Calcitriol
ROCALTROL
Pronunciation: kal-si-TRYE-oel
“Calcit-royal”
What it isActive 1,25-dihydroxyvitamin D requiring no renal hydroxylation; CKD mineral bone disorder and hypoparathyroidism.
Why it mattersIt bypasses the failing kidney, which cholecalciferol cannot, and acts within hours rather than weeks.
What it changesHypercalcemia is the limiting toxicity and needs monitoring. Its short half-life means the effect is quickly lost, and quickly reversed in overdose.
FDA-approved for
- hypocalcemia (renal disease) (1978)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Dialysis patients (renal osteodystrophy) | Adults | 0.25 mcg QD | 0.5–1 mcg QD | |
| Hypoparathyroidism / pseudohypoparathyroidism | Adults & children ≥6y | 0.25 mcg QAM | 0.5–2 mcg QD | |
| Hypoparathyroidism | Children 1–5y | 0.25–0.75 mcg QD | 0.25–0.75 mcg QD | |
| Predialysis patients | Adults & children ≥3y | 0.25 mcg QD | up to 0.5 mcg QD | 0.5 mcg QD |
| Predialysis patients | Children <3y | 10–15 ng/kg/day | 10–15 ng/kg/day |
Titration Dialysis: 4–8 week intervals; hypoparathyroidism and predialysis: 2–4 week intervals between increases
Renal Dosed per renal/dialysis status (see indications)
Hepatic Undefined
Instructions
- Start at the lowest possible dose; do not increase without monitoring serum calcium
- Ensure adequate dietary calcium (≥600 mg/day)
- Check serum calcium ≥twice weekly during titration, then monthly
- Discontinue immediately if hypercalcemia occurs, until normocalcemia returns
Available strengths
- cap 0.25, 0.5 mcg
- sol 1 mcg/mL
- ointment 3 mcg/g
- inj 0.001 mg/mL
Contraindications
- Hypercalcemia or evidence of vitamin D toxicity
Cautions
- Hypercalcemia / vitamin D intoxication — monitor serum calcium
- Soft-tissue calcification with concurrent hyperphosphatemia
- Requires adequate but not excessive calcium intake
Adverse reactions
- Early hypercalcemia: weakness, headache, nausea, vomiting, dry mouth, constipation, bone/muscle pain, anorexia
- Late: polyuria, polydipsia, weight loss, nocturia, nephrocalcinosis, hypertension, cardiac arrhythmias
- Hypersensitivity reactions (pruritus, rash, urticaria)
Pregnancy Pregnancy Category C; teratogenic in rabbits at high doses; use only if benefit justifies fetal risk
Lactation Undefined
Cost
Generic entry2001
NO BOXED WARNINGS
Principal riskHypercalcemia
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.