Pharmacy & Therapeutics - May 2008 - (Page 300) Pharmaceutical Approval Update be diagnosed in the U.S. in 2008. Patients with CLL often have normal lives for many years because of treatments that control the disease over the long term. Granted orphan drug status by the FDA, bendamustine is an option that offers a delay in disease progression, an important goal for patients with CLL. Bendamustine damages the DNA in cancer cells. Bendamustine-treated patients had a significantly longer progressionfree survival at 18 months vs. six months (hazard ratio = 0.27; P < 0.0001) with no worsening of disease for a significant period of time. The duration of response to bendamustine lasted longer for treated patients (19 months) than in patients who received chlorambucil (seven months). Common adverse events in the trial were myelosuppression, fever, nausea, and vomiting. Sources: www.cephalon.com; www.fda.gov/cder/foi/ label/2008/022249lbl.pdf may be present in plasma products. Physicians and health care providers should notify Cangene Corporation about any infections suspected to have been transmitted by HepaGam B. The risks and benefits of this product should be discussed with the patient. Anaphylactic precautions: Although allergic reactions have not been reported, the product should be given only where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. If hypotension or anaphylaxis occurs, therapy should be discontinued immediately and supportive care given as needed. Interference with blood glucose testing: The maltose contained in HepaGam B can interfere with some types of blood glucose–monitoring systems based on the glucose dehydrogenase–pyrroloquinequinone (GDH–PQQ) method. This can result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, thereby leading to life-threatening hypoglycemia. Cases of true hypoglycemia may remain untreated if the hypoglycemic state is masked by falsely elevated results. Monitoring of serum anti-HBs antibody levels: A quantitative assay should be used to monitor liver transplant patients at regular intervals for serum anti-HBs antibody levels. Infusion reactions: Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate (2 mL/minute) must be closely followed. Patients must be monitored and carefully observed for any symptoms throughout the infusion period and immediately afterward. Coagulation disorders: For postexposure prophylaxis indications, HepaGam B is intended for intramuscular (IM) use only. In patients who have severe thrombocytopenia or a coagulation disorder that would contraindicate IM injections, HepaGam B should be given only if the expected benefits outweigh the potential risks. Nonclinical toxicology: Nonclinical pharmacology studies in animals have not been performed with HepaGam B, because there is broad experience in humans with IV and IM administration of immune globulin products. Because of HepaGam B’s human origin, immunogenicity is expected when this product is administered to animals. Toxicology studies have not been performed with HepaGam B because it has been formulated with ingredients that are known to be nontoxic at levels present in the final product. Special Populations: Pregnancy Category C: Studies of reproduction in animals have not been conducted with HepaGam B, and it is not known whether the product causes fetal harm when given to pregnant women or whether it affects reproductive capacity. The product should be given to pregnant women only if it is clearly indicated. Nursing Mothers: It is not known whether HepaGam B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the product is given to nursing mothers. Dosage and Administration: Any vials of HepaGam B that have been entered should be used promptly and should not be reused or saved for future use. The product contains no preservatives; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin Intravenous, Human (HepaGam B) Manufacturer: Cangene, Winnipeg, Manitoba, Canada, and Apotex, Weston, Fla. Indication: HepaGam B has been approved to prevent the recurrence of hepatitis B infection following liver transplantation in hepatitis B surface antigen (HBsAg)–positive patients. It was previously licensed to prevent hepatitis B virus (HBV) infection after acute exposure to blood or certain body fluids containing HBV; after perinatal exposure of infants to mothers exposed to HBV; after sexual exposure to persons exposed to HBV; and after household exposure to persons with acute HBV infection. Drug Class: HepaGam B is a solvent/detergent–treated sterile solution of purified gamma globulin containing antiHBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs. It is purified by anionexchange column chromatography. Uniqueness of Drug: This purified antibody targets the hepatitis B virus. Patients who undergo liver transplantation because of HBV infection need long-term post-transplant therapy with hepatitis B immune globulin. In clinical trials, the product was highly effective in preventing recurrences of hepatitis B, and the dosing regimen used consistently yielded anti-HBsAg concentrations that exceeded target therapeutic levels. Warnings and Precautions: General: HepaGam B is made from human plasma. Products made from human plasma may contain infectious entities, such as viruses and, theoretically, the Creutzfeldt–Jakob disease agent. The risk of transmitting an infectious agent has been reduced by screening plasma donors for exposure to certain viruses, by testing for the presence of current viral infections, and by inactivating or removing certain viruses. The manufacturing process includes a step using a solvent/detergent, tri-n-butyl phosphate/Triton X-100 (Union Carbide), which inactivates enveloped viruses such as HBV, HCV, and HIV. A Planova 20N Virus Filter is used to reduce the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, plasma products still have the potential to transmit disease, and unknown infectious agents 300 P&T® • May 2008 • Vol. 33 No. 5 http://www.cephalon.com http://www.fda.gov/cder/foi/label/2008/022249lbl.pdf http://www.fda.gov/cder/foi/label/2008/022249lbl.pdf
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