Hectorol Side Effects

Generic Name: doxercalciferol

Please note - some side effects for Hectorol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Hectorol - for the Consumer

Hectorol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Hectorol:

Abscess; difficulty sleeping; joint pain; stomach upset; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; dizziness; drowsiness; dry mouth; excessive thirst; excessive urination; headache; irregular heartbeat; itching; loss of appetite; metallic taste; muscle or bone pain; nausea; seizures; shortness of breath; slow heartbeat; swelling; vomiting; weakness.

Hectorol Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Hectorol Capsules:

Abscess; difficulty sleeping; general body discomfort; indigestion; joint pain; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; dizziness; drowsiness; dry mouth; excessive thirst; excessive urination; headache; irregular heartbeat; itching; loss of appetite; metallic taste; muscle or bone pain; nausea; seizures; slow heartbeat; swelling; vomiting; weakness.

Hectorol Side Effects - for the Professional

Hectorol

Dialysis:

Hectorol has been evaluated for safety in clinical studies in 165 patients with chronic kidney disease on hemodialysis. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol for four to six months (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in 3.3% of 61 patients treated with placebo for two months. Adverse events occurring in the Hectorol group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3 below:

Pre-dialysis:

Hectorol has been evaluated for safety in clinical studies in 55 patients (27 active and 28 placebo) with chronic kidney disease, Stages 3 or 4. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in one (3.7%) of 27 patients treated with Hectorol for 24 weeks (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in three (10.7%) of 28 patients treated with placebo for 24 weeks. Adverse events occurring in the Hectorol group at a frequency of 5% or greater and more frequently than in the placebo group are as follows: Body as a Whole – Infection, Chest Pain; Digestive System – Constipation, Dyspepsia; Hematologic and Lymphatic – Anemia; Metabolic and Nutritional – Dehydration; Nervous System – Depression, Hypertonia, Insomnia, Paresthesia; Respiratory System – Cough increased, Dyspnea, Rhinitis.

Potential adverse effects of Hectorol 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:

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

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.

Side Effects by Body System

General

Studies of intravenous doxercalciferol did not include a placebo group and adverse effects reported are from placebo-controlled studies of oral doxercalciferol. The intravenous formulation was evaluated in 70 patients with chronic renal disease on hemodialysis previously treated with oral doxercalciferol.

Metabolic

Early signs and symptoms of hypercalcemia have included weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

Prolonged hypercalcemia may result in 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.

Hyperphosphatemia may exacerbate hyperparathyroidism.

Hypercalciuria may accelerate the onset of renal failure.

Metabolic side effects have frequently included hypercalcemia, hyperphosphatemia, and hypercalciuria. Metabolic side effects of doxercalciferol in relation to placebo therapy have included edema (34.4% vs. 21.3%) and weight gain (4.9% vs. 0%).

Endocrine

Endocrine side effects have included oversuppression of parathyroid hormone.

Oversuppression of iPTH may result in adynamic bone syndrome.

Cardiovascular

Cardiovascular side effects of doxercalciferol in relation to placebo therapy have included bradycardia (6.6% vs. 4.9%).

Gastrointestinal

Gastrointestinal side effects of doxercalciferol in relation to placebo therapy have included anorexia (4.9% vs. 3.3%), constipation(3.3% vs. 3.3%), dyspepsia (4.9% vs. 1.6%), and nausea/vomiting (21.3% vs. 19.7%).

Gastrointestinal side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included constipation and dyspepsia.

Musculoskeletal

Musculoskeletal side effects of doxercalciferol in relation to placebo therapy have included arthralgia (4.9% vs. 0%).

Nervous system

Nervous system side effects of doxercalciferol in relation to placebo therapy have included dizziness (11.5% vs. 9.8%) and sleep disorders (3.3% vs. 0%).

Nervous system side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included hypertonia, insomnia, and paresthesia.

Dermatologic

Dermatologic side effects of doxercalciferol in relation to placebo therapy have included pruritus (8.2% vs. 6.6%).

Respiratory

Respiratory side effects of doxercalciferol in relation to placebo therapy have included dyspnea (11.5% vs. 6.6%).

Respiratory side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included increased cough, dyspnea, and rhinitis.

Other

Other side effects of doxercalciferol in relation to placebo therapy have included abscess (3.3% vs. 0%), headache (27.9% vs. 18%), and malaise (27.9% vs. 19.7%).

Other side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included infection, chest pain, and dehydration.

Hematologic

Hematological side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included anemia.

Psychiatric

Psychiatric side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included depression.

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