GC Wellbeing Bon Health Co., Ltd. (Ibandronate Sodium Monohydrate)

Adult administration

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

This drug must be administered intravenously; administering it into arteries or around veins can cause damage to surrounding tissues. This drug should not be administered to patients with allergic reactions to this drug or its components or to patients with untreated hypocalcemia. Administration of this drug may cause side effects such as gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, musculoskeletal pain, joint pain, myalgia, headache, and rash. Some patients may experience influenza-like symptoms, including fever, chills, fatigue, muscle pain, joint pain, nausea, loss of appetite, and bone pain, which are generally temporary and mild. This drug may temporarily lower serum calcium levels, so hypocalcemia or diseases concerning bone and mineral metabolism should be treated before administration, and adequate calcium and vitamin D intake during treatment is important. Patients receiving this drug are at risk of osteonecrosis of the jaw, so maintaining good oral hygiene and receiving dental care if necessary before and during treatment is essential. Additionally, some patients receiving this drug have reported rare occurrences of osteonecrosis not only in the jaw but also in the external auditory canal, or atypical femoral fractures; any pain in the legs or groin should be promptly discussed with a doctor. This drug may cause severe allergic reactions or anaphylaxis; if any unusual symptoms appear during administration, discontinue use immediately and seek appropriate medical care. It is advisable for pregnant or breastfeeding women not to use this drug, and safety and effectiveness in children under 18 have not been established. This drug has a low risk of interactions with other medications; however, patients with impaired renal function or other diseases should regularly be monitored during treatment. Overdose may cause damage to the kidneys and liver; hence if an overdose is suspected, monitoring and appropriate treatment at a hospital are necessary. This drug should not be mixed with solutions containing calcium, and syringes and needles should be disposed of safely without reuse. Store out of the reach of children, and use exclusively for intravenous administration during injection.

Serious side effects

• Urticaria
• angioedema
• facial swelling/edema
• anaphylactic reaction/shock
• Stevens-Johnson syndrome
• erythema multiforme
• bullous dermatitis
• thrombophlebitis
• acute renal failure
• dyspnea

Mild side effects

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

This drug should be stored in a closed container, maintaining a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance

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

Package unit

1 prefilled syringe/box [(3 mL x 1 tube)]