Hectorol Injection
- Generic Name: doxercalciferol injection
- Brand Name: Hectorol Injection
Hectorol Injection (Doxercalciferol Injection) side effects drug center
Hectorol Injection Side Effects Center
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.
Hectorol Injection Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; chest discomfort, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using doxercalciferol and call your doctor at once if you have:
- chest pain, slow heartbeats;
- high calcium levels--nausea, vomiting, constipation, increased thirst or urination, confusion, lack of energy, weight loss, tiredness;
- signs of infection--fever, chills, flu-like symptoms, warmth, redness, vomiting, diarrhea, pain or burning when you urinate;
- low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, cold hands and feet; or
- dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.
Common side effects may include:
- numbness, tingling, burning pain;
- infections, not feeling well;
- cold symptoms such as stuffy nose, sneezing, cough;
- itching;
- headache, dizziness, weakness;
- depressed mood, trouble sleeping;
- upset stomach, nausea, vomiting, constipation;
- feeling short of breath;
- swelling; or
- muscle stiffness.
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.
Read the entire detailed patient monograph for Hectorol Injection (Doxercalciferol Injection)
Hectorol Injection Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in another section of the label:
- Hypercalcemia [see WARNINGS AND PRECAUTIONS]
- Serious Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Adynamic Bone Disease [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
HECTOROL Capsules
Adverse reactions in patients with stage 3 or 4 CKD
HECTOROL capsules have been evaluated in two placebo-controlled, double-blind 24 week studies in patients with Stage 3 or 4 CKD. Patients were treated with HECTOROL capsules (n=27) or placebo (n=28) [see Clinical Studies]. Adverse reactions occurring in the HECTOROL capsules group at a frequency of 5% or greater and more frequently than in the placebo group are presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥5% HECTOROL
Capsule-Treated Patients with CKD on Predialysis and Greater than Placebo in
Two Double- Blind Clinical Studies
| Adverse Reaction* | HECTOROL (n=27) % |
Placebo (n=28) % |
| Infection/bacterial infection/viral infection | 30 | 25 |
| Constipation | 26 | 11 |
| Rhinitis | 22 | 11 |
| Anemia | 19 | 4 |
| Cough | 19 | 4 |
| Dyspnea | 19 | 11 |
| Paresthesia | 15 | 11 |
| Asthenia | 15 | 11 |
| Insomnia | 15 | 4 |
| Hypertonia | 11 | 4 |
| Angina pectoris | 8 | 0 |
| Dehydration | 7 | 4 |
| Depression | 7 | 0 |
| Dyspepsia | 7 | 4 |
| Edema | 7 | 4 |
| Urinary tract infection | 7 | 4 |
| Leukopenia | 7 | 0 |
| Chest pain | 7 | 4 |
| Pruritus | 7 | 4 |
| Sinusitis | 7 | 4 |
| *Pooled data on adverse reactions from clinical study reports (Studies BCI-CH-115 and BCI-CH-119). | ||
Adverse Reactions In Patients With CKD On Dialysis
HECTOROL capsules have been evaluated in two placebo-controlled, double-blind studies in patients with CKD on hemodialysis. Patients were treated with HECTOROL capsules (n=61) or placebo (n=61) [see Clinical Studies]. After randomization to two groups, eligible patients underwent an 8-week washout period during which no vitamin D derivatives were administered to either group. Subsequently, all patients received HECTOROL capsules in an open-label fashion for 16 weeks followed by a double-blind period of 8 weeks during which patients received either HECTOROL capsules or placebo. Adverse reactions occurring in the HECTOROL capsule groups at a frequency of 2% or greater, and more frequently than in the placebo group are presented in Table 2.
Table 2: Adverse Reactions Occurring in ≥2% HECTOROL
Capsule-Treated Patients with CKD on Dialysis and Greater than Placebo in Two
Double-Blind Clinical Studies
| Adverse Reaction* | HECTOROL (n=61) % |
Placebo (n=61) % |
| Edema | 34 | 21 |
| Malaise | 28 | 20 |
| Headache | 28 | 18 |
| Nausea/Vomiting | 21 | 20 |
| Dizziness | 12 | 10 |
| Dyspnea | 12 | 7 |
| Pruritus | 8 | 7 |
| Bradycardia | 7 | 5 |
| Anorexia | 5 | 3 |
| Dyspepsia | 5 | 2 |
| Arthralgia | 5 | 0 |
| Weight increase | 5 | 0 |
| Abscess | 3 | 0 |
| Sleep disorder | 3 | 0 |
| *A patient who reported the same medical term more than once was counted only once for that medical term. | ||
HECTOROL Injection
Adverse Reactions In Patients With CKD On Hemodialysis
HECTOROL injection has been studied in 70 patients with CKD on hemodialysis in two 12-week, open-label, single-arm, multicenter studies [see Clinical Studies]. The incidence of hypercalcemia and hyperphosphatemia increased during therapy with HECTOROL injection. Patients with higher pretreatment serum levels of calcium (>10.5 mg/dL) or phosphorus (>6.9 mg/dL) were more likely to experience hypercalcemia or hyperphosphatemia.
There was no placebo group included in the studies of HECTOROL injection. Adverse reactions in patients with CKD on hemodialysis receiving HECTOROL injection are expected to be similar to those reported in placebo-controlled studies of HECTOROL capsules presented in Table 2.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of HECTOROL. 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.
Read the entire FDA prescribing information for Hectorol Injection (Doxercalciferol Injection)
&Copy; Hectorol Injection Patient Information is supplied by Cerner Multum, Inc. and Hectorol Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.