Medication info

Boniva (Ibandronate Sodium Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
주식회사케이에스제약
Appearance
The injection is a colorless, transparent solution contained in a colorless, transparent glass prefilled syringe with a single-use needle attached.
Packaging
3 milliliters/prefilled syringe
Approval status
Active

MFDS item code 202001286 · Notified 2020.02.24 · Insurance code 059000621

Summary

Main use
Improvement of osteoporosis in postmenopausal women
Who receives it
Adults
Adult administration
3mg is administered via intravenous injection every 3 months over 15-30 seconds.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis in postmenopausal women.

How it is given

Adult administration

3mg is administered via intravenous injection every 3 months over 15-30 seconds.

Precautions

This medication should be administered solely via intravenous injection; care must be taken to avoid injecting around arteries or veins as this can cause tissue damage. It should not be used in patients with an allergy to this drug or any of its components, or in patients with untreated hypocalcemia. During treatment with this drug, side effects such as gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, muscle and joint pain, headache, and rash may occur. In some patients, flu-like symptoms, fatigue, and injection site reactions may develop; these symptoms are usually temporary and mild. This drug may temporarily lower calcium levels, so it is important to treat hypocalcemia or disorders of bone and mineral metabolism before administration, and to ensure adequate intake of calcium and vitamin D. Patients requiring dental work should have oral examinations in advance and should avoid excessive dental procedures during treatment. Rare cases of osteonecrosis of the jaw or ear canal have been reported in patients receiving this drug; immediate consultation with a physician is advised if any related symptoms occur. If there is pain in the thigh or groin, the possibility of atypical femoral fracture should be suspected and further examination should be conducted. This medication is not metabolized in the liver and is primarily eliminated through the kidneys, thus regular monitoring is required for patients with impaired kidney function. It is preferable that this drug is not used by pregnant or breastfeeding women, and safety in children has not been established. In cases of overdose, electrolyte abnormalities such as hypocalcemia may occur, thus immediate medical treatment and monitoring are necessary. This drug should not be mixed with other calcium-containing solutions and must be administered solely via intravenous injection. After use, do not reuse the injection needle and syringe; dispose of them safely.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever-related respiratory distress, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination.

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • indigestion
  • nausea
  • constipation
  • musculoskeletal pain
  • joint pain
  • muscle pain
  • flu-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reaction
  • phlebitis/thrombophlebitis
  • dizziness
  • fever
  • hypothyroidism
  • peripheral neuropathy
  • hearing reduction
  • skin desquamation
  • insomnia
  • anxiety
  • tinnitus
  • lipoma
  • ocular hemorrhage
  • heart failure
  • urinary disorders
  • hematuria
  • toothache
  • laryngitis
  • vaginitis
  • menopausal symptoms
  • blood.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent exposure to air or humidity. The storage temperature should be maintained between 1 and 30 degrees Celsius (room temperature) to preserve its efficacy.

Appearance and packaging

Appearance

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

Package unit

3 milliliters/prefilled syringe

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.