicated for patients with a known hypersensitivity to hydroxyethyl starch, with pulmonary edema or congestive heart failure, with renal failure with oliguria or anuria not related to hypovolemia, with severe hypernatremia or severe hyperchloremia, and with intracranial bleeding, as well as for patients receiving dialysis. Commentar y: Voluven helps draw the blood into the capillaries, preventing the potentially fatal cases of shock that can result from a massive loss of blood. Clinical trials have shown that the safety and efficacy of the product are comparable to those of other approved blood volume expanders (e.g., fluids containing hetastarch in sodium chloride) during major surgery for a wide range of ages, including children younger than two years old and even for patients up to 75 years of age. Source: www.fda.gov/CBER/ndalabel/volvulenLB.pdf I 6% Hydroxyethyl Starch in 0.9% Sodium Chloride Infusion (Voluven) Manufacturer: Fresenius Kabi, Raleigh, N.C. Indication: Voluven is a plasma volume substitute indicated for the treatment and prevention of hypovolemia. It is available in a 500-mL Freeflex flexible plastic intravenous (IV) solution container. Drug Class: The starch is synthetic and does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. 116 P&T® • February 2008 • Vol. 33 No. 2 http://www.frx.com http://www.fda.gov/cber/nda/voluven.htm

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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