Doxercalciferol (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
Doxercalciferol injection is a sterile, clear, colorless aqueous solution supplied in multi-dose amber glass vials containing 4 mcg doxercalciferol in 2 mL of solution as follows. The closure consists of a fluorocarbon-coated bromobutyl stopper, with an aluminum seal and an orange plastic flip-off cap.
Total Strength per Total Volume | Strength per mL | Flip-off Cap Color | Vial Count per Carton × Total Vial Volume and Vial Type | Carton NDC | Vial NDC |
4 mcg/2 mL | 2 mcg/mL | Orange | 10 × 2 mL multiple-dose vials | 68180-718-12 | 68180-718-01 |
50 × 2 mL multiple-dose vials | 68180-718-52 | 68180-718-01 |
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Dosage Form | Storage temperature | Excursions permitted to | In-use storage |
Multiple-dose vial * | 25°C (77°F) | 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature] | 2°C to 8°C (36°F to 46°F), Discard 3 days after opening |
17 PATIENT COUNSELING INFORMATION
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 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 [see Drug Interactions (7)].
$ The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
Manufactured For:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States.
Revised: July 2019 ID: 258369
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Doxercalciferol Injection, 4 mcg/2 mL
2 mL Multi-dose Vial Label
NDC 68180-718-01
Doxercalciferol Injection, 4 mcg/2 mL
Carton Label- 2 mL Multi-dose Vials in Package of 50
NDC 68180-718-52
DOXERCALCIFEROL doxercalciferol injection, solution | |||||||||||||||||||||||||
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Labeler — Lupin Pharmaceuticals, Inc. (089153071) |
Revised: 12/2023 Lupin Pharmaceuticals, Inc.
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