ibandronic acid

CLINICAL USE

Reduction of bone damage in bone metastases in breast cancerHypercalcaemia of malignancy Post-menopausal osteoporosis

DOSE IN NORMAL RENAL FUNCTION

Oral: 50 mg daily IV: 6 mg every 3–4 weeks Hypercalcaemia of malignancy: 2–4 mg as a single dose, repeated according to serum calcium levelPost-menopausal osteoporosis: 150 mg monthly (oral), 3 mg every 3 months (IV bolus)

PHARMACOKINETICS

  • Molecular weight                           :319.2 (Ibandronate Na 359.2)
  • %Protein binding                           :87
  • %Excreted unchanged in urine     : 50–60
  • Volume of distribution (L/kg)       :90 litres
  • half-life – normal/ESRD (hrs)      :10–72/Insignificantly increased1

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

    30–50 Dose as in normal renal function. See ‘Other Information’10–30 Oral: 50 mg weekly,

    IV infusion

    : 2 mg every 3–4 weeks.

  • <10           : Oral: 50 mg weekly,

    IV infusion

    : 2 mg every 3–4 weeks.

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :Unknown dialysability. Dose as in GFR <10 mL/min
  • HD                     :Dialysed.2 Dose as in GFR
  • <10           : mL/min
  • HDF/high flux   :Dialysed. Dose as in GFR
  • <10           : mL/min
  • CAV/VVHD      :Unknown dialysability. Dose as in GFR=10–30 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs

  • None known

    ADMINISTRATION

    Reconstition

    Route

    Oral,

    IV infusion

    , IV bolus

    Rate of Administration

    Infusion: over 15 minutes – 2 hours (depends on indication and renal function)IV bolus: over 15–30 seconds

    Comments

    Add dose to 100–500 mL glucose 5% or sodium chloride 0.9% (depends on indication and renal function)

    OTHER INFORMATION

    Oral bioavailability <1% Swallow tablets whole with a glass of water on an empty stomach, at least 30 minutes before breakfast and any other oral medicationThe patient should stand or sit upright for at least 60 minutes after taking tabletsDon’t give infusion over 15 minutes if creatinine clearance <50 mL/min; give in 500 mL over 1 hourBolus dose is contraindicated if GFR<30 mL/min due to lack of studiesOne study used a dose of 6 mg over 30 minutes in various degrees of renal impairment with no deterioration in renal function.1Clearance is reduced in severe renal impairmentDue to the high bone-binding effect with ibandronic acid a dose of 2 mg monthly in haemodialysis patients is equivalent to a dose of 4–5 mg in patients with normal renal function.3 May cause osteonecrosis of the jaw similar to other bisphosphonates

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