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Brand Name
Doxercalciferol
View Brand InformationFDA approval date: September 26, 2019
Classification: Vitamin D2 Analog
Form: Injection, Capsule
What is Doxercalciferol?
Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease and adult patients with CKD on dialysis. Doxercalciferol Capsules is a synthetic vitamin D2 analog: Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease and adult patients with CKD on dialysis.
Approved To Treat
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Brand Information
Doxercalciferol (Doxercalciferol)
1INDICATIONS AND USAGE
- Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.
2DOSAGE FORMS AND STRENGTHS
- 0.5 mcg – White, opaque, oval shaped soft gelatin capsules. Each capsule is imprinted with
3CONTRAINDICATIONS
Doxercalciferol is contraindicated in patients with:
- Hypercalcemia
- Vitamin D toxicity
- Known hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol capsules; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in another section of the label:
- Hypercalcemia
- Serious Hypersensitivity Reactions
- Adynamic Bone Disease
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions in patients with stage 3 or 4 CKD
Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind 24 week studies in patients with Stage 3 or 4 CKD. Patients were treated with doxercalciferol capsules (n=27) or placebo (n=28)
Adverse reactions in patients with CKD on dialysis
Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind studies in patients with CKD on hemodialysis. Patients were treated with doxercalciferol capsules (n=61) or placebo (n=61)
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of doxercalciferol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus, and skin burning sensation.
5DRUG INTERACTIONS
Tables 3 and 4 include clinically significant drug interactions with doxercalciferol.
6OVERDOSAGE
Overdosage of doxercalciferol may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia
Based on similarities between doxercalciferol and its active metabolite, 1α,25-(OH)
7DESCRIPTION
Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D
Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C
Doxercalciferol capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), ethanol, and medium-chain triglycerides. The capsule shells contain gelatin, glycerin, iron oxide black and titanium dioxide. In addition, the 0.5 mcg capsule shells contain shellac glaze, the 1 mcg capsule shells contain FD&C Blue No. 1, FD&C Yellow No. 6, shellac and the 2.5 mcg capsule shells contain FD&C Red No. 40 and shellac.
8HOW SUPPLIED/STORAGE AND HANDLING
Doxercalciferol capsules are oval, soft gelatin capsules supplied as follows
0.5 mcg, Capsule Color: White, Opaque, Imprint Code: HP 538
NDC: 70518-4642-00
NDC: 70518-4642-01
NDC: 70518-4642-02
OUTER PACKAGING: 50 in 1 BOX
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)
[see USP Controlled Room Temperature.]
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
9PATIENT 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)
Hypersensitivity
Inform patients that hypersensitivity reactions can occur with doxercalciferol
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
DrugInteractions
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
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762