In the field of oncology
This product is indicated for the treatment of postmenopausal osteoporosis.
Prevention of breast cancer bone metastasis SREs (including pathological fractures, bone complications requiring radiotherapy or surgery).
Treatment of hypercalcemia caused by malignant tumors, with or without bone metastasis.
Treat hypercalcemia caused by malignant tumors with or without bone metastasis.
Clinical trial adverse reactions
This section mainly describes adverse reactions related to the treatment with Sodium Ibandronate Injection observed in foreign clinical trials.
The frequency of adverse reactions is graded in descending order from very common (≥10%), common (≥1% and <10%), uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%), to very rare (≤0.01%).
Treatment of hypercalcemia caused by tumors:
Five clinical trials were mainly conducted for this indication, including pre-marketing and post-marketing trials (MF4104, MF4223, MF4302, MF4442, MF4490 studies). The most common adverse reaction after treatment with the recommended dose of intravenous Sodium Ibandronate Injection was elevated temperature. Individual patients reported flu-like syndromes including fever, chills, bone pain, and/or muscle pain. In most cases, these symptoms disappeared within hours or days without special treatment.
This product is contraindicated in individuals with allergies to the product, excipients or other bisphosphonates;
It is also contraindicated in individuals with uncorrected hypocalcemia;
Children, pregnant and lactating women;
Patients with severe renal insufficiency.
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