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

Glossary

  • Calcium:

    Mineral in the body that is important for strong teeth and bones1

  • Chronic kidney disease (CKD):

    Gradual loss of kidney function over time2

  • Dialysis:

    Process of removing waste from the blood3

  • Hemodialysis:

    Dialysis for patients with CKD whose kidneys are not working4

  • Hormone:

    Chemical substance that regulates different reactions in the body5

  • Hypercalcemia:

    Condition in which there is too much calcium in the blood6

  • Parathyroid hormone (PTH):

    Hormone released by the parathyroid glands that manages the use of calcium in the body7

  • Phosphate binder:

    Substance that removes extra phosphorus from the blood8

  • Phosphorus:

    An important mineral in the body that helps cells grow and repair themselves9

  • Secondary hyperparathyroidism:

    Condition caused by too much PTH in patients with CKD, which can lead to problems with calcium and phosphorus levels in the blood10

  • Vitamin D:

    Hormone that regulates calcium and phosphorus levels in the body11,12

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. Dorland’s 31st ed./p 274
  2. Dorland’s 31st ed./p 538
  3. Dorland’s 31st ed./p 515
  4. Dorland’s 31st ed./p 850
  5. Dorland’s 31st ed./p 881
  6. Dorland’s 31st ed./p 899
  7. Dorland’s 31st ed./p 882-3
  8. Dorland’s 31st ed./p 219
  9. Dorland’s 31st ed./p 1459
  10. Dorland’s 31st ed./p 905
  11. Dorland’s 31st ed./p 2097
  12. Hectorol Capsules PI/p 1/col 1/para 3,4

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