General: Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bonviva therapy. Adequate intake of calcium and vitamin D is important in all patients.
Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bonviva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions (see Dosage & Administration).
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Bonviva and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Bonviva.
Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (eg, chemotherapy, including angiogenesis inhibitors, radiotherapy, corticosteroids), and co-morbid disorders (eg, anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
Renal Impairment: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Patients with renal impairment under Actions.
Hepatic Impairment: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Patients with hepatic impairment under Actions.
Use in Children: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Children under Actions.
Use in the Elderly: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Elderly under Actions.