Hectorol (Intravenous)

Doxercalciferol injection is used to treat secondary hyperparathyroidism (overactive parathyroid glands) 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 should only be given by a doctor or under their direct supervision.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

This medicine may increase the calcium in your blood (hypercalcemia). Contact your doctor right away if you experience 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 happen while using this medicine. Inform your doctor immediately if you have pain or swelling in your 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. Contact your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on your face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around your eyes, face, lips, or tongue, or unusual tiredness or weakness.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Taking other medicines (e.g., digoxin, Lanoxin®) along 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 of taking it compared to the benefits it may provide. 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 provider know about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have been no appropriate studies to see how doxercalciferol injection affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not shown any specific problems for elderly patients that would limit the use of doxercalciferol injection. However, older adults are more likely to have liver or heart problems related to aging, which may require careful monitoring and possible dose adjustments for those taking 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 potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together under certain circumstances. If you are prescribed this medicine, it is especially important for your healthcare provider to know if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

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

• Burosumab-twza

Using this medicine with any of the following is usually not recommended, but it may be necessary in some cases. If you are prescribed both, your doctor may adjust the dose or frequency of one or both medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine is used. Be sure to tell your doctor about any other medical conditions you have, 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 or nurse immediately if any of the following side effects occur:

Incidence not known

• Blurred vision
• Bone pain
• Chest tightness
• Confusion
• Constipation
• Cough
• Difficulty swallowing
• Depression
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Fast heartbeat
• 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
• Metallic taste
• Muscle weakness
• Nausea
• No breathing
• No pulse or blood pressure
• Puffiness or swelling of the eyelids or around the face, lips, or tongue
• Stomach pain
• Sweating
• Thirst
• Trouble breathing
• Unconscious
• Unusual tiredness or weakness
• 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:

Incidence not known

• Chest discomfort
• Pain, itching, redness, or swelling at the injection site
• Sensation of skin burning

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:

• Solution

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin D Analog

A nurse or other trained health professional will give you this medicine in a hospital or dialysis center. This medicine is given through a needle placed in one of your veins. It is usually given 3 times a week after your 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.

Use 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.