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Hectorol Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Hectorol safely and effectively. Before taking Hectorol please consult with your doctor. See full prescribing information for Hectorol.

Indications And Usage

Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Does this card cost me anything?

NO - The Pharmacy Savings Card alone does not cost you anything

Dosage And Administration

Table 5: Initial Dosing
iPTH Level Hectorol ® Dose
>400 pg/mL 4 mcg three times per week at the end of dialysis, or approximately every other day
Dose Titration
iPTH Level Hectorol ® Dose
Decrease by <50% and above 300 pg/mL Increase by 1 to 2 mcg at eight-week intervals as necessary
Decrease by >50% and above 300 pg/mL Maintain
150 - 300 pg/mL Maintain
<100 pg/mL Suspend for one week, then resume at a dose that is at least 1 mcg lower

Contraindications

Hectorol should not be given to patients with a tendency towards hypercalcemia or current evidence of vitamin D toxicity.

Adverse Reactions

Hectorol Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral Hectorol) 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 Injection, Table 4 provides the adverse event incidence rates from placebo-controlled studies of oral Hectorol. Table 4: Adverse Events Reported by ≥2% of Hectorol® Treated Patients and More Frequently Than Placebo During the Double-blind Phase of Two Clinical Studies Adverse Event Hectorol® (n=61) % Placebo (n=61) % Body as a Whole Abscess 3.3 0.0 Headache 27.9 18.0 Malaise 27.9 19.7 Cardiovascular System Bradycardia 6.6 4.9 Digestive System Anorexia 4.9 3.3 Constipation 3.3 3.3 Dyspepsia 4.9 1.6 Nausea/Vomiting 21.3 19.7 Musculo-Skeletal System Arthralgia 4.9 0.0 Metabolic and Nutritional Edema 34.4 21.3 Weight increase 4.9 0.0 Nervous System Dizziness 11.5 9.8 Sleep disorder 3.3 0.0 Respiratory System Dyspnea 11.5 6.6 Skin Pruritus 8.2 6.6 A patient who reported the same medical term more than once was counted only once for that medical term. 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: Early Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia. Late 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.

Drug Interactions

Drug Interactions Specific drug interaction studies have not been conducted. Magnesium-containing antacids and Hectorol 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 glutethimide and phenobarbital) may affect the 25-hydroxylation of Hectorol and may necessitate dosage adjustments. Cytochrome P450 inhibitors (such as ketoconazole and erythromycin) may inhibit the 25-hydroxylation of Hectorol. Hence, formation of the active Hectorol moiety may be hindered.

Always pay a fair price for your medication!

Our FREE Hectorol discount card helps you save money on the exact same Hectorol prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Hectorol prescription filled. Hand it to them and save between 10% - 85% off this prescription!

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Save on the cost of your prescription with our free Hectorol Discount Card

Be sure to ask your pharmacist not to substitute another card for ours as we are confident we offer the highest savings possible.

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