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VELCADETM (bortezomib) for Relapsed and Refractory Multiple Myeloma

Approved for use by the FDA in May 2003. bortezomib is the newest medication indicated to treat multiple myeloma. It belongs to a new class of oncology drugs known as proteosome inhibitors. VElCADETM is indicated for patients whose disease has relapsed after two prior treatments and who have demonstrated resistance to their last treatment.

The approval of VElCADETM was based on a study of 202 patients who had received at least two prior therapies and demonstrated disease progression on their most recent therapy. Out of 188 patients evaluated for response, twenty eight percent showed a response to VElCADE TM. The response lasted a median time of one year. Another trial in 54 patients with relapsed multiple myeloma showed similar responses.

As part the approval process, VElCADETM'S developer, Millenium TM, will perform additional studies to investigate patient improvement in survival.

Proteosome inhibition is an important new mechanism of action for antineoplastic drugs. Proteosomes are enzyme complexes which playa significant role in the break-down of proteins that regulate the cell cycle. Because proteosomes are present in every cell, VElCADETM impacts a variety of biologic pathways important to cancerous cells.

The recommended dosage is 1.3 mg/m2/dose administered as an IV bolus injection twice weekly for 2 weeks (days 1,4,8. and 11) This is followed by a 10-day rest period (days 12 to 21). This 21-day period is known as a treatment cycle. A maximum of 8 treatment cycles were administered in the clinical trail. Consecutive doses should be separated for at least 72 hours.

Adverse reactions that have been observed included: peripheral neuropathy, hypotension, thrombocytopenia, anemia, neutropenia, malaise. weakness. nausea, vomiting, diarrhea, and pyrexia.

Because VElCADETM is an antineoplastic. caution should be used in its handling and administration. Although local skin irritation has been reported, extravasation has not resulted in tissue damage. Please see detailed prescribing information for more information on clinical studies, adverse reactions, precautions, and recommendations. (IS/lKl)

Further information: www.velcade.com

Advate@ is Approved for Hemophilia

On July 25, 2003, the FDA approved the first plasma and albumin-free recombinant factor VIII product for use in the treatment and prevention of bleeding episodes in patients with hemophilia A. The manufacturer, Baxter, developed this product in response to concerns from the hemophilia community. By preparing the product without the addition of human or animal proteins, Advate@ further limits exposure to inadvertent blood-borne pathogens which may elude purification processes for serum-derived proteins. While Advate@ contains the same recombinant factor VIII molecule as Recombinate@, it offers a higher concentration, lower infusion volume, and added safety.    (ANV)

Further information:
1. www.advate.com
2. Adyate@ Prescribing Information, 2003.

Preparing for West Nile Virus in 2003

As of August 15th 2003, the CDC has reported the appearance of the West Nile virus (WNV) in humans, birds, horses, and mosquitoes. A total of 470 human cases have been cited. In past years, peak incidence of WNV in humans occurred between late August and early September. For this reason, the CDC has begun a campaign to educate clinicians in the clinical features, diagnosis, reporting, and treatment of WNV.

WNV as been described as a febrile illness of sudden onset. It is thought that the incubation period for WNV infection is 3 to 14 days, and symptoms last from 3 to 6 days. Although the full clinical picture of WNV has not been determined in the United States, symptoms have included malaise, anorexia, nausea, vomiting, eye pain, headache, myalgia, rash, and lymphadenopathy. Individuals, who have contracted WNV, have largely experienced mild disease. Severe neurological disease, encephalitis and less commonly meningitis, affected 0.7% of patients, most of whom were elderly.

Treatment of patients with WNV is largely supportive and often requires hospitalization, intravenous fluids, respiratory support, and prevention of secondary infections. Ribavirin, interferon alpha-2b, steroids, and anti-seizure therapy have been found to be useful in some patients, although data from controlled studies is lacking.

Disease prevention is elementary and includes community reduction of carrier mosquito populations, use of mosquito repellant, avoidance of areas infested by carrier mosquitoes, use of window screens, and wearing long-sleeved shirts and long pants.    (ANV)

Further information:
1. www.cdc.gov
2. West Nile Virus 2003 Human Cases
2. Petersen LR, Marlin AA. West Nile Virus: A Primer for the Clinician. Annals of Internal Medicine 2002; 137: 173-179.

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©2003 Option Care, Inc. All rights reserved.
The articles herein are provided for general information and are not intended to provide specific advice or recommendations for any reader.