Ibandronato

ATC code

M05BA06

Therapeutic class

Agent affecting bone structure and mineralization · Bisphosphonate

Forms

film-coated tablet, concentrate for solution for infusion

Brand names

Ibandronic acid Accord (EU) · ACIDO IBANDRONICO CINFA (ES) · Bonviva (EU)

Overall confidence

high

Regulatory sources consulted

Approved indications

Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Treatment of tumour induced hypercalcaemia with or without metastases.

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients.
Hypocalcaemia.
Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia.
Inability to stand or sit upright for at least 60 minutes.

Clinical warnings

Major warning · Upper gastrointestinal irritation: May cause disorders such as oesophagitis, oesophageal ulcers and oesophageal erosions. It is crucial to follow dosing instructions. — EMA
Major warning · Osteonecrosis of the jaw (ONJ): ONJ has been reported, mainly in cancer patients treated with bisphosphonates. A dental examination is recommended before starting treatment. — EMA
Atypical femoral fractures: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy. — EMA

Drug interactions

HighCalcium supplements, Antacids, medications with polyvalent cationsA12A, A02A
Mechanism: Formation of non-absorbable chelates with polyvalent cations (Ca, Mg, Al, Fe), drastically reducing the oral bioavailability of ibandronate.
Recommendation: Administer ibandronate at least 60 minutes before any other oral medication, supplement, or food. Take with plain water only.
EMA SPC

Adverse events

Common (≥1%)

oesophagitis · abdominal pain · dyspepsia · nausea · arthralgia · myalgia · influenza-like illness

Rare but serious

osteonecrosis of the jaw · atypical femoral fractures · severe hypersensitivity reactions · uveitis · scleritis

Pregnancy and lactation

Pregnancy: Should not be used during pregnancy. There are no adequate data from the use of ibandronic acid in pregnant women. Lactation: It is not known whether it is excreted in human milk. Use during lactation is not recommended.

Recent literature (PubMed)

Aminobisphosphonates: Reconsideration 25 years after their approval for the treatment of osteoporosis.
González Macías J, et al. · Med Clin (Barc) · 2022 · Relevance 4/5
Revisión que posiciona a los aminobifosfonatos como fármacos de referencia en osteoporosis por su balance eficacia-coste-seguridad. Discuten su mecanismo, el aumento de masa ósea, la reducción del riesgo de fracturas y la gestión de 'vacaciones terapéuticas' para evitar complicaciones como la fractura femoral atípica.