Ibandronate
BONIVA
What it isFPPS-inhibiting nitrogen bisphosphonate; postmenopausal osteoporosis.
Why this oneMonthly oral or quarterly IV dosing, which suits patients who cannot manage weekly upright dosing.
What limits itVertebral fracture data only — no hip fracture evidence, unlike alendronate and zoledronate. Same esophagitis precautions; avoid below eGFR 30.
FDA-approved for
- postmenopausal osteoporosis (2003)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Postmenopausal osteoporosis (treatment/prevention) | Adults | 150 mg once monthly (same day each month) | 150 mg once monthly |
Renal Not recommended if CrCl <30 mL/min (severe renal impairment)
Hepatic Undefined
Missed dose: if next scheduled day >7 days away, take one tablet next morning then resume; if 1–7 days away, skip and wait for next month
Instructions
- Swallow whole with 6–8 oz plain water only, standing/upright
- Take ≥60 min before first food, drink, or medication of the day
- Do not lie down for ≥60 min after dosing
- Do not chew or suck the tablet
- Take supplemental calcium/vitamin D if intake inadequate (not within 60 min of dose)
Contraindications
- Esophageal abnormalities that delay emptying (stricture, achalasia)
- Inability to stand or sit upright for ≥60 minutes
- Hypocalcemia
Cautions
- Upper GI adverse reactions (esophagitis, ulcers)
- Hypocalcemia — correct before starting
- Severe, occasionally incapacitating bone/joint/muscle pain
- Osteonecrosis of the jaw
- Atypical low-energy femoral shaft fractures
- Not recommended in severe renal impairment (CrCl <30 mL/min)
Adverse reactions
- Back pain
- Dyspepsia
- Pain in extremity
- Diarrhea
- Headache
- Myalgia
Pregnancy Not indicated in women of reproductive potential; no human data; animal maternal/fetal toxicity
Lactation Not indicated in women of reproductive potential; unknown in human milk (present in rat milk)
NO BOXED WARNINGS
Principal riskEsophagitis; no hip fracture data
Cost, est. cash$5–$150/month
Generic entry2012
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.
Mechanism of action: Ibandronate ballicule
