Ibandronate Sodium (ibandronate sodium)

Dosage of ibandronate sodium, which is commercially available as the monosodium monohydrate, is expressed in terms of ibandronate.

The optimal duration of bisphosphonate therapy for osteoporosis has not been established. Safety and efficacy of ibandronate for the management of osteoporosis are based on clinical data over 3 years (for the oral formulation) or 1 year (for the IV formulation). Some evidence suggests that increased durations of bisphosphonate use may be associated with a higher risk of some adverse effects (e.g., jaw osteonecrosis, atypical fractures). (See Cautions.) All patients receiving a bisphosphonate should have periodic evaluations to determine the need for continued therapy with the drug. Discontinuance of bisphosphonate therapy may be considered after 3-5 years of use for patients who are assessed to be at low risk of fracture. Risk of fracture should be evaluated periodically in patients who discontinue therapy.

Ibandronate sodium is administered orally or by IV injection.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Hypocalcemia or known hypersensitivity to ibandronate or any ingredient in the formulation.

With oral ibandronate, abnormalities of the esophagus that delay esophageal emptying, such as stricture or achalasia.

With oral ibandronate, inability to stand or sit upright for at least 60 minutes.

• Aseptic necrosis of jaw bone
• Hypocalcemia

• Atypical femoral fracture
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Invasive dental procedure
• Vitamin D deficiency

• Arthralgia
• Bone pain
• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Malignancy
• Myalgia

Adverse effects occurring in at least 2% of patients receiving daily oral ibandronate therapy in osteoporosis treatment or prevention studies and in more patients than with placebo include upper respiratory tract infection, back pain, dyspepsia, bronchitis, pain in the extremities, diarrhea, headache, pneumonia, myalgia, urinary tract infection, hypercholesterolemia, infection (unspecified), dizziness, joint disorder, asthenia, tooth disorder, arthritis, vertigo, vomiting, allergic reaction, pharyngitis, gastritis, and nerve root lesion.

Adverse effects occurring in at least 2% of patients receiving once-monthly oral ibandronate include upper abdominal or abdominal pain, hypertension, dyspepsia, arthralgia, nausea, diarrhea, back pain, constipation, influenza, pain in the extremities, nasopharyngitis, headache, influenza-like illness and acute phase inflammatory reaction, localized osteoarthritis, bronchitis, urinary tract infection, dizziness, rash (including pruritic, macular, papular, erythematous, or generalized rash; dermatitis or allergic dermatitis; exanthem; erythema; and dermatitis medicamentosa), myalgia, upper respiratory tract infection, and insomnia.

Adverse effects occurring in at least 2% of patients receiving quarterly IV ibandronate therapy for the treatment of osteoporosis include arthralgia, back pain, cystitis, gastroenteritis, upper abdominal or abdominal pain, influenza-like illness and acute phase inflammatory reaction, headache, dyspepsia, nasopharyngitis, constipation, fatigue, diarrhea, pain in the extremities, myalgia, urinary tract infection, osteoarthritis, rash (including pruritic, macular, papular, erythematous, or generalized rash, dermatitis or allergic dermatitis, exanthem, erythema, and dermatitis medicamentosa), bronchitis, and nausea.

Less Frequent

• Injection site sequelae
• Pneumonia
• Urinary tract infection

Rare or Very Rare

• Acute renal failure
• Anaphylaxis
• Angioedema
• Aseptic necrosis of bone in orofacial region
• Aseptic necrosis of jaw bone
• Asthma exacerbation
• Atypical femoral fracture
• Bone pain
• Bullous dermatitis
• Erythema multiforme
• Esophageal perforation
• Esophageal ulcer
• Esophagitis
• Hypocalcemia
• Ocular inflammation
• Stevens-johnson syndrome
• Stricture of esophagus
• Uveitis

More Frequent

• Acute abdominal pain
• Arthralgia
• Back pain
• Diarrhea
• Dyspepsia
• Flu-like symptoms
• Headache disorder
• Upper respiratory infection

Less Frequent

• Arthritis
• Bronchitis
• Constipation
• Dizziness
• Gastritis
• General weakness
• Hypertension
• Infection
• Injection site erythema
• Myalgia
• Nausea
• Pain in extremities
• Pharyngitis
• Skin rash
• Tooth disorder
• Vertigo
• Vomiting

Rare or Very Rare

• Cramps
• Insomnia
• Iritis

No enhanced messaging available.

Safety and efficacy have not been established in children. Ibandronate is not indicated for use in children.

There are no data in pregnant women to inform any drug-associated risks with ibandronate. The drug is not indicated for use in women of childbearing potential. In reproductive animal studies, maternal and fetal toxicity (including postimplantation loss, developmental anomalies, and deaths) have been observed.

Ibandronate is distributed into milk in rats at concentrations averaging 1.5 times that in plasma; it is not known whether the drug is distributed into milk in humans. It is not known whether ibandronate has any effects on the nursing infant or on milk production.

No overall differences in safety and efficacy relative to younger adults have been observed. However, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. The greater frequency of decreased renal function observed in the elderly also should be considered.