Ibandronic acid

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[edit] BRAND NAMES

[edit] STRUCTURE

Ibandronic acid.jpg

[edit] MECHANISM OF ACTION

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone estrogen fall, since estrogen helps to keep bones healthy. Approximately 40% of 50-year-old women will experience an osteoporosis-related fracture during their remaining lifetimes.

Osteoblasts make bone, while osteoclasts resorb or take away bone. Ibandronate is a bisphosphonate, it has no direct effect on bone formation, but it stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Ibandronate is internalized by osteoclasts, causing disruption of osteoclast cytoskeleton, loss of the ruffled border, and the subsequent loss of ability to resorb bone.

In postmenopausal women, Ibandronate reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

[edit] INDICATIONS

  • Treatment and prevention of postmenopausal osteoporosis
  • To reduce hypercalcemia in tumor-induced bone disease

[edit] DOSAGE

  • Treatment and prevention of postmenopausal osteoporosis: One 150 mg tablet once monthly on the same day each month.
    Swallow tablet with a glass of water, at least one hour before the first food, beverage, or medication of the day.
    Avoid lying down for 30 minutes.
    Take supplemental calcium and vitamin D if dietary intake is inadequate.
    The optimal duration of use has not been determined. For patients at low risk for fracture, consider drug discontinuation after 3 to 5 years of use.
  • Treatment of Tumour-induced Hypercalcemia: Prior to treatment with Ibandronate the patient should be adequately rehydrated with (0.9%) sodium chloride solution. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type.
    In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia.
    In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
    In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
    The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
    [1] Ibandronate should be added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours

[edit] DOSAGE FORMS AND STRENGTHS

  • Tablets: 150 mg
  • Vials with 2 ml concentrate for solution for infusion

[edit] CONTRAINDICATIONS

  • Hypersensitivity to Ibandronic acid
  • Hypocalcemia
  • Inability to stand or sit upright for at least one hour
  • Abnormalities of the esophagus which delay emptying such as stricture or achalasia

[edit] PRECAUTIONS

  • Bisphosphonates have been associated with esophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcers. (follow the dosing instructions carefully).
  • Hypocalcemia may worsen during treatment and must be corrected prior to use
  • Bisphosphonates may cause osteonecrosis of of the jaw. Potential predisposing factors are tooth extractions, poor oral hygiene, corticosteroids use, alcohol abuse, chemotherapy and radiotherapy.
  • Atypical Femur Fractures have been reported. Patients should be advised to report any thigh or groin pain to rule out an incomplete femur fracture.
  • Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop

[edit] INTERACTIONS

  • Products containing calcium, including milk, and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of ibandronate. Patients should fast overnight (at least 6 hours) before taking Ibandronate and continue fasting for 1 hour following adminstration.
  • Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac and naproxen) may irritate the stomach and intestine. Bisphosphonates may also do so. caution should be exercised in the concomitant use of Biphosphonates and NSAIDs

[edit] PREGNANCY AND LACTATION

  • Pregnancy Category C (US). Ibandronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
  • It is not known whether Ibandronate is excreted in human milk, caution should be exercised if administered to nursing women.

[edit] SIDE EFFECTS

Most common adverse reactions are arthralgia (joint pain) and influenza (flu-like symptoms).These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures. Other common side effects (≥ 1/100 to < 1/10) are headache, esophagitis, gastritis, dyspepsia, rash and myalgia, (See precautions for serious side effects).

[edit] RELATED LINKS

How osteoporosis develops

[edit] BIBLIOGRAPHY

[edit] REFERENCES

  1. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000101/WC500053178.pdf