Bonthield (Ibandronic Acid Sodium Hydrate)

Adult administration

3mg is injected intravenously once every 3 months over 15 - 30 seconds.

This drug must be administered only by intravenous injection, and caution is required as incorrect injection near arteries or veins can cause tissue damage. It should not be administered to patients who have hypersensitivity to this drug or untreated hypocalcemia. This drug is used for the treatment of osteoporosis and has shown similar safety to placebo in most patients in clinical trials. However, some patients may experience gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation, as well as musculoskeletal adverse reactions such as musculoskeletal pain, arthralgia, and myalgia. Additionally, flu-like symptoms (joint pain, muscle pain, fever, chills, fatigue, etc.) may temporarily occur after injection, usually mild and resolve without treatment. Rarely, serious side effects such as hypersensitivity reactions, angioedema, urticaria, severe skin reactions, anaphylaxis, osteonecrosis, and atypical fractures have been reported. In particular, osteonecrosis of the jaw and external auditory canal may occur in patients using this drug, so it is important to have oral examinations and preventive dental treatments before administration. It is advisable to avoid excessive dental treatment during therapy. This drug may temporarily lower serum calcium levels, so any hypocalcemia and bone and mineral metabolism disorders must be treated before administration, along with sufficient intake of calcium and vitamin D. It may affect kidney function; therefore, patients with kidney disease or those taking medications affecting the kidneys require regular examinations and monitoring. The safety for pregnant and lactating women has not been established and it is recommended not to use it as reproductive toxicity was observed in animal studies. In case of overdose, renal and hepatic functions should be carefully monitored, and appropriate treatment should be administered if electrolyte imbalances such as hypocalcemia occur. This drug should not be mixed with calcium-containing solutions or other intravenous drugs, and must be diluted with normal saline or dextrose solution for administration. Keep out of reach of children, and safely dispose of used injection needles and syringes without reuse.

Serious side effects

Urticaria, angioedema, facial swelling/edema, severe allergic reactions (anaphylactic reaction/shock), Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, vasculitis/thromboembolic disease, osteonecrosis (of the jaw and external auditory canal), acute renal failure, difficulty breathing, multiple organ failure, death, skin desquamation, severe skin adverse reactions (severe rash, blisters, skin sloughing, oral/ocular mucosal pain)

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• dyspepsia
• nausea
• constipation
• musculoskeletal pain
• arthralgia
• myalgia
• flu-like illness

This drug should be stored in a sealed container to prevent air from entering and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy and prevents deterioration.

Appearance

A colorless, transparent solution contained in a colorless, transparent glass prefilled syringe, with a single-use injection needle attached.

Package unit

3mL/prefilled syringe x 1