Universal reference book for medicines
Product name: BEYODAYM ® (BEYODYM)

Active substance: pertuzumab, trastuzumab

Type: Antitumor drug.
Monoclonal antibodies
Producer: R-PHARM (Russia) manufactured component No. 1 Roche Diagnostics (Germany) manufactured component No. 2 Genentech (USA) component No. 3 manufactured F.Hoffmann-La Roche (Switzerland) packed with ORTAT (Russia)
Set:
Concentrate for the preparation of a solution for infusions (Perieta ® - component No. 1 ) in the form of a transparent or opalescent liquid colorless or slightly brownish in color.

1 ml of 1 fl.
(14 ml)
Pertuzumab 30 mg 420 mg

Excipients: L-histidine - 43.5 mg, glacial acetic acid - 9.2 mg, sucrose - 575.1 mg, polysorbate 20 - 2.8 mg, water d / and - up to 14 ml.

Lyophilizate for the preparation of a concentrate for the preparation of a solution for infusions (Herceptin ® component No. 2) from white to light yellow;reconstituted solution - a clear or slightly opalescent liquid from colorless to light yellow color.

1 f.

trastuzumab 440 mg

Excipients: L-histidine hydrochloride - 9.9 mg, L-histidine - 6.4 mg,?,? - trehalose dihydrate - 400 mg, polysorbate 20 - 1.8 mg.

Bacteriostatic water d / and (solvent for Herceptin ® - component No. 3 ) is a clear liquid, colorless or with a slight yellowish tinge.

1 bottle with a solvent for Herceptin ® contains: benzyl alcohol - 229.9 mg, water d / and - 20.9 ml.

Bacteriostatic water d / and (20 ml) contains 1.1% benzyl alcohol as an antimicrobial preservative.

Vials of colorless glass (3) (including component number 1 - 420 mg / 14 ml, component number 2 - 440 mg, component number 3 - 20 ml) - cardboard pallets (1) - cardboard packs with control of the first opening.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Mechanism of action

Pertuzumab is a recombinant humanized monoclonal antibody that selectively interacts with the extracellular subdomain II HER2 (epidermal growth factor receptor of type 2 receptor) responsible for dimerization.
Binding of pertuzumab to subdomain II blocks the process of ligand-dependent heterodimerization of HER2 with other proteins of the HER family, including EGFR (human epidermal growth factor receptor), HER3 (human type 3 epidermal growth factor receptor) and HER4 (human type E epidermal growth factor receptor). Thus, pertuzumab inhibits ligand-initiated transfer of intracellular signals along two main signaling pathways: the pathway of mitogen-activated protein kinase (MAP) and the pathway of phosphoinositide-3-kinase (PI3K). The inhibition of these signaling pathways can lead to the arrest of cell growth and apoptosis, respectively. In addition, pertuzumab promotes the activation of antibody-dependent cellular cytotoxicity (AZKTS).
Molecular weight of pertuzumab is about 148 kDa, and it is expected that, like other monoclonal antibodies, pertuzumab practically does not pass through the BBB.

Pertuzumab in the form of a monoagent inhibits the proliferation of human tumor cells.
Increased antitumor activity of pertuzumab on models of xenografts with overexpression of HER2 when used in combination with trastuzumab is shown.
Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that selectively interacts with the extracellular domain of human type 2 epidermal growth factor receptor (HER2) receptors.
These antibodies are IgG1, consisting of human regions (constant regions of heavy chains) and determining the complementarity of mouse regions of the p185 HER2 antibody to HER2.
The proto-oncogene HER2 or c-yegB2 encodes a transmembrane receptor-like protein with a molecular weight of 185 kDa, which is structurally similar to other members of the epidermal growth factor receptor family.
Hyperexpression of HER2 is found in the tissue of primary breast cancer (breast cancer) in 15-20% of patients. Amplification of the HER2 gene leads to overexpression of the HER2 protein on the tumor cell membrane, which in turn causes a constant activation of the HER2 receptor.
Studies show that patients with breast cancer who have experienced amplification or overexpression of HER2 in tumor tissue have a less survival without symptoms of disease compared to patients without amplification or overexpression of HER2 in the tumor tissue.

Trastuzumab blocks the proliferation of human tumor cells with overexpression of HER2 in vivo and in vitro.
In vitro, the antibody-dependent cellular cytotoxicity of trastuzumab is primarily directed towards tumor cells with overexpression of HER2.
Immunogenicity

Pertuzumab

Approximately 6.2% of patients with metastatic breast cancer who received trastuzumab plus docetaxel and 2.8% of patients who received trastuzumab in combination with docetaxel and pertuzumab had anti-therapeutic antibodies (ATA).
The association of the formation of antibodies to pertuzumab with the development of anaphylactic reaction / hypersensitivity reaction has not been reliably established in any of the patients.
Trastuzumab

With neoadjuvant-adjuvant therapy for early breast cancer, antibodies to trastuzumab (regardless of the presence of antibodies initially) appeared in 8.1% of patients receiving Herceptin ® IV.
Neutralizing antibodies to trastuzumab were detected after baseline in 2 of the 24 patients receiving the Herceptin ® preparation for IV administration.
The clinical significance of these antibodies is unknown.
However, apparently, they do not have a negative effect on pharmacokinetics, efficacy (determined by the complete pathological response) or safety of the Herceptin ® preparation for intravenous administration, determined by the frequency of infusion reactions.
Comparing the frequency of detection of antibodies to pertuzumab and trastuzumab and the frequency of detection of antibodies to other biological preparations may not be informative, since the results of the immunogenicity assay are highly dependent on various factors, such as the sensitivity and specificity of the assay, the assay methodology, the manipulation of the collected samples, the time of sampling samples, concomitant medications and the nature of the underlying disease.

PHARMACOKINETICS

Pertuzumab

The pharmacokinetics of pertuzumab was studied after IV administration at various doses (2 to 25 mg / kg) in patients with different types of tumors.

Suction

Pertuzumab is administered iv.
Other ways of drug administration have not been studied.
Distribution

After IV introduction, the volume of distribution in the peripheral chamber (V p ) is 2.46 liters, and in the central chamber (V c ) is 3.11 liters and is approximately equal to the plasma volume.
The values ​​of V c and the volume of distribution of pertuzumab in the equilibrium state (V ss ) indicate that the distribution occurs only in plasma and extracellular fluid.
Metabolism

Metabolism of pertuzumab has not been studied.
Like other antibodies, pertuzumab is mainly exposed to catabolism.
Excretion

The clearance of pertuzumab is approximately 0.239 l / day and does not depend on the dose and indications.
The initial concentration of albumin and the "lean body weight" (a value that characterizes the body weight minus the fat mass of the fat) have a negligible effect on the clearance of pertuzumab, and there is no need to adjust the dose of pertuzumab depending on the initial concentration of albumin or body weight.
T 1/2 is approximately equal to 18 days.

Trastuzumab

The pharmacokinetics of trastuzumab were evaluated on the basis of population pharmacokinetic analysis using a two-chamber model with parallel linear and nonlinear elimination from the central chamber.
Due to nonlinear elimination, a decrease in the concentration of the drug was accompanied by an increase in overall clearance. The linear clearance was 0.127 l / day in patients with breast cancer (metastatic breast cancer (MMR) and early breast cancer (breast cancer)). The values ​​of the nonlinear excretion parameters by the Michaelis-Menten model were 8.81 mg / day for the maximum elimination rate and 8.92 mg / l for the Michaelis-Menten constant. The volume of the central chamber was 2.62 l in patients with breast cancer. The values ​​of drug exposure (5 th -95 th percentile) and the values ​​of pharmacokinetic parameters at clinically significant concentrations (C max and C min ) in patients with breast cancer (BC) under the approved dosage regimens calculated in the population analysis are given in Tables 1 and 2 .
Table 1. Calculated values ​​of exposure in 1 cycle for IV administration in patients with breast cancer (5th -95th percentile)

Dosing regimen Tumor type n - number of patients C min (μg / ml) C max (μg / ml) AUC (μg / day)

8 mg / kg + 6 mg / kg once every 3 weeks WDM / breast cancer 1195 29.4 (5.8-59.5) 178 (117-291) 1373 (736-2245)

4 mg / kg + 2 mg / kg once a week breast and liver cancer 1195 37.7 (12.3-70.9) 88.3 (58-144) 1066 (586-1754)

Table 2. Calculated values ​​of population pharmacokinetic parameters in equilibrium for dosing regimens of Herceptin ® for intravenous administration in patients with breast cancer (5th -95th percentile)

Dosage regimen Tumor type n - number of patients C min, ss (μg / ml) C max, ss (μg / ml) AUC ss (μg / day) Time to equilibrium (weeks) Range of total clearance in equilibrium (l / day)

8 mg / kg + 6 mg / kg once every 3 weeks WDM / breast cancer 1195 47.4 (5-115) 179 (107-309) 1794 (673- 3618) 12 0.173-0.283

4 mg / kg + 2 mg / kg once a week breast cancer / breast cancer 1195 66.1 (14.9-142) 109 (51.0-209) 1765 (647-3578) 12 0.201-0.244

The time of trastuzumab removal from the body after iv injection of Herceptin ® was evaluated by means of population pharmacokinetic modeling.

At 7 months after the last dose, at least 95% of patients have a trastuzumab concentration in the blood serum of <1 μg / ml (corresponding to approximately 3% of the calculated C min at equilibrium or 97% of the drug).

The circulating extracellular domain of the HER2 receptor ("sluschivayuschiesya" with the cell antigen)

In the serum of some patients with breast cancer and overexpression of HER2, a circulating extracellular domain of the HER2 receptor ("slipping" from the cell antigen) was detected.
In 64% of the examined patients, the "antigen" that "slipped" from the cell was detected in the initial serum samples at a concentration reaching 1880 ng / ml (median 11 ng / ml). Patients who had a high concentration of "sluschivayuschegosya" with the cell antigen, probably could have a lower C min. However, in most patients with an elevated "sluschivayuschegosya" with the cell antigen when the drug was administered weekly, the target concentration of trastuzumab in the serum was reached by week 6. There was no significant relationship between the baseline level of the antigen "slipping" from the cell and the clinical response.
Pharmacokinetics in specific patient groups

Pertuzumab

The pharmacokinetic parameters of pertuzumab are independent of gender and ethnicity (Japanese and other ethnic groups).

Patients of elderly and senile age.
Special studies of the pharmacokinetics of pertuzumab in elderly (? 65 years) and senile (? 75 years) patients have not been conducted. According to the results of the population analysis, age does not affect the pharmacokinetic parameters of pertuzumab.
Patients with impaired renal function.
Special studies of the pharmacokinetics of pertuzumab in patients with renal insufficiency have not been carried out. According to the results of the population analysis, renal failure of the lung (KK 60-90 ml / min), medium (KK 30-60 ml / min), severe (QC <30 ml / min, including the terminal stage) does not affect the exposure of pertuzumab. Data for patients with moderate and severe renal insufficiency (including those with terminal stage) are limited.
Patients with impaired liver function.
The study of the pharmacokinetics of pertuzumab in patients with impaired liver function was not conducted.
Trastuzumab

Special studies of the pharmacokinetics of trastuzumab in elderly and senile patients and patients with renal or hepatic insufficiency have not been carried out.

According to the population analysis, renal failure does not affect the pharmacokinetics of trastuzumab.

Age does not affect the distribution of trastuzumab.

INDICATIONS

Metastatic breast cancer

- in combination with docetaxel in metastatic or locally recurrent, inoperable breast cancer with tumor overexpression of HER2 in the absence of prior HER2-specific therapy or chemotherapy for metastatic disease.

Neoadjuvant therapy for breast cancer

- in combination with docetaxel for locally advanced, edematous-infiltrative or early breast cancer (tumor diameter greater than 2 cm) with overexpression of HER2 in a treatment regimen containing fluorouracil, epirubicin and cyclophosphamide (FEC) or carboplatin.

DOSING MODE

Before the start of treatment, the components of the Beyondime ® kit should be tested for tumor expression of HER2.
An obligatory criterion is 3+ points based on the results of immunohistochemical analysis (IHC) and / or the degree of amplification of 2.0 2.0 based on the results of in situ hybridization (ISH).
It is necessary to use accurate and validated testing methods.
Detailed instructions for carrying out HER2 testing and interpretation of its results are given in the instructions for the use of validated test systems designed to determine HER2 status.
Components of the Beyondime ® kit (Perieta ® and Herceptin ® ) are administered only in / in the drip.
You can not inject Beyondime ® components into / in a jet or bolus.
The components of the Beyondime ® kit (Perieta ® and Herceptin ® ) can be entered in any sequence.
If premedication is required prior to the administration of Herceptin ® , it should be administered first. After each infusion of Perieta ® and before the administration of Herceptin ® or docetaxel, monitoring of the patient for 30-60 minutes is recommended. Docetaxel is recommended to be administered after the administration of all components of the Beyodime ® kit.
To avoid medical errors, you should check the labels on the vials and make sure that Perieta ® is used in combination with Herceptin ® (trastuzumab) for IV administration, and not with the Cadsil ® (trastuzumab emtansin) preparation.

Perieta ® (pertuzumab) - component number 1

The duration of infusion with the administration of the first dose should be 60 minutes.
If the first infusion is well tolerated, subsequent ones can be carried out for 30-60 minutes.
The loading dose of Perieta ® is 840 mg in the form of a 60-minute IV infusion.

The maintenance dose of Perieta ® is 420 mg every 3 weeks as an intravenous drip infusion for 30-60 minutes.
The maintenance dose is given 3 weeks after loading.
Herceptin ® (trastuzumab) - component number 2

The loading dose of Herceptin ® is 8 mg / kg of body weight as a 90-minute IV infusion.

The maintenance dose of Herceptin ® is 6 mg / kg of body weight every 3 weeks in the form of IV infusion for 30-90 min.
The maintenance dose is given 3 weeks after loading. If the previous loading dose was well tolerated, the drug can be administered as a 30-minute drop infusion.
Docetaxel

When used in combination with the Beyodym ® kit, the recommended initial dose of docetaxel is 75 mg / m 2 as an IV infusion, after which the drug should be given at the same dose every 3 weeks.
With good tolerability in the first cycle, the dose of docetaxel can be increased to 100 mg / m 2 in subsequent cycles.
Neoadjuvant therapy for breast cancer

Preparations Perieta ® , Herceptin ® for intravenous administration and docetaxel are used before the surgery according to the above described dosing regimen.
The use of Perieta ® , Herceptin ® for intravenous administration and docetaxel is indicated in one of the following treatment regimens for early breast cancer:
- 4 cycles of therapy with Perieta ® and Herceptin ® for intravenous administration in combination with docetaxel, followed by 3 cycles of postoperative therapy with fluorouracil, epirubicin and cyclophosphamide (FEC);

- 3 cycles of preoperative therapy with fluorouracil, epirubicin and cyclophosphamide, followed by 3 cycles of therapy with Perieta ® and Herceptin ® for intravenous administration in combination with docetaxel;

- 6 cycles of therapy with Perieta ® and Herceptin ® in combination with docetaxel and carboplatin (increasing the dose of docetaxel above 75 mg / m 2 is not recommended).

After surgery, continue therapy with Herceptin ® until the total duration of therapy with this drug is 1 year.
The available data are insufficient to recommend the simultaneous use of Perieta ® with anthracyclines.
Duration of treatment

Metastatic breast cancer

Treatment should continue until signs of disease progression or unacceptable toxicity.

Neoadjuvant therapy for breast cancer

Treatment should be carried out for 3, 4 or 6 cycles, depending on the chosen therapy scheme (see above).

Skipping in the planned introduction

Perieta ® (pertuzumab) - component number 1

If a break in the planned introduction of Perieta ® was less than 6 weeks, it should be administered as soon as possible in a dose of 420 mg in the form of a 30-60-minute IV infusion, without waiting for the next scheduled injection.

If the break in the introduction Pereta preparation ® was 6 weeks and more, the drug should enter the initial dose of 840 mg in a 60-min / in drip infusion. Then, after 3 weeks, continued administration of the drug in a maintenance dose of 420 mg every 3 weeks in a 30-60 minute / v infusion.
Herceptin ® (trastuzumab) - component №2
If break in the scheduled administration of the drug Herceptin ® was less than 6 weeks, the drug can be used to introduce a dose of 6 mg / kg, without waiting for the next scheduled administration.
If a break in the introduction of the drug Herceptin ®up to 6 weeks and more, the drug should enter a loading dose of 8 mg / kg as / in drip infusion of approximately 90 min. Then, after 3 weeks, continued administration of the drug in a maintenance dose of 6 mg / kg every 3 weeks.
Correction dose
Dose reduction of each of the components is not recommended.
If the treatment with one of the components set Beyodaym ® canceled, another application kit component Beyodaym ® should also cancel.
When canceling docetaxel treatment of metastatic breast cancer kit components Beyodaym ® can be continued until disease progression or unacceptable toxicity.
During the occurrence of reversible myelosuppression caused by chemotherapy, therapy kit components Beyodaym ® can be continued with careful control of complications caused by neutropenia. Guidelines for dose modification docetaxel and other chemotherapy drugs are given in the instructions for use of said medical preparations.
Impaired function of left ventricular
therapy kit components Beyodaym ® should be suspended for at least 3 weeks in the following cases:
- LVEF decline to below 40%;
- the values of LVEF 40-45% with a decrease in left ventricular ejection fraction of 10% relative to the values observed before treatment?.
Possible to resume treatment if the LVEF was restored to a level> 45% or 40-45% with a decrease of <10% relative to the values observed before treatment.
If according to the re-evaluation of LVEF after 3 weeks will not increase or will reduce it further, treatment should be discontinued, unless the benefits for the individual patient is not greater than the risk.
Infusion reactions
Infusion should conduct a medical specialist with experience in the treatment of anaphylaxis, as well as access to funds to provide emergency aid.
With the development of infusion reactions should reduce the rate of infusion or temporarily stop the introduction.
Hypersensitivity reactions / anaphylaxis
With the development of severe hypersensitivity reactions should immediately stop the infusion and the complete cessation of therapy.
Specific guidance on dosing
dose adjustment kit components Beyodaym ® in patients with middle and old age is not required.
The efficacy and safety Beyodaym set of components ® in patients with renal impairment have not been studied.
Drug dose correction Pereta ® in patients with mild renal failure (creatinine clearance of 60-90 ml / min) and average (CC 30-60 ml / min) the severityrequired.
On the pharmacokinetics of data frompatients with severe renal impairment (creatinine clearance <30 mL / min, including end-stage) is limited. Give special instructions on dosing Pereta drug ® patients with severe renal failure (including end-stage) and the drug Herceptin ® in renal failure patients of all severities not possible.
The efficacy and safety Beyodaym set of components ® in patients with hepatic impairment have not been studied.
The efficacy and safety Beyodaym set of components ® in children and adolescents under the age of 18 years have not been studied.
Solution for infusion
Kit components Beyodaym ® (Pereta ® and Herceptin ® ) should only be used in series. Stud components necessarily carried out in separate infusion bags.
Pereta ® (pertuzumab) - component №1
drug Pereta ® is not compatible with a 5% dextrose solution. Dilution in such a solution leads to chemical and physical instability pertuzumab.
The drug should be diluted only in 0.9% sodium chloride solution.
Preparation Pereta ® not be mixed or diluted with other drugs.
The solution preparation Pereta ®compatible with infusion bags made of polyvinyl chloride (PVC), polyethylene and polyolefin (containing no PVC).
Preparation for the introduction of the drug should be performed under aseptic conditions. Pereta ® (pertuzumab) contains no antimicrobial preservatives. Therefore, you must take precautions to preserve the sterility of the prepared solution for infusion.
Pereta drug vial ® is intended for single use.
From bottle (bottles) should select all of the liquid concentrate and enter it into an infusion bag with 250 ml of 0.9% sodium chloride solution. Final solution concentration is approximately 3.36 mg / ml (840 mg / 250 ml) for loading and 1.68 mg / ml (420 mg / 250 ml) for a maintenance dose.
Then the infusion package must carefully turn the stirring solution while avoiding foaming. Before the introduction of the drug should be to check (visually) for mechanical impurities and discoloration. The infusion solution is administered immediately after its preparation.
In exceptional cases, the drug solution prepared Pereta ® can be stored for more than 24 hours at a temperature of 2-8 ° C if the solution preparation for infusion occurred in a controlled and validated aseptic conditions. At the same time due to storage conditions (storage rules and duration) responsible professionals ready solution.
Herceptin ® (trastuzumab) - component №2
Herceptin ®not compatible with the 5% dextrose solution due to the possibility of protein aggregation.
Herceptin ® not be mixed or diluted with other drugs.
A solution of the drug Herceptin ® compatible with infusion bags made of polyvinyl chloride, polyethylene and polypropylene.
Preparation for the introduction of the drug should be performed under aseptic conditions.
Instructions for preparing the concentrate
contents of the vial with the drug Herceptin ®dissolved in 20 ml supplied in the kit bacteriostatic water for injection containing 1.1% benzyl alcohol as an antimicrobial preservative. This results in a concentrate solution which is suitable for multiple use, containing 21 mg of the drug Herceptin ® in 1 ml and having a pH of 6.0.
At the time of dissolution should be handled carefully and with the drug. When dissolved avoid excessive foaming, the latter set may hinder the desired dose of the drug vial.
1. The sterile syringe slowly introduce 20 ml of bacteriostatic water for injection into the vial with 440 mg drug Herceptin ® , directing a jet of fluid directly at the lyophilisate.
2. To dissolve gently shake the bottle rotation. Do not shake!
Upon dissolution of the drug is often a small amount of foam. To avoid this, you must allow the solution to stand for about 5 minutes. The prepared concentrate must be clear and colorless or have a light yellow color.
The concentrate solution of the drug Herceptin ® , prepared in bacteriostatic water for injection, is stable for 28 days at 2-8 ° C. The prepared concentrate contains a preservative, and therefore can be used repeatedly. After 28 days, the unused balance of the concentrate should be destroyed. Do not freeze!
As the solvent, the drug Herceptin ®allowed sterile water for injection (without preservative). The use of other solvents is not recommended. In the case of using as the solvent of sterile water for injection concentrate is chemically and physically stable for only 24 hours at 2-8 ° C and should be discarded after this time. Do not freeze!
Instructions for preparing the solution for infusion
volume required for the loading dose Herceptin preparation ® equal to 8 mg / kg body weight, or maintenance doses of 6 mg / kg every 3 weeks, is determined by the following formula:
Volume (ml) = body weight (kg) dose (8 mg / kg loading or 6 mg / kg maintenance) / 21 (mg / ml, the concentration of the prepared solution)
From the vial with the concentrate should dial the appropriate volume and enter it into an infusion bag with 250 ml of 0.9% sodium chloride solution. Then the infusion bag should be carefully turn the stirring solution while avoiding foaming. Before the introduction of the solution should check (visually) for mechanical impurities and discoloration. The infusion solution is administered immediately after its preparation.
In exceptional cases, the prepared solution for infusion may be stored no longer than 24 hours at a temperature of 2-8 ° C if the dissolution of the concentrate and the solution for infusion occurred in a controlled and validated aseptic conditions. At the same time due to storage conditions (storage rules and duration) responsible professionals ready solution.
Instructions for the destruction of unused medicines or drugs that have expired
Contact medicines into the environment should be minimized. You should not dispose of medicines via wastewater or with household waste. Destruction of unused medicines or drugs that have expired should be carried out in accordance with the requirements of the facility. If possible, a special system for the disposal of drugs should be used.
Needles and syringes can not be reused. Used needles and syringes are placed in a container protected from puncture (container). Recycle components set Beyodaym® and consumables should be performed in accordance with local requirements.
SIDE EFFECT

Metastatic breast cancer is
the most common adverse events (observed in more than 50% of patients), associated with the use of the drug Pereta ® in combination with the drug Herceptin ®and docetaxel as a treatment for metastatic breast cancer were diarrhea, alopecia and neutropenia.
The most frequently observed (> 10%) adverse reactions 3-4th severity classification of the National Cancer Institute National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE), version 3.0, were neutropenia, febrile neutropenia and leukopenia.
The most severe and clinically significant adverse reactions observed with a frequency of less than 10%, it was left ventricular dysfunction, including symptomatic left ventricular systolic dysfunction (chronic heart failure).
After the cancellation of docetaxel all undesirable reactions were observed with the lower frequency (<10%), except for diarrhea (28.1%), rash (18.3%) upper respiratory infection (18.3%), headache (17%), nasopharyngitis (17% ), pruritus (13.7%), fatigue (13.4%), asthenia (13.4%), nausea (12.7%) and arthralgia (11.4%).
Neoadjuvant therapy is breast cancer
In case kit components Beyodaym ®in combination with docetaxel used in preoperative for 4 cycles followed by 3 cycles of postoperative therapy FETS, the most common adverse reactions (≥ 50%) were alopecia and neutropenia. The most common (≥10%) adverse reaction was Grade 3-4 neutropenia.
If the components of a kit Beyodaym ® in combination with docetaxel applied for 3 cycles after preoperative 3 FETS preoperative therapy cycles, the most common adverse reactions (≥ 50%) were diarrhea, nausea and alopecia. The most common (≥10%) adverse reactions were Grade 3-4 neutropenia and leukopenia.
If the components of a kit Beyodaym ®used in combination with docetaxel and carboplatin for 6 preoperative cycles, the most common adverse reactions (≥ 50%) were diarrhea and alopecia. The most common (≥10%) adverse reactions were Grade 3-4 neutropenia, febrile neutropenia, anemia, leukopenia, and diarrhea.
Metastatic prostate and breast cancer, neoadjuvant therapy of breast cancer
are presented below undesirable reactions which were reported in the study of the components set Beyodaym ® in combination with docetaxel in metastatic breast cancer in studies set Beyodaym components ®in combination with chemotherapeutic agents as a neoadjuvant therapy for locally advanced, edematous infiltrative or early breast cancer.
As used combination of drugs is problematic precisely to establish a causal relationship between an adverse event and a particular drug. The following classification is used to describe the frequency of adverse reactions: very common (1/10?), Often, infrequently, rarely (1 / (1/100 and <1/10?) (1/1, 000 and <1/100?)? 10,000 and <1/1000) and very rare (<1/10 000), including isolated cases.
From hemopoiesis system: very often - neutropenia, anemia, leukopenia, febrile neutropenia (including fatal).
Immune system:very often - hypersensitivity / anaphylaxis, infusion reactions / cytokine release syndrome.
Psychiatric disorders: very often - insomnia.
From the nervous system: very often - peripheral neuropathy, headache, dysgeusia (distortion of taste perception); often - dizziness.
From a sight organ: often - increased lacrimation.
Cardio-vascular system: often - left ventricular dysfunction; infrequently - chronic heart failure.
The respiratory system: very often - cough; often - shortness of breath, pleural effusion; Infrequent - Interstitial lung disease.
From the digestive system:very often - loss of appetite, diarrhea, nausea, vomiting, constipation, stomatitis, dyspepsia.
Skin and subcutaneous tissue disorders: very often - alopecia, rash, nail pathology; often - itching, dry skin, paronychia.
On the part of the musculoskeletal system: very often - myalgia, arthralgia.
Other: very often - fatigue, asthenia, peripheral edema, inflammation of the mucous membranes of different localization, pain, fever, addition of secondary infections (upper respiratory tract infection, nasopharyngitis); often - chills.
The following provides more detailed information about specific unwanted reactions.
Left ventricular dysfunction
In patients with metastatic breast cancer incidence of left ventricular dysfunction (DLZH) and the frequency of symptomatic DLZH against treatment kit components Beyodaym ® and docetaxel (6.6% and 1.5%, respectively) were lower than during the treatment only drug Herceptin ® and docetaxel (8.6 % and 1.8% respectively).
On the background of neoadjuvant therapy kit components Beyodaym ® in combination with docetaxel (4 preoperative cycle) was observed DLZH frequency higher than background neoadjuvant treatment only drug Herceptin ® and docetaxel (7.5% and 1.9% respectively). When using only the components of the kit Beyodaym®registered a case of symptomatic DLZH (chronic heart failure).
On the background of neoadjuvant therapy kit components Beyodaym ® and docetaxel for 3 cycles before the operation that preceded the 3 cycle FETS therapy DLZH rate was 9.3% and the frequency of symptomatic DLZH - 1.3%.
On the background of neoadjuvant therapy kit components Beyodaym ® , Docetaxel and Carboplatin DLZH frequency was 6.6%, and the incidence of symptomatic DLZH - 1

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