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DOXERCALCIFEROL capsule


  1. Hypercalcemia:
  2. Hypersensitivity:
  3. Monitoring:
  4. Drug Interactions:
  5. Patient Information

Hypercalcemia: 

Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) [see Warnings and Precautions (5.1)].

Hypersensitivity: 

Inform patients that hypersensitivity reactions can occur with doxercalciferol [see Warnings and Precautions (5.3)].

Monitoring: 

Inform patients that they will need routine monitoring of laboratory parameters such as calcium and intact PTH while receiving doxercalciferol. Inform patients that more frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued [see Dosage andAdministration (2), Drug Interactions (7)].

Drug Interactions: 

Advise patients to inform their physician of all medications, including prescription and nonprescription drugs, and supplements they are taking. Advise patients to also inform their physician that they are receiving doxercalciferol if a new medication is prescribed [see Drug Interactions (7)].

Made in India.

Manufactured by:
Cipla Limited
Kurkumbh, Maharashtra, India

Manufactured for:
West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

21072711

Revised April 2019

Patient Information 

Hypercalcemia

Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss)[seeWarnings and Precautions (5.1)].

Hypersensitivity

Inform patients that hypersensitivity reactions can occur with doxercalciferol[seeWarnings and Precautions (5.3)].

Monitoring

Inform patients that they will need routine monitoring of laboratory parameters such as calcium and intact PTH while receiving doxercalciferol. Inform patients that more frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued[seeDosage and Administration (2),Drug Interactions (7)].

Drug Interactions

Advise patients to inform their physician of all medications, including prescription and nonprescription drugs, and supplements they are taking. Advise patients to also inform their physician that they are receiving doxercalciferol if a new medication is prescribed[seeDrug Interactions (7)].

Doxercalciferol Capsules

Manufactured by Catalent Pharma Solutions for:
Winthrop U.S.,
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

HECTOROL Injection

Manufactured by:
Genzyme Corporation
Cambridge, MA 02142



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