Ibandrazhu (Ibandronate Sodium Hydrate)

Adult administration

Administer 3 mg intravenously every 3 months over 15 - 30 seconds.

This medication must be administered intravenously, and care should be taken as injection into an artery or around a vein can cause tissue damage. It should not be used in patients with allergies to this drug or its components, or in patients with untreated hypocalcemia. This drug is used for the treatment of osteoporosis and has shown a safety profile similar to placebo in clinical trials; however, various adverse reactions such as gastrointestinal disturbances, myalgia, arthralgia, headache, and rash may occur in some patients. Temporary influenza-like symptoms (joint pain, muscle pain, fever, chills, etc.) may occur with intravenous administration but are mostly mild and resolve without treatment. Serious side effects such as osteonecrosis of the jaw, external auditory canal osteonecrosis, severe allergic reactions, skin abnormalities, and atypical femoral fractures have been reported rarely; therefore, if any abnormal symptoms occur, you should consult a doctor immediately. This drug may temporarily lower serum calcium levels, so hypocalcemia must be treated before administration, and it is important to consume adequate calcium and vitamin D. Patients with poor kidney function or those taking medications that may affect the kidneys need regular monitoring. Patients requiring dental treatment should undergo an oral examination before administration and avoid excessive dental procedures during treatment. Safety for pregnant or breastfeeding women has not been established, so it is recommended not to use it. No dose adjustment is needed for the elderly, but safety and efficacy have not been established in children under 18. In cases of overdose, careful monitoring is required as it may affect kidney and liver function, and appropriate treatment should be administered if electrolyte abnormalities such as hypocalcemia occur. This drug should not be mixed with calcium-containing solutions or other intravenous medications, and used needles and syringes should not be reused and must be disposed of safely.

Serious side effects

Urticaria, severe swelling (edema), angioedema, facial swelling/edema, severe allergic reactions, anaphylactic reactions/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin adverse reactions, high fever, severe rash, blisters, skin peeling, pain in mouth/eye mucosa, difficulty breathing, shortness of breath, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice of the skin or eyes, liver abnormalities, sudden.

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• indigestion
• nausea
• constipation
• musculoskeletal pain
• arthralgia
• myalgia
• influenza-like illness

This drug should be stored in a sealed container to prevent exposure to air or moisture, preferably at a temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness and prevent deterioration.

Appearance

An injection solution that is colorless and transparent, contained in a colorless, transparent glass pre-filled syringe with a single-use needle attached.

Package unit

3 milliliters/pre-filled syringe, 1 pre-filled syringe/box