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New Antibiotic/New Class

Daptomycin, Cubicin@, from Cubist pharmaceuticals was approved for the treatment of complicated skin and skin structure infections caused by susceptible strains of several gram-positive micro-organisms, including MRSA. Daptomycin is the first cyclic lipopeptide to enter the market for the treatment of serious bacterial infections. Cubicin@ binds to bacterial membranes and causes a rapid depolarization of membrane potential. The loss of membrane potential leads to inhibition of protein, DNA, and RNA synthesis, which leads to cell death (bactericidal). Dosing of daptomycin is 4 mg/kg intravenously over 30 minutes every 24 hours for 7-14 day. Renal dosing adjustment for a creatinine clearance <30 mL/minutes and dialysis patients is 4 mg/kg every 48 hours for 7-14 days. Adverse effects to monitor are gastrointestinal disorders, injection site reactions. fever. headache, insomnia, dizziness, and rash. Patients should also be counseled to report diarrhea and muscle weakness or pain because of possible pseudomembranous colitis and myopathies. It is recommended that creatine phosophokinase (CPK) levels should be monitored weekly. (LLS)

References: Manufacturer product information 11/03; Drug Topics 10/20/03

Gallium Nitrate

Ganite@, gallium nitrate by Genta Incorporated. has been approved for the treatment of symptomatic cancer-related hypercalcemia that has not responded to hydration therapy. Gallium nitrate should not be given to patients with severe renal impairment (serum creatinine > 2.5 mg/dL). The recommended dose is 200 mg per square meter of body surface area daily for 5 days. Mild hypercalcemia may be treated with a lower dose of 100 mg/m2/day for 5 days. It is recommended that Ganite@ be diluted with 0.9% Sodium Chloride or 5% Dextrose 1000 ml and infused over 24 hours. It is imperative that patients treated for hypercalcemia are properly and adequately hydrated prior to starting gallium nitrate. The use of nephrotoxic drugs in conjunction with gallium nitrate may increase the risk of developing renal insufficiency. BUN and creatinine must be monitored while on therapy. (LLS)

Reference: Manufacturer product information 09/03

5-year Trial to Assess Chelation
Therapy (TACT)

The U.S. government has initiated a study on EDTA (ethylene diamine tetra-acetic acid) Chelation Therapy for the treatment of coronary artery disease. "The public health imperative to undertake a definitive study of chelation therapy is clear. The widespread use of chelation therapy in lieu of established therapies, the lack of adequate prior research to verify its safety and effectiveness, and the overall impact of coronary artery disease convinced NIH that the time is right to launch this rigorous study," said Stephen E Straus, MD, NCCAM Director.

Chelation therapy involves the use of EDTA that is administered intravenously. EDT A has been FDA approved to treat lead poisoning and has been used to speed removal of heavy metals and minerals such as lead, iron, copper, and calcium from the blood. Over 800,000 patient visits were made for chelation therapy in the US in 1997.

Scientific evidence is needed to answer the question of whether chelation therapy should be added to the list of proven treatments for coronary artery disease. This is a joint study by the National Center for Complimentary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI) components of the National Institutes of Health (NIH). This will be a randomized, double blind study of 2,372 patients, 50 years or older, who have had a heart attack and no previous revascularization procedures. Half the group will receive chelation and half a placebo over 30 weeks of therapy followed by 10 bimonthly infusions. Each of the two groups will additionally be randomized to receive high-dose vitamin/mineral supplements versus low dose vitamin and mineral supplements. Primary endpoints of the trial will be a heart attack, stroke, hospitalization for angina, coronary revascularization and death. The study will also evaluate cardiac deaths, nonfatal heart attacks, health-related quality of life and cost effectiveness. (SP)


Reference: NIH News Release: NIH Launches Large Clinical Trial on EDTA Chelation Therapy for Coronary Artery Disease
http://nccam.nih.gov/news/2002/chelation/pressrelease.htm
 

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The articles herein are provided for general information and are not intended to provide specific advice or recommendations for any reader.