DONGKWANG Ibandronate Sodium Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

Administer 3mg intravenously every 3 months over 15-30 seconds. If a dose is missed on the scheduled administration date, inject as soon as possible, and then continue with regular administration at 3-month intervals.

This medication must be administered intravenously, and caution is required as tissue damage may occur if administered intra-arterially or around the vein. It should not be administered to patients with a known allergy to this drug or its ingredients, or to patients with untreated hypocalcemia. During administration, various adverse reactions such as gastrointestinal discomfort, myalgia, arthralgia, headache, fatigue, skin rash, etc., may occur, most of which are mild to moderate and often do not require cessation of treatment. In some patients, acute influenza-like symptoms, injection site reactions, or vascular inflammation may occur, and if any symptoms appear, notify the healthcare team. Serious side effects such as osteonecrosis of the jaw and external auditory canal osteonecrosis have been reported during osteoporosis treatment with this drug, so it is important for cancer patients or those requiring dental treatment to undergo oral examinations and preventive dental care before administration. If dental treatment is necessary, it should be planned with a specialist to avoid excessive procedures during treatment with this drug. This drug can temporarily lower serum calcium levels, so it is essential to correct hypocalcemia or bone/mineral metabolism disorders before administration and ensure adequate intake of calcium and vitamin D. Patients with poor kidney function or taking medications that may affect the kidneys require regular check-ups and tests. Severe bone, joint, or muscle pain may occur after administering this drug, and if such symptoms arise, consult a healthcare professional immediately. Some patients receiving this drug have reported rare occurrences of atypical femoral fractures or atypical fractures of other bones, thus evaluation should be conducted if pain occurs in the thigh or groin. The safety for pregnant or nursing women has not been established, so it is advisable not to use this drug in those populations. Toxicity may occur in the kidneys and liver in cases of overdose, so if an overdose is suspected, immediately inform healthcare professionals and receive appropriate treatment and monitoring. This drug should not be mixed with other intravenous medications or calcium-containing solutions, and must be diluted with normal saline or 5% dextrose solution for use. Do not reuse the syringe or needle after use, and dispose of them safely in a puncture-resistant container. Store out of reach of children, and the effects on driving or operating machinery are unknown, so caution is needed.

Serious side effects

• Hives
• severe swelling (edema)
• angioedema
• facial swelling
• chest tightness
• difficulty breathing
• anaphylactic reactions/shock
• hypersensitivity
• severe rash with fever
• blisters

Mild side effects

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

This medication should be stored in a sealed container to protect it from air, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Proper storage helps to maintain the drug's effectiveness.

Appearance

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

Package unit

3ml/prefilled syringe X 1