Avegra BIOCAD - Instructions For Use, Reviews, Drug Price

Table of contents:

Avegra BIOCAD - Instructions For Use, Reviews, Drug Price
Avegra BIOCAD - Instructions For Use, Reviews, Drug Price

Video: Avegra BIOCAD - Instructions For Use, Reviews, Drug Price

Video: Avegra BIOCAD - Instructions For Use, Reviews, Drug Price
Video: Сравнительное исследование биоаналога бевацизумаба (BIOCAD) 2024, November
Anonim

Avegra BIOCAD

Avegra BIOCAD: instructions for use and reviews

  1. 1. Release form and composition
  2. 2. Pharmacological properties
  3. 3. Indications for use
  4. 4. Contraindications
  5. 5. Method of application and dosage
  6. 6. Side effects
  7. 7. Overdose
  8. 8. Special instructions
  9. 9. Application during pregnancy and lactation
  10. 10. Use in childhood
  11. 11. In case of impaired renal function
  12. 12. For violations of liver function
  13. 13. Use in the elderly
  14. 14. Drug interactions
  15. 15. Analogs
  16. 16. Terms and conditions of storage
  17. 17. Terms of dispensing from pharmacies
  18. 18. Reviews
  19. 19. Price in pharmacies

Latin name: Avegra BIOCAD

ATX code: L01XC07

Active ingredient: bevacizumab (Bevacizumab)

Manufacturer: Biocad, CJSC (Russia)

Description and photo update: 2019-09-07

Prices in pharmacies: from 8000 rubles.

Buy

Concentrate for preparation of solution for infusion Avegra BIOCAD
Concentrate for preparation of solution for infusion Avegra BIOCAD

Avegra BIOCAD - a drug for the treatment of cancer; monoclonal antibodies.

Release form and composition

The drug is produced in the form of a concentrate for the preparation of a solution for infusion: opalescent or transparent liquid from colorless to pale brown (0.5; 4 or 16 ml in a bottle made of colorless neutral glass of I hydrolytic class, sealed with a rubber stopper, with a rolling aluminum cap; 1 bottle of 4 or 16 ml in a cardboard box; 1 bottle of 0.5 ml in a blister strip made of PVC film, in a cardboard box 1 package and instructions for use of Avegra BIOCAD).

1 ml of solution contains:

  • active substances: bevacizumab - 25 mg;
  • additional components: polysorbate 20, sodium hydrogen phosphate, α, α-trehalose dihydrate, sodium dihydrogen phosphate monohydrate, water for injection.

Pharmacological properties

Pharmacodynamics

Bevacizumab, the active ingredient of Avegra BIOCAD, is a humanized recombinant hyperchimeric monoclonal antibody that selectively binds to and neutralizes biologically active vascular endothelial growth factor (VEGF). Bevacizumab, preventing VEGF from binding to its type I and II receptors (Flt-1, KDR) on the surface of endothelial cells, leads to a decrease in vascularization and suppression of tumor growth.

The active substance contains fully human framework regions with complementary regions of the mouse hyperchimeric antibody that bind to VEGF. To obtain bevacizumab, the technology of recombinant deoxyribonucleic acid (DNA) is used in an expression system that is a Chinese hamster ovary cell. Bevacizumab contains 214 amino acids and has a molecular weight of approximately 149,000 daltons (Da).

The use of Avegra BIOCAD provides suppression of the metastatic progression of the disease and a decrease in microvascular permeability against the background of various human tumors, such as cancer of the pancreas, colon, breast and prostate gland.

In preclinical studies, the carcinogenic and mutagenic effects of bevacizumab have not been studied. However, in studies on animals, a teratogenic and embryotoxic effect of the substance was revealed. The use of bevacizumab in actively growing individuals with open growth zones has been associated with epiphyseal plate dysplasia.

Pharmacokinetics

Pharmacokinetics of the active substance of the drug Avegra BIOCAD was studied in patients with various solid tumors after intravenous administration (IV) in the following doses: 0.1–10 mg / kg every week; 3–20 mg / kg every 2 or 3 weeks; 5 mg / kg every 2 weeks or 15 mg / kg every 3 weeks. As with other antibodies, the pharmacokinetics of bevacizumab are described in a two-chamber model. The distribution of bevacizumab is characterized by low clearance, a small volume of distribution in the central chamber (V c) and a long half-life (T ½), which ensures that the required therapeutic plasma concentration of the drug is maintained when it is administered once every 2 or 3 weeks.

The clearance of the active substance does not depend on the patient's age.

There was no significant difference in the pharmacokinetics of Avegra BIOCAD depending on race, body weight or age, in accordance with the data of the population pharmacokinetic meta-analysis.

The clearance of bevacizumab in patients with a large tumor mass is higher by 7%, and in patients with a low level of albumin - by 30%, in comparison with patients with average values of tumor mass and albumin. In women and men, V c is 2.73 and 3.28 liters, respectively, which is similar to the volume of distribution of other monoclonal antibodies, including class G immunoglobulins (IgG).

When using bevacizumab with other antineoplastic agents, the volume of distribution in the peripheral chamber (V p) in women and men is 1.69 and 2.35 liters, respectively. After changing the dose taking into account body weight, V c in men is 20% higher than in women.

With a single intravenous administration of 125 I-bevacizumab, the characteristics of its biotransformation correspond to the characteristics of a natural IgG molecule that does not bind to VEGF. Metabolism and excretion of the active substance correspond to the metabolism and excretion of endogenous IgG, that is, they are carried out not through the liver and kidneys, but mainly through proteolytic catabolism in all cells of the body, including endothelial cells. The binding of IgG to neonatal receptors to its crystallizing fragment (FcRn receptors) protects against cellular metabolism and ensures its long-term T ½.

In the dose range from 1.5 to 10 mg / kg per week, the pharmacokinetics of bevacizumab are linear. The clearance of the substance is 0.22 l / day for men and 0.188 l / day for women. After changing the dose depending on body weight, the clearance of bevacizumab in men exceeds by 17% that in women. According to the two-chamber model, T ½ is 18 days for women and 20 days for men.

There is limited information on the pharmacokinetic parameters of bevacizumab in children and adolescents. According to research data, there is no difference between the volume of distribution and clearance of the active substance in patients under 18 years of age and adults with solid tumors.

Indications for use

  • metastatic colorectal cancer - in combination with chemotherapy based on fluoropyrimidine derivatives;
  • locally recurrent or metastatic breast cancer - as first-line treatment in combination with paclitaxel;
  • advanced and / or metastatic renal cell carcinoma - as the first line of treatment in combination with interferon alpha-2a;
  • Common, inoperable, recurrent, or metastatic non-squamous cell non-small cell lung cancer - as first-line treatment in addition to platinum-based chemotherapy; as a first line of treatment in the presence of activating mutations in the EGFR gene (epidermal growth factor receptor) in combination with erlotinib;
  • epithelial cancer of the fallopian tube, ovary and primary cancer of the peritoneum - as the first line of treatment in combination with paclitaxel and carboplatin for advanced [IIIB, IIIC and IV stage according to the International Federation of Obstetricians and Gynecologists (FIGO)] epithelial cancer of the fallopian tube, ovary and primary cancer of the peritoneum; in combination with carboplatin and gemcitabine for recurrent, platinum-sensitive epithelial cancer of the fallopian tube, ovary and primary peritoneal cancer in patients who have not previously received treatment with bevacizumab or other VEGF inhibitors; in combination with topotecan, or paclitaxel, or pegylated liposomal doxorubicin for recurrent platinum-resistant epithelial cancer of the fallopian tube, ovary and primary peritoneal cancer in patients who have received no more than two chemotherapy regimens before;
  • glioblastoma [grade IV glioma according to the classification of the World Health Organization (WHO)] - in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma; in monotherapy or in combination with irinotecan for recurrent glioblastoma or progression of the lesion;
  • Recurrent, persistent, or metastatic cervical cancer - in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Contraindications

Absolute:

  • age up to 18 years;
  • pregnancy and lactation;
  • renal and / or hepatic impairment;
  • hypersensitivity to any component of the drug, to other recombinant human or close to human antibodies, or to drugs based on Chinese hamster ovary cells.

Relative (should use Avegra BIOCAD with caution):

  • age over 65;
  • a history of clinically significant cardiovascular disease, including ischemic heart disease (CHD) or chronic heart failure (CHF);
  • venous thromboembolism;
  • arterial hypertension;
  • congenital hemorrhagic diathesis and acquired coagulopathy;
  • a history of arterial thromboembolism;
  • bleeding / hemoptysis;
  • wound healing;
  • taking anticoagulants to treat thromboembolism before starting treatment with bevacizumab;
  • a history of gastrointestinal perforation;
  • posterior reversible encephalopathy syndrome;
  • diabetes;
  • neutropenia;
  • proteinuria.

Avegra BIOCAD, instructions for use: method and dosage

Avegra BIOCAD is injected only by intravenous drip, it is prohibited to inject the solution into / into the jet!

The drug is not indicated for intravitreal administration and is pharmaceutically incompatible with dextrose solutions.

The required dose of the drug is diluted with 0.9% sodium chloride solution to the required volume, subject to the rules of asepsis. In the resulting solution, the concentration of bevacizumab should be in the range of 1.4-16.5 mg / ml.

The initial dose of the drug is injected intravenously as an infusion over 90 minutes. With good tolerance of the first infusion, the duration of the second can be 60 minutes. If the infusion is well tolerated for 60 minutes, then all further intravenous infusions can last 30 minutes. Due to the development of adverse events, it is not recommended to reduce the dose of the drug; if necessary, its use should be completely or temporarily stopped.

Recommended standard dosing regimen (Avegra BIOCAD is administered as an intravenous infusion):

  • metastatic colorectal cancer: as a first-line drug - once every 14 days at a dose of 5 mg / kg or once every 21 days at a dose of 7.5 mg / kg, for a long time; as a second-line drug in the progression of a lesion after first-line therapy - 1 time in 14 days at a dose of 5 mg / kg or 1 time in 21 days at a dose of 7.5 mg / kg (if patients have previously received Avegra BIOCAD) or 1 once every 14 days at a dose of 10 mg / kg or once every 21 days at a dose of 15 mg / kg (if Avegra BIOCAD was not included in the first line therapy), for a long time;
  • metastatic or locally recurrent breast cancer (BC): 1 time in 14 days at a dose of 10 mg / kg, long-term;
  • common inoperable, recurrent or metastatic non-squamous cell non-small cell lung cancer: as a first-line drug in combination with chemotherapy based on platinum preparations, the maximum duration of which is 6 cycles (in the future, Avegra BIOCAD continues to be used in monotherapy mode) - once every 21 days in a dose of 7.5 mg / kg in addition to chemotherapy based on cisplatin or at a dose of 15 mg / kg in addition to chemotherapy based on carboplatin; as the first line of therapy for non-small cell lung cancer with activating mutations in the EGFR gene in combination with erlotinib - once every 21 days at a dose of 15 mg / kg;
  • advanced and / or metastatic renal cell carcinoma: 1 time in 14 days at a dose of 10 mg / kg, long-term;
  • glioblastoma: for a newly diagnosed lesion - once every 14 days at a dose of 10 mg / kg in combination with radiation therapy and temozolomide for 6 weeks, after a four-week interval of drug administration, resume at the same dose in combination with temozolomide, the latter is used for 4 weeks cycles with a duration of therapy up to 6 cycles; subsequently Avegra BIOCAD is used as monotherapy once every 21 days at a dose of 15 mg / kg; in case of relapse - 1 time in 14 days at a dose of 10 mg / kg, for a long time;
  • epithelial cancer of the fallopian tube, ovary and primary cancer of the peritoneum: as a first-line drug - once every 21 days at a dose of 15 mg / kg in addition to paclitaxel and carboplatin (the maximum duration of chemotherapy is 6 cycles), then the drug is administered as monotherapy, total the duration of treatment for Avegra BIOCAD is 15 months; in case of relapses of the disease: with sensitivity to platinum drugs - once every 21 days at a dose of 15 mg / kg in combination with gemcitabine and carboplatin (6-10 cycles), then the drug is administered as monotherapy; with resistance to platinum drugs - 1 time in 14 days at a dose of 10 mg / kg in combination with one of such drugs as paclitaxel, topotecan (with topotecan administration on days 1, 8 and 15 every 4 weeks) or pegylated liposomal doxorubicin;or once every 21 days at a dose of 15 mg / kg in combination with topotecan used daily for 5 consecutive days every 3 weeks;
  • persistent, metastatic or recurrent cervical cancer: once every 21 days at a dose of 15 mg / kg in combination with chemotherapy regimens: paclitaxel and topotecan or paclitaxel and cisplatin.

If signs of disease progression or unacceptable toxicity occur, Avegra BIOCAD therapy should be discontinued.

Before carrying out infusion infusions, the solution must be visually examined for discoloration and mechanical impurities. As part of Avegra BIOCAD, there is no antimicrobial preservative, as a result of which it is required to ensure the sterility of the resulting solution and use it immediately after preparation. If necessary, if the dilution of the concentrate was carried out under validated and controlled aseptic conditions, it is allowed to store the prepared solution for no more than 24 hours at a temperature of 2–8 ° C.

In a 0.9% sodium chloride solution, the physical and chemical stability of the resulting solution at a temperature of 2–30 ° C is maintained for 48 hours. The unused solution remaining in the vial must be destroyed.

Side effects

Side effects of all degrees of severity according to the National Cancer Institute (NCI-CTC) classification, recorded in patients receiving bevacizumab in combination with different chemotherapy regimens for all indications:

  • blood and lymphatic system: very often (≥ 10%) - thrombocytopenia, neutropenia, leukopenia, febrile neutropenia; often (≥ 1% and <10%) - anemia, lymphocytopenia;
  • nervous system: very often - headache, dysgeusia, dysarthria, peripheral sensory neuropathy; often - drowsiness, syncope, stroke;
  • organ of vision: very often - increased lacrimation, visual impairment;
  • respiratory system, organs of the chest and mediastinum: very often - rhinitis, shortness of breath, epistaxis; often - hypoxia, pulmonary embolism (PE), hemoptysis, pulmonary hemorrhage;
  • cardiovascular system: very often - increased blood pressure (BP), presumably dose-dependent, venous embolism; often - deep vein thrombosis, arterial thromboembolism, CHF, supraventricular tachycardia, bleeding, including intracranial, pulmonary, from the skin and mucous membranes, gastrointestinal tract (GIT) and from the tumor;
  • liver and biliary tract: with an unknown frequency (it is impossible to establish the frequency of occurrence of adverse reactions) - perforation of the gallbladder;
  • Gastrointestinal tract: very often - stomatitis, vomiting, diarrhea, abdominal pain, nausea, constipation, rectal bleeding, anorexia; often - pain in the rectum, gastrointestinal disorders, fistulas between the vagina and the rectum (most often between the vagina and the gastrointestinal tract), intestinal obstruction, including obstructive, gastrointestinal perforation;
  • musculoskeletal and connective tissue: very often - arthralgia; often - back pain, muscle weakness, fistulas, myalgia;
  • skin and subcutaneous tissues: very often - discoloration of the skin, dry skin, exfoliative dermatitis, complications of wound healing; often - inflammation of the subcutaneous fat, palmar-plantar syndrome;
  • kidneys and urinary tract: very often - proteinuria; often - urinary tract infection;
  • genitals and mammary gland: very often - ovarian failure, including amenorrhea from 3 months or more [follicle-stimulating hormone (FSH) level ≥ 30 mIU / ml with a negative pregnancy test with the detection of human beta chorionic gonadotropin (β-hCG) in serum]; often - pain in the small pelvis;
  • laboratory and instrumental data: hyponatremia, hypokalemia, hyperglycemia, increased prothrombin time, increased international normalized ratio (INR);
  • general disorders and disorders at the injection site: very often - increased fatigue, pain, including at the injection site, asthenia, weight loss, pyrexia, paronychia, inflammation of the mucous membranes of various localization; often - lethargy, lethargy, cellulitis, dehydration, abscess, sepsis, accession of secondary infections.

During the clinical use of the drug Avegra BIOCAD, the following violations were registered:

  • respiratory system, organs of the chest and mediastinum: often - dysphonia; with an unknown frequency - pulmonary hypertension, perforation of the nasal septum;
  • nervous system: rarely (≥ 0.01% and <0.1%) - posterior reversible encephalopathy syndrome; extremely rare (<0.01%) - hypertensive encephalopathy;
  • vessels: with an unknown frequency - thrombotic microangiopathy of the kidneys, the clinical manifestation of which is proteinuria;
  • liver and biliary tract: with unknown frequency - gallbladder perforation;
  • Gastrointestinal tract: with an unknown frequency - gastrointestinal ulcer;
  • musculoskeletal and connective tissue: with an unknown frequency - osteonecrosis of the jaw (mainly with concomitant or previously received therapy with bisphosphonates), osteonecrosis of other localization (except for the mandibular);
  • general disorders and disorders at the injection site: rarely - necrotizing fasciitis, usually against the background of gastrointestinal tract perforation or fistula formation, impaired wound healing; with an unknown frequency - hypersensitivity reactions, infusion reactions, the manifestations of which may be: chills, chest pain, hot flashes / redness / rash, shortness of breath / difficulty breathing, decreased oxygen saturation, decreased / increased blood pressure, nausea / vomiting;
  • hereditary, congenital and genetic disorders: fetal abnormalities when receiving bevacizumab as a monotherapy drug or in combination with embryotoxic chemotherapy drugs.

Overdose

When using the drug every 14 days at a maximum dose of 20 mg / kg IV, in some cases, severe headache (migraine) was developed. Against the background of an overdose, the above dose-dependent adverse reactions may worsen. There is no specific antidote, the treatment is symptomatic.

special instructions

Avegra BIOCAD therapy can only be carried out under the supervision of a physician who has experience in anticancer therapy.

In patients receiving bevacizumab, the threat of perforation of the gastrointestinal tract and gallbladder is aggravated. Severe cases of gastrointestinal perforation, including fatal ones, were recorded in 0.2–1% of all patients receiving bevacizumab. Against the background of persistent, recurrent or metastatic cervical cancer during therapy with Avegra BIOCAD, cases of gastrointestinal tract perforation (varying degrees of severity) were observed in 3.2% of patients who had previously received radiation therapy. In some cases, initial intraperitoneal inflammation was noted due to tumor necrosis, gastric ulcer, colitis or diverticulitis associated with chemotherapy. The relationship between therapy with bevacizumab, intraperitoneal inflammation and gastrointestinal perforation has not been identified.

In the treatment of metastatic colorectal cancer and ovarian cancer, 2% of patients developed gastrointestinal fistulas, less often at other tumor locations. People who have received bevacizumab to treat recurrent, metastatic, or persistent cervical cancer are more likely to develop fistulas between the vagina and any part of the gastrointestinal tract (gastrointestinal-vaginal fistulas). According to the results of studies in such patients, the incidence of this complication was 8.3%, while in all cases, radiation therapy of the pelvic organs was previously performed. In patients with an emerging gastrointestinal-vaginal fistula, intestinal obstruction may also develop, and surgical intervention may be necessary, including the imposition of a stoma.

During treatment with bevacizumab for persistent, recurrent or metastatic cervical cancer, cases of fistulas of the urinary, vaginal or female genital tract were observed in 1.8% of patients. Also, extremely rare cases of the development of bronchopleural and biliary fistulas were recorded. Most often, fistula formation was observed during the first 6 months of therapy, but it was also recorded both after 1 week and 1 year after the start of treatment.

During the period of therapy, the risk of bleeding is aggravated. Most often bleeding from a tumor or minor bleeding from the mucous membrane and skin (including nosebleeds) were recorded, the frequency of the latter being dependent on the dose of the agent. Massive / profuse pulmonary bleeding / hemoptysis was observed mainly in patients with non-small cell lung cancer. Risk factors for such complications include: previous radiation therapy, taking anticoagulants, anti-inflammatory / antirheumatic drugs, central location of the tumor, atherosclerosis, cavity formation before or during therapy. Patients who have recently had bleeding / hemoptysis (over 2.5 ml of blood) are not recommended to use Avegra BIOCAD.

Patients with colorectal cancer may experience gastrointestinal bleeding, including melena and rectal bleeding due to the tumor. Bleeding, including intracranial hemorrhage, was rarely recorded in patients with glioblastoma or metastatic lesions of the central nervous system, which requires monitoring for signs of intracranial hemorrhage.

After unregistered intravitreal administration of the drug, there have been reports of serious side effects from the organ of vision, including inflammatory lesions, including infectious endophthalmitis. Some of these impairments caused the loss of visual acuity of varying severity, including permanent blindness. Avegra BIOCAD is not indicated for intravitreal use.

Treatment with the drug can only be carried out in patients with previously compensated arterial hypertension and further control of blood pressure. There are no data on the effects of bevacizumab in patients with uncontrolled arterial hypertension at the time of initiation of the course of therapy. In the vast majority of cases, normalization of blood pressure was achieved through the use of slow calcium channel blockers, diuretics and angiotensin-converting enzyme (ACE) inhibitors. Hospitalization / withdrawal of treatment was rarely required. The development of hypertensive encephalopathy, sometimes with a fatal outcome, was extremely rare. If during the period of therapy it is not possible to normalize blood pressure, or the occurrence of a hypertensive crisis or hypertensive encephalopathy is noted, the introduction of Avegra BIOCAD must be stopped.

Against the background of therapy, the development of the syndrome of posterior reversible encephalopathy was extremely rare, the manifestations of which may include: visual impairment, headache, mental disorders, epileptic seizures, lesions of the visual centers of the cerebral cortex with or without arterial hypertension. In the event of this complication, careful monitoring of blood pressure, symptomatic therapy and drug withdrawal are required. As a rule, improvement or resolution of symptoms was noted after several days, but neurological complications were recorded in some patients. In such patients, the safety of reuse of Avegra BIOCAD has not been established.

The risk of arterial thromboembolism is exacerbated by a history of the disease, diabetes mellitus, or in patients over 65 years of age.

In patients receiving treatment with bevacizumab and chemotherapy, with a history of venous thromboembolism, there is an increased risk of recurrence of this lesion.

The occurrence of CHF was recorded with the use of bevacizumab for all indications, but mainly in metastatic breast cancer in patients treated with anthracyclines, a history of radiation therapy to the chest area, or with other risk factors for this side effect. Both asymptomatic left ventricular dysfunction and CHF requiring treatment or hospitalization were noted.

During the period of therapy, there were serious cases of complications of wound healing, including with a lethal outcome. It is recommended to start using Avegra BIOCAD no earlier than 28 days after a major surgical intervention or only after the surgical wound has completely healed. In case of complications caused by wound healing during treatment, it is necessary to suspend the use of the drug until it is completely scarred. You should also temporarily stop the introduction of bevacizumab if surgery is necessary.

Influence on the ability to drive vehicles and complex mechanisms

Studies on the effect of the drug Avegra BIOCAD on the ability to drive transport and other complex mechanisms have not been conducted. If unwanted reactions such as drowsiness, syncope or visual impairment occur during therapy, it is recommended to refrain from driving and other complex and potentially dangerous equipment.

Application during pregnancy and lactation

The use of Avegra BIOCAD during pregnancy is contraindicated. Patients of childbearing age during the period of therapy and for at least 6 months after its completion are recommended to use adequate methods of contraception without fail. The drug can lead to impaired fertility in women, but in most cases, fertility is restored after discontinuation of bevacizumab. Long-term effects of treatment affecting fertility have not been recorded.

Nursing women, if it is necessary to use Avegra BIOCAD, should stop breastfeeding for the entire duration of treatment and for at least 6 months after its completion.

Pediatric use

Avegra BIOCAD is contraindicated in patients under 18 years of age, since the effectiveness and safety of drug treatment in patients of this age group have not been established.

In the literature, there are reports of cases of osteonecrosis in children and adolescents during treatment with bevacizumab with localization in various anatomical areas except the jaws.

With impaired renal function

Due to the fact that the kidneys are not the main organ of metabolism and excretion of bevacizumab, its effectiveness and safety in patients with renal insufficiency have not been studied.

In the presence of renal failure, the use of Avegra BIOCAD is contraindicated.

For violations of liver function

Since the liver does not belong to the main organs of metabolism and excretion of bevacizumab, its efficacy and safety have not been studied in patients with hepatic insufficiency.

For patients with hepatic impairment, the appointment of Avegra BIOCAD is contraindicated.

Use in the elderly

There was no significant difference in the pharmacokinetic parameters of Avegra BIOCAD depending on age. Individual selection is not required for patients over 65 years of age.

When treating elderly patients with the drug, the risk of headache, fatigue, diarrhea, nausea, arterial thromboembolism (including transient ischemic attack, stroke, myocardial infarction), thrombocytopenia, grade 3-4 leukopenia, neutropenia (all severity), compared with patients under 65 years of age.

In the study of bevacizumab in patients over 65 years of age in the treatment of metastatic colorectal cancer, the increase in the incidence of other undesirable effects associated with the use of bevacizumab, including CHF, gastrointestinal perforation, complications associated with wound healing and bleeding, compared with patients 65 years of age and younger, did not was recorded.

Drug interactions

  • chemotherapy drugs [capecitabine, doxorubicin, IFL (irinotecan, fluorouracil, and leucovorin), FU / LV (fluorouracil / leucovorin), carboplatin / paclitaxel, cisplatin / gemcitabine], interferon alfa-2a / erlotinevorin not statistically significant, clinically significant in patients with these combinations and during monotherapy with the drug;
  • erlotinib and OSI-240 (its active metabolite), interferon alpha-2a, chemotherapy drugs [oxaliplatin, capecitabine (total and free platinum levels), cisplatin, irinotecan and SN38 (its active metabolite), gemcitabine]: no clinically significant effects bevacizumab on the pharmacokinetics of these drugs;
  • chemotherapy based on platinum or taxanes: there has been an increase in the incidence of severe neutropenia, febrile neutropenia, or infections with or without severe neutropenia (including fatalities) in combination with bevacizumab, mainly for the treatment of metastatic breast cancer and non-small cell lung cancer;
  • sunitinib (daily at a dose of 50 mg): there have been cases of microangiopathic hemolytic anemia (MAGA) when combined with bevacizumab (10 mg / kg once every 14 days) in patients with metastatic renal cell carcinoma; MAGA belongs to the subgroup of hemolytic anemias, manifested by anemia, thrombocytopenia, fragmentation of erythrocytes; in some cases, neurological disorders, an increase in creatinine levels, arterial hypertension, including a hypertensive crisis were additionally recorded; these phenomena were reversible after completion of combination therapy;
  • chemotherapy (temozolomide) and radiation therapy: no new adverse reactions associated with bevacizumab have been reported in patients with newly diagnosed glioblastoma; for other indications in combination with radiation therapy, the efficacy and safety of bevacizumab has not been determined;
  • monoclonal antibodies specific to EGFR (cetuximab and panitumumab): the combination of these drugs with bevacizumab and chemotherapy is not recommended for the treatment of metastatic colorectal cancer; when compared with chemotherapy alone and bevacizumab, this combination is associated with decreased survival rates and increased toxicity.

Analogs

The analogues of Avegra BIOCAD are Avastin, Bevacizumab.

Terms and conditions of storage

Store in a place protected from light, at a temperature of 2–8 ° C, without freezing.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Avegra BIOCAD

Reviews about Avegra BIOCAD on medical sites are rare and are predominantly positive. Many patients, as well as specialists, believe that the drug, which is a biosimilar of Avastin, is not significantly inferior to the latter in terms of effectiveness and safety of use in the treatment of oncological diseases. However, the reviews also often mention the negative side reactions of this drug, which is primarily associated with the individual tolerance of bevacizumab and the general condition of the patient.

Price for Avegra BIOCAD in pharmacies

The price of Avegra BIOCAD, a concentrate for the preparation of a solution for infusion (25 mg / ml), can be: 4500-9000 rubles. for a bottle of 4 ml; 12,500-30,000 rubles. per bottle of 16 ml.

Avegra BIOCAD: prices in online pharmacies

Drug name

Price

Pharmacy

Avegra BIOCAD 25 mg / ml concentrate for solution for infusion 4 ml 1 pc.

RUB 8,000

Buy

Avegra BIOCAD 25 mg / ml concentrate for solution for infusion 16 ml 1 pc.

RUB 30,000

Buy

Elena Minkina
Elena Minkina

Elena Minkina Doctor anesthesiologist-resuscitator About the author

Education: graduated from the Tashkent State Medical Institute, specializing in general medicine in 1991. Repeatedly passed refresher courses.

Work experience: anesthesiologist-resuscitator of the city maternity complex, resuscitator of the hemodialysis department.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!

Recommended: