July 29, 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




Hectorol Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/5/2016

Hectorol (doxercalciferol injection) is a synthetic (man-made) form of vitamin D used to reduce elevated intact parathyroid hormone (iPTH) levels in the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. Contact your doctor if you experience side effects of Hectorol including nausea, vomiting, decreased appetite, dry mouth, constipation, weakness, headache, dizziness, metallic taste, muscle or bone pain, increased thirst or urination, shortness of breath, or itching.

The optimal dose of Hectorol is carefully determined for each patient. The recommended initial dose is 4 mcg administered intravenously as a bolus dose three times weekly at the end of dialysis (approximately every other day). Hectorol may interact with antacids containing magnesium, digoxin, vitamin D supplements, mineral oil, or cholestyramine. Tell your doctor all medications and supplements you use. Do not take Hectorol without first talking to your doctor if you are pregnant. It is unknown if this drug passes into breast milk. It is believed this drug could affect a nursing baby. Do not take Hectorol if you are breastfeeding.

Our Hectorol (doxercalciferol injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Hectorol Injection in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking doxercalciferol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular heartbeat;
  • increased nighttime urination; or
  • abdominal pain.

Contact your doctor if you experience any of the following side effects:

  • nausea, vomiting, or decreased appetite;
  • dry mouth;
  • constipation;
  • weakness;
  • headache;
  • dizziness;
  • a metallic taste;
  • muscle or bone pain;
  • increased thirst or urination;
  • shortness of breath; or
  • itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hectorol Injection (Doxercalciferol Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Hectorol Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Hectorol Injection (Doxercalciferol Injection)

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.