Pharmacy & Therapeutics - November 2008 - (Page 673)

Pharmaceutical Approval Update located on vagal afferents to initiate the vomiting reflex. Warnings and Precautions: Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists. Hypersensitivity reactions, rarely reported for intravenous (IV) palonosetron, include dyspnea, bronchospasm, swelling or edema, erythema, pruritus, rash, and urticaria. No hypersensitivity reactions have been reported for oral palonosetron capsules. Dosage and Administration: The adult dosage is one 0.5-mg capsule, with or without food, approximately one hour before chemotherapy starts. Commentar y: Patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetic agents often given on the day of chemotherapy, about 30% to 45% of patients experience nausea or vomiting or require rescue therapy after moderately emetogenic chemotherapy. Failure to control acute CINV on the first day of chemotherapy increases the risk of CINV on subsequent days and in subsequent cycles of chemotherapy. Palonosetron HCl capsules are indicated for preventing acute nausea and vomiting associated with initial and subsequent courses of moderately emetogenic chemotherapy. In one study, oral palonosetron was equivalent to IV palonosetron in preventing CINV. Source: www.aloxi.com Warnings and Precautions: Hypersensitivity reactions: Hypersensitivity reactions have been reported after injection. Before the product is administered, patients should be asked about a history of any previous reactions to iodine, any iodine-containing contrast agent, or any other product containing iodine. If the patient has or is suspected to have hypersensitivity to any of these agents or products containing iodine, the decision to give iobenguane 123I injection should be based upon an assessment of the expected benefits and potential hypersensitivity risks. Anaphylactic and hypersensitivity measures should be available beforehand. Risk of benzyl alcohol toxicity in infants: This product contains benzyl alcohol at a concentration of 10.3 mg/mL. Benzyl alcohol has been associated with a fatal “gasping syndrome” in premature and low-birth-weight infants. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in newborns, and an increased incidence of kernicterus, particularly in small preterm infants. Rare reports of deaths, primarily in preterm infants, have been associated with exposure to excessive amounts of benzyl alcohol. Infants should be observed for signs or symptoms of benzyl alcohol toxicity following injection. The injection’s safety and effectiveness have not been established in neonates younger than one month of age. Radiation exposure in patients with severe renal impairment: Iobenguane 123I injection is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment may be increased because of the drug’s delayed elimination. Delayed clearance may also reduce the target-to-background ratios and may decrease the quality of scintigraphic images. These risks may limit the role of the agent in the diagnostic evaluation of patients with severe renal impairment. The product’s safety and efficacy have not been established in these patients. Accumulation in the thyroid gland: Failure to block the thyroid uptake of 123I injection may result in an increased longterm risk of thyroid neoplasia. Thyroid-blocking medications should be given before the injection is administered. Risks of concomitant medication withdrawal: Drugs that interfere with NE uptake or retention may decrease the drug’s uptake in neuroendocrine tumors and may lead to falsenegative imaging results. When it is medically feasible, such drugs should not be given before administration of iobenguane 123I injection. Patients should be monitored for clinically significant withdrawal symptoms, especially if levels of circulating catecholamines and their metabolites are elevated. Hypertension: The patient’s pulse and blood pressure should be measured before and intermittently for 30 minutes after the product is given. The injection may increase the release of NE from chromaffin granules and may produce a transient episode of hypertension, although this effect was not observed in the clinical study. Before giving the injection, health care providers should ensure that emergency cardiac and antihypertensive treatments are readily available. Dosage and Administration: Radiation safety: Iobenguane 123I injection emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to staff members and patients. Radiopharmaceuticals should be used by, or should be under the Iobenguane 123I Injection (AdreView) Manufacturer: GE (General Electric) Healthcare, Inc., Princeton, N.J. Indication: 123Iobenguane injection (also known as 123Imeta-iodobenzylguanidine sulfate) is a diagnostic radiopharmaceutical agent used in gamma-scintigraphy to detect rare neuroendocrine tumors in children and adults. Granted orphan drug status by the FDA, this agent is indicated for the diagnosis of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. Drug Class: This sterile, pyrogen-free radiopharmaceutical product is used as an IV injection. Each milliliter contains 0.08 mg of iobenguane sulfate, 2 millicuries (2 mCi), or 74 megabecquerels (MBq), of 123I (as iobenguane sulfate I-123) at the calibration time and date on the label, 23 mg of sodium dihydrogen phosphate dihydrate, 2.8 mg of disodium hydrogen phosphate dihydrate, and 10.3 mg (1% volume to volume) of benzyl alcohol. The drug’s pH is 5.0 to 6.5. This cyclotronproduced radionuclide decays to tellurium-123 (123Te) by electron capture. Its physical half-life is 13.2 hours. Uniqueness of Drug: Iobenguane is similar in structure to the antihyper tensive drug guanethidine monosulfate (Ismelin, Novartis) and to the neurotransmitter norepinephrine (NE). Iobenguane is thus largely subject to the same uptake and accumulation pathways as NE. Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and is stored in the presynaptic storage vesicles. Iobenguane accumulates in adrenergically innervated tissues (e.g., adrenal medulla, salivary glands, heart, liver, spleen, and lungs) as well as tumors derived from the neural crest. When iobenguane is labeled with the isotope iodine-123, it is possible to obtain scintigraphic images of the organs and tissues in which the radiopharmaceutical accumulates. Vol. 33 No. 11 • November 2008 • P&T® 673 http://www.aloxi.com

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - November 2008

Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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