Nexfarm Ibandronate Injection (Ibandronic Acid Sodium Hydrate)

Adult administration

Administer 3mg intravenously every 3 months over 15-30 seconds. Patients are advised to additionally take calcium and vitamin D. If a dose is missed on the regular administration date, it should be administered as soon as possible, maintaining a regular schedule every 3 months thereafter.

This medication must be administered intravenously, and caution should be exercised as tissue damage may occur if administered intra-arterially or around the vein. It should not be used in patients with known hypersensitivity to this drug or its components, or in patients with untreated hypocalcemia. Gastric-related symptoms such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation may occur while taking this medication, as well as musculoskeletal pain such as myalgia and arthralgia. Some patients may experience influenza-like symptoms, fatigue, headache, and rash, typically of mild to moderate severity, and recovery occurs without discontinuation of treatment. Adequate intake of calcium and vitamin D is important while using this drug, and supplements should be taken if there is a deficiency. Serious side effects such as osteonecrosis of the jaw have been reported, especially in cancer patients or those taking certain medications; a thorough examination of oral health before dental treatment is recommended, and excessive dental procedures should be avoided during treatment. Additionally, very rarely, serious adverse reactions such as osteonecrosis of the outer ear, severe allergic reactions, skin reactions, and atypical fractures may occur; report any unusual symptoms to healthcare providers immediately. This drug is not metabolized by the liver and is primarily excreted through the kidneys, so patients with impaired kidney function should undergo regular examinations, and monitoring of kidney and liver function should be increased in cases of overdose. Safety during pregnancy or lactation has not been established, so its use is not recommended. This drug should not be mixed with other calcium-containing solutions and used syringes and needles should not be reused but safely discarded. Lastly, the effects on driving or operating machinery are unknown, so caution is advised.

Serious side effects

• Hives
• angioedema
• facial swelling/edema
• anaphylactic reaction/shock
• worsening asthma
• Stevens-Johnson syndrome
• erythema multiforme
• vesicular dermatitis
• acute renal failure
• dyspnea

Mild side effects

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

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

Appearance

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

Package unit

3ml/pre-filled syringe X 1