Drugs Details

Drugs Info of Hectorol
Drugs Details
  • Drugs Type  : Multum
  • Date : 29th Jan 2015 10:05 pm
  • Brand Name : Hectorol
  • Generic Name : doxercalciferol (Pronunciation: dock sir kal SIH fer all)
Descriptions

Doxercalciferol, the active ingredient in Hectorol (doxercalciferol injection) , is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(0H)2D2), a naturally occurring, biologically active form of vitamin D2. Hectorol (doxercalciferol injection) is available as a sterile, clear, colorless aqueous solution for intravenous injection. Mectorol Injection is supplied as either 4 mcg/2mL or 2 mcg/mL each in a stoppered, single use 2 mL amber glass vial, with an aluminum seal and yellow (4 mcg/2mL) or green (2 mcg/mL) flip-off cap. Each milliliter (mL) of solution contains doxercalciferol, 2 meg; ethanol, 100%, 0.05 mL; Polysorbate 20,10 mg; sodium chloride, 1.5 mg; butylated hydroxytoluene, 0.02 mg; sodium phosphate dibasic, heptahydrate, 14.4 mg; sodium phosphate monobasic, monohydrate, 1.8 mg; and disodium edetate, 1.1 mg.

Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol and has the structural formula presented in Figure 1.

Figure 1: Chemical Structure of Doxercalciferol

HECTOROL (doxercalciferol) structural formula illustration

Other names frequently used for doxercalciferol are 1a-hydroxyvitamin D2,1a-0H-D2, and 1a-hydroxy-ergocalciferol.

What are the possible side effects of doxercalciferol (Hectorol)?

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...

Read All Potential Side Effects and See Pictures of Hectorol Injection »


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

Indications

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

Dosage Administration

Adult Administration

For intravenous use only. The optimal dose of Hectorol (doxercalciferol injection) must be carefully determined for each patient. The recommended initial dose of Hectorol (doxercalciferol injection) is 4 mcg administered intravenously as a bolus dose three times weekly at the end of dialysis (approximately every other day). The initial dose should be adjusted, as needed, in order to lower blood iPTH into the range of 150 to 300 pg/mL. The dose may be increased at 8-week intervals by 1 to 2 mcg if iPTH is not lowered by 50% and fails to reach the target range. Dosages higher than 18 mcg weekly have not been studied. Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted one week later at a dose that is at least 1 mcg lower than the last administered dose. During titration, iPTH, serum calcium, and serum phosphorus levels should be obtained weekly. If hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg2/dL2is noted, the dose of Hectorol (doxercalciferol injection) should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is 1 mcg lower.

Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels. Table 5 presents a suggested approach in dose titration.

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
Decreased by < 50% and above 300 pg/mL Increase by 1 to 2 mcg at eight-week intervals as necessary
Decreased 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

Discard unused portion.

How Supplied

Hectorol (doxercalciferol injection) (doxercalclferol injection) is supplied in single-use amber glass vials containing 4 mcg doxercalclferol in 2 mL of solution or 2 mcg in 1 mL of solution. The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and either a yellow (4 mcg/2 mL) or green (2 mcg/mL) plastic flip-off cap.

NDC 58468-0123-1 4 mcg/2 mL vial

NDC 58468-0126-1 2 mcg/mL vial

Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]

Protect from light.

Manufactured by: Genzyme Biosurgery For: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142


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

Side Effects

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
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 (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:

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.

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

Interactions

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.


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

Warnings

Overdosage of any form of vitamin D, including Hectorol is dangerous (see OVERDOSAGE). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The serum calcium times serum phosphorus (Ca X P) product should be maintained at <55 mg2/dL2in patients with chronic kidney disease. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.

Since doxercalciferol is a precursor for 1α,25-(0H)2D2, a potent metabolite of vitamin D2, pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol (doxercalciferol injection) treatment to avoid possible additive effects and hypercalcemia.

Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis. Uncontrolled serum phosphorus exacerbates secondary hyperparathyroidism and can lessen the effectiveness of Hectorol (doxercalciferol injection) in reducing blood PTH levels. If hypercalcemia occurs after initiating Hectorol (doxercalciferol injection) therapy, the dose of Hectorol (doxercalciferol injection) and/or calcium-con-taining phosphate binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol (doxercalciferol injection) , the dose of Hectorol (doxercalciferol injection) should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for Hectorol under DOSAGE AND ADMINISTRATION section.)

Magnesium-containing antacids and Hectorol (doxercalciferol injection) should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.

Precautions

General

The principal adverse effects of treatment with Hectorol (doxercalciferol injection) Injection are hypercalcemia, hyperphosphatemia, and oversuppression of PTH (iPTH less than 150 pg/mL.) Prolonged hypercalcemia can lead to calcification of soft tissues, including the heart and arteries, and hyperphosphatemia can exacerbate hyperparathyroidism. Oversuppression of PTH may lead to adynamic bone syndrome. All of these potential adverse effects should be managed by regular patient monitoring and appropriate dosage adjustments. During treatment with Hectorol (doxercalciferol injection) , patients usually require dose titration, as well as adjustment in co-therapy (i.e., dietary phosphate binders) in order to maximize PTH suppression while maintaining serum calcium and phosphorus levels within prescribed ranges.

In two open-label, single-arm, multi-centered studies, the incidence of hypercalcemia and hyperphosphatemia increased during therapy with Hectorol Injection (see ADVERSE REACTIONS section). The observed increases during Hectorol (doxercalciferol injection) treatment underscore the importance of regular safety monitoring of serum calcium and phosphorus levels throughout treatment. Patients with higher pre-treatment serum levels of calcium (> 10.5 mg/dL) or phosphorus (> 6.9 mg/dL) were more likely to experience hypercalcemia or hyperphosphatemia. Therefore, Hectorol (doxercalciferol injection) should not be given to patients with a recent history of hypercalcemia or hyperphosphatemia, or evidence of vitamin D toxicity.

Table 3: Incidence Rates of Hypercalcemia and Hyperphosphatemia In Two Phase 3 Studies with Hectorol (doxercalciferol injection) '9 Injection

Study Hypercalcemia (per 100 patient weeks) Hyperphosphatemia (per 100 patient weeks)
Washout (Off Treatment) Open-Label (Treatment) Washout (Off Treatment) Open-Label (Treatment)
Study C 0.9 0.9 0.9 2.4
Study D 0.3 1.0 1.2 3.7

Laboratory Tests

Serum levels of IPTH, calcium, and phosphorus should be determined prior to Initiation of Hectorol (doxercalciferol injection) treatment. During the early phase of treatment (I.e., first 12 weeks), serum IPTH, calcium, and phosphorus levels should be determined weekly. For dialysis patients In general, serum or plasma IPTH and serum calcium, phosphorus, and alkaline phosphatase should be determined periodically.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies In animals to evaluate the carcinogenic potential of doxercalclferol have not been conducted. No evidence of genetic toxicity was observed In an in vitro bacterial mutagenicity assay (Ames test) or a mouse lymphoma gene mutation assay. Doxercalclferol caused structural chromatid and chromosome aberrations In an in vitro human lymphocyte clastogenlclty assay with metabolic activation. However, doxercalclferol was negative In an in vivo mouse micronucleus clastogenlclty assay. Doxercalclferol had no effect on male or female fertility In rats at oral doses up to 2.5 mcg/kg/day (approximately 3 times the maximum recommended human oral dose of 60 mcg/wk based on mcg/m body surface area).

Use in Pregnancy

Pregnancy Category B

Reproduction studies In rats and rabbits, at doses up to 20 mcg/kg/day and 0.1 mcg/kg/day (approximately 25 times and less than the maximum recommended human oral dose of 60 meg/week based on mcg/m2 body surface area, respectively) have revealed no teratogenic or fetotoxic effects due to doxercalclferol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether doxercalclferol is excreted in human milk. Because other vitamin D derivatives are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from doxercalclferol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy of Hectorol (doxercalciferol injection) in pediatric patients have not been established.

Geriatric Use

Of the 70 patients treated with Hectorol (doxercalciferol injection) Injection in the two Phase 3 clinical studies, 12 patients were 65 years or over. In these studies, no overall differences in efficacy or safety were observed between patients 65 years or older and younger patients.

Hepatic Insufficiency

Studies examining the influence of hepatic insufficiency on the metabolism of Hectorol (doxercalciferol injection) were inconclusive. Since patients with hepatic insufficiency may not metabolize doxercalclferol appropriately, the drug should be used with caution in patients with impaired hepatic function. More frequent monitoring of iPTH, calcium, and phosphorus levels should be done in such individuals.


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

OverDose

Administration of Hectorol (doxercalciferol injection) to patients in excess doses can cause hypercalcemia, hypercalciuria, hyperphosphatemia, and over-suppression of PTH secretion leading in certain cases to adynamic bone disease. High intake of calcium and phosphate concomitant with Hectorol (doxercalciferol injection) may lead to similar abnormalities. High levels of calcium in the dialysate bath may contribute to hypercalcemia.

Treatment of Hypercalcemia and Overdosage

General treatment of hypercalcemia (greater than 1 mg/dL above the upper limit of the normal range) consists of immediate suspension of Hectorol (doxercalciferol injection) therapy, institution of a low calcium diet, and withdrawal of calcium supplements. Serum calcium levels should be determined at least weekly until normocalcemia ensues. Hypercalcemia usually resolves in 2 to 7 days. When serum calcium levels have returned to within normal limits, Hectorol (doxercalciferol injection) therapy may be reinstituted at a dose that is at least 1 meg lower than prior therapy. Serum calcium levels should be obtained weekly after all dosage changes and during subsequent dosage titration. Persistent or markedly elevated serum calcium levels may be corrected by dialysis against a reduced calcium or calcium-free dialysate.

Treatment of Accidental Overdosage of Hectorol (doxercalciferol injection)

The treatment of acute accidental overdosage of Hectorol (doxercalciferol injection) should consist of general supportive measures. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion, and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and institution of a low calcium diet are also indicated in accidental overdosage. If persistent and markedly elevated serum calcium levels occur, treatment with standard medical care should be followed, as needed. Based on similarities between Hectorol (doxercalciferol injection) and its active metabolite, 1a,25-(0H)2D2, it is expected that Hectorol (doxercalciferol injection) is not removed from the blood by dialysis.

ContrainDications

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


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

Clinical Pharamacology

Vitamin D levels in humans depend on two sources: (1) exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D3 (cholecalciferol) and (2) dietary intake of either vitamin D2 (ergocalciferol) or vitamin D3. Vitamin D2 and vitamin D3 must be metabolically activated in the liver and kidney before becoming fully active on target tissues. The initial step in the activation process is the introduction of a hydroxyl group in the side chain at C-25 by the hepatic enzyme, CYP 27 (a vitamin D-25-hydroxylase). The products of this reaction are 25-(OH)D2 and 25-(0H)D3, respectively. Further hydroxylation of these metabolites occurs in the mitochondria of kidney tissue, catalyzed by renal 25-hydroxyvitamin D-1-a-hydroxylase to produce 1a,25-(0H)2D2, the primary biologically active form of vitamin D2, and 1 a,25-(0H)2D3 (calcitriol), the biologically active form of vitamin D3.

Mechanism of Action

Calcitriol (1α,25-(OH)2D3) and 1α,25-(0H)2D2 regulate blood calcium at levels required for essential body functions. Specifically, the biologically active vitamin D metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney and, in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton. They act directly on bone cells (osteoblasts) to stimulate skeletal growth, and on the parathyroid glands to suppress PTH synthesis and secretion. These functions are mediated by the interaction of these biologically active metabolites with specific receptor proteins in the various target tissues. In uremic patients, deficient production of biologically active vitamin D metabolites (due to lack of or insufficient 25-hydroxyvitamin D-1-alpha-hydroxylase activity) leads to secondary hyperparathyroidism, which contributes to the development of metabolic bone disease in patients with renal failure.

Pharmacokinetics and Metabolism

After intravenous administration, doxercalciferol is activated by CYP 27 in the liver to form 1α,25-(OH)2D2 (major metabolite) and 1α,24-dihydroxyvitamin D2 (minor metabolite). Activation of doxercalciferol does not require the involvement of the kidneys.

Peak blood levels of 1α,25-(0H)2D2 are reached at 8 +/-5.9 hours (mean +/-SD) after a single intravenous dose of 5 meg of doxercalciferol. The mean elimination half-life of 1α,25-(0H)2D2 after an oral dose is approximately 32 to 37 hours with a range of up to 96 hours. The mean elimination half-life in patients with end stage renal disease (ESRD) and in healthy volunteers appears to be similar following an oral dose. Hemodialysis causes a temporary increase in 1α,25-(OH)2D2 mean concentrations presumably due to volume contraction. 1α,25-(OH)2D2 is not removed from blood during hemodialysis.

Clinical Studies

The safety and effectiveness of Hectorol (doxercalciferol injection) Injection were evaluated in two open-label, single-arm, multi-centered clinical studies (Study C and Study D) in a total of 70 patients with chronic kidney disease on hemodialysis (Stage 5 CKD). Patients in Study C were an average age of 54 years (range: 23-73), were 50% male, and were 61% African American, 25% Caucasian, and 14% Hispanic, and had been on hemodialysis for an average of 65 months. Patients in Study D were an average age of 51 years (range: 28-76), were 48% male, and 100% African-American and had been on hemodialysis for an average of 61 months. This group of 70 of the 138 patients who had been treated with Hectorol (doxercalciferol injection) Capsules in prior clinical studies (Study A and Study B) received Hectorol (doxercalciferol injection) Injection in an open-label fashion for 12 weeks following an 8-week washout (control) period. Dosing of Hectorol (doxercalciferol injection) Injection was initiated at the rate of 4 meg administered at the end of each dialysis session (3 times weekly) for a total of 12 meg per week. The dosage of Hectorol (doxercalciferol injection) was adjusted in an attempt to achieve iPTH levels within a targeted range of 150 to 300 pg/mL. The dosage was increased by 2 meg per dialysis session after 8 weeks of treatment if the iPTH levels remained above 300 pg/mL and were greater than 50% of baseline levels. The maximum dosage was limited to 18 meg per week. If at any time during the trial iPTH fell below 150 pg/mL, Hectorol (doxercalciferol injection) Injection was immediately suspended and restarted at a lower dosage the following week.

Results

Fifty-two of the 70 patients who were treated with Hectorol (doxercalciferol injection) Injection achieved iPTH levels ≤ 300 pg/mL. Forty-one of these patients exhibited plasma iPTH levels ≤ 300 pg/mL on at least 3 occasions. Thirty-six patients had plasma iPTH levels < 150 pg/mL on at least one occasion during study participation.

Mean weekly doses in Study C ranged from 8.9 meg to 12.5 meg. In Study D, the mean weekly doses ranged from 9.1 meg to 11.6 meg.

Decreases in plasma iPTH from baseline values were calculated using as baseline the average of the last 3 values obtained during the 8-week washout period and are displayed in the table below. Plasma iPTH levels were measured weekly during the 12-week study.

Table 1: iPTH Summary Data lor Patients Receiving Hectorol (doxercalciferol injection) Injection:

iPTH Level Study C Study D Combined Protocols
(n=28) (n=42) (n=70)
Baseline (Mean of Weeks -2, -1 and 0)
Mean (SE) 698 (60) 762 (65) 736 (46)
Median 562 648 634
On-treatment (Week 12*)
Mean (SE) 406 (63) 426 (60) 418 (43)
Median 311 292 292
Change from Baseline**
Mean (SE) -292 (55) -336 (41) -318 (33)
Median -274 -315 -304
P-value*** .004 .001 .001
*Values were carried forward for the two patients on study for 10 weeks  
**Treatment iPTH minus baseline iPTH
***Wilcoxon one-sample test

In both studies, iPTH levels increased progressively and significantly in 62.9% of patients during the 8-week washout (control) period during which no vitamin D derivatives were administered. In contrast, Hectorol (doxercalciferol injection) Injection treatment resulted in a clinically significant reduction (at least 30%) from baseline in mean iPTH levels during the 12-week open-label treatment period in more than 92% of the 70 treated patients.

Table 2 shows the numbers of patients who achieved iFTH levels below 300 pg/mL on one, two, or three or more non-consecutive occasions during the 12-week treatment period. Tliiriy-seven of 70 patients (53%) had plasma iPTH levels within the targeted range (150-300 pg/mL) during Weeks 10-12.

Table 2 shows the numbers of patients who achieved iFTH levels below 300 pg/mL on one, two, or three or more non-consecutive occasions during the 12-week treatment period. Tliiriy-seven of 70 patients (53%) had plasma iPTH levels within the targeted range (150-300 pg/mL) during Weeks 10-12.

Table 2: Number of times iPTH ≤ 300 pg/mL

  1 2 ≥3
Study C 3/28 0/28 16/28
Study D 4/42 4/42 25/42


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

Patient Information

The patient, spouse, or guardian should be informed about adherence to instructions about diet, calcium supplementation, and avoidance of the use of nonprescription drugs without prior approval from the patient's physician. Patients should also be carefully informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS section).


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

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

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Patient Detailed Side Effect

Brand Names: Hectorol

Generic Name: doxercalciferol (Pronunciation: dock sir kal SIH fer all)

  • What is doxercalciferol (Hectorol Injection)?
  • What are the possible side effects of doxercalciferol (Hectorol Injection)?
  • What is the most important information I should know about doxercalciferol (Hectorol Injection)?
  • Who should not take doxercalciferol (Hectorol Injection)?
  • How should I take doxercalciferol (Hectorol Injection)?
  • What happens if I miss a dose (Hectorol Injection)?
  • What happens if I overdose (Hectorol Injection)?
  • What should I avoid while taking doxercalciferol (Hectorol Injection)?
  • What other drugs will affect doxercalciferol (Hectorol Injection)?
  • Where can I get more information?

What is doxercalciferol (Hectorol Injection)?

Doxercalciferol is a synthetic (man-made) form of vitamin D. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Doxercalciferol is used to reduce elevated intact parathyroid hormone (iPTH) levels in the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

Doxercalciferol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of doxercalciferol (Hectorol Injection)?

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

Learn More »

What is the most important information I should know about doxercalciferol (Hectorol Injection)?

Contact your doctor if you experience weakness, headache, nausea and vomiting, dry mouth, constipation, a metallic taste in the mouth, increased thirst and/or urination, or decreased appetite. These can be early signs of too much calcium in the body.

Do not take antacids that contain magnesium while taking doxercalciferol, unless otherwise directed by your doctor.

Side Effects Centers
  • Hectorol
  • Hectorol Injection

Patient Detailed How Take

Who should not take doxercalciferol (Hectorol Injection)?

Do not take doxercalciferol if you have high levels of vitamin D, calcium, or phosphorus in your body.

Before taking this medication, tell your doctor if you have liver disease. You may not be able to take doxercalciferol, or you may require a dosage adjustment or special monitoring during treatment if you have liver disease.

Doxercalciferol is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take doxercalciferol without first talking to your doctor if you are pregnant.

It is also not known whether doxercalciferol passes into breast milk. However, it is believed that doxercalciferol could affect a nursing baby. Do not take doxercalciferol if you are breast-feeding a baby.

How should I take doxercalciferol (Hectorol Injection)?

Take doxercalciferol exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with water.

Doxercalciferol is usually taken three times a week during dialysis. Follow your doctor's instructions.

Store doxercalciferol at room temperature away from moisture, light, and heat.

Side Effects Centers
  • Hectorol
  • Hectorol Injection

Patient Detailed Avoid Taking

What happens if I miss a dose (Hectorol Injection)?

Notify your doctor if you miss a dose of doxercalciferol.

What happens if I overdose (Hectorol Injection)?

Seek emergency medical attention.

Symptoms of a doxercalciferol overdose are not known but may include irregular heartbeats, abdominal pain, nausea, vomiting, dry mouth, decreased appetite, constipation, weakness, muscle pain, bone pain, tiredness, headache, and a metallic taste in the mouth.

What should I avoid while taking doxercalciferol (Hectorol Injection)?

Do not take antacids that contain magnesium while taking doxercalciferol, unless otherwise directed by your doctor.

What other drugs will affect doxercalciferol (Hectorol Injection)?

Before taking this medication, tell your doctor if you are taking any of the following medicines:

  • antacids that contain magnesium;
  • digoxin (Lanoxin, Lanoxicaps);
  • a vitamin D supplement;
  • mineral oil; or
  • cholestyramine (Questran).

You may not be able to take doxercalciferol, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with doxercalciferol. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about doxercalciferol written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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