This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Ibandronic acid parenteral infusion


Infusions of ibandronic acid

Drugs List

  • BONDRONAT 6mg/6ml concentrate for solution for infusion
  • ibandronic acid 2mg/2ml concentrate for solution for infusion
  • ibandronic acid 6mg/6ml concentrate for solution for infusion
  • Therapeutic Indications


    Bone complications: prevention in breast cancer + bone metastases
    Hypercalcaemia due to malignant disease
    Pathological fracture: prevention in breast cancer + bone metastases



    Treatment of tumour-induced hypercalcaemia
    The patient should be adequately rehydrated with 0.9% w/v sodium chloride infusion before treatment with ibandronic acid.

    Consideration should be given to the severity of the hypercalcaemia and the tumour type. Generally patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia.

    Severe hypercalcaemia (albumin-corrected serum calcium equal to or greater than 3 mmol/l or 12 mg/dl): single dose of 4 mg given by intravenous infusion over 2 hours.
    Moderate hypercalcaemia (albumin-corrected serum calcium less than 3 mmol/l or 12 mg/dl): single dose of 2 mg given by intravenous infusion over 2 hours.

    A limited number of patients have received a second infusion for hypercalcaemia. Repeated treatment may be considered in cases of recurrent hypercalcaemia or insufficient efficacy.

    Prevention of skeletal events in patients with breast cancer and bone metastases
    6 mg ibandronic acid infused intravenously over a period of at least 15 minutes, every 3 to 4 weeks. A shorter infusion time (e.g. 15 minutes) should only be used in patients with normal renal function or mild renal impairment.


    (See Dosage; Adults)

    Patients with Renal Impairment

    Prevention of skeletal events in patients with breast cancer and bone metastases
    Creatinine clearance 30 to 50 ml/min: 4 mg of ibandronic acid in 500 ml of infusion fluid given over at least 1 hour
    Creatinine clearance less than 30 ml/min: 2 mg of ibandronic acid in 500 ml of infusion fluid given over at least 1 hour

    A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance less than 50 ml/min.

    Additional Dosage Information

    Tumour-induced hypercalcaemia
    The highest dose used in clinical trials for treatment was 6 mg but this dose does not add any further benefit in terms of efficacy.

    In most cases, a raised serum calcium level can be reduced to the normal range within 7 days. The median time to relapse (re-increase of albumin-corrected serum calcium above 3 mmol/l) was 18 to 19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with a dose of 6 mg.


    For intravenous infusion after dilution.


    Children under 18 years

    Precautions and Warnings

    Predisposition to cardiac failure
    Renal impairment - creatinine clearance below 50ml/minute
    Severe hepatic impairment

    Avoid overhydration in patients at risk of cardiac failure
    Consider a dental exam & appropriate preventive dentistry before treatment
    Maintain adequate hydration during therapy
    Dilute and use as an infusion
    Must be given as an intravenous infusion
    Resuscitation facilities must be immediately available
    Treatment to be administered under the supervision of a specialist
    Correct disturbances of calcium and mineral metabolism before initiation
    Ensure patient's dietary intake of calcium and vitamin D is adequate
    Monitor renal function
    Monitor serum calcium levels
    Monitor serum magnesium regularly
    Monitor serum phosphate levels
    Advise patient to report any ear pain, discharge or infection
    Advise patient to report any new thigh, hip or groin pain
    Consider discontinuation if atypical femoral fracture occurs
    Discontinue if serious allergic or anaphylactic reaction occurs
    Advise patient of need for high oral hygiene standards
    Advise patient to report any dental mobility, pain or swelling
    Give patient package leaflet and patient reminder card
    Patient to inform dentist of bisphosphonate use: avoid invasive procedures

    Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, most cases have been in patients with advanced malignancies involving bone. In studies patients who developed ONJ had known risk factors, including a diagnosis of cancer with bone lesions, concomitant therapies (e.g., chemotherapy, antiangiogenic biologics, corticosteroids, radiotherapy to head and neck), poor oral hygiene, invasive dental procedures including extractions and dental implants, co-morbid disorders (e.g., pre-existing dental disease, anaemia, coagulopathy, infection) and previous treatment with bisphosphonates.

    Dental examination with appropriate preventative procedures and an individual benefit-risk assessment is recommended prior to bisphosphonate therapy in patients with risk factors for ONJ. While on treatment, patients should avoid invasive dental procedures if possible. Good oral hygiene practices and regular routine dental check-ups should be maintained during treatment with bisphosphonates.

    For patients who develop ONJ during treatment, dental surgery may exacerbate the condition. If ONJ occurs during treatment with bisphosphonates, use clinical judgement and guide the management plan of each patient based on individual benefit/risk evaluation. The management plan for patients with ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ. Temporary interruption of treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.

    Osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonates, mainly in association with long term therapy (2 years or longer). Risk factors include steroid use and chemotherapy and/or local risk factors as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.

    Atypical femoral fractures have been reported in patients receiving bisphosphonates. Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur. Consider discontinuation of bisphosphonate therapy in patients suspected to have an atypical femoral fracture pending an individual risk/benefit assessment. During bisphosphonate therapy, advise patients to report new or unusual thigh, hip or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.

    Pregnancy and Lactation


    Ibandronic acid is contraindicated in pregnancy.

    There are no adequate data from the use of ibandronic acid in pregnant women, therefore the potential risk to humans is unkown. Animal studies have shown reproduction toxicological effects on skeletal development. If exposure occurs during gestation, detailed ultrasound examination of the foetal skeleton appears to be warranted (Briggs, 2011) although Schaeffer (2007) states that accidental use of a single dose does not justify interruption of the pregnancy or additional diagnostic procedures.

    Briggs (2011) states that the amount of drug retained in the bone and eventually released back into systemic circulation is directly related to the dose and duration of treatment and that ibandronate probably crosses the placenta, treatment of the mother before conception could result in continuous exposure of the embryo and foetus to an unknown amount of the drug. Therefore treatment with ibandronic acid in women who may become pregnant or during pregnancy is not recommended.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Ibandronic acid is contraindicated in breastfeeding.

    It is unknown if ibandronic acid is excreted in human breast milk, animal studies have shown the presence of low levels of ibandronic acid in rat milk following intravenous administration. However, Briggs (2011) suggests that with a molecular weight of around 318 (for the free acid), prolonged elimination half life and lack of metabolism that the active drug will be excreted in breast milk.

    The low oral bioavailability of ibandronic acid (less than 1% fasting, lower with food) and the fact that it binds to calcium in milk make it likely that the amount absorbed by a nursing infant would be insignificant.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Anaphylactic reaction
    Atypical femoral fracture
    Benign skin neoplasms
    Blood dyscrasias
    Bone pain
    Bundle branch block
    Candidiasis (mouth or throat)
    Cardiovascular disturbances
    Cerebrovascular disorders
    Exacerbation of pre-existing asthma
    Gamma glutamyl transferase (GGT) increased
    Gastro-intestinal pain
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase in creatinine
    Influenza-like syndrome
    Joint disorder
    Lability of affect
    Local pain (injection site)
    Local reaction at injection site
    Myocardial ischaemia
    Nerve damage
    Ocular inflammation
    Oral paraesthesia
    Oral ulceration
    Osteonecrosis (primarily of the jaw)
    Osteonecrosis of the external auditory canal
    Pelvic pain
    Peripheral oedema
    Possible alteration in tests for parathyroid function
    Pulmonary oedema
    Renal cysts
    Skin disorder
    Sleep disturbances
    Tooth disorder
    Urinary retention
    Varicose veins
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: September 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 11 September 2015.

    Summary of Product Characteristics: Bondronat 2mg Concentrate for solution for infusion. Roche Products Ltd. Revised May 2015.

    Summary of Product Characteristics: Ibandronic acid Accord 2 mg Concentrate for solution for infusion. Accord Healthcare Ltd. Revised July 2014.
    Summary of Product Characteristics: Ibandronic acid Accord 6 mg Concentrate for solution for infusion. Accord Healthcare Ltd. Revised July 2014.

    Summary of Product Characteristics: Ibandronic acid 2mg/2ml Concentrate for solution for infusion. Teva UK Limited. Revised June 2012.
    Summary of Product Characteristics: Ibandronic acid 6mg/6ml Concentrate for solution for infusion. Teva UK Limited. Revised June 2012.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    MHRA Drug Safety Update December 2015
    Available at:
    Last accessed: 13 January 2016

    MHRA Drug Safety Update July 2015
    Available at:
    Last accessed: 11 September 2015

    MHRA Drug Safety Update November 2009
    Available at:
    Last accessed: 11 September 2015

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.