Pharmacy Times
Volume 0

Fludarabine Phosphate Injection

Parenta Pharmaceuticals(WestColumbia, SC), anEbewe Pharma Co,recently launchedFludarabine PhosphateInjection 50mg/2 mL (25 mg/mL), which compares with Fludara. Theproduct is indicated for the treatmentof adult patients with B-cell chroniclymphocytic leukemia who have notresponded to or whose disease hasprogressed during treatment with atleast one standard alkylating-agentcontainingregimen. The recommendedadult dose of Fludarabine PhosphateInjection is 25 mg/m2 diluted in 100 ccto 125 cc of 5% dextrose injection USPor 0.9% sodium chloride USP administeredintravenously over a period ofapproximately 30 minutes daily for 5consecutive days. Each 5-day course oftreatment should commence every 28days. Dosage may be decreased or delayedbased on evidence of hematologictoxicity.

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Fosphenytoin SodiumInjection

Abraxis Pharmaceutical Products(Schaumburg, Ill) recently received FDAapproval for its abbreviated new drugapplication for Fosphenytoin SodiumInjection, USP, 100 mg/2 mL and 500mg/10 mL. The product is the genericequivalent of Cerebyx (Pfizer Inc).Fosphenytoin Sodium Injection is indicatedfor short-term parenteral administrationwhen other means of phenytoinadministration are unavailable,inappropriate, or deemed less advantageous.The safety and effectiveness ofthe product in this use has not beensystematically evaluated for >5 days.Fosphenytoin Sodium Injection can beused for the control of generalized convulsivestatus epilepticus and the preventionand treatment of seizuresoccurring during neurosurgery. It canalso be substituted, short-term, for oralphenytoin. The product is AP-rated,preservative-free, and latex-free.

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Thrombin-JMI Epistaxis Kit

King Pharmaceuticals Inc (Bristol,Tenn) recently received FDA approvalfor its Thrombin-JMI (thrombin, topical,bovine, USP) Epistaxis Kit—a newintranasal spray delivery device forThrombin-JMI for use to aid in stoppingepistaxis (nosebleeds). The kit offershealth care professionals in the emergencydepartment and trauma center aconvenient new alternative to achievequick, active hemostasis during epistaxis.Thrombin-JMI is indicated as anaid to hemostasis whenever oozingblood and minor bleeding from capillariesand small venules is accessible.About 3 in 5 Americans experience nosebleedsduring their lifetime. Certainhigh-risk groups, such as the elderly,require rapid intervention to stembleeding, in order to prevent furthercomplications and potentially lifethreateningevents.

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VIDAS D-Dimer Exclusion

bioM?rieux Inc's (Durham, NC) VIDASD-Dimer Exclusion is indicated toexclude both pulmonary embolism (PE)and deep vein thrombosis (DVT) as adiagnosis in outpatients. VIDAS D-DimerExclusion is the first and only D-dimerassay to receive FDA clearancefor exclusion of both conditions—withno further testing—when used in conjunctionwith a pretest probabilityassessment in low-to-moderate-probabilityoutpatients. The clearance meansthat patients who present to the emergencydepartment with suspected PEor DVT may no longer be subjected toinvasive and costly imaging examinationsfor a negative diagnosis. Theproduct provides easy-to-use, singledosereagents, and an automated,rapid ELISA result in less than 1 hour.

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Campath (alemtuzumab)

Genzyme Corp (Cambridge,Mass) and BayerHealthCare PharmaceuticalsInc (Wayne,NJ) recently grantedregular approval for single-agent Campath forthe treatment of B-cellchronic lymphocytic leukemia. Campathwas initially approved in 2001under accelerated approval regulations.The product has a boxed warningwhich includes information on cytopenias,infusion reactions, and infections.Campath treatment is initiated at adose of 3 mg administered as a 2-hourintravenous (IV) infusion daily. Dosetitration continues as tolerated (3 mg,10 mg, and 30 mg) until the recommended30-mg dose is reached. Oncethe full 30-mg daily treatment commences,the product is administered asa 2-hour IV infusion per session, 3times a week for 12 weeks. Campath issupplied in single-use clear glass vialscontaining 30 mg of alemtuzumab in 1mL of solution.

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888-84-BAYER (888-842-2937)

Ixempra (ixabepilone)

Bristol-Myers Squibb (Princeton, NJ) recently received FDAapproval for Ixempra as monotherapy for the treatment ofpatients with metastatic or locally advanced breast cancer inpatients whose tumors are resistant or refractory to anthracyclines,taxanes, and capecitabine. The FDA also grantedapproval for Ixempra in combination with capecitabine forthe treatment of patients with metastatic or locally advancedbreast cancer resistant to treatment with an anthracycline,and a taxane, or whose cancer is taxane-resistant and forwhom further anthracycline therapy is contraindicated. Therecommended dose of Ixempra is 40 mg/m2 infused intravenouslyover 3 hours every 3 weeks. Dose reduction isrequired in certain patients with elevated AST, ALT, or bilirubin.

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888-IXEMPRA (888-493-6772)

Doribax (doripenem for injection)

Ortho-McNeil Inc (Raritan,NJ) recently received FDA approvalfor Doribax. The productis indicated as a singleagent for the treatment ofintra-abdominal infectionscaused by susceptible strains,including Escherichia coli,Klebsiella pneumoniae, Pseudomonasaeruginosa, Bacteroidesfragilis, B uniformis, andB vulgatus; and for the treatmentof complicated urinarytract infections, includingpyelonephritis caused by susceptiblestrains of E coli, including cases with concurrent bacteremia,K pneumoniae, P mirabilis, and P aeruginosa. Therecommended dose of Doribax is 500 mg every 8 hours byintravenous infusion administered over 1 hour for patients≥18 years of age.

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