Doxercalciferol

Doxercalciferol is a prescription medication used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. 

• Doxercalciferol is available under the following different brand names: Hectorol.

Common side effects of Doxercalciferol include:

• Numbness,
• Tingling,
• Burning pain,
• Infections,
• Feeling unwell,
• Stuffy nose,
• Sneezing,
• Cough,
• Itching,
• Headache,
• Dizziness,
• Weakness,
• Depression,
• Trouble sleeping,
• Upset stomach,
• Nausea,
• Vomiting,
• Constipation,
• Shortness of breath,
• Swelling, and
• Muscle stiffness

Serious side effects of Doxercalciferol include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Chest pain,
• Slow heartbeats,
• Nausea,
• Vomiting,
• Constipation,
• Increased thirst or urination,
• Confusion,
• Lack of energy,
• Weight loss,
• Tiredness,
• Fever,
• Chills,
• Flu-like symptoms,
• Warmth,
• Redness,
• Vomiting,
• Diarrhea,
• Pain or burning while urinating,
• Pale skin,
• Lightheadedness,
• Shortness of breath,
• Cold hands and feet,
• Feeling very thirsty or hot,
• Being unable to urinate,
• Heavy sweating, and
• Hot and dry skin

Rare side effects of Doxercalciferol include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 0.5 mcg
• 2.5 mcg

Injectable solution

• 4 mcg/2 mL multidose 2-mL vial
• 10 mcg/5 mL multidose 5-mL vial

Dialysis

Adult dosage

• Initial dose
  • 10 mcg orally 3 times/week at end of dialysis, may increase by 2.5 mcg/dose, no more than 20 mcg/dose 3 times/week OR
  • 4 mcg IV bolus 3 times/week following dialysis, may increase by 1-2 mcg/dose every 8 weeks

Pre-dialysis

Adult dosage

• Initial: 1 mcg orally once a day, may increase by 0.5 mcg/dose every 2 weeks
• Reduce or interrupt dose if intact parathyroid hormone (iPTH) concentration falls or calcium and phosphorus are persistently above the normal range (consult package insert); reinitiate at least 0.5 mcg lower than the last dose.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Doxercalciferol has severe interactions with no other drugs.
• Doxercalciferol has serious interactions with no other drugs.
• Doxercalciferol has moderate interactions with the following drugs
  • cholestyramine
  • colesevelam
  • colestipol
  • magnesium supplement
  • orlistat
  • sodium sulfate/magnesium sulfate/potassium chloride
  • sodium sulfate/potassium sulfate/magnesium sulfate
• Doxercalciferol has minor interactions with the following drugs
  • magnesium chloride
  • magnesium citrate
  • magnesium hydroxide
  • magnesium oxide
  • magnesium sulfate

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Hypercalcemia, hyperphosphatemia, hypervitaminosis D

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Doxercalciferol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Doxercalciferol?”

Cautions

• Monitor serum calcium and phosphorus frequently; reduce the dose or stop the drug if Ca x P product is above 75 mg²/dL²
• 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; in chronic kidney disease maintain Ca x P product at below 55 mg²/dL²
• Use with caution in patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia
• Decrease dose if hypercalcemia or hyperphosphatemia occurs.
• Serious hypersensitivity reactions, including fatal outcome, in patients on hemodialysis, reported post-marketing; hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue, and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest; reactions may occur separately or together
• Use oral calcium-based or other non-aluminum-containing phosphate binders and a low-phosphate diet to control serum phosphorus levels in patients undergoing dialysis.

Pregnancy and Lactation

• Limited available data on pregnant women are insufficient to identify drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother and fetus associated with chronic kidney disease in pregnancy as it increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery polyhydramnios, stillbirth, and low-birthweight infants.
• Lactation
  • There is no information available on the presence of doxercalciferol in human milk, the effects of the drug on the breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or underlying maternal condition.
  • Infants exposed to the drug through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation, and weight loss; consider monitoring serum calcium in the infant.