Doxercalciferol (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 manage the levels of calcium and phosphorus in your blood.

This medicine is to be given only by or under the direct supervision of a doctor.

It is very important that your doctor checks 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 raise the calcium levels 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 occur 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 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 (e.g., digoxin, Lanoxin®) together with doxercalciferol may require your doctor to adjust the dose of this medicine.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how doxercalciferol injection affects children. Safety and effectiveness for this age group have not been proven.

Geriatric

Studies conducted so far have not shown any specific problems for elderly patients that would limit the effectiveness of doxercalciferol injection. However, older adults are more likely to have age-related liver or heart issues, which may need careful monitoring and possible dose adjustments for those taking this medicine.

Breast Feeding

There are no adequate studies on the risks to infants when this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before using 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 occur. In these situations, your doctor may need 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 while you are receiving this medicine. The following interactions are based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of the other medicines you are taking.

• Burosumab-twza

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

• Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime, or with certain types of food, due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can 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 necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away 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. Your health care professional may also be able to tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.