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CMV_prophylaxis.qxp 6/24/09 2:21 PM Page 2 34 Renal & Urology News JULY 2009 Longer CMV Prophylaxis More Effective High-risk renal transplant patients better protected with 200 vs. 100 days of oral valganciclovir BY JODY A. CHARNOW The findings emerged from the nors. All patients were prescribed oral Clinicians usually refer to the 100- and BOSTON—Longer duration of oral Improved Protection Against Cyto- valganciclovir 900 mg daily for 100 200-day courses as three- and six- valganciclovir prophylaxis against megalovirus in Transplant (IMPACT) days. For the next 100 days, some month courses. cytomegalovirus (CMV) in high-risk study. This randomized, double-blind patients continued to receive oral val- At one year post transplant, CMV renal transplant patients significantly trial involved 326 CMV-seronegative ganciclovir at the same dosage (the disease developed in 36.8% of pa- reduces the incidence of CMV dis- renal transplant patients who received 200-day group) and others were tients in the 100-day valganciclovir ease one year post transplant. organs from CMV-seropositive do- switched to placebo (100-day group). group vs. 16.1% in the 200-day val- ganciclovir group, a 56% decrease, according to data presented here at surface area, respectively) have revealed no teratogenic or fetotoxic effects due to doxercalciferol. There are, how- ever, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not the American Transplant Congress. always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers “That’s a bigger reduction in disease It is not known whether doxercalciferol is excreted in human milk. Because other vitamin D derivatives are excret- See package insert for full prescribing information. ed in human milk and because of the potential for serious adverse reactions in nursing infants from doxercal- than I expected at the start of the BRIEF SUMMARY ciferol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into INDICATIONS AND USAGE account the importance of the drug to the mother. trial,” said Robert S. Gaston, MD, one Hectorol® Capsules Pediatric Use Dialysis Patients: Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients Safety and efficacy of Hectorol in pediatric patients have not been established. of the IMPACT investigators. with chronic kidney disease on dialysis. Geriatric Use Pre-Dialysis Patients: Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients Capsules The rates of acute rejection in 100- with Stage 3 or Stage 4 chronic kidney disease. Of the 138 patients treated with Hectorol Capsules in two Phase 3 clinical studies, 30 patients were 65 Hectorol Injection years or over. In these studies, no overall differences in efficacy or safety were observed between patients 65 years or older and younger patients. and 200-day prophylaxis groups were Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. CONTRAINDICATIONS Injection Of the 70 patients treated with Hectorol Injection in the two Phase 3 clinical studies, 12 patients were 65 17.2% and 11%, respectively, and the Hectorol should not be given to patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity. years or over. In these studies, no overall differences in efficacy or safety were observed between patients WARNINGS 65 years or older and younger patients. rates of graft loss were 1.8% and Overdosage of any form of vitamin D, including Hectorol, is dangerous (see OVERDOSAGE). Progressive Hepatic Insufficiency hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency Since patients with hepatic insufficiency may not metabolize Hectorol appropriately, the drug should be used 1.9%. The differences between the attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may with caution in patients with impaired hepatic function. More frequent monitoring of iPTH, calcium, and phos- potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The serum calcium times serum phosphorus (Ca X P) product should be phorus levels should be done in such individuals. groups were not significant. The study ADVERSE REACTIONS maintained at <55 mg2/dL2 in patients with chronic kidney disease. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Dialysis: Hectorol capsules have been evaluated for safety in clinical studies in 165 patients with chronic kidney revealed no significant difference in Since doxercalciferol is a precursor for 1α,25-(OH)2D2, a potent metabolite of vitamin D2, pharmacologic disease on hemodialysis. In two placebo-controlled, double-blind, multicenter studies, discontinuation of ther- doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible addi- apy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol for four to six months, see overall valganciclovir tolerability and tive effects and hypercalcemia. CLINICAL PHARMACOLOGY/Clinical Studies section of Hectorol full prescribing information) and in 3.3% of Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet should be used 61 patients treated with placebo for two months. Adverse events occurring in the Hectorol group at a frequen- cy of 2% or greater and more frequently than in the placebo group are presented in the following table: the incidence and grading of hemato- to control serum phosphorus levels in patients with chronic kidney disease. Uncontrolled serum phosphorus exac- erbates secondary hyperparathyroidism and can lessen the effectiveness of Hectorol in reducing blood PTH levels. Adverse Events Reported by 2% of Hectorol Treated Patients and More Frequently Than Placebo During the logic parameters (neutrophils, hemo- If hypercalcemia occurs after initiating Hectorol therapy, the dose of Hectorol and/or calcium-containing phosphate Double-blind Phase of Two Clinical Studies binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol, the dose of Hectorol should be decreased and/or the dose of phosphate binders increased. (See DOSAGE AND ADMINISTRATION section of Adverse Event Hectorol (n=61) Placebo (n=61) globin, and platelets). % % Hectorol full prescribing information.) Body as a Whole Magnesium-containing antacids and Hectorol should not be used concomitantly in patients on chronic renal dialy- Abscess 3.3 0.0 sis because such use may lead to the development of hypermagnesemia. Headache 27.9 18.0 Malaise 27.9 19.7 PRECAUTIONS General Active vitamin D sterols should not be used as initial treatment of nutritional vitamin D deficiency (as defined Cardiovascular System Bradycardia Digestive System Anorexia 6.6 4.9 4.9 3.3 Another 100 days by low 25-hydroxy vitamin D). Patients should be checked and treated for nutritional vitamin D deficiency prior to initiating treatment with Hectorol. The principal adverse effects of treatment with Hectorol are hypercalcemia, hyperphosphatemia, hypercalci- uria, and oversuppression of iPTH. Prolonged hypercalcemia can lead to calcification of soft tissues, includ- Constipation Dyspepsia Nausea/Vomiting Musculo-Skeletal System 3.3 4.9 21.3 3.3 1.6 19.7 of valganciclovir cut CMV disease ing the heart and arteries, and hyperphosphatemia can exacerbate hyperparathyroidism. Hypercalciuria can Arthralgia 4.9 0.0 accelerate the onset of renal failure through nephrocalcinosis. Oversuppression of iPTH may lead to adynam- Metabolic and Nutritional Edema 34.4 21.3 ic bone syndrome. All of these potential adverse effects should be managed by regular patient monitoring Weight increase 4.9 0.0 and appropriate dosage adjustments. During treatment with Hectorol, patients usually require dose titration, incidence by 56%. Nervous System as well as adjustment in co-therapy (i.e., dietary phosphate binders) in order to effect and sustain PTH sup- Dizziness 11.5 9.8 pression while maintaining serum calcium and phosphorus within prescribed ranges. Sleep disorder 3.3 0.0 Respiratory System Capsules Dyspnea 11.5 6.6 Dialysis: In four adequate and well-controlled studies, the incidence of hypercalcemia and hyperphos- Skin phatemia increased during therapy with Hectorol. The observed increases during Hectorol treatment, Pruritus 8.2 6.6 although occurring at a low rate, underscore the importance of regular safety monitoring of serum calci- A patient who reported the same medical term more than once was counted only once for that medical term. um and phosphorus levels throughout treatment. Patients with higher pre-treatment serum levels of cal- cium (>10.5 mg/dL) or phosphorus (>
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