"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
Hectorol (doxercalciferol injection) Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral Hectorol (doxercalciferol injection) ) from two 12-week, open-label, single-arm, multi-centered studies. (Dosage titrated to achieve target plasma iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies.)
Because there was no placebo group included in the studies of Hectorol (doxercalciferol injection) Injection, Table 4 provides the adverse event incidence rates from placebo-controlled studies of oral Hectorol (doxercalciferol injection) .
Table 4: Adverse Events Reported bv z 2% of Hectorol (doxercalciferol injection) Treated Patients and More Freauentlv Than Placebo Durino the Double-blind Phase of Two Clinical Studies
|Adverse Event|| Hectorol (n=61)
| Placebo (n=61)|
|Body as a Whole|
|Metabolic and Nutritional|
|A patient who reported the same medical term more than once was counted only once for that medical term.|
Potential adverse effects of Hectorol (doxercalciferol injection) are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
Read the Hectorol Injection (doxercalciferol injection) Side Effects Center for a complete guide to possible side effects »
Specific drug Interaction studies have not been conducted. Magnesium-containing antacids and Hectorol (doxercalciferol injection) should not be used concomitantly because such use may lead to the development of hypermagnesemia (see WARNINGS). Although not examined specifically, enzyme Inducers (such as glutethlmlde and phe-nobarbital) may affect the 25-hydroxylatlon of Hectorol (doxercalciferol injection) and may necessitate dosage adjustments. Cytochrome P450 Inhibitors (such as ketoconazole and erythromycin) may Inhibit the 25-hydroxylatlon of Hectorol (doxercalciferol injection) . Hence, formation of the active Hectorol (doxercalciferol injection) moiety may be hindered.
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Hectorol Injection Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.