Boneva Injection (Ibandronate Sodium Monohydrate)

Adult administration

3mg by intravenous injection every 3 months for 15-30 seconds.

This medication must be administered only by intravenous injection. Care must be taken as improper administration into arteries or around veins can cause tissue damage. Patients with an allergy to this medication or its components or those with untreated hypocalcemia should not use this medication. Gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation may occur during the use of this medication. Additionally, discomfort in muscles or joints, such as musculoskeletal pain and arthralgia, may also be experienced. Some patients may temporarily experience flu-like symptoms, including fever, chills, fatigue, arthralgia, and myalgia, which are generally mild and resolve naturally in a short period. Rarely, symptoms such as skin rash, headache, and fatigue may occur after administration of this medication. Long-term use of this medication may increase the risk of osteonecrosis of the jaw, so cancer patients or those needing dental treatment should undergo a dental examination before using the drug and avoid excessive dental treatment during therapy. This medication can also cause osteonecrosis in the bones around the ear, so caution is necessary if there is an ear infection or pain. Severe bone, joint, or muscle pain may occur after administration of this medication, and if such symptoms arise, immediate consultation with a physician is advised. Patients using this medication long-term have reported atypical fractures of the femur and other bones, so rapid evaluation is important if pain occurs in the thigh or groin areas. This medication may temporarily lower serum calcium levels, so it is necessary to treat hypocalcemia or any bone and mineral metabolism disorders before administration, and to ensure sufficient intake of calcium and vitamin D. For patients with renal impairment or those taking medications that may affect kidney function, regular check-ups and monitoring are necessary. Serious allergic reactions such as anaphylaxis may occur upon administration of this medication, so if such symptoms appear, administration should be stopped immediately and emergency treatment sought. It is safe for pregnant or breastfeeding women not to use this medication. The efficacy and safety of this medication have not been established in children, thus it should not be administered to those under 18 years of age. In case of overdose, kidney and liver function should be closely monitored, and appropriate treatment should be administered in the event of electrolyte abnormalities like hypocalcemia. This medication should not be mixed with calcium-containing solutions or other intravenous drugs and must be diluted only with saline or 5% dextrose solution before administration. After use, the syringe and needle should not be reused but should be disposed of safely.

Serious side effects

Hives, facial swelling/edema, angioedema, anaphylaxis/reaction/shock, severe allergic reactions, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin reactions, atypical subtrochanteric and diaphyseal femoral fractures, multiple organ failure, death, acute renal failure, dyspnea, vasculitis/thrombophlebitis.

Mild side effects

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

This medication should be stored in a tightly sealed container to avoid contact with air. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius. This ensures the effectiveness and safety of the medication is preserved for a long time.

Appearance

This medication is an injection in a clear and colorless solution contained in a clear and colorless glass prefilled syringe, with a single-use syringe needle attached.

Package unit

3ml/prefilled syringe x 1 unit