Paricalcitol
ZEMPLAR
What it isSelective vitamin-D receptor agonist; secondary hyperparathyroidism in chronic kidney disease.
Why this oneIt suppresses PTH with less calcium and phosphate elevation than calcitriol.
What limits itHypercalcemia still requires monitoring, while excessive PTH suppression can cause adynamic bone disease.
FDA-approved for
- secondary hyperparathyroidism (1998)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Secondary hyperparathyroidism, CKD stage 3–4 | Adults | iPTH ≤500: 1 mcg QD or 2 mcg 3×/wk; iPTH >500: 2 mcg QD or 4 mcg 3×/wk | titrate to iPTH target | |
| Secondary hyperparathyroidism, CKD stage 5 | Adults | baseline iPTH ÷ 80 mcg, 3×/wk | titrate (iPTH ÷ 80) | |
| Secondary hyperparathyroidism, CKD stage 3–4 | Children 10–16 yr | 1 mcg 3×/wk | titrate to iPTH target | |
| Secondary hyperparathyroidism, CKD stage 5 | Children 10–16 yr | baseline iPTH ÷ 120 mcg, 3×/wk | titrate |
Titration Adjust at 2–4 week intervals (pediatric: every 4 weeks)
Renal Undefined
Hepatic Undefined
CKD stage 5: initiate only after baseline serum calcium ≤9.5 mg/dL. When dosing 3×/week, not more often than every other day.
Instructions
- Take with or without food
- When dosing 3×/week, administer no more often than every other day
- Reduce or withhold dose if hypercalcemia occurs
- In CKD stage 5, initiate only after baseline serum calcium reduced to ≤9.5 mg/dL
- Do not chronically co-administer aluminum-containing preparations
- Monitor serum calcium, phosphorus, and iPTH
Contraindications
- Evidence of hypercalcemia
- Evidence of vitamin D toxicity
Cautions
- Hypercalcemia / over-suppression of PTH / adynamic bone disease
- Digitalis toxicity potentiated by hypercalcemia
- May increase serum creatinine and decrease eGFR (pre-dialysis)
- Aluminum overload and toxicity with chronic aluminum-containing preparations
Adverse reactions
- Diarrhea, nausea, vomiting
- Nasopharyngitis
- Dizziness
- Hypertension
- Hypersensitivity
- Edema
Pregnancy Insufficient human data; animal studies showed slightly increased embryofetal loss at maternally toxic doses.
Lactation Breastfeeding not recommended during treatment (risk of infant hypercalcemia).
NO BOXED WARNINGS
Principal riskHypercalcemia; adynamic bone disease 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.
Mechanism of action: Paricalcitol ballicule
