Npfone Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

Administer 3 mg intravenously every 3 months for 15 to 30 seconds.

This medication must be administered intravenously, and great care should be taken to avoid administering it intra-arterially or around the vein, as it can cause tissue damage. It should not be used in patients with an allergic reaction to this drug or its ingredients or in patients with untreated hypocalcemia. During treatment, gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, as well as musculoskeletal adverse reactions including musculoskeletal pain, arthralgia, and myalgia may occur. Systemic and nervous system adverse reactions such as flu-like symptoms, headache, rash, and fatigue have been reported in some patients, typically mild to moderate, and recover without treatment interruption. There is a risk of osteonecrosis of the jaw during the administration of this medication, so especially patients with cancer or those with certain risk factors should undergo dental examinations before administration and avoid excessive dental procedures during treatment. Additionally, rare side effects such as external auditory canal osteonecrosis have been reported, making it important to immediately inform healthcare professionals if any abnormal symptoms in the ear occur. This medication may temporarily lower calcium levels, so hypocalcemia or bone metabolism disorders should be addressed before administration, and adequate calcium and vitamin D intake is necessary. If severe pain occurs in muscles, joints, or the skeleton, it is essential to consult healthcare professionals immediately as the possibility of atypical fractures, such as femoral fractures, may need to be evaluated in case of pain onset. The safety of this medication in pregnant or breastfeeding women has not been established, and its use is not recommended. This medication is metabolized in the kidneys, not the liver, so caution is needed in patients with impaired renal function, and regular monitoring is required. In cases of overdose, toxicity can manifest in the kidneys and liver, necessitating careful monitoring and appropriate treatment. This medication should not be mixed with calcium-containing solutions or other intravenous medications, and must be diluted with the specified solution for intravenous administration. After use, the injection needle and syringe should not be reused and must be disposed of safely.

Serious side effects

Urticaria, severe swelling (edema), anaphylactic reactions/shock, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, angioedema, facial swelling/edema, vascular anomalies, thrombophlebitis, hypersensitivity reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe systemic effects.

Mild side effects

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

This medication must be stored in a sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness and safety of the medication for a longer period.

Appearance

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

Package unit

3 mL/prefilled syringe (1 vial)