Doxercalciferol

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Before initiating treatment, ensure serum calcium is not above the upper limit of normal.
• ( 2.1 ) Dosage for doxercalciferol injection in patients with CKD on dialysis :
• Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
• Maximum dose is 18 mcg weekly.
• ( 2.4 ) Target the maintenance dose of doxercalciferol injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
• ( 2 ) See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions.
• ( 2 )
• 2.1 Prior to Initiation of Doxercalciferol Injection Ensure serum calcium is not above the upper limit of normal before initiating treatment with doxercalciferol injection [see Warnings and Precautions (5.1) ].
• 2.4 Important Administration Instructions for Doxercalciferol Injection Administer doxercalciferol injection intravenously as a bolus dose at the end of dialysis.
• Inspect doxercalciferol injection visually prior to administration; the solution should appear clear and colorless.
• Do not use if the solution is not clear or particles are present.
• After initial vial use:
• discard unused portion of the single-dose vial; store opened multiple-dose vial for up to 3 days at 2°C to 8°C (36°F to 46°F).
• Discard unused portion of multiple-dose vial after 3 days [see How Supplied/Storage and Handling (16) ].
• 2.5 Dosage Recommendations for Doxercalciferol Injection in Patients with CKD on Dialysis Initiate doxercalciferol injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
• Target the maintenance dose of doxercalciferol injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
• Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment.
• Titrate the dose of doxercalciferol injection based on intact PTH.
• The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range.
• The maximum dose is 18 mcg weekly.
• Prior to raising the dose, ensure serum calcium is within normal limits.
• Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4) ] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1) ].
• If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower.
• 2.6 Drug Interactions that May Require Dosage Adjustments of Doxercalciferol Injection Increased monitoring of serum calcium and dose adjustment of doxercalciferol injection may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7) ].
• Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of doxercalciferol injection may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions (7) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and efficacy of doxercalciferol in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of doxercalciferol did not include sufficient numbers of patients 65 years or over to determine whether they respond differently from younger subjects.
• In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed in greater detail in another section of the label:
• Hypercalcemia [see Warnings and Precautions (5.1) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical 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.
• Doxercalciferol Capsules 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).
• After randomization to two groups, eligible patients underwent an 8-week washout period during which no vitamin D derivatives were administered to either group.
• Subsequently, all patients received doxercalciferol capsules in an open-label fashion for 16 weeks followed by a double-blind period of 8 weeks during which patients received either doxercalciferol capsules or placebo.
• Adverse reactions occurring in the doxercalciferol capsule groups at a frequency of 2% or greater, and more frequently than in the placebo group are presented in Table 2.
• Table 2:
• Adverse Reactions Occurring in ≥2% Doxercalciferol Capsule-Treated Patients with CKD on Dialysis and Greater than Placebo in Two Double-Blind Clinical Studies * A patient who reported the same medical term more than once was counted only once for that medical term.
• Adverse Reaction* Doxercalciferol (n=61) % Placebo (n=61) % Edema 34 21 Malaise 28 20 Headache 28 18 Nausea/Vomiting 21 20 Dizziness 12 10 Dyspnea 12 7 Pruritus 8 7 Bradycardia 7 5 Anorexia 5 3 Dyspepsia 5 2 Arthralgia 5 0 Weight increase 5 0 Abscess 3 0 Sleep disorder 3 0 Doxercalciferol Injection Adverse reactions in patients with CKD on hemodialysis Doxercalciferol injection has been studied in 70 patients with CKD on hemodialysis in two 12-week, open-label, single-arm, multicenter studies [see Clinical Studies (14.3) ] .
• The incidence of hypercalcemia and hyperphosphatemia increased during therapy with doxercalciferol injection.
• Patients with higher pretreatment serum levels of calcium (>10.5 mg/dL) or phosphorus (>6.9 mg/dL) were more likely to experience hypercalcemia or hyperphosphatemia.
• There was no placebo group included in the studies of doxercalciferol injection.
• Adverse reactions in patients with CKD on hemodialysis receiving doxercalciferol injection are expected to be similar to those reported in placebo-controlled studies of doxercalciferol capsules presented in Table 2.
• 6.2 Postmarketing 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, including fatal outcome, have been reported in patients on hemodialysis following administration of doxercalciferol injection.
• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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) ] .
• Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd.
• E.
• Windsor, NJ 08520 Manufactured by:
• Eugia Pharma Specialities Limited Hyderabad - 500032 India

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• clear and colorless aqueous solution available as follows:
• 2 mcg per mL single-dose vial 4 mcg per 2 mL (2 mcg/mL) single-dose vial 4 mcg per 2 mL (2 mcg/mL) multiple-dose vial Injection:
• ( 3 ) 2 mcg per mL single-dose vial 4 mcg per 2 mL (2 mcg/mL) single-dose vial 4 mcg per 2 mL (2 mcg/mL) multiple-dose vial

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Doxercalciferol injection is a clear, colorless aqueous solution supplied in 2 mL amber glass vials as follows.
• 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 2 mcg per mL 2 mcg/mL Yellow 1 × 1 mL single-dose vial 55150-357-01 55150-357-01 50 × 1 mL single-dose vials 55150-357-50 4 mcg per 2 mL 2 mcg/mL Sky blue 1 × 2 mL single-dose vial 55150-358-01 55150-358-01 50 × 2 mL single-dose vials 55150-358-50 4 mcg per 2 mL 2 mcg/mL Magenta 1 × 2 mL multiple-dose vial 55150-359-01 55150-359-01 50 × 2 mL multiple-dose vials 55150-359-50 Storage and Handling *Protect from light.
• Store unopened vial in original carton.
• Dosage Form Storage temperature Excursions permitted to In-use storage Single-dose vial* 25°C (77°F) 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature] Discard unused portion 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 The vial stopper is not made with natural rubber latex.

Quoted from the official label, section “How Supplied”.

What is in it

• Doxercalciferol injection contains doxercalciferol, which is a synthetic vitamin D 2 analog.
• Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D 2 (1α,25-(OH) 2 D 2 ), a naturally occurring, biologically active form of vitamin D 2 .
• Doxercalciferol, USP is a white to off-white crystallized powder with a calculated molecular weight of 412.66 and a molecular formula of C 28 H 44 O 2 .
• It is soluble in oils and organic solvents, but is relatively insoluble in water.
• Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol.
• The structural formula is:
• Injection Doxercalciferol injection 1 mL single-dose vials contain 2 mcg/mL of doxercalciferol.
• Doxercalciferol injection 2 mL single-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol.
• Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients:
• butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); ethanol, 100% (0.05 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); and sodium phosphate monobasic, monohydrate (1.8 mg).
• Doxercalciferol injection 2 mL multiple-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol.
• Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients:
• butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); ethanol, 100% (0.075 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); and sodium phosphate monobasic, monohydrate (1.8 mg).
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

13 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Doxercalciferol