Pronunciation:

dox-er-kal-SIF-er-ol

Brand Names:

• Hectorol

Dosage Forms:

• Capsule, Liquid Filled

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Vitamin D Analog

Uses of This Medicine:

Doxercalciferol is used to treat secondary hyperparathyroidism (overactive parathyroid glands) in patients with stage 3 or 4 chronic kidney disease and in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone helps to control the concentrations of calcium and phosphorus in your blood.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of doxercalciferol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxercalciferol in the elderly. However, elderly patients are more likely to have age-related liver or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Burosumab-twza

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone disease—Use with caution. May make this condition worse.

• Hypercalcemia (high calcium levels in the blood) or
• Vitamin D overdose—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This medicine is usually taken at the time you have dialysis treatment.

Carefully follow your doctor's instructions about any special diet. Do not use vitamin D, phosphate, or calcium supplements, or antacids or other medicines containing magnesium without asking your doctor.

Take this medicine at least 1 hour before or 4 to 6 hours after taking cholestyramine, mineral oil, or other products that may affect fat absorption.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For hyperparathyroidism with chronic kidney disease on dialysis:
    • Adults—At first, 10 micrograms (mcg) 3 times a week during dialysis. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mcg per week.
    • Children—Use and dose must be determined by your doctor.
  • For hyperparathyroidism with stage 3 or 4 chronic kidney disease:
    • Adults—At first, 1 microgram (mcg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 3.5 mcg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

This medicine may increase the calcium in your blood (hypercalcemia). Check with your doctor right away if you have confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, nausea, stomach pain, thirst, unusual tiredness, vomiting, or weight loss.

Adynamic bone disease (low bone turnover) with high risk of fractures may occur while using this medicine. Tell your doctor right away if you have pain or swelling in the arms or legs without any injury.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Taking other medicines (eg, digoxin, Lanoxin®) together with doxercalciferol may require your doctor to change the dose of this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Arm, back, or jaw pain

black, tarry stools

bladder pain

chest pain, discomfort, tightness, or heaviness

confusion

cough or hoarseness

decreased urination

fast or irregular heartbeat

fever or chills

frequent urge to urinate

increase in heart rate

lightheadedness, dizziness, or fainting

lower back or side pain

nausea

painful, burning, or difficult urination

pale skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sunken eyes

sweating

swollen glands

thirst

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

wrinkled skin

Incidence not known

Blurred vision

constipation

cough

depression

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

heart stops

hives, itching, skin rash

incoherent speech

increased urination

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

low bone turnover

metallic taste

muscle weakness

no breathing

no pulse or blood pressure

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach pain

thirst

unconscious

vomiting

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving

excessive muscle tone

heartburn

indigestion

muscle pain, stiffness, tension, or tightness

pain in the joints

pain or tenderness around the eyes and cheekbones

stomach discomfort or upset

stuffy or runny nose

swelling

trouble sleeping

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.