Doxercalciferol is a vitamin D2 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis Doxercalciferol is a synthetic vitamin D 2 analog. MedsAcross supplies Doxercalciferol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis Doxercalciferol is a synthetic vitamin D 2 analog: • Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Source: US FDA prescribing information
Doxercalciferol is a synthetic vitamin D 2 analog that requires metabolic activation to form the active 1α,25-(OH) 2 D 2 metabolite, which binds to the vitamin D receptor (VDR) to result in the selective activation of vitamin D responsive pathways. Vitamin D and doxercalciferol have been shown to reduce PTH levels by inhibiting PTH synthesis and secretion.
Source: US FDA prescribing information
Before initiating treatment, ensure serum calcium is not above the upper limit of normal. 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. Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions.
Source: US FDA prescribing information
Doxercalciferol Injection is contraindicated in patients with: Hypercalcemia Vitamin D toxicity Known hypersensitivity to doxercalciferol or any of the inactive ingredients of Doxercalciferol Injection, serious hypersensitivity reactions including anaphylaxis and angioedema have been reported. • Hypercalcemia. • Vitamin D toxicity. • Know hypersensitivity to doxercalciferol or any of the inactive ingredients of Doxercalciferol Injection
Source: US FDA prescribing information
• Hypercalcemia: Can occur during treatment with Doxercalciferol Injection and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. • Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of Doxercalciferol Injection.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia Serious Hypersensitivity Reactions Adynamic Bone Disease The most common adverse reactions in patients with Stage 3 or 4 CKD (incidence >5%) were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leucopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, cough increased, dyspnea, pruritus, sinusitis, and rhinitis. The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia.
Source: US FDA prescribing information
Tables 3 include clinically significant drug interactions with Doxercalciferol. Table 3: Clinically Significant Drug Interactions with Doxercalciferol Injection and Doxercalciferol Capsules. Drugs that May Increase the Risk of Hypercalcemia Clinical Impact Concomitant administration of high doses of calcium-containing preparations or other vitamin D compounds may increase the risk of hypercalcemia. Thiazide diuretics are known to induce hypercalcemia by reducing excretion of calcium in the urine. Examples Calcium-containing products, other vitamin D compounds or thiazide diuretics Intervention Monitor serum calcium concentrations more frequently and adjust Doxercalciferol dose as needed. Digitalis Compounds Clinical Impact Doxercalciferol can cause hypercalcemia which can potentiate the risk of digitalis toxicity.
Source: US FDA prescribing information
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) 2°C to 8°C (36°F to 46°F), Discard 3 days after opening *Protect from light. Store unopened vial in original carton.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Doxercalciferol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Doxercalciferol 4 mcg/2 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Doxercalciferol 0.5 mcg capsuleOralGeneric name | — | US FDA | Available on request |
| Doxercalciferol 1 mcg capsuleOralGeneric name | — | US FDA | Available on request |
| Doxercalciferol 2.5 mcg capsuleOralGeneric name | — | US FDA | Available on request |
| Doxercalciferol 2 mcg/1 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 9 June 1999 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Doxercalciferol in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 5 presentations of Doxercalciferol and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Doxercalciferol on 9 June 1999, according to Drugs@FDA.
No listed presentation of Doxercalciferol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Doxercalciferol is classified under ATC code H05BX03 (Doxercalciferol).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.