July 28, 2016
Recommended Topic Related To:

Hectorol Injection

"The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is re"...

A A A

Hectorol Injection




Side Effects
Interactions

SIDE EFFECTS

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 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./p>

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/V omiting 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.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

Hypersensitivity reactions, including fatal outcome, have been reported in patients on hemodialysis following administration of Hectorol Injection. Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus and skin burning sensation (see WARNINGS). These reactions may occur separately or together.

Read the Hectorol Injection (doxercalciferol injection) Side Effects Center for a complete guide to possible side effects

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/9/2016

Side Effects
Interactions

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.


Women's Health

Find out what women really need.