Alendronate can cause local irritation of the mucous membrane of the upper gastrointestinal tract. In this regard, during the administration of alendronate should be careful when prescribing the drugpatients with diseases of the upper gastrointestinal tract, for example, with dysphagia, esophageal disease, gastritis, duodenitis, ulcer, a serious gastrointestinal disease, transferred in the previous 12 months, for example, in peptic ulcer, as well as with active gastrointestinal bleeding, surgery at the upper departments of the digestive tract, with the exception of pyloroplasty. For patients with a diagnosed Barrett's esophagus, the question of the appointment of alendronate should be decided on an individual basis by assessing the relationship between the expected benefit and the potential risk.
In the treatment of alendronate, there are cases of adverse reactions from the side of the esophagus (esophagitis, ulcer or erosion of the esophagus), sometimes occurring in severe form and requiring hospital treatment, and in rare cases complicated by the formation of stricture. In connection with this, doctors need to pay special attention to any signs or symptoms indicating possible abnormalities on the part of the esophagus, and patients should be warned about the need to stop taking alendronate and seek medical advice if symptoms of esophageal irritation such as dysphagia, pain when swallowing or pain behind the sternum, the appearance or intensification of heartburn.
The risk of severe adverse events on the part of the esophagus is higher in those patients who violate the recommendations for taking the drug and / or continue to take it when symptoms of esophageal irritation appear. It is especially important to give the patient recommendations but taking the drug so that he understands that the risk of developing an esophageal lesion increases if these recommendations are not implemented.
Although there was no increased risk in the extended clinical trials of alendronate, post-marketing reports reported rare cases of stomach and duodenum ulcers, sometimes severe and complicated.
Patients with cancer, who were treated with intravenous bisphosphonates, had cases of osteonecrosis of the jaw, mainly due to previous tooth extraction and / or local infection (including osteomyelitis). Many of the patients also received chemotherapy and glucocorticosteroids. There are also cases of osteonecrosis of the jaw in patients with osteoporosis who took bisphosphonates orally.
When assessing the individual risk of developing necrosis of the jaw, the following risk factors should be considered:
- activity of bisphosphonate (highest in zoledronic acid), route of administration (see above) and total dose;
- cancer, chemotherapy, radiotherapy, glucocorticosteroids, smoking;
- dental disease in history, poor oral hygiene, periodontal disease, invasive dental procedures and poorly selected dentures.
Before starting oral bisphosphonate therapy, patients with unsatisfactory dental status are recommended to have a dental examination and preventive medical measures.
During the course of bisphosphonates, it is recommended that such patients avoid invasive dental procedures whenever possible. If a patient develops an osteonecrosis of the jaw during therapy with bisphosphonates, surgical dental treatment may worsen his condition. It is not known whether the discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw in patients who require dental procedures. In each case, the decision should be made by the attending physician on the basis of an estimate of the relationship between the expected benefit and the possible risk for the particular patient.
During therapy with bisphosphonates, patients should explain to patients the importance of proper oral hygiene,preventive examinations, and also warn them about the need to report any symptoms from the oral cavity, such as mobility of the teeth, pain or swelling.
It is known about cases of pain in the bones, joints and / or muscles during the course of bisphosphonates. During post-use use in rare cases, these symptoms were severe and / or caused disability. The time of onset of symptoms varied from one day to several months after the start of treatment. In most patients, symptoms were resolved after discontinuation of treatment. In some of them, the symptoms appeared again with the resumption of the same drug or other bisphosphonate.
It is known about cases of atypical susceptible or diaphyseal fractures of the thigh during treatment with bisphosphonates, mainly in patients receiving long-term therapy for osteoporosis. These transverse or oblique fractures can occur along the entire length of the thigh from the small trochanter of the femur to the supracondylar expansion. These fractures occur after minor or no trauma, some patients experience severe pain in the thigh or inguinal area, which is often combined with radiologic symptoms of stress fractures, several weeks or months before the appearance of a complete picture of a hip fracture. Fractures are often bilateral, so in patients with a hip fracture, taking bisphosphonates, the second (contralateral) thigh should be examined. It is known that these fractures are poorly fused. If suspected atypical fracture of the thigh, consideration should be given to discontinuing bisphosphonate therapy before an individual assessment of the relationship between expected benefit and possible risk.
During therapy with bisphosphonates, patients should be advised to report any pain in the thigh or in the groin. All patients who have received such complaints should be examined for incomplete fracture of the femur.
During post-marketing use, rare reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.
Patients should be warned that with an occasional missed dose of FOSAMAX® Once a week they should take 1 tablet the morning of the next day after they remember. Do not take two tablets on the same day, but in the subsequent it is necessary to return to taking the drug once a week on the day of the week that was chosen at the beginning of treatment.
The drug FOSAMAX® It is not recommended for patients with renal failure at a glomerular filtration rate <35 ml / min.
Other causes of osteoporosis should be taken into account, in addition to estrogen deficiency and age.
In the presence of hypocalcemia, the concentration of calcium in the blood should be normalized before treatment with alendronate. Other disorders of mineral metabolism (eg, vitamin deficiency D and hypoparathyroidism) should also be effectively treated before alendronate therapy begins. In patients with these disorders during therapy with the drug FOSAMAX®, it is necessary to monitor the concentration of calcium in the blood serum and the symptoms of hypocalcaemia.
Since alendronate increases the mineral content in the bones, a decrease in the concentration of calcium and phosphate in the blood serum can be observed, especially in patients taking glucocorticosteroids, in which calcium absorption can be reduced. Usually, this decrease is small and asymptomatic.Nevertheless, there are rare cases of symptomatic hypocalcemia, which sometimes reached a severe degree and developed in patients with a corresponding predisposition (eg, hypoparathyroidism, vitamin deficiency D and calcium malabsorption).
This medicinal product contains anhydrous lactose. Patients with rare hereditary diseases of galactose intolerance, deficiency of lactase or glucose-galactose malabsorption should take this medication.