Bivalos is a drug that affects the structure and mineralization of bone tissue. It is used to treat bone diseases and, in particular, to reduce the risk of fractures of the femur and vertebrae.
Release form and composition
Available Bivalos in the form of granules for the preparation of suspensions. One sachet contains:
- 2,632 g strontium ranelate hydrate (equivalent to 2 g anhydrous strontium ranelate):
- Auxiliary components: maltodextreme, aspartame, mannitol.
The drug is sold in two-gram sachets of 7, 14, 28, 56, 84 or 100 pcs. packaged.
Indications for use
According to the instructions for Bivalos, the use of this drug is indicated for the treatment of:
- Osteoporosis (a progressive systemic metabolic disease that is characterized by a decrease in bone tissue density, an increase in its fragility and a violation of its microarchitecture) in men with an increased risk of fractures and in postmenopausal women;
- Deforming osteoarthritis of the spine, hip and knee joints (the goal of structural-modifying therapy is to slow down the process of destruction of the cartilage tissue of the joints and reduce the severity of the clinical symptoms of the disease).
As indicated in the instructions for Bivalos, the use of the drug is contraindicated:
- In case of hypersensitivity to strontium ranelate or any of the excipients;
- With venous thromboembolism (VTE), as well as patients with a history of VTE episodes, including deep vein thrombosis or pulmonary artery;
- Permanently or temporarily immobilized patients (for example, in cases when a person is forced to follow bed rest during the postoperative period);
- In ischemic heart disease, chronic obliterating disease of the arteries of the lower extremities and / or in cerebrovascular disease, as well as if any of these diseases are noted in history;
- With uncontrolled arterial hypertension.
With caution, Bivalos is prescribed to patients with severe forms of renal failure (accompanied by a decrease in creatinine clearance below 30 ml per minute), as well as to people who are at risk of developing VTE.
Reliable studies of the safety and therapeutic efficacy of the drug in the treatment of children and adolescents under 18, as well as pregnant women have not been conducted, so the use of Bivalos is not recommended for these categories of patients.
Strontium is excreted in breast milk, so bivalos should not be used during lactation, or it is worth considering whether to stop breastfeeding.
Dosing and Administration
Bivalos, according to the instructions, must be taken orally, after having dissolved the contents of one sachet (2 g of strontium ranelate) in at least 30 ml of water until a homogeneous suspension is obtained.
During the research it was found that the active component of the drug retains its pharmacological properties within 24 hours after preparation of the solution, however, it is recommended to prepare the suspension immediately before use.
In addition, it is worth noting that strontium ranelate is absorbed slowly, and even more its absorption slows down the simultaneous ingestion of food (especially milk and dairy products). For this reason, it is necessary to take Bivalos at least two hours after eating, optimally - before bedtime.
Elderly dose adjustment is not required. Since the active substance of Bivalos is not metabolized, a revision of the dose is also not needed in patients with impaired liver function.
Relatively common side effects from bivalos are nausea and diarrhea.
Much less likely to occur:
- Impairment of consciousness;
- Eczematous rash;
- Vascular disorders (in particular, VTE);
- Memory impairment;
- Venous thromboembolism;
- Increased seizure activity;
- Increased activity of creatine phosphokinase.
In very rare cases, the patient's body to receive Bivalos reacts with abdominal pain, vomiting, irritation or ulcers on the oral mucosa. In some cases, can develop stomatitis.
In the presence of hypersensitivity or intolerance to any component of the drug may develop allergic reactions, including skin rash, itching and angioedema.
When conducting animal studies, no negative effects of Bivalos on female reproductive function were noted, however, this drug is prescribed to women only during the postmenopausal period.
Patients with osteoporosis should be supplemented with Bivalos treatment with vitamin D and calcium supplements (if they are ingested with insufficient amounts of food).
Calcium-containing products, medicines and food additives reduce the bioavailability of strontium ranelate by about 60-70%.
It is not recommended to apply Bivalos with antibiotics of the tetracycline and quinolone series at the same time, since strontium reduces their absorption. No clinically significant interactions with other drugs have been identified.
Negative impact on visual acuity, reaction rate and ability to concentrate the drug has no effect.
The structural analogue of Bivalos is Osteolate, which is also available in powder form for the preparation of suspensions.
The following drugs can be considered analogs of the mechanism of action: Osteogenon, Osteoca, Osteohel C, Prolia, Exjiva.
Terms and conditions of storage
Bivalos is a drug that can be bought at a pharmacy only if you have a prescription from a doctor. According to the recommendations of the manufacturer, it should be stored in a dry place inaccessible to the sun. The optimum temperature is up to 25 ºС. Under these conditions, the shelf life of the granules is 3 years.