Pharmacy & Therapeutics - May 2008 - (Page 301) Pharmaceutical Approval Update ulin after the procedure. In a clinical trial, HepaGam B was effective in preventing recurrences and the dosing regimen used consistently yielded antiHBsAg levels that exceeded target therapeutic levels. Anhepatic Week 1 Weeks 2 to 12 Month 4 In 2005, about 6,500 liver transplant procedures Phase Postoperatively Postoperatively Onward were performed in the U.S. The number of liver First dose Daily from Every two weeks Monthly transplants performed per year has been increasdays 1 to 7 from day 14 ing steadily for more than 15 years. Approximately * Each dose should contain 20,000 IU calculated from the measured potency, as 17,000 Americans are currently on a waiting list stamped on the vial label. for a liver transplant. The most common reason for needing a liver in adults is cirrhosis. Sources: www.hepagamb.com; www.rxlist.com To prevent hepatitis B recurrence after liver transplantation in HBsAg–positive patients, clinicians should administer HepaGam B intravenously according to a set dosing regimen Fibrin Sealant, Human (Artiss) designed to attain serum levels of antibodies to anti-HBs above Manufacturer: Baxter Healthcare, Deerfield, Ill. 500 IU/L. On the basis of the clinical trial, patients should Indication: Artiss sealant is designed to facilitate the adherreceive 20,000 IU per dose. The volume of each 20,000 IU ence of autologous skin grafts to surgically prepared wound dose should be calculated from the measured potency of the beds resulting from burns in adults and children. It is not particular lot, as stamped on the vial label. indicated for hemostasis. The first dose should be administered concurrently with the Drug Class: Artiss is a biologically active sealant consistgrafting of the transplanted liver (the anhepatic phase) with ing of human fibrinogen and a low concentration human thromsubsequent dosing (Table 1). Dose adjustments may be necbin. essary if patients do not achieve anti-HBs levels of 500 IU/L Uniqueness of Product: Essential for blood clotting, within the first week after transplantation. Patients who exArtiss contains less thrombin compared with other fibrin perience surgical bleeding or abdominal fluid drainage (more sealants. The lower concentration allows surgeons more time than 500 mL) or patients who undergo plasmapheresis are to position skin grafts over burns before the graft begins to particularly susceptible to extensive loss of circulated antiadhere to the skin. Artiss also contains aprotinin, a synthetic HBs. In these cases, the dosing regimen should be increased protein that delays the breakdown of blood clots. to a half-dose (10,000 IU calculated from the measured potency, Warnings and Precautions: as stamped on the vial label) intravenously every six hours until Hypersensitivity and allergic or anaphylactic re the target anti-HBs antibody levels are achieved. actions: Fewer than one in 10,000 cases of allergic reactions HepaGam B is most effective when patients have no or low have been reported in postmarketing experience with Artiss levels of HBV replication at the time of transplantation. Regusealant. These reactions have sometimes progressed to severe lar monitoring of serum HBsAg and anti-HBs antibody levels anaphylaxis and may be more likely to occur if the sealant is should be performed before the infusion in order to track applied repeatedly over time or in the same setting, or if patients’ responses to therapy and to allow for adjustments in patients have previously received systemic aprotinin. Even if treatment. the first treatment was well tolerated, another administration The product should be prepared under aseptic conditions of Artiss or systemic aprotinin does not exclude the possibiland should be given through a separate IV line via an infusion ity of an allergic reaction. Such reactions can also occur in pump. The rate of administration should be set at 2 mL/minute patients receiving the sealant for the first time. and should be decreased to 1 mL/minute or more slowly if the If a hypersensitivity reaction does occur, the application patient experiences discomfort or infusion-related adverse should be discontinued. The already applied polymerized prodevents or if the speed of infusion is a concern. uct should be removed from the surgical field. Mild reactions Commentar y: Hepatitis is contagious and is caused by can be managed with antihistamines. Patients experiencing HAV, HBV, or HCV. HBV (serum hepatitis) spreads through severe hypotensive reactions require an immediate intervention that uses the current principles of shock therapy. infected body fluids, such as blood, saliva, semen, vaginal fluids, tears, and urine. Approximately 8,500 new cases of hepaRisk of infection from human plasma: Artiss sealant is titis B are reported annually in the U.S. Exposure to HBV can made from human plasma. Products made from human plasma lead to acute (short-lived) or chronic (long-term) infection. may contain infectious agents, such as viruses, that can cause About 1% of acute hepatitis B (fulminant hepatitis) patients die disease. The risk that such products will transmit an infectious of liver damage in this early stage, and 10% of hepatitis B agent is reduced by screening plasma donors for prior expopatients develop chronic, life-long infection. Patients with sure to certain viruses, by testing for the presence of certain chronic hepatitis B might not have symptoms, but they can current virus infections, and by inactivating and removing become carriers and can spread the disease. This infection certain viruses. Despite these measures, such products can increases the chance of permanent liver damage, including still transmit disease. Made from human blood, Artiss carries cirrhosis and liver cancer. a risk of transmitting infection (viruses, and theoretically, the Patients with HBV infection who undergo liver transplantaCreutzfeldt–Jakob disease agent). All infections suspected to tion require long-term therapy with hepatitis B immune globhave been transmitted by this product should be reported to Table 1 Dosing Regimen for Intravenous (Human) Hepatitis B Immune Globulin (HepaGam B)* Vol. 33 No. 5 • May 2008 • P&T® 301 http://www.hepagamb.com http://www.rxlist.com
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