Mirae Ibandronate Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

Administer 3 mg intravenously every 3 months for 15-30 seconds. Patients should also supplement with calcium and vitamin D. If a dose is missed on the scheduled day, administer it as soon as possible, and continue dosing regularly at 3-month intervals.

Child administration

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

This medication must be administered intravenously and great care should be taken to avoid causing tissue damage if administered intra-arterially or peri-venously. It should not be given to patients with hypersensitivity to this drug or untreated hypocalcemia. Administration may lead to gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation, as well as musculoskeletal issues such as myalgia or arthralgia. Moreover, influenza-like symptoms such as fever, chills, fatigue, myalgia, and arthralgia may occur temporarily but are usually mild and resolve without treatment. This drug can temporarily lower serum calcium levels, so it should be administered after treatment in cases of hypocalcemia or bone and mineral metabolism disorders. Sufficient calcium and vitamin D intake are essential, and supplements should be taken if necessary. Patients undergoing dental treatment are at risk of jaw osteonecrosis, so it is advisable to check oral condition before administration and avoid excessive dental procedures during treatment. Patients receiving this medication can rarely experience osteonecrosis of the jaw or external auditory canal, so they should consult a doctor immediately if they have ear pain or discharge. Additionally, if there is dull pain in the thigh or groin area after drug administration, the possibility of atypical femoral fracture should be suspected and evaluated. This medication can cause acute renal failure or severe allergic reactions (anaphylaxis), so monitoring by healthcare professionals is necessary during administration, and administration should be discontinued immediately if adverse reactions occur. Safety for pregnant or nursing women has not been established, so avoidance is recommended. The safety and efficacy of this medication in children have not been confirmed, so it should not be used. Overdosage may affect kidney and liver function, requiring careful monitoring and appropriate treatment. This medication should not be mixed with solutions containing calcium or other intravenously administered drugs, and the syringe and needle should not be reused and must be disposed of safely.

Serious side effects

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

Mild side effects

Gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, influenza-like illness (including arthralgia, myalgia, fever, chills, fatigue, nausea, loss of appetite, bone pain), fatigue, headache, rash, bone pain, weakness, injection site reactions, dizziness, fever, hypothyroidism, peripheral neuropathy, hearing loss, skin desquamation, insomnia, anxiety, tinnitus, lipoma, ocular hemorrhage, heart failure, abdominal

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. Proper storage will preserve the effectiveness and safety of the medication for a longer period.

Appearance

This injection is a colorless, transparent solution contained in a colorless, transparent glass pre-filled syringe, accompanied by a single-use injection needle.

Package unit

3 milliliters / pre-filled syringe