Avastin is an innovative antitumor drug that has recently appeared in the pharmacy assortment. The drug is in demand in oncology practice due to its ability to fight the most aggressive forms of cancer. Avastin contains recombinant humanized antibodies that are not toxic to the human body. But during treatment there is a possibility of developing adverse reactions. Therefore, it is advisable to use the drug only as prescribed by a doctor in the dosage regimen specified by him.
Characteristics of Avastin
Avastin is a product of genetic engineering. Its composition is formed from nucleic acids, which were obtained by combining foreign fragments with nucleotides. This combination is considered in medicine and pharmacology to have properties as close as possible to the cells of the human body. Monoclonal antibodies selectively combine with the bioactive factor VEGF, which leads to its rapid neutralization. The malignant tumor gradually decreases in size and then disappears altogether.
Avastin is available in the form of a fine crystalline powder. This is a concentrate that is diluted with an isotonic sodium chloride solution before use. The powder is packaged in glass bottles with rubber stoppers and aluminum caps of 4 or 16 ml. The cardboard box also contains an annotation, the recommendations of which will help to carry out the treatment correctly.
What is Avastin for?
The main indication for treatment with Avastin is malignant neoplasms, including those complicated by metastases. Oncologists prescribe the drug to patients after diagnosing the following pathologies:
- colorectal cancer - a tumor that forms in the rectum, as part of complex therapy;
- inoperable forms of lung cancer in combination with drugs containing platinum compounds;
- malignant neoplasms affecting renal structures, together with immunomodulators alpha-2a interferons;
- focal cancer localized in the fallopian tube, ovary, one of the abdominal organs in combination with Carboplatin or Paclitaxel.
Avastin is also included in therapeutic regimens when other anticancer drugs are ineffective.
Avastin concentration for infusion 400mg/16ml bottle N1x1 Genentech
Avastin is administered only intravenously; It is impossible to administer the drug intravenously as a bolus or bolus! Avastin is not intended for intravitreal administration. Avastin is pharmaceutically incompatible with dextrose solutions. The required amount of Avastin is diluted to the required volume with 0.9% sodium chloride solution in compliance with aseptic rules. The concentration of bevacizumab in the prepared solution should be in the range of 1.4-16.5 mg/ml. The initial dose of the drug is administered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion can be given over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions can be given within 30 minutes. It is not recommended to reduce the dose of bevacizumab due to adverse events. If necessary, treatment with Avastin should be stopped completely or temporarily. Standard dosage regimen. Metastatic colorectal cancer. As first line of therapy: 5 mg/kg once every 2 weeks or 7.5 mg/kg once every 3 weeks as an intravenous infusion, long-term. It is recommended that Avastin therapy be continued until signs of disease progression or unacceptable toxicity occur. As a second-line therapy: patients previously treated with Avastin after the first progression of the disease can continue treatment with Avastin, subject to a change in chemotherapy regimen: - if the disease progresses after first-line therapy that included Avastin: 5 mg/kg once every 2 weeks or 7.5 mg/kg once every 3 weeks as an intravenous infusion, long-term; — with disease progression after first-line therapy that did not include Avastin: 10 mg/kg once every 2 weeks or 15 mg/kg once every 3 weeks as an intravenous infusion, long-term. Locally recurrent or metastatic breast cancer (BC) 10 mg/kg once every 2 weeks as an intravenous infusion, long-term. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Advanced inoperable, metastatic or recurrent non-squamous non-small cell lung cancer. — First-line therapy for non-small cell lung cancer in combination with platinum-based chemotherapy. Avastin is prescribed in addition to platinum-based chemotherapy (maximum duration of chemotherapy is 6 cycles), then Avastin is continued as monotherapy. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Recommended doses: - 7.5 mg/kg once every 3 weeks as an intravenous infusion in addition to cisplatin-based chemotherapy; — 15 mg/kg once every 3 weeks as an intravenous infusion in addition to carboplatin-based chemotherapy. — First-line therapy for non-small cell lung cancer with activating mutations in the EGFR gene in combination with erlotinib 15 mg/kg once every 3 weeks as an intravenous infusion in addition to erlotinib therapy. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. For patient selection and dosing information, see the complete prescribing information for erlotinib. Advanced and/or metastatic renal cell carcinoma. 10 mg/kg once every 2 weeks as an intravenous infusion, long-term. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Glioblastoma (glioma grade IV according to WHO classification). For newly diagnosed disease: 10 mg/kg once every 2 weeks as an intravenous infusion in combination with radiation therapy and temozolomide for 6 weeks. After a 4-week break, Avastin administration is resumed at a dose of 10 mg/kg once every 2 weeks in combination with temozolomide. Temozolomide is prescribed in 4-week cycles, the duration of temozolomide therapy is up to 6 cycles. Further, the administration of Avastin continues as monotherapy at a dose of 15 mg/kg once every 3 weeks. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. For recurrent disease: 10 mg/kg once every 2 weeks as an intravenous infusion, long-term. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Epithelial cancer of the ovary, fallopian tube and primary peritoneal cancer As first line of therapy: 15 mg/kg once every 3 weeks as an intravenous infusion in addition to carboplatin and paclitaxel (maximum duration of chemotherapy 6 cycles), then Avastin continues as monotherapy . The total duration of therapy with Avastin is 15 months. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. For recurrent disease: - sensitive to platinum drugs: 15 mg/kg once every 3 weeks as an intravenous infusion in combination with carboplatin and paclitaxel (6-8 cycles); then the administration of Avastin continues as monotherapy or 15 mg/kg once every 3 weeks as an intravenous infusion in combination with carboplatin and gemcitabine (6-10 cycles), then the administration of Avastin continues as monotherapy. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. - resistant to platinum drugs: 10 mg/kg once every 2 weeks as an intravenous infusion in combination with one of the following drugs: paclitaxel, topotecan (with a “weekly” regimen of topotecan administration - that is, on days 1, 8 and 15 every 4 weeks) or pegylated liposomal doxorubicin or 15 mg/kg once every 3 weeks as an intravenous infusion in combination with topotecan administered daily for 5 consecutive days every 3 weeks. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Persistent, recurrent or metastatic cervical cancer 15 mg/kg once every 3 weeks as an intravenous infusion in combination with chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan. If signs of disease progression or unacceptable toxicity occur, Avastin therapy should be discontinued. Dosage regimen for special groups of patients. Children and teenagers. Avastin is contraindicated in children under 18 years of age. The safety and effectiveness of Avastin in patients under 18 years of age has not been established. The addition of Avastin to standard therapy in clinical trials did not show clinical benefit in pediatric patients with high-grade glioma and in pediatric patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. The publications describe cases of osteonecrosis of various localizations, except for osteonecrosis of the jaw, observed in patients under the age of 18 years who received Avastin®. Elderly patients (over 65 years of age) No dose adjustment is required in patients over 65 years of age. Patients with renal impairment The safety and effectiveness of bevacizumab in patients with renal impairment have not been studied. Patients with liver failure. The safety and effectiveness of bevacizumab in patients with hepatic impairment have not been studied. Instructions for use, handling and destruction. Before use, the solution must be inspected for mechanical inclusions and color changes. Avastin does not contain an antimicrobial preservative, so it is necessary to ensure that the prepared solution is sterile and use it immediately. If the drug is not used immediately, then the time and storage conditions of the prepared solution are the responsibility of the user. The prepared solution can be stored for no more than 24 hours at a temperature from +2°C to +8°C, if the dilution is carried out under controlled and validated aseptic conditions. The chemical and physical stability of the prepared solution is maintained for 48 hours at temperatures from +2°C to +30°C in a 0.9% sodium chloride solution. The unused drug remaining in the bottle is destroyed, as it does not contain preservatives.
How Avastin works
Its course use prevents the formation of additional blood vessels that feed the tumor. It stops increasing in size, growing, and metastasizing. The therapeutic effects of Avastin are due to the properties of its active ingredient bevacizumab, which represents a clinical and pharmacological group of drugs with recombinant monoclonal antibodies. Under its influence, the receptors of growth factors of the first and second types, which are located on the surface of the endothelium, are blocked. First, vascularization decreases, and after some time a decrease in the tumor is noted. How much does the anticancer drug Avastin cost? Go to the corresponding section of the site to find out.
Pharmacokinetics
The maximum therapeutic concentration of the active substance Avastin is ensured by its parenteral administration once every 1-2 times a month. The age of the patient does not affect the clearance of bevacizumab. It is almost a third higher in patients whose blood contains low levels of albumin. The active ingredient is metabolized by proteolytic catabolism by all cells of the body.
Avastin drug interactions
The effect of anticancer drugs on the pharmacokinetics of Avastin. No clinically significant effect on the distribution of Avastin has been reported when used concomitantly with chemotherapy. Avastin clearance did not differ between patients who received Avastin alone and those who received Avastin in combination with IPF (bolus regimen). The effect of other chemotherapeutic drugs (fluorouracil-LV, carboplatin-paclitaxel, capecitabine or doxorubicin) on the clearance of Avastin is not considered clinically significant. Effect of Avastin on the pharmacokinetics of other anticancer drugs Avastin does not significantly affect the pharmacokinetics of irinotecan and its active metabolite (SN38); capecitabine and its metabolites, as well as oxaliplatin (determined by free and total platinum levels); interferon alpha-2a; cisplatin. There are no reliable data on the effect of Avastin on the pharmacokinetics of gemcitabine. With the combined use of warfarin (treatment of venous thrombosis) and Avastin, no increase in the incidence of serious bleeding was noted. When Avastin (10 mg/kg, once every 2 weeks) was used in combination with sunitinib (50 mg/day), cases of microangioplastic hemolytic anemia (MAHA) have been reported in patients with metastatic renal cell cancer. MAHA belongs to a subgroup of hemolytic anemias that may present with red blood cell fragmentation, anemia, and thrombocytopenia. Some patients additionally experience neurological disorders, elevated creatinine levels, hypertension (arterial hypertension), including hypertensive crisis. These symptoms were reversible after stopping treatment with bevacizumab and sunitinib. Radiation therapy The safety and effectiveness of Avastin in combination with radiation therapy have not been established. Incompatibility Avastin and bags made of polyvinyl chloride and polyolefin are incompatible with each other. Avastin is not pharmaceutically compatible with dextrose solutions. When diluting Avastin with 5% dextrose solution, a concentration-dependent profile of Avastin degradation was noted.
Instructions for use
You can find out the cost of the antitumor drug from our catalog. Avastin is used as an injection solution for intravenous administration. During the preparation of the medicine, compliance with the rules of asepsis is required. When calculating single doses, the oncologist takes into account the type of cancer, tumor size, and severity of symptoms. He focuses on the patient’s age and the presence of other chronic diseases. When the concentrate is mixed with an isotonic solution, a drug is obtained in which the content of bevacizumab varies between 1.4–16.5 mg/ml. There are several nuances to Avastin therapy:
- The first treatment procedure cannot last less than one and a half hours. If no adverse reactions occur, then the next intravenous administration lasts no more than an hour.
- The injection solution is administered not by junior medical personnel, but by an oncologist with practical experience in treating cancer with monoclonal antibodies.
- Throughout the treatment, the patient's condition is monitored based on functional indicators of the liver and kidneys.
No dosage adjustment is required for elderly and senile patients. But it is necessary for people with liver and kidney pathologies.
Avastin in ophthalmology
Avastin is a medical drug used in the treatment of ophthalmic diseases since 2004. It was developed as an oncological agent that can slow down the growth of tumors and reduce their volume for subsequent surgical treatment. However, in the course of clinical studies, another ability was noted - to slow down the growth of newly formed vessels, which is now successfully used in ophthalmology in the treatment of age-related macular degeneration and other eye diseases accompanied by abnormal proliferation of blood vessels (neovascularization).
Thus, injections of Avastin into the vitreous body for proliferative diabetic retinopathy turned out to be very effective and well tolerated by patients. In addition, it is highly effective in stabilizing the development of the subretinal neovascular membrane - the growth of newly formed vessels in the fundus.
Ophthalmological practice of using Avastin shows that in the majority of patients, after treatment there was a significant improvement in the functional state of the organ of vision. The drug is especially effective in cases of hemorrhages into the vitreous body, with neovascularization of the iris. Intravitreal administration of the drug is also used in the treatment of wet forms of macular degeneration in the elderly, macular edema, diabetic retinopathy, and neoplasms of the perimacular region.
The effect of Avastin administration is expressed in the thinning of the macular region of the retina and stabilization of the subretinal neovascular membrane, which is confirmed by fluorescein angiography, which shows a decrease in fluorescein extravasation.
Injections of the drug into the vitreous minimize the risk of developing systemic side effects due to microdosing, which is sufficient for a targeted effect (400-500 times less than the dose used for intravenous administration), however, even this allows the doctor to create the necessary concentration of the substance in a given area. Avastin in a dosage of 1.25 mg is injected into the vitreous body once every 3-4 weeks. The maximum effect is often observed immediately after the first injections.
Since the beginning of the use of Avastin, there have been positive changes in the treatment of the wet form of age-related macular degeneration. This drug has high effectiveness and affordable cost. The response to treatment with it, as studies show, does not depend on photodynamic therapy and the administration of the drug Macudzhen - the results will be the same as with treatment carried out for the first time. In addition, there are no age restrictions when treating AMD with Avastin.
The limitations of using the drug intraocularly include only childhood, pregnancy, and the period of breastfeeding, due to the rather painful procedure for intraocular administration.
Over the past years since the drug was first used in ophthalmology, a large number of scientific papers have been published regarding Avastin therapy methods, with an analysis of the results obtained in the treatment of patients with the exudative form of AMD. The conclusion of these studies is clear: thanks to the administration of Avastin, there is a significant increase in visual acuity in almost a third of patients, and in more than half of patients, visual acuity is stabilized.
Contraindications to treatment with Avastin
An absolute contraindication to antitumor therapy is hypersensitivity to one of the components. Avastin is used with caution in the treatment of patients with the following pathological conditions:
- hypertension;
- thromboembolism;
- hemorrhagic diathesis;
- blood clotting disorders;
- severe cardiovascular diseases;
- agranulocytosis;
- history of perforation of ulcers;
- acquired coagulopathy;
- proteinuria.
In pediatric practice, treatment with Avastin is prohibited. This is also true during pregnancy and breastfeeding. For patients with severe renal or liver failure, safer drugs are selected.
Buy Avastin concentrate for the preparation of solution for infusion 100 mg/4 ml vial. No. 1 in pharmacies
AVASTIN
MANUFACTURERS Genentech Inc. (United States of America) Hoffmann-La Roche Ltd. (Switzerland) Hoffmann-La Roche Ltd. packaged Ortat (Switzerland)
GROUP Antitumor agents of different groups
COMPOSITION The active substance is bevacizumab.
INTERNATIONAL NON-PROPENTED NAME Bevacizumab
PHARMACOLOGICAL ACTION Suppresses metastatic disease progression and reduces microvascular permeability in various human tumors, including colon, breast, pancreas and prostate cancer.
INDICATIONS FOR USE Metastatic colorectal cancer: as first-line therapy in combination with chemotherapy with fluoropyrimidine derivatives.
CONTRAINDICATIONS Hypersensitivity, metastases in the central nervous system, renal and/or liver failure, pregnancy, lactation, childhood. With caution: arterial hypertension, history of arterial thromboembolism, old age over 65 years, wound healing, bleeding, gastrointestinal perforation.
SIDE EFFECTS In case of combined theparia: increased blood pressure, arterial thromboembolism, deep vein thrombosis, CHF, leukopenia, neutropenia, anemia, abdominal pain, diarrhea, constipation, bleeding from the rectum, stomatitis, bleeding gums, gastrointestinal perforation, nosebleeds, shortness of breath, rhinitis, dry skin, exfoliative dermatitis, skin discoloration, taste perversion, anorexia, syncope, cerebral ischemia, blurred vision, pain at the injection site, asthenia, abscess, sepsis, fever, vaginal bleeding, proteinuria, hypokalemia, hyperkalemia , hyponatremia, hypophosphatemia, hyperglycemia and increased alkaline phosphatase activity.
INTERACTION During combination therapy with the drug and IFL, an increase in the concentration of the active metabolite of irinotecan SN38 by 33% was observed. With combination therapy with the drug and IPF, a slight increase in the frequency of diarrhea and leukopenia was noted, as well as a more frequent need to reduce the dose of irinotecan. If severe diarrhea, leukopenia or neutropenia develops during combination therapy with irinotecan, dose adjustment of the latter is necessary. Pharmaceutically incompatible with dextrose solutions.
METHOD OF ADMINISTRATION AND DOSAGE Only slowly intravenously (CANNOT BE ADMINISTERED BY STREAM!), 5 mg/kg 1 time every 14 days.
OVERDOSE Symptoms: increase in the above side effects. Treatment: symptomatic. There is no specific antidote.
SPECIAL INSTRUCTIONS Treatment is carried out only under the supervision of a physician experienced in the use of antitumor therapy. If signs of disease progression appear, with the development of perforation, in the case of optional surgical intervention, with the development of grade 4 proteinuria. , if bleeding occurs 3 or 4 tbsp. severity, therapy should be discontinued. For more detailed information, see the instructions for use.
STORAGE CONDITIONS Store in a place protected from light at a temperature of 2-8 degrees. C. Do not freeze.
