Zolerix, 0.8 mg/ml, concentrate for solution for infusion, 5 ml, 1 pc.
Before infusion of Zolerix®, ensure that the patient is adequately hydrated. If necessary, it is recommended to administer a 0.9% sodium chloride solution before the infusion of Zolerix®. Overhydration of the patient should be avoided due to the risk of cardiovascular complications.
After administration of zoledronic acid, constant monitoring of the concentrations of calcium (adjusted for albumin), phosphorus, magnesium and creatinine in the blood plasma is necessary. If hypocalcemia, hypophosphatemia or hypomagnesemia develops, short-term additional administration of the corresponding substances may be necessary. Patients with untreated hypercalcemia usually have impaired renal function, so careful monitoring of renal function in this category of patients is necessary.
When deciding whether to treat patients with bone metastases with Zolerix® to reduce the risk of pathological fractures, spinal cord compression, tumor-related hypercalcemia, and reduce the need for radiation therapy or bone surgery, it should be taken into account that the therapeutic effect occurs 2–3 months after starting to use the drug.
Renal dysfunction
There are isolated reports of renal dysfunction associated with the use of bisphosphonates. Risk factors for such complications include dehydration, pre-existing renal impairment, repeated administration of zoledronic acid or other bisphosphonates, as well as the use of nephrotoxic drugs, and too rapid administration of the drug. Although the risk of the above-described complications is reduced when zoledronic acid is administered at a dose of 4 mg over at least 15 minutes, the possibility of renal dysfunction remains.
There have been cases of deterioration in renal function, progression of renal dysfunction up to the occurrence of renal failure and the need for hemodialysis with the first or single use of zoledronic acid.
Increases in plasma creatinine concentrations have also been observed in some patients with long-term use of zoledronic acid at recommended doses, although with less frequency.
The concentration of creatinine in the blood plasma should be determined before each administration of the drug. In patients with mild to moderate renal impairment, bone metastases from solid malignant tumors and multiple myeloma, a lower starting dose of the drug is recommended (see section "Dosage and Administration"). If signs of renal dysfunction are detected during therapy, treatment with Zolerix® should be resumed only after the creatinine concentration reaches values within ±10% of the initial value (see section “Dosage and Administration”). The use of Zolerix® in patients with severe renal impairment is contraindicated (see section “Contraindications”).
When deciding on the use of zoledronic acid in patients with hypercalcemia caused by a malignant tumor against the background of impaired renal function, it is necessary to assess the patient's condition and conclude whether the potential benefit of administering the drug outweighs the possible risk.
The physician should inform patients about the main manifestations of hypocalcemia and ensure regular monitoring of patients at risk.
To reduce the incidence of some adverse events observed within 3 days after drug administration, paracetamol or ibuprofen can be prescribed immediately after the zoledronic acid infusion.
Osteonecrosis
Cases of osteonecrosis of the jaw have been described, mainly in patients with cancer during treatment with bisphosphonates, including zoledronic acid. Many of these patients received concurrent corticosteroid therapy or chemotherapy. Many patients had signs of a local infectious and inflammatory process, including osteomyelitis.
In clinical practice, the development of osteonecrosis of the jaw was most often observed in patients with advanced breast cancer and multiple myeloma, as well as in the presence of dental diseases (after tooth extraction, periodontal diseases, unsatisfactory fixation of dentures). Known risk factors for the development of osteonecrosis of the jaw are cancer, concomitant treatment (chemotherapy, radiation therapy, antiangiogenic drugs, glucocorticosteroids), concomitant diseases (anemia, coagulopathy, infection, previous oral disease).
Before using bisphosphonates in patients with cancer, a dental examination and necessary preventive procedures should be performed, and strict oral hygiene should be recommended.
During treatment with bisphosphonates, dental surgery should be avoided if possible. In patients with osteonecrosis of the jaw resulting from bisphosphonate therapy, invasive dental intervention may worsen the condition. There is no evidence that interrupting bisphosphonate treatment before dental procedures reduces the risk of developing osteonecrosis of the jaw. The treatment plan for a particular patient should be based on an individual assessment of the risk/benefit ratio.
Cases of osteonecrosis of other localizations, including the pelvic bone, femur, and external auditory canal, have been described, mainly in adult patients receiving therapy with bisphosphonates, including zoledronic acid.
Cases of osteonecrosis of the external auditory canal have mostly been reported with long-term use of zoledronic acid. Risk factors for the development of osteonecrosis of the external auditory canal: simultaneous use with glucocorticosteroids, chemotherapy and/or local factors such as infection and trauma. The possibility of developing osteonecrosis of the external auditory canal should also be considered in patients with chronic ear infections taking bisphosphonates.
Atypical femur fractures.
Cases of atypical subtrochanteric and diaphyseal fractures of the femur have been described in patients receiving long-term treatment with bisphosphonates for osteoporosis. Transverse or short oblique fractures can be located anywhere along the femur from the lesser trochanter to the supracondylar fossa. The described fractures occur after minimal trauma or spontaneously.
Some patients experience hip or groin pain, often accompanied by visual signs of stress fractures, which occur weeks and months before the development of a complete femur fracture. Fractures often occur on both sides, so in patients receiving bisphosphonates who experience a fracture of one femur, the contralateral femur should be evaluated. Slow healing (healing) of these fractures has also been reported. The cause-and-effect relationship of such fractures with zoledronic acid therapy has not been established. The decision to discontinue zoledronic acid therapy in patients suspected of having an atypical femoral fracture should be based on an individualized risk/benefit assessment.
Patients receiving zoledronic acid therapy should be advised to inform medical personnel of any pain in the hip or groin area. Each patient complaining of such symptoms should be examined to identify a possible incomplete (incomplete) fracture of the femur.
Musculoskeletal pain
In clinical practice, rare cases of severe and in some cases disabling pain in bones, joints and muscles have been reported with the use of bisphosphonates, which include zoledronic acid. These symptoms developed over a period of one day to several months after the start of treatment. After cessation of treatment, most patients experienced resolution of symptoms. In several patients, symptoms recurred when therapy was restarted or another bisphosphonate was prescribed.
Hypocalcemia
In clinical practice, the development of hypocalcemia has been reported in patients receiving zoledronic acid. In the case of severe hypocalcemia, adverse events from the nervous system (convulsions, tetany and numbness), and cardiac arrhythmia may occur. In some cases, hypocalcemia can be life-threatening.
Caution should be exercised when using Zolerix® concomitantly with other drugs that can cause hypocalcemia, as this may lead to a synergistic interaction and the development of severe hypocalcemia. Before starting treatment, it is necessary to determine the concentration of calcium in the blood plasma and correct hypocalcemia.
If hypocalcemia is present, before starting the use of zoledronic acid, it is necessary to treat with adequate doses of calcium and vitamin D. Also, if possible, treatment should be carried out for other existing disorders of mineral metabolism (for example, occurring after surgery on the thyroid and parathyroid glands, with hypoparathyroidism or decreased absorption of calcium in intestines) and ensure regular monitoring of patients with hypocalcemia.
Use in children
The safety and effectiveness of zoledronic acid when used in children 1–17 years of age have not been established.
Other information
There have been isolated cases of bronchoconstriction in patients with a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history) during the use of bisphosphonates. Although there were no such cases in clinical studies with zoledronic acid, it is recommended that the drug be used with caution in patients with aspirin-induced asthma.
Patients receiving Zolerix should not receive other bisphosphonate medications concomitantly.
In animal studies, zoledronic acid suppressed fertility at a dose of 0.1 mg/kg/day.
There are no data on the effects of zoledronic acid on fertility in humans.
Influence on the ability to drive vehicles and machinery.
The effect of zoledronic acid on the ability to drive vehicles and operate machinery has not been studied. In the event of adverse reactions from the nervous system, patients are advised to refrain from driving vehicles and other mechanisms, as well as engaging in activities that require concentration and strain on psychomotor functions.
What do patients think about new treatments for varicose veins?
Until now, despite the widespread use of laser and other endovenous thermoobliteration techniques, doctors in most specialties (especially open surgeons) have a prejudice against this procedure. These misconceptions lead to misinformation of the patient who consulted such a doctor, as a result of which this skepticism is transferred to the patient, who is sent instead of a low-traumatic and cosmetic laser procedure to open surgery under anesthesia.
Most often, these misconceptions come from the lack of personal experience working with laser equipment (most information is obtained from “third”, equally incompetent persons), as well as the lack of actual patients treated with laser equipment and observation of them. That is, all the problems come from the lack of simple educational literature, although there are a huge number of scientific articles on the Internet (mainly in the foreign press) on this issue. Let's take a closer look at why this happens, namely the main misconceptions of doctors.
The second misconception is that laser surgery is expensive, but traditional intervention is free:
For some reason, it is believed that laser surgery is prohibitively expensive, while simple surgery is done free of charge and on a quota basis.
Reality:
remember how much time, effort and nerves you need to spend to get a quota from the state for a free operation, in quotes, how many doctors you need to visit and tests. It is unknown which doctor you will see after. It is absolutely unlikely that you will end up with a renowned surgeon who will do everything well; most likely, you will be operated on by a novice specialist, or at best by an “average” doctor.
Currently, taking into account summer discounts, surgery on one leg in our center costs 47,600 rubles. Doctors with extensive experience in thousands of similar interventions will operate on you using the most modern equipment. After the operation, you will have access to free annual follow-up, which includes all types of consultations and studies available at the clinic.
The first misconception is that classical surgery is more reliable than laser surgery:
Why do many patients believe that open surgery is more reliable than laser surgery? “Old school” surgeons have a saying: “a vein in the arm (i.e., pulled out from the body) will never be recanalized. Yes, indeed, removed vein fragments cannot be restored, however, for example, in the area of the sapheno-femoral anastomosis, neovasculogenesis (growth of neovessels) is possible 5-10 years after surgery, leading to the reappearance of varicose veins - although surgeons do not know about this they love to talk.
Reality:
The reliability of laser surgery (subject to the technology and experience of the surgeon) is currently approaching 100%. This became possible due to the accumulation of significant experience in the use of these technologies and the constant improvement of laser technology. Currently, the most “advanced” are water-absorbing laser devices (with a wavelength of 1470 or 1530 nm) in combination with the use of radial type light guides (which shine “around” the tip of the light guide, and not forward, like the end type) (*I would like to note that In our clinic we work ONLY with the latest and most modern equipment). The use of modern equipment and technologies leads to high-quality and safe damage to the venous wall from the inside, as a result of which the diseased vein affected by varicose veins is completely “brewed” and the blood flow through it is blocked. What happens to the vein after this? Over the course of about 6 months, the vein turns into a thin connective tissue cord, indistinguishable by ultrasound from the surrounding tissue (fiber and structures of the superficial fascia). No ultrasound specialist will be able to find a laser-operated vein 1 year after the operation.
Questions that patients most often ask during a consultation with a phlebologist
The doctor at the clinic said that surgical removal of veins is more reliable than laser. Is it so?
Modern medical research has proven that endovenous laser obliteration is as effective in removing varicose veins as surgery. Moreover, the laser allows you to more accurately and even accurately eliminate pathologically altered veins. The minimal trauma of endovascular interventions allows one to avoid both complications and relapses of varicose veins, which cannot be said about classical vein surgery.
Laser treatment of varicose veins is very expensive. Wouldn't it be better to have a regular operation in a hospital?
Prices for endovascular laser interventions today are not exorbitant. An ordinary person with average income can easily afford modern laser treatment for varicose veins. The costs of concomitant treatment for classical vein surgery often exceed the cost of innovative laser intervention.
I was told that my veins were not suitable for laser treatment and offered conventional surgery. What do you think about it?
This is usually said in those medical institutions where they do not know endovasal technologies or have insufficient experience in laser interventions. For an experienced endovascular surgeon, the diameter of the vein and other anatomical nuances have long been no longer a significant problem.
Today laser is fashionable, but is it effective?
Yes, today laser endovascular interventions, in their modern version, are the latest fashion in the treatment of varicose veins. And this situation is not just a trend, but a statement of the fact that today there is simply nothing better and more effective than a laser for the treatment of varicose veins.
