Doxercalciferol (Oral)

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 occurs when the parathyroid glands in the neck produce too much parathyroid hormone (PTH). This hormone helps control the levels of calcium and phosphorus in your blood.

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

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.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

Appropriate studies have not been done on how age affects the effects of doxercalciferol in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of doxercalciferol. However, older adults are more likely to have age-related liver or heart issues, which may require caution and a dose adjustment for patients using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the possible benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you take this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are not necessarily exhaustive.

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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times or with certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any additional medical issues, especially:

• Bone disease—Use with caution. This may worsen your condition.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require 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.

In the U.S.

• Hectorol

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Vitamin D Analog

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.