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Avastin - instructions for use, reviews, analogs and forms of release (injections in ampoules for injection of 100 mg and 400 mg) drugs for the treatment and chemotherapy of breast, kidney and intestinal cancer in adults, children and pregnancy. Composition

Avastin - instructions for use, reviews, analogs and forms of release (injections in ampoules for injection of 100 mg and 400 mg) drugs for the treatment and chemotherapy of breast, kidney and intestinal cancer in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Avastin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Avastin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Avastin in the presence of existing structural analogues. Use for treatment and chemotherapy of breast, kidney and intestinal cancer in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Avastin - antitumor drug. Avastin (bevacizumab) is a humanized recombinant hyperchimeric monoclonal antibody that selectively binds to the biologically active vascular endothelial growth factor (VEGF) and neutralizes it. Avastin inhibits the binding of vascular endothelial growth factor to its Type 1 and 2 receptors (Flt-1, KDR) on the surface of endothelial cells, which leads to a reduction in vascularization and inhibition of tumor growth.

 

Bevacizumab contains fully human framework regions with complementarity determining regions of the hyperchimeric mouse antibody that bind to VEGF. Bevacizumab is produced by recombinant DNA technology in a system for expression represented by Chinese hamster ovary cells. Bevacizumab consists of 214 amino acids and has a molecular weight of about 149,000 daltons.

 

Introduction Avastin leads to suppression of metastatic progression of the disease and a decrease in microvascular permeability in various human tumors, including colon, breast, pancreas and prostate cancer.

 

Preclinical safety data

 

The carcinogenic and mutagenic potential of Avastin was not studied.

 

When Avastin was administered to animals, embryotoxic and teratogenic effects were observed.

 

In actively growing animals with open growth zones, Avastin was associated with dysplasia of the cartilaginous plate.

 

Composition

 

Bevacizumab + excipients.

 

Pharmacokinetics

 

Avastin distribution is characterized by low clearance, low volume of distribution in the central chamber (Vc) and a long half-life (T1 / 2), which allows to maintain the required therapeutic concentration of the drug in the plasma once every 2-3 weeks.

 

The clearance of bevacizumab does not depend on the age of the patient. Bevacizumab clearance is 30% higher in patients with low albumin levels and 7% higher in patients with a large tumor mass compared to patients with average albumin and tumor mass.

 

Metabolism

 

After a single intravenous injection of 125I-bevacizumab, its metabolic characteristics are similar to those of a natural IgG molecule that does not bind to VEGF.Metabolism and excretion of bevacizumab corresponds to the metabolism and excretion of endogenous IgG, i.e. mainly carried out by proteolytic catabolism in all cells of the body, including endothelial cells, and not through the kidneys and liver. Binding of IgG to neonatal receptors to a crystallizing fragment of IgG (FcRn receptors) protects it from cellular metabolism and provides a long T1 / 2.

 

Excretion

 

The clearance of bevacizumab is 0.188 liters per day in women and 0.220 liters per day in men. After correction of the dose, taking into account the body weight in men, the clearance of bevacizumab is 17% higher than that of women. According to the two-chamber model, T1 / 2 for women is 18 days, for men - 20 days.

 

Pharmacokinetics in specific patient groups

 

Patients of advanced age (over 65 years)

 

There was no significant difference in the pharmacokinetics of bevacizumab, depending on age.

 

Children and teens

 

There are limited data on the pharmacokinetics of bevacizumab in children and adolescents. The available data indicate that there is no difference between Vd and the clearance of bevacizumab in children, adolescents and adult patients with solid tumors.

 

Indications

 

Metastatic colorectal cancer:

  • in combination with chemotherapy based on fluoropyrimidine derivatives.

 

Locally recurrent or metastatic breast cancer:

  • as the first line of therapy in combination with paclitaxel.

 

Common inoperable, metastatic or recurrent non-cell lung non-small cell lung cancer:

  • as the first line of therapy in addition to chemotherapy based on platinum drugs.

 

Common and / or metastatic renal cell carcinoma:

  • as the first line of therapy in combination with interferon alpha-2a.

 

Glioblastoma (glioma 4 degrees of malignancy according to WHO classification):

  • in combination with radiotherapy and temozolomide in patients with newly diagnosed glioblastoma;
  • in monotherapy or in combination with irinotecan in patients with relapse of glioblastoma or progression of the disease.

 

Epithelial cancer of the ovary, uterine tube and primary cancer of the peritoneum:

  • as the first line of therapy in combination with carboplatin and paclitaxel in the disseminated (3B, 3C and 4 stage according to FIGO classification) epithelial ovarian cancer, uterine tube and primary peritoneal cancer;
  • in combination with carboplatin and gemcitabine with relapsing platinum-sensitive epithelial ovarian cancer, fallopian tube and primary peritoneal cancer in patients who have not previously been treated with bevacizumab or other VEGF inhibitors;
  • in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin in relapsing, platinum-resistant epithelial ovarian cancer, fallopian tube and primary peritoneal cancer in patients who received no more than two regimens of chemotherapy.

 

Forms of release

 

Concentrate for the preparation of a solution for infusions of 100 mg and 400 mg (injections in ampoules for injection 4 ml).

 

Other dosage forms, be it tablets or capsules, do not exist.

 

Instructions for use and dosing regimen

 

Avastin is administered only by intravenous drip (in the form of droppers); You can not inject the drug intravenously!

 

Avastin is not intended for intravitreal administration (injections into the eye area).

 

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 accordance 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 given IV infusion for 90 minutes. If the first infusion is well tolerated, then the second infusion can be performed within 60 minutes. If the infusion is well tolerated within 60 minutes, all subsequent infusions can be carried out within 30 minutes.

 

It is not recommended to reduce the dose of bevacizumab because of undesirable phenomena. If necessary, Avastin should be completely or temporarily discontinued.

 

Standard dosing regimen

 

Metastatic colorectal cancer

 

As the first line of therapy: 5 mg / kg every 2 weeks or 7.5 mg / kg once every 3 weeks as an IV infusion, long-term.

 

It is recommended that Avastin therapy be given before signs of disease progression or to unacceptable toxicity.

 

As a second line of therapy: patients who previously received Avastin therapy after the first progression of the disease can continue treatment with Avastin with the condition of changing the chemotherapy regimen:

  • with the progression of the disease after first-line therapy, including Avastin: 5 mg / kg every 2 weeks or 7.5 mg / kg once every 3 weeks as an IV infusion, long-term;
  • with the progression of the disease after first-line therapy, not including Avastin: 10 mg / kg once every 2 weeks or 15 mg / kg once every 3 weeks as an IV infusion, long-term.

 

Locally recurrent or metastatic breast cancer

 

The drug is prescribed in a dose of 10 mg / kg once every 2 weeks as an IV infusion, long-term.

 

If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

Common inoperable, metastatic or recurrent non-cell lung non-small cell lung cancer

 

Avastin is prescribed in addition to chemotherapy on the basis of platinum preparations (the maximum duration of chemotherapy is 6 cycles), then Avastin is continued as a monotherapy. If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

Recommended doses:

  • 7.5 mg / kg once every 3 weeks as an IV infusion in addition to cisplatin-based chemotherapy;
  • 15 mg / kg once every 3 weeks as an intravenous infusion in addition to carboplatin-based chemotherapy.

 

Common and / or metastatic renal cell carcinoma

 

The drug is prescribed in a dose of 10 mg / kg once every 2 weeks as an IV infusion, long-term.

 

If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

Glioblastoma (glioma 4 degrees of malignancy according to WHO classification)

 

For the first time diagnosed, 10 mg / kg once every 2 weeks as an IV infusion in combination with radiotherapy and temozolomide for 6 weeks. After a 4-week break, the Avastin drug is resumed at a dose of 10 mg / kg every 2 weeks in combination with temozolomide. Temozolomide appointed 4-week cycles, duration of therapy with temozolomide - up to 6 cycles. Further, Avastin is continued as monotherapy at a dose of 15 mg / kg once every 3 weeks. If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

In case of recurrent disease: 10 mg / kg once every 2 weeks as an IV infusion, prolonged. If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

Epithelial ovarian cancer, fallopian tube and primary peritoneal cancer

 

As the first line of therapy: 15 mg / kg once every 3 weeks as an IV infusion in addition to carboplatin and Paclitaxel (the maximum duration of chemotherapy is 6 cycles), then Avastin continues as a monotherapy. The total duration of therapy with Avastin is 15 months. If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

With a recurrent disease:

  • sensitive to platinum preparations - 15 mg / kg once every 3 weeks as an IV infusion in combination with carboplatin and gemcitabine (6-10 cycles), then Avastin continues as a monotherapy. If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.
  • resistant to platinum preparations - 10 mg / kg once every 2 weeks as an intravenous infusion in combination with one of the following drugs: paclitaxel, topotecan (weekly topotecan administration - i.e., 1, 8 and 15 days every 4 weeks) or pegylated liposomal doxorubicin

 

or

 

15 mg / kg once every 3 weeks as an IV infusion in combination with topotecan, applied daily for 5 consecutive days every 3 weeks.

 

If there is evidence of progression of the disease or unacceptable toxicity, Avastin should be discontinued.

 

Dosage regimen for specific patient groups

 

In elderly patients (over 65 years of age), dose adjustment is not required.

 

The safety and efficacy of bevacizumab in patients with renal insufficiency has not been studied.

 

The safety and efficacy of bevacizumab in patients with hepatic insufficiency has not been studied.

 

The safety and efficacy of bevacizumab in children and adolescents have not been established.

 

Instructions for use, handling and destruction of the drug

 

Before use, the solution should be inspected for mechanical inclusions and discoloration.

 

Avastin does not contain an antimicrobial preservative, so it is necessary to ensure the sterility of the prepared solution and use it immediately. If the preparation is not used immediately, the time and storage conditions of the prepared solution are the responsibility of the user.

 

Store the prepared solution for no more than 24 hours at a temperature of +2 to +8 degrees Celsius if dilution is carried out in controlled and validated aseptic conditions.

 

The chemical and physical stability of the prepared solution (in 0.9% sodium chloride solution) is maintained for 48 hours at a temperature of +2 to +30 degrees Celsius. The unused drug remaining in the vial is destroyed. it does not contain preservatives.

 

Side effect

  • hemorrhages, including pulmonary hemorrhage / hemoptysis (more common in patients with non-small cell lung cancer);
  • arterial thromboembolism;
  • increased blood pressure;
  • weakness or asthenia;
  • febrile neutropenia, leukopenia, neutropenia, thrombocytopenia, anemia;
  • peripheral sensory neuropathy;
  • dysgeusia;
  • headache;
  • dysarthria;
  • stroke;
  • hypertensive encephalopathy;
  • impaired vision;
  • increased lacrimation;
  • chronic heart failure;
  • supraventricular tachycardia;
  • deep vein thrombosis;
  • dyspnea;
  • nose bleed;
  • rhinitis;
  • thromboembolism of the pulmonary artery (PE);
  • hypoxia;
  • anorexia;
  • nausea, vomiting;
  • diarrhea, constipation;
  • abdominal pain;
  • stomatitis;
  • perforation of the gastrointestinal tract;
  • rectal bleeding;
  • gastrointestinal ulcer;
  • intestinal obstruction (including obturation);
  • gastrointestinal disorders;
  • insufficiency of ovarian function (amenorrhea lasting 3 months or more);
  • exfoliative dermatitis;
  • dry skin;
  • discoloration of the skin;
  • palmar-plantar syndrome;
  • arthralgia;
  • muscle weakness;
  • myalgia;
  • urinary tract infection;
  • pain in the injection site;
  • increased fatigue;
  • pyrexia (fever);
  • perforation of the nasal septum;
  • inflammation of the mucous membranes of different locations;
  • lethargy;
  • retardation;
  • sepsis;
  • abscess;
  • joining of secondary infections, dehydration;
  • increased MHO;
  • osteonecrosis of the jaw (mainly in patients who received concomitant bisphosphonate therapy or who received bisphosphonate therapy earlier);
  • perforation of the gallbladder;
  • necrotizing fasciitis, as a rule, against a background of wound healing.

 

Contraindications

  • hypersensitivity to bevacizumab or any other component of the drug, preparations based on Chinese hamster ovary cells or to other recombinant human or human-like antibodies;
  • renal and hepatic impairment (efficacy and safety of use not established);
  • pregnancy;
  • the period of breastfeeding;
  • children under 18 years of age (efficacy and safety not established).

 

Application in pregnancy and lactation

 

The drug is contraindicated for use in pregnancy and during lactation.

 

Men and women of childbearing age during treatment with Avastin and at least 6 months after the end of treatment should use reliable methods of contraception.

 

Avastin can interfere with fertility in women. In most patients, fertility was restored after Avastin discontinued therapy. The long-term effects of Avastin therapy on fertility are unknown.

 

Breastfeeding is not recommended during treatment with Avastin and, for at least 6 months after the end of Avastin therapy.

 

Use in children

 

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety not established).

 

Application in elderly patients

 

With care appoint elderly patients (over 65 years).

 

special instructions

 

In the patient's medical records, the trade name of the drug (Avastin) should be indicated.Replacement of the drug with any other biological medicinal product requires agreement with the attending physician. The information presented in this description applies only to Avastin.

 

Treatment with Avastin can be done only under the supervision of a doctor who has experience in the use of antitumor therapy.

 

In patients receiving Avastin, there is an increased risk of perforation of the gastrointestinal tract and gallbladder. There were severe cases of perforation of the gastrointestinal tract, incl. and fatal (in 0.2-1% of all patients receiving Avastin). The clinical picture of perforations of the gastrointestinal tract differed in severity and varied depending on the signs of free gas in the radiography of the abdominal cavity, which disappeared without treatment, before perforations with abscess of the abdominal cavity and lethal outcome. In some cases, the initial intraperitoneal inflammation occurred as a result of gastric ulcer, tumor necrosis, diverticulitis or colitis associated with chemotherapy. The relationship between the development of intraperitoneal inflammation and GI tract perforations and Avastin therapy has not been established.With the development of perforation of the digestive tract, treatment with Avastin should be discontinued.

 

During treatment with Avastin, serious cases of fistula formation have been recorded, including fatal cases. Gastrointestinal fistulas often occurred in patients with metastatic colorectal cancer and ovarian cancer (up to 2% of patients), less often with other tumor localizations. Infrequently (more than 0.1- less than 1%) cases of formation of fistulas of other localizations (bronchopleural, urogenital, biliary) were recorded. The formation of fistulas is more often observed in the first 6 months of Avastin therapy, but can occur as in 1 week, and after 1 year and later after the initiation of therapy.

 

If a tracheo-esophageal fistula or fistula occurs in any location of the 4th degree of severity, Avastin should be withdrawn. There is limited information about continued use of Avastin in patients with fistulae of other sites. If an internal fistula does not penetrate into the digestive tract, then the question of withdrawal of Avastin should be considered.

 

Patients receiving Avastin receive an increased risk of bleeding, especially bleeding from the tumor.Avastin should be withdrawn if bleeding occurs at grade 3 or grade 4 according to the NCI-CTC classification. The overall incidence of bleeding 3-5 degrees of severity with Avastin for all indications is 0.4-6.5%. Most often, bleeding from the tumor or small bleeding from the mucous membrane and skin (for example, epistaxis) was observed.

 

The most frequently observed nasal bleeding of 1 severity according to the NCI-CTC classification, lasting less than 5 minutes, resolved without medical intervention and did not require a change in the dosage regimen of Avastin. The frequency of minor bleeding from the mucous membrane and the skin depends on the dose of the drug. Less frequent bleeding gums or vaginal bleeding.

 

Abundant or massive pulmonary hemorrhage / hemoptysis was observed mainly with non-small cell lung cancer. Admission of anti-rheumatic / anti-inflammatory drugs, anticoagulants, previous radiation therapy, atherosclerosis, central tumor location, cavity formation before or during treatment are possible risk factors for pulmonary hemorrhage / hemoptysis,while only for squamous cell lung cancer, a statistically significant association with the development of bleeding has been established.

 

Patients who recently had bleeding / hemoptysis (more than 2.5 ml of blood) should not receive Avastin.

 

In patients with colorectal cancer, gastrointestinal bleeding associated with a tumor is possible, incl. rectal bleeding and melena.

 

Seldom observed bleeding, incl. intracranial hemorrhage, in patients with metastatic CNS disease or with glioblastoma.

 

It is necessary to monitor the symptoms of intracranial hemorrhages, in case of their occurrence, to cancel Avastin therapy.

 

In patients with congenital hemorrhagic diathesis, acquired coagulopathy, or who received a full dose of anticoagulants for thromboembolism, care should be taken before prescribing Avastin because of lack of information on the safety profile of the drug in such patients. There was no increase in the incidence of bleeding of grade 3 and higher in patients receiving Avastin and warfarin.

 

Individual cases were reported,as well as a series of cases of serious adverse events on the part of the visual organ (including infective endophthalmitis and other inflammatory diseases) after unregistered intravitreal administration of Avastin. Some of these phenomena led to loss of visual acuity of varying severity, including persistent blindness. Avastin is not intended for intravitreal administration (injections into the eye area).

 

Patients receiving Avastin had an increased incidence of arterial hypertension of all severity levels (up to 42.1%). For all indications, the frequency of arterial hypertension 3-4 degrees of severity according to the NCI-CTC classification was 0.4% -17.9%; 4 degrees of severity (hypertensive crisis) was observed in 1% of patients.

 

Clinical safety data suggest that the incidence of elevated BP is likely to depend on the dose of bevacizumab.

 

Avastin can be prescribed only to patients with pre-compensated hypertension with further control of blood pressure. Information about the effect of Avastin in patients with uncontrolled arterial hypertension at the time of initiation of therapy is absent.In patients with hypertension, which requires drug therapy, it is recommended to temporarily stop Avastin therapy before achieving normalization of blood pressure.

 

In most cases, the normalization of blood pressure is achieved with standard antihypertensive agents (ACE inhibitors, diuretics and slow calcium channel blockers), selected individually for each patient. The abolition of Avastin or hospitalization was rarely required.

 

Very rarely there were cases of hypertensive encephalopathy, some with a fatal outcome. The risk of arterial hypertension associated with Avastin therapy does not correlate with the patient's baseline characteristics, concomitant disease or concomitant therapy.

 

Therapy with Avastin should be discontinued in the absence of normalization of AD, the development of hypertensive crisis or hypertensive encephalopathy.

 

With Avastin, single cases of reverse reversible encephalopathy syndrome, manifested by epileptic seizure, headache, mental disorders, visual impairment, damage to the visual centers of the cerebral cortex, with or without hypertension, and other symptoms have been reported.The diagnosis can be confirmed using brain imaging techniques (preferably with MRI). In case of development of a syndrome of a back reversible encephalopathy it is necessary to appoint or nominate symptomatic therapy, carefully supervise a BP and to cancel preparation Avastin. Usually resolution or improvement of symptoms occurs in a few days, but neurological complications were observed in some patients. The safety of re-appointment of Avastin in such patients is not established.

 

When Avastin was administered in combination with chemotherapy, the frequency of arterial thromboembolism, including stroke, transient ischemic attack and myocardial infarction, and other phenomena of arterial thromboembolism was higher than with the appointment of chemotherapy alone. The overall incidence of arterial thromboembolism was 3.8%. When arterial thromboembolism occurs, Avastin should be discontinued. Arterial thromboembolism in history or age 65 or older is associated with an increased risk of arterial thromboembolism during treatment with Avastin.Care should be taken when treating such patients.

 

During treatment with Avastin, there is an increased risk of venous thromboembolism (PE, deep vein thrombosis, thrombophlebitis). The overall incidence of venous thromboembolism (deep vein thrombosis and PE) varies from 2.8% to 17.3%.

 

Therapy with Avastin should be discontinued if there is a life-threatening phenomenon (4 severity) of venous thromboembolism, including PE, and if the degree of severity of venous thromboembolism is less than 3, careful monitoring of the patient's condition should be carried out.

 

Chronic heart failure (CHF) occurred when Avastin was used for all indications, but mainly for metastatic breast cancer. There was an asymptomatic decrease in the left ventricular ejection fraction and CHF that required therapy or hospitalization.

 

CHF of 3 severity and higher was observed in 3.5% of patients receiving Avastin. In patients who received Avastin in combination with anthracycline-based drugs, the incidence of CHF of 3 severity and higher did not differ from the available data in the treatment of metastatic breast cancer.In most patients, there was an improvement in the symptoms and / or fraction of the left ventricular ejection with appropriate treatment.

 

Data on the risk of CHF in patients with CHF 2-4 class in the history of NYHA in the history of absent.

 

In most cases, CHF occurred in patients with metastatic breast cancer who received therapy with anthracyclines, radiation therapy on the chest area in the anamnesis or with other risk factors for the development of CHF.

 

Caution should be exercised in prescribing Avastin to patients with a clinically significant cardiovascular disease in history, such as ischemic heart disease or CHF.

 

In patients who did not receive therapy with anthracycline-based drugs earlier, with Avastin and anthracycline drugs, there was no increase in the incidence of CHF of any severity compared with monotherapy with anthracycline-based drugs. CHF 3 severity and higher appeared somewhat more often in the Avastin treatment group in combination with chemotherapy compared with chemotherapy alone, which is consistent with other data obtained in patients with metastatic breast cancer and not receiving concomitant anthracycline therapy.

 

In patients with diffuse large B-cell lymphoma with the treatment of bevacizumab and doxorubicin in a cumulative dose of more than 300 mg / m 2, there was an increase in the number of new cases of CHF. When comparing rituximab / cyclophosphamide / doxorubicin / vincristine / Prednisolone (R-CHOP) + bevacizumab and R-CHOP therapy, the number of new cases did not differ, but was higher than that observed with doxorubicin therapy. The incidence of CHF was higher in the R-CHOP + bevacizumab group.

 

Avastin can adversely affect the healing of wounds. Bevacizumab should be treated at least 28 days after extensive surgery or with a complete healing of the surgical wound. When developing complications related to wound healing during treatment, Avastin should be temporarily discontinued until the wound is completely healed. The administration of Avastin should also be temporarily discontinued in the event of a planned surgical intervention.

 

Rare cases of necrotizing fasciitis (including fatal cases) were registered in patients treated with Avastin. This complication, as a rule, developed against the background of a violation of wound healing, perforation of the gastrointestinal tract, or the formation of fistulas.In the case of necrotizing fasciitis, Avastin should be withdrawn and promptly initiated treatment.

 

Proteinuria was observed in 0.7-38% of patients receiving Avastin. In terms of severity, proteinuria varied from transient asymptomatic traces of protein in the urine and in 1.4% of patients to nephrotic syndrome (proteinuria of the 4th degree of severity). Proteinuria of the 3rd degree of severity was registered in 8.1% of patients who received Avastin for various indications. Proteinuria was not associated with impaired renal function and rarely required the abolition of Avastin. The risk of developing proteinuria is increased in patients with an arterial hypertension in the anamnesis. Probably, proteinuria 1 degree depends on the dose of Avastin.

 

With the development of proteinuria of the 4th degree, Avastin should be withdrawn. Before and during Avastin therapy, urine testing for proteinuria is recommended.

 

In most cases, with proteinuria more than 2 grams per day, Avastin was temporarily suspended until proteinuria decreased to less than 2 g per day.

 

When Avastin was used in combination with myelotoxic regimens of chemotherapy, there was an increase in the incidence of severe neutropenia, febrile neutropenia, or infections with severe neutropenia (including fatal cases).

 

Patients may have an increased risk of developing infusion reactions / hypersensitivity reactions. There is evidence of a more frequent development of anaphylactic reactions and anaphylactoid type reactions in patients who received Avastin in combination with chemotherapy, compared with patients receiving chemotherapy alone.

 

It is recommended that the patient be closely monitored during and after Avastin. If an infusion reaction occurs, the infusion should be interrupted and appropriate medical measures taken. Systematic premedication can not be a guarantee of the absence of infusion reactions / hypersensitivity reactions.

 

There were reports of cases of osteonecrosis of the jaw in cancer patients receiving Avastin. Most of these patients received IV bisphosphonates earlier or as concomitant therapy; osteonecrosis of the jaw is an identified risk for bisphosphonates.Caution should be exercised when using Avastin and bisphosphonates IV in a simultaneous or sequential manner. Invasive dental procedures are also an identified risk factor. Before the treatment with Avastin, a dental examination and appropriate preventive dental procedures should be performed. If possible, avoid invasive dental procedures in patients who have previously received or are currently receiving IV bisphosphonates.

 

Patients over 65 years of age: when Avastin is prescribed to patients older than 65 years, there is an increased risk of arterial thromboembolism (including stroke, transient ischemic attack, myocardial infarction), leukopenia 3-4 degrees of severity and thrombocytopenia, as well as neutropenia (all degrees of severity), diarrhea, nausea, headache and fatigue compared with patients younger than 65 years. An increase in the incidence of other adverse reactions associated with the use of Avastin (gastrointestinal perforation, complications associated with wound healing, arterial hypertension, proteinuria, CHF and bleeding) in patients older than 65 years compared with patients younger than 65 years was not noted.

 

Disposal of an unused product or expired must be performed in accordance with the requirements of the medical institution.

 

Impact on the ability to drive vehicles and manage mechanisms

 

Studies to study the effect of the drug on the ability to drive vehicles and mechanisms were not carried out. Patients who experience such undesirable effects as syncope, drowsiness, or visual impairment should refrain from managing vehicles and mechanisms.

 

Drug Interactions

 

The effect of antitumor drugs on the pharmacokinetics of Avastin

 

There was no clinically significant effect on the pharmacokinetics of the Avastin drug when combined with chemotherapy. There were no statistically or clinically significant differences in the clearance of Avastin in patients receiving monotherapy and in patients who received Avastin in combination with Interferon alpha-2a or other chemotherapeutic drugs (IFL, FU / LV, carboplatin / paclitaxel, capecitabine, doxorubicin, or Cisplatin / gemcitabine).

 

The effect of Avastin on the pharmacokinetics of other antitumor drugs

 

Avastin has no significant effect on 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 alfa-2a, cisplatin.

 

There are no reliable data on the effect of Avastin on the pharmacokinetics of gemcitabine.

 

Combination of Avastin and Sunitinib

 

When Avastin was used (10 mg / kg once every 2 weeks) in combination with sunitinib (50 mg daily), cases of development of microangiopathic hemolytic anemia (MAGA) were recorded in patients with metastatic renal cell carcinoma. MAGA belongs to a subgroup of hemolytic anemia, which can be manifested by erythrocyte fragmentation, anemia and thrombocytopenia. Some patients additionally have neurologic disorders, increased creatinine concentrations, hypertension, including hypertensive crisis. These symptoms were reversible after discontinuation of therapy with bevacizumab and sunitinib.

 

Radiation therapy

 

When Avastin is used in combination with radiation therapy and chemotherapy (temozolomide) in patients with newly diagnosed glioblastoma, the safety profile of the drug remains unchanged.

 

The safety and efficacy of Avastin in combination with radiotherapy for other indications is not established.

 

Pharmaceutical interaction

 

Avastin is pharmaceutically incompatible with dextrose solutions.

 

Analogues of the drug Avastin

 

Avastin does not have structural analogs for the active substance.

 

Analogues for the pharmacological group (antineoplastic agents monoclonal antibodies):

  • Arzerra;
  • Acellbia;
  • Beyodeim;
  • Vectibix;
  • Gaziva;
  • Herceptin;
  • Cadsi;
  • Campas;
  • MabThera;
  • Perieta;
  • Removab;
  • Rituximab;
  • Tizabry;
  • Erbitux.

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