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Hectorol Injection Prescribing Information Hectorol Capsules Prescribing Information Healthcare Professionals For U.S. Residents Only

  • What is chronic kidney disease (CKD)?

    When you have CKD, your kidneys aren’t healthy.1 As a result, they are less able to filter waste products, maintain the right balance of fluids and minerals in your body, and activate certain hormones.1

    You should not take Hectorol (doxercalciferol) if you have a history of abnormally high calcium blood levels (hypercalcemia) or if you have very high vitamin D levels.2

  • What are the different stages of CKD?

    There are 5 stages of CKD that your doctor may discuss with you.3 In stages 3 and 4, the kidneys are not fully working like they should and need some help to provide the body with a normal balance of fluids and minerals.3 Diet changes and medicines might be recommended.3 In stage 5, kidneys will need the support of dialysis.3

  • What is parathyroid hormone (PTH)?

    The parathyroid gland checks the levels of calcium and phosphorus in your body and sends out a hormone to control those levels.4 This hormone is called PTH.4,5

    When your kidneys aren’t healthy, they are not able to activate vitamin D, so your body can have trouble maintaining the right balance of calcium and phosphorus.1,5 Low calcium levels will cause the parathyroid gland to send out too much PTH.1,5 When you have too much PTH, you may have secondary hyperparathyroidism (SHPT).4,5

  • Why is SHPT bad for me?

    Over time, hyperparathyroidism can cause serious problems with your bones, lungs, and heart.5,6 It can result in too much calcium being taken from your bones, leaving them weak.5,6 SHPT can also contribute to calcium buildup in your heart or other areas where it doesn’t belong.6

    SHPT may become hard to manage if left untreated. If you have been diagnosed with SHPT as a result of CKD, ask your doctor what you can do to help manage these conditions.

Contact Us

Contact Hectorol® for more informationSanofi US
500 Kendall Street
Cambridge, MA 02142
Contact Hectorol® for more information Toll Free: 800-847-0069 Contact Hectorol® for more information Fax: 617-591-5986

Indication

  • Hectorol Injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
  • Hectorol capsules are indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease not on dialysis and patients with chronic kidney disease on dialysis.

Important Safety Information

  • You should not take Hectorol if you have a history of abnormally high calcium blood levels (hypercalcemia) or if you have very high vitamin D levels
  • Do not take Hectorol injection if you are allergic to doxercalciferol or any of the ingredients in Hectorol injection.
  • Overdosage of any form of vitamin D is dangerous and may require emergency attention.
  • Before taking Hectorol, tell your doctor if you have ever had an irregular heartbeat or seizure, or if you are taking any digitalis drugs (or cholestyramine if you are taking Hectorol capsules).
  • Do not take other vitamin D related drugs if you are currently taking Hectorol.
  • It is important for anyone taking Hectorol to talk to their doctor before taking any non-prescription drugs or magnesium-containing antacids, supplements and herbal preparations and to adhere to instructions about following a low phosphorus diet and calcium supplementation.
  • Your doctor should monitor your calcium, phosphorus and PTH levels.
  • Serious allergic reactions (including fatal outcome) have been reported in patients on hemodialysis after Hectorol injection. Hectorol Injection can cause allergic reactions including life-threatening allergic reactions (anaphylaxis) with symptoms of swelling of the face, lips, tongue and airways, low blood pressure, unresponsiveness, chest discomfort, shortness of breath, and cardiac arrest. Before taking Hectorol injection, it is important to tell your doctor if you had any allergic reactions to Hectorol injection in the past.
  • Tell your doctor if you experience symptoms of hypercalcemia such as weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste and loss of appetite.
  • Your doctor should check and treat you for nutritional vitamin D deficiency before starting you on Hectorol capsules.
  • The main side effects of treatment with Hectorol injection are hypercalcemia, hyperphosphatemia, and oversuppression of PTH. The main side effects of treatment with Hectorol capsules are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of PTH. Your doctor may ask you questions to see if you are experiencing any symptoms related to these conditions.
  • During treatment, your doctor may change your dose of Hectorol as well as the dose of your phosphate binder.
  • Common side effects seen in Hectorol-treated patients on dialysis were swelling, headache, ill feeling, nausea/vomiting, dizziness, shortness of breath, itching and slow heartbeat.
  • Common side effects seen in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease were infection, chest pain, constipation, indigestion, anemia, dehydration, depression, muscle stiffness, insomnia, tingling, increased cough, shortness of breath and runny/stuffy nose.
  • Tell your doctor if you are pregnant or nursing.
  • This drug should be used with caution if you have impaired liver function.

Please click here for Hectorol Capsules Full Prescribing Information or click here for Hectorol Injection Full Prescribing Information.

The health information contained herein is provided for general education purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.
References:
  1. KDIGO 2009/p S3/col 1/para 1
  2. Hectorol ISI/first bullet
  3. KDIGO 2009/p S3/col 1/para 2
  4. Dorland’s 31st ed./p 793
  5. Hectorol PI Injection/p 1/col 1/para 4
  6. KDIGO 2009/p S3/col 1/para 2,3
  7. KDIGO 2009/p S3/col 1/para 3

Contact Us

Contact Hectorol® for more informationSanofi US
500 Kendall Street
Cambridge, MA 02142
Contact Hectorol® for more informationToll free: 800-847-0069 Contact Hectorol® for more informationFax: 617-591-5986

IMPORTANT SAFETY INFORMATION
You should not take Hectorol if you have a history of abnormally high calcium blood levels (hypercalcemia) or if you have very high vitamin D levels. VIEW MORE