Ibandronic Acid Injection (Sodium Ibandronate Trihydrate)

Adult administration

Administer 3 mg by intravenous injection every three months for 15 - 30 seconds. Patients should additionally intake calcium and vitamin D. If a dose is missed on the scheduled day, inject it as soon as possible and continue regular treatment every three months thereafter.

Child administration

Efficacy and safety in children under 18 years of age have not been studied.

This medication must be administered intravenously, and great caution must be exercised to prevent tissue damage if administered intra-arterially or around the vein. It should not be used in patients with a known allergy to this drug or its ingredients. Additionally, it should not be administered to patients with untreated hypocalcemia. During treatment, gastrointestinal-related adverse reactions, such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation, may occur. Musculoskeletal issues such as musculoskeletal pain, arthralgia, and myalgia may also appear. Some patients have reported systemic and skin adverse reactions, including influenza-like symptoms, fatigue, headache, and rash. Before administering this medication, hypocalcemia and bone and mineral metabolism disorders must be treated, and sufficient calcium and vitamin D intake is necessary. In particular, caution is required as this medication may temporarily lower serum calcium levels. Patients undergoing dental treatment or with poor oral hygiene are at risk for osteonecrosis of the jaw; therefore, dental examination prior to administration is recommended, and excessive dental procedures should be avoided during treatment. Moreover, rare cases of external auditory canal osteonecrosis have been reported, so caution should be exercised if there is ear pain or discharge. In patients who have used this medication for a long period, atypical fractures may occur in the femur and other bones; thus, if there is pain in the legs or groin, immediate evaluation is necessary. Severe allergic reactions such as hypersensitivity or anaphylaxis may occur, and if these symptoms arise, administration should be stopped immediately and appropriate treatment should be sought. It is recommended that pregnant or breastfeeding women do not use this medication, and the safety and efficacy in children under 18 years of age have not been established. This medication should not be mixed with solutions containing calcium and must be administered only as an intravenous injection. After use, the injection needle and syringe should not be reused and must be disposed of safely.

Serious side effects

Urticaria, angioedema, facial swelling/edema, anaphylactic reaction/shock, severe allergic reactions, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin adverse reactions, phlebitis/thrombophlebitis, dyspnea, worsening of asthma, severe edema, acute renal failure, multiple organ failure, osteonecrosis (jaw and external auditory canal), atypical femoral fractures, severe neurological symptoms (optic nerve atrophy, lower motor neuron lesions, tremor).

Mild side effects

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

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

Appearance

A colorless, transparent solution in a colorless, transparent glass prefilled syringe, accompanied by a single-use needle.

Package unit

3 mL/prefilled syringe × 1