Hectorol (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 happens 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 a 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 the 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 (for example, digoxin, Lanoxin®) together with doxercalciferol may require your doctor to change the dose of this medicine.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, like those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies to understand how doxercalciferol affects children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of doxercalciferol. However, older patients are more likely to have age-related liver or heart issues, which may require caution and dose adjustments for patients taking this medicine.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been selected based on 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 necessary in some cases. If both medicines are prescribed, your doctor may change the dose or how often you use one or both medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at mealtime or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Bone disease—Use with caution. May worsen this condition.

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

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.

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.