Zometa - bisphosphonate; bone resorption inhibitor used in the treatment of bone diseases.
Release form and composition
Dosage Forms Zometa:
- Solution for infusions 4 mg / 100 ml (in plastic bottles of 100 ml);
- Concentrate for preparation of solution for injections of 4 mg / 5 ml (in plastic bottles with a volume of 5 ml).
The active ingredient of the drug is zoledronic acid (in the form of monohydrate).
- The solution - sodium citrate dihydrate, mannitol and injection water;
- The concentrate is sodium citrate, mannitol, injectable water and nitrogen.
Indications for use
Zometa is intended for the treatment of:
- Bone metastases of common malignant tumors, including breast cancer and prostate cancer;
- Hypercalcemia due to malignant tumor.
Zometa is also used for myeloma, including reducing the risk of pathological fractures, the development of hypercalcemia and compression of the spinal cord caused by a tumor, as well as to reduce the need for surgery on the bone and the need for radiation therapy.
The use of the drug is contraindicated in:
- Severe renal dysfunction;
- Hypersensitivity to zoledronic acid, any auxiliary component of the drug or other bisphosphonates.
Dosing and Administration
Zometa solution is intended for intravenous drip infusion (lasting at least 15 minutes). The recommended dosage is 4 mg. If necessary, it is increased to 8 mg.
Concentrate immediately before the introduction of diluted 100 ml of 0.9% sodium chloride solution or 5% dextrose solution.
In myeloma and bone metastases, patients are additionally prescribed to take calcium supplements (500 mg / day) and vitamin D (400 IU / day).
Patients with mild and moderately impaired renal function dose is determined on the basis of QC:
- 50-60 - 3.5 mg;
- 40-49 - 3.3 mg;
- 30-39 - 3 mg.
After the start of Zomet's treatment, the concentration of serum creatinine is determined before each subsequent injection of the solution. In the event that a renal dysfunction is detected, the next infusion is delayed, and therapy is resumed only after the QC reaches a value within the initial value (a slight deviation of ± 10% is allowed), at the same dosage that was prescribed before the break.
The most common side effects of Zometa are:
- Nausea and / or vomiting, anorexia;
- Myalgia, bone pain, arthralgia;
- Impaired renal function;
- Heat and flu-like syndrome, manifested by chills, fever, pain in the bones and / or muscles;
- Hypophosphatemia, hypocalcemia, increased serum creatinine and urea levels.
Sometimes there are such side effects:
- Anemia, thrombocytopenia, leukopenia;
- Disturbance of taste sensations, dizziness, paresthesia, hypoesthesia, hypostezia, weakness, hyperesthesia, tremor;
- Sleep disorders, anxiety;
- Blurred vision;
- Abdominal pain, dyspepsia, stomatitis, constipation or diarrhea, dry mouth;
- Dyspnea, cough;
- Increased sweating, itching, rash (including erythematous and macular);
- Muscle cramps;
- Hematuria, proteinuria, acute renal failure;
- Hypersensitivity reactions;
- Chest pain, asthenia, peripheral edema, weight gain;
- Pain, swelling, irritation and the formation of infiltration at the injection site;
In rare cases, possible:
- Confusion of consciousness;
- Uveitis, episcleritis;
- Hypokalemia, hyperkalemia, hypernatremia.
With an acute overdose of zoledronic acid, impaired renal function (including renal failure) and a change in electrolyte composition may occur.
The solution of Zometa, including that prepared from concentrate, must not be mixed with any other drug, including solutions containing calcium or other divalent cations (for example, Ringer's lactate solution).
Before infusion, it is necessary to exclude dehydration from the patient. To ensure adequate hydration before, during or after the application of Zometa, the introduction of saline is recommended. However, it is important to avoid overhydration as well. this is fraught with the development of complications in the cardiovascular system.
During the period of treatment, constant monitoring of serum concentrations of calcium, creatinine, phosphorus and magnesium is necessary. If hypocalcemia, hypomagnesaemia, or hypophosphatemia develops, short-term maintenance therapy is also prescribed. Untreated hypercalcemia, as a rule, is accompanied by impaired renal function, therefore, monitoring of their function is especially needed in patients of this category.
The risk of impaired renal function during the period of Zomet's treatment increases:
- during dehydration;
- in patients with renal failure in history;
- with too fast introduction of the solution;
- with long-term use of the drug in high doses (8 mg);
- with the simultaneous introduction of nephrotoxic drugs;
- with repeated use of zoledronic acid or other bisphosphonates.
Despite the fact that under the condition of slow administration (for at least 15 minutes) Zometa at a dose of 4 mg reduces the risk of complications, the likelihood of impaired renal function still remains.
Safety and effectiveness of zoledronic acid in pediatrics has not been established.
With the simultaneous use of all bisphosphonates, including Zometa, with aminoglycosides, the level of calcium in the blood can remain reduced longer than is required, due to the additive effect on serum calcium concentration.
When prescribing Zometa in combination with drugs that potentially have a nephrotoxic effect, the likelihood of impaired renal function increases.
Aklast, Blaztera, Veroklast, Zoleriks, Zoledronat-Teva, Zelendronic-Rus 4, Zoledrax, Resoclastin FS, Resorba.
Terms and conditions of storage
Zometa should be stored in any form of release at temperatures up to 30 ºС. Shelf life - 3 years. The solution prepared from a concentrate can be stored no more than 24 hours in the refrigerator (at a temperature of 2-8 ºС).