BONEJOA Injection (Ibandronic Acid Sodium Monohydrate)

Adult administration

3mg is administered intravenously every 3 months for 15 - 30 seconds. Patients are advised to take calcium and vitamin D as adjunct therapy. If a scheduled dose is missed, it should be administered as soon as possible and then regularly every 3 months.

Child administration

Efficacy and safety in children under 18 years have not been studied.

This drug must be administered as an intravenous injection, and caution should be exercised as improper administration around arteries or veins may cause tissue damage. It should not be used in patients with hypersensitivity to this drug or untreated hypocalcemia. During the use of this drug, gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation may appear. Musculoskeletal symptoms such as myalgia, arthralgia, and musculoskeletal pain have also been reported. In some patients, influenza-like symptoms may occur, which include fever, chills, fatigue, and arthralgia, usually mild and temporary. Adverse effects related to the nervous system and skin, such as headache, rash, and fatigue, may also occur. Long-term use of this drug has been rarely associated with serious bone-related side effects such as osteonecrosis of the jaw or external auditory canal, thus oral hygiene and dental care should be prioritized. During osteoporosis treatment, muscle, joint, and bone pain may worsen; should these symptoms occur, consult with healthcare professionals. If pain in the thigh or groin is present, consider the possibility of atypical femoral fractures and further examination is needed. In cases of pregnancy or breastfeeding, the safety of this drug is not established and should be avoided. As this drug is excreted through the kidneys, patients with renal impairment need regular monitoring. In cases of overdose, there may be a burden on the kidneys and liver, requiring careful monitoring, and appropriate treatment is necessary if hypocalcemia occurs. This drug should not be mixed with solutions that contain calcium and must be administered only by intravenous injection. Do not reuse needles and syringes; safely dispose of them after use. While the potential for interaction with other drugs during the use of this drug is low, it is recommended to consult with a physician or pharmacist.

Serious side effects

• Urticaria
• angioedema
• facial swelling/edema
• anaphylaxis reactions/shock
• exacerbation of asthma
• Stevens-Johnson syndrome
• erythema multiforme
• bullous dermatitis
• phlebitis/thrombophlebitis
• acute renal failure

Mild side effects

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

This drug should be stored in a sealed container to prevent air or moisture from entering, ideally at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the effectiveness of the drug and prevents deterioration.

Appearance

The injection is a colorless, transparent solution contained in a colorless, transparent glass prefilled syringe, which comes with a single-use needle.

Package unit

3ml x 1 vial