Ibaron Injection (Ibandronic Acid Sodium Hemihydrate)

Adult administration

3 mg intravenously every 3 months, infused over a period of 15 - 30 seconds.

This medication must be administered exclusively intravenously, as improper injection into the arteries or around the veins can cause tissue damage. It should not be used in patients with known allergies to this drug or its ingredients, or in untreated hypocalcemia patients. This drug is primarily used for the treatment of osteoporosis; clinical trials have shown safety profiles similar to placebo, although some patients may experience varied adverse reactions such as gastrointestinal disturbances, musculoskeletal pain, headache, and rash. In particular, flu-like symptoms such as arthralgia, myalgia, fever, chills, and fatigue may temporarily occur shortly after initial administration, but these are mostly mild and resolve without treatment. Before administering this drug, it is essential to confirm that calcium levels are normal; if there is hypocalcemia, it should be treated first. During treatment, adequate calcium and vitamin D intake is crucial, and supplements should be taken if necessary. Regular monitoring of kidney function and other health conditions is required during the use of this drug. As a bisphosphonate, there is a rare risk of osteonecrosis of the jaw; therefore, thorough oral hygiene should be maintained before and during treatment, and unnecessary dental procedures should be avoided. Additionally, otologic-related side effects such as external auditory canal osteonecrosis have been reported; if there are any abnormal ear symptoms, consult a physician. Severe pain in bones, joints, or muscles may occur after taking this medication; should these symptoms arise, inform healthcare personnel immediately. This medication may cause rare fractures such as atypical femoral fractures; if there is pain in the thigh or groin, an examination should be conducted. When administering intravenously, there is a possibility of hypersensitivity or allergic reactions, so appropriate measures should be in place for emergencies. The safety for pregnant and breastfeeding women has not been established; it is recommended not to use this medication in such cases. This drug is not metabolized in the liver and is mainly excreted by the kidneys, thus precautions should be taken for patients with liver or kidney issues. In case of overdose, careful monitoring of calcium, phosphorus, and magnesium levels is required, and appropriate treatment should be initiated if necessary, knowing that dialysis may not be effective. This drug should not be mixed with other intravenous medications or solutions containing calcium and should only be diluted and administered with normal saline or 5% dextrose solution. Keep this medication out of the reach of children, and dispose of used syringes and needles securely without reusing.

Serious side effects

• Hives
• severe swelling (edema)
• anaphylaxis reaction/shock
• severe allergic reactions
• Stevens-Johnson syndrome
• erythema multiforme
• bullous dermatitis
• severe skin adverse reactions
• angioedema
• facial swelling/edema

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent exposure to air, and the storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Proper storage will help preserve the medication's efficacy for a longer duration.

Appearance

A colorless, transparent solution in a colorless, transparent prefilled syringe with a single-use needle attached.

Package unit

3.0 mL/prefilled syringe x 1