Ibandronate Sodium Injection

Adult administration

3mg administered intravenously once every 3 months over 15 - 30 seconds. If a dose is missed on the scheduled dosing date, administer it as soon as possible, maintaining a regular dosing interval of 3 months thereafter.

This medication must be administered strictly by intravenous injection; care must be taken to avoid injecting incorrectly around arteries or veins, as this may cause tissue damage. Do not use in individuals with an allergy to this drug or its components, or those with untreated hypocalcemia. Adverse reactions may occur during treatment, primarily gastrointestinal disturbances, musculoskeletal pain, fatigue, headache, skin rash, etc. Upon initial administration, flu-like symptoms such as joint pain, muscle pain, fever, and chills may occur temporarily; however, they are generally mild and resolve without treatment. This medication may temporarily lower serum calcium levels, so calcium levels should be maintained within normal ranges before administration, and it is important to take sufficient calcium and vitamin D. Patients with poor oral hygiene or those undergoing cancer treatment may have an increased risk of osteonecrosis of the jaw, hence dental examination and preventive treatment are needed before administration. It is advisable to avoid excessive dental treatment during administration; if osteonecrosis of the jaw occurs, professional consultation is necessary as the condition may worsen. Additionally, long-term use of this medication may lead to atypical fractures in the femur or other bones, so if pain occurs in the thigh or groin, notify a doctor immediately. This medication is excreted by the kidneys, therefore patients with impaired kidney function should undergo regular examinations, and renal and liver function should be closely monitored in case of overdose. Women who are pregnant or breastfeeding should not use this medication as its safety has not been established. The safety and efficacy in children and adolescents under 18 years of age have not been confirmed. This medication should not be mixed with calcium-containing solutions or other intravenous drugs, and needles and syringes should not be reused and must be disposed of safely. Serious allergic reactions such as anaphylaxis may occur during the administration of this medication, so if any adverse symptoms appear, discontinue administration immediately and seek appropriate treatment.

Serious side effects

Hives, angioedema, facial swelling/edema, severe allergic reactions (anaphylaxis, shock), Stevens-Johnson syndrome, erythema multiforme, severe skin reactions such as blistering dermatitis, osteonecrosis (jaw and external ear canal), atypical femoral fractures, acute renal failure, multiple organ failure, death, respiratory distress, vasculitis/thrombophlebitis, severe edema accompanied by elevated blood pressure

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• dyspepsia
• nausea
• constipation
• musculoskeletal pain
• joint pain
• muscle pain
• flu-like illness

Store this medication in a sealed container to avoid exposure to air. It is advisable to maintain room temperature between 1 to 30 degrees Celsius. This storage will help preserve the efficacy of the medication for a longer period.

Appearance

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

Package unit

3ml x 1 vial