Boniem Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

3 mg is administered intravenously every 3 months over a period of 15 - 30 seconds. If a dose is missed on the regular dosing day, administer as soon as possible, and then continue dosing regularly every 3 months.

Child administration

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

This medication must be administered intravenously and must be injected very carefully, as injection into the artery or near the vein can cause tissue damage. It should not be used in patients with hypersensitivity to this medication or untreated hypocalcemia. During use, gastrointestinal symptoms such as dyspepsia, abdominal pain, nausea, and diarrhea may occur, and musculoskeletal symptoms such as myalgia or arthralgia have also been reported. Additionally, flu-like symptoms may temporarily appear after injection, which is usually mild and resolves on its own over time. Before administering this medication, any hypocalcemia or bone and mineral metabolism disorders must be treated, and sufficient calcium and vitamin D intake is required. Patients undergoing dental treatment or with poor oral hygiene are at risk for serious side effects such as osteonecrosis of the jaw, thus it is recommended to have a dental examination before administration. Long-term use of this medication may increase the risk of atypical fractures in the femur; therefore, prompt consultation with a physician is necessary if there is leg pain. In cases of overdose, it may affect the kidneys and liver, requiring careful monitoring, and appropriate treatment is needed if severe hypocalcemia occurs. Pregnant or breastfeeding women are advised not to use this medication as its safety has not been established. This medication has a low risk of metabolic interactions with other drugs, but patients with renal impairment require regular checks. Syringes and needles should not be reused and must be disposed of safely, kept out of reach of children.

Serious side effects

Allergic reactions including urticaria, angioedema, facial swelling/edema, anaphylactic reactions/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, osteonecrosis (mandible and external ear canal), acute renal failure, multiple organ failure, death, severe edema, respiratory distress, severe allergic reactions, severe skin adverse reactions, severe neurological symptoms, severe edema or urinary abnormalities

Mild side effects

Gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, influenza-like illness (including joint pain, muscle pain, fever, chills, fatigue, nausea, loss of appetite, bone pain), fatigue, headache, rash, back pain, weakness, injection site reactions, sensory impairment, dizziness, hearing loss, insomnia, anxiety, tinnitus, lipoma, hematuria, urinary disorders, skin peeling, hypothyroidism, peripheral neuropathy, toothache

This medication should be stored in a sealed container to prevent contact with air, and it is safe to store at room temperature between 1 and 30 degrees Celsius.

Appearance

A colorless and transparent solution contained in a pre-filled syringe with a single-use injection needle attached.

Package unit

3 milliliters / vial X 1