Megalivanron Injection (Sodium Ivanthronate Dihydrate)

Adult administration

3 mg administered intravenously every 3 months over 15 - 30 seconds. Patients are advised to take calcium and vitamin D as adjunct therapy. If a dose is missed on the scheduled date, administer the injection as soon as possible, and continue regular dosing every 3 months.

This drug must be administered intravenously, and great care must be taken when administering it intra-arterially or perivascularly, as it may cause tissue damage. This medication should not be used in patients who are allergic to this drug or any of its components, or in patients with untreated hypocalcemia. During the use of this drug, gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, or constipation may occur. Additionally, cases of muscle pain, joint pain, headache, rash, fatigue, and flu-like symptoms have also been reported. Particularly, when this medication is given as an intravenous injection, transient flu-like symptoms may occur during the initial administration, typically mild to moderate in severity and self-resolving without treatment. Prior to administration, it is important to check for hypocalcemia or any bone and mineral metabolism disorders, and if necessary, ensure adequate intake of calcium and vitamin D. In patients undergoing dental treatment or with poor oral hygiene, there is a risk of jaw osteonecrosis, therefore it is advisable to undergo a dental check-up before administration. It is safe to avoid excessive dental treatments during administration. Moreover, in patients who have used this drug for a long time, atypical fractures may occur in the femur or other bones; therefore, if pain occurs in the thigh or groin, consult a physician immediately. This drug is excreted through the kidneys, so patients with impaired renal function should undergo regular renal function tests and follow the physician's instructions for administration. Safety during pregnancy or breastfeeding has not been established, so it is advisable to avoid use. In cases of overdose, hypocalcemia, hypophosphatemia, and hypomagnesemia may occur, immediate medical attention is necessary, and renal and liver function should be monitored closely. This drug should not be mixed with calcium-containing solutions or other intravenous medications, and must be administered only intravenously. After use, the injection needle and syringe should not be reused but disposed of safely. During the administration of this drug, serious allergic reactions such as anaphylaxis may occur. If symptoms appear, immediate cessation of administration and notification to medical staff is necessary.

Serious side effects

Urticaria, angioedema, facial swelling/edema, hypersensitivity reactions, anaphylaxis/shock, Stevens-Johnson syndrome, erythema multiforme, pemphigoid dermatitis, vasculitis/thrombophlebitis, osteonecrosis (jaw and external ear), uveitis, scleritis, exacerbation of asthma, dyspnea, multiple organ failure, death, skin sloughing, hypothyroidism, optic nerve atrophy, tremor, heart failure, urinary disorders, hematuria, acute renal failure, severe headache (suspected serious neurologic symptoms)

Mild side effects

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

This drug should be stored in a sealed container to prevent exposure to air or moisture and should be kept at room temperature, ideally between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance

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

Package unit

3mL × 1 vial