Doxercalciferol (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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

Storage and Handling

*
Protect from light. Store unopened vial in original carton.
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

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 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

Image 01
(click image for full-size original)

Doxercalciferol Injection, 4 mcg/2 mL

Carton Label- 2 mL Multi-dose Vials in Package of 50

NDC 68180-718-52

Image 03
(click image for full-size original)
DOXERCALCIFEROL doxercalciferol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-718
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXERCALCIFEROL (DOXERCALCIFEROL) DOXERCALCIFEROL 4 ug in 2 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 0.15 mL in 2 mL
BUTYLATED HYDROXYTOLUENE 0.04 mg in 2 mL
EDETATE DISODIUM 2.2 mg in 2 mL
POLYSORBATE 20 20 mg in 2 mL
SODIUM CHLORIDE 3 mg in 2 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 28.8 mg in 2 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 3.6 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-718-52 50 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68180-718-52)
2 NDC:68180-718-12 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 2 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68180-718-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210801 12/17/2019
Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Revised: 12/2023 Lupin Pharmaceuticals, Inc.

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