Doxercalciferol
HECTOROL
What it isVitamin D2 prodrug requiring only hepatic activation; secondary hyperparathyroidism in CKD.
Why this oneIt bypasses the failing kidney while retaining some physiological regulation, unlike calcitriol.
What limits itHypercalcemia and hyperphosphatemia require monitoring. Oversuppression causes adynamic bone disease.
FDA-approved for
- secondary hyperparathyroidism (1999)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Secondary hyperparathyroidism, Stage 3–4 CKD | Adults | 1 mcg QD | titrate to PTH | 3.5 mcg QD |
| Secondary hyperparathyroidism, CKD on dialysis | Adults | 10 mcg 3×/week at dialysis | titrate to PTH | 20 mcg 3×/week (60 mcg/wk) |
Titration Stage 3–4: may increase by 0.5 mcg at 2-week intervals based on intact PTH.
Renal Dose is defined by CKD stage / dialysis status (see dosing)
Hepatic May not metabolize normally; monitor intact PTH, calcium, phosphorus more frequently
Dialysis: three times weekly, no more frequently than every other day.
Instructions
- Ensure serum calcium is not above the upper limit of normal before initiating.
- Dialysis dosing: three times weekly, no more often than every other day.
- Monitor calcium, phosphorus, and intact PTH; suspend or decrease dose if PTH abnormally low or calcium high; if suspended, restart after 1 week at ≥0.5 mcg lower.
Contraindications
- Hypercalcemia
- Vitamin D toxicity
Cautions
- Hypercalcemia (risk of arrhythmias, seizures); higher risk with calcium/thiazides/vitamin D compounds
- Increased digitalis toxicity risk with hypercalcemia
- Serious hypersensitivity/anaphylaxis reported in hemodialysis patients
- Adynamic bone disease if PTH oversuppressed
Adverse reactions
- Infection
- UTI
- Chest pain / angina
- Constipation
- Dyspepsia
- Anemia
- Edema
- Dyspnea
- Pruritus
Pregnancy Limited data insufficient to identify risk; CKD itself poses maternal/fetal risks
Lactation Undefined
NO BOXED WARNINGS
Principal riskHypercalcemia; adynamic bone with oversuppression
Cost, est. cash$20–$1,500/month
Generic entry2011
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Active metabolites
Mechanism of action: Doxercalciferol ballicule
