Zoledronic acid
RECLAST
Pronunciation: zoe-le-DRON-ik AS-id (REE-klast)
What it isIntravenous FPPS-inhibiting bisphosphonate; as RECLAST (5 mg), osteoporosis and Paget disease. Skeletal events in malignancy are ZOMETA (4 mg), a separate product.
Why this oneA single intermittent infusion removes oral-adherence and esophagitis problems while reducing vertebral and hip fractures.
What limits itAn acute-phase reaction is common after the first infusion. RECLAST is contraindicated at CrCl below 35 mL/min; check calcium and address dental risk first.
Pearls
- Yearly for treatment; every 2 years for prevention.
- Hydrate first; acetaminophen blunts the post-infusion flu-like reaction.
Zoledronic acid prescription history
Animated chart of estimated U.S. prescriptions per year, Osteoporosis meds (1975–2026). Zoledronic acid enters in 2007 (estimated).
FDA-approved for
- osteoporosis/bone metastases (2001)
Principal riskAcute-phase reaction after the first infusion
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Postmenopausal osteoporosis (treatment) | Women | 5 mg IV once yearly | ||
| Postmenopausal osteoporosis (prevention) | Women | 5 mg IV once every 2 years | ||
| Osteoporosis in men | Men | 5 mg IV once yearly | ||
| Glucocorticoid-induced osteoporosis (treatment/prevention) | Adults | 5 mg IV once yearly | ||
| Paget's disease of bone | Adults | 5 mg IV single infusion |
Renal Contraindicated if CrCl <35 mL/min or acute renal impairment; no adjustment needed if CrCl ≥35 mL/min. Calculate CrCl before each dose.
Hepatic Not hepatically metabolized; no clinical data in hepatic impairment
Single dose must not exceed 5 mg; infusion duration ≥15 min
Instructions
- Infuse IV over ≥15 min at a constant rate; follow with a 10 mL normal saline flush
- Ensure adequate hydration before administration
- Acetaminophen after the infusion may reduce acute-phase reaction symptoms
- Osteoporosis: supplement calcium/vitamin D if intake inadequate. Paget's: 1500 mg elemental calcium + 800 IU vitamin D daily, especially the 2 weeks after dosing
- Perform a routine oral examination before initiating
- Do not allow contact with calcium or other divalent-cation solutions; use a separate infusion line
Available strengths
- inj 0.04, 0.05 mg/mL
Contraindications
- Hypocalcemia
- CrCl <35 mL/min or evidence of acute renal impairment (increased risk of renal failure)
Cautions
- Hypocalcemia — correct before treatment; ensure calcium/vitamin D supplementation
- Renal impairment/acute renal failure — monitor CrCl before each dose, hydrate, avoid in dehydration
- Osteonecrosis of the jaw — oral exam before treatment
- Atypical femoral (and other) fractures — evaluate thigh/groin pain
- Severe, occasionally incapacitating bone/joint/muscle pain
- Bronchoconstriction in aspirin-sensitive patients
- Do not give to patients receiving Zometa (same active ingredient)
Adverse reactions
- Pyrexia
- Myalgia
- Arthralgia
- Headache
- Pain in extremity
- Influenza-like illness
- Nausea
- Vomiting
- Diarrhea
- Acute-phase reaction
Pregnancy Insufficient human data; discontinue when pregnancy is recognized. Animal studies show fetal skeletal harm; bisphosphonate is retained in bone for years.
Lactation No data on presence in human milk or effects on the breastfed infant.
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 0.04 mg/mL | inj | per unit | not offered | |
| 0.05 mg/mL | inj | per unit | not offered |
Generic entry2013
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Self-check
- Which product/dose is specified for osteoporosis and Paget disease?
RECLAST 5 mg. - Below what CrCl is RECLAST contraindicated?
35 mL/min.