HaniBanju (Ibandronic Acid Sodium Monohydrate) (Pre-filled)

Adult administration

Administer 3 mg intravenously once every 3 months over 15-30 seconds. Patients are advised to additionally take calcium and vitamin D. If a regular dosing day is missed, the injection should be given as soon as possible, and thereafter, administration should continue regularly at 3-month intervals.

This medication must be administered intravenously, and it must be used with great caution when administering it into an artery or around a vein as it may cause tissue damage. It should not be used in patients with an allergy to this drug or its components, or in patients with untreated hypocalcemia. During the use of this drug, some patients may experience gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation. Musculoskeletal symptoms such as myalgia, arthralgia, and musculoskeletal pain have also been reported, and symptoms such as fatigue, headache, and rash may occur as well. Some patients may temporarily experience flu-like symptoms such as arthralgia, myalgia, fever, chills, fatigue, nausea, appetite loss, and bone pain. Severe allergic reactions or anaphylaxis may occur, so if these symptoms arise during administration, treatment should be stopped immediately and appropriate care should be sought. This drug can temporarily lower serum calcium levels, so it is essential to treat hypocalcemia or bone and mineral metabolism disorders before administration. Proper intake of calcium and vitamin D is required during the treatment period, and supplements should be taken if necessary. Particular caution should be taken in patients undergoing dental treatment or those with risk factors due to the risk of jaw osteonecrosis, and an oral examination and preventive dental treatment should be considered before administration. During the administration of this drug, excessive dental procedures should be avoided, and if symptoms associated with osteonecrosis arise, a specialist should be consulted. This drug can rarely cause osteonecrosis of the external auditory canal, so if ear infections or pain persist, inform the doctor. Long-term use may pose risks for atypical fractures, particularly femoral fractures, so if there is pain in the thigh or groin, assessment should be promptly obtained. It may affect kidney function, so patients with kidney disease or those taking medications affecting the kidneys should have regular check-ups with their doctor. It is advisable not to use this drug in pregnant or lactating women, as safety has not been established. In the case of overdose, monitoring kidney and liver functions is essential, and if side effects like hypocalcemia occur, appropriate treatment should be sought. This drug should not be mixed with calcium-containing solutions or other intravenous medications and must be administered only with the specified solution. Used needles and syringes should not be reused and must be disposed of safely.

Serious side effects

Urticaria, angioedema, facial swelling/edema, anaphylactic reactions/shock, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe allergic reactions, severe skin adverse reactions, dyspnea, difficulty breathing, asthma attacks, skin desquamation, multiple organ failure, death, acute renal failure, vascular issues (phlebitis/thrombophlebitis), severe swelling, severe edema, osteonecrosis, fractures, atypical fractures.

Mild side effects

Gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, flu-like symptoms (including arthralgia, myalgia, fever, chills, fatigue, nausea, appetite loss, bone pain), fatigue, headache, rash, bone pain, weakness, injection site reactions, back pain, fever, hypothyroidism, peripheral neuropathy, hearing loss, dizziness, insomnia, anxiety, tinnitus, lipoma, ocular hemorrhage, heart failure, and urinary issues.

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, ideally at a temperature between 1 degree to 30 degrees Celsius. Proper storage preserves the drug's efficacy and prevents deterioration.

Appearance

It is a colorless and transparent solution in a colorless and transparent glass pre-filled syringe with a disposable needle attached.

Package unit

1 package (3mL) x 1 pre-filled syringe