Gercidad (trastuzumab) for breast and stomach cancer

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In 2015, clinical trials of a new biological preparation were conducted in Russia. "Gercidad" is the bio-analogue of "Trastuzumab used in the treatment of neoplasms in the mammary gland and stomach. It is made on the basis of a humanized monoclonal antibody, due to which, it destroys only cancer cells. At the moment, it is one of the most effective drugs in the elimination of breast and stomach tumors.

Clinical studies and anti-cancer properties

Monoclonal antibodies are one of the most promising methods, to which high hopes are placed not only by doctors, but also by patients. It is proved that the use of "Gertikad" in the treatment of breast and stomach tumors can significantly reduce the toxicity of therapy, compared with treatment with chemotherapy drugs.

International clinical studies of Phase III showed that the Russian bioanalog is equivalent to the Swiss "Trastuzumab". They were compared in different parameters:

  1. pharmacokinetics;
  2. efficiency;
  3. security;
  4. immunogenicity.

The transition from drugs that temporarily reduce the size of the tumor, to those that directly affect tumor cells of the tumor, will help improve the results of treatment for many patients.

What kind of cancer is Gercadia?

The drug is used for patients with hormone-insensitive aggressive tumors, which are not helped by standard chemotherapy. It is prescribed for women who have been diagnosed with breast cancer and patients with stomach cancer. Scientists have found that patients with a high level of the HER2 gene in the neoplasm are more difficult to defeat the disease. These indicators signal a high aggressiveness and rapid progression of the tumor.

Over the past 10 years, breast cancer is the leading cause of death among cancer patients. If doctors diagnose cancer, the next thing they must do is assign a test to determine the HER2 scores. What is it and why is it so important to know its quantity? HER2 (membrane protein) is an epidermal growth receptor that is located on the surface of cells of the stomach and breast. It can be negative and positive. The definition of status is very important, because according to its results, treatment is prescribed.

With the positive status of the HER2 protein, there is an overabundance of the hormone on the surface of the tumor cells. It forces the cells to share chaotically. Therefore, such patients are not suitable for conventional treatment. They are prescribed a targeted anti-HER2 therapy, for which they use "Gercadia".

With treatment, you should not postpone, because research shows that in 30% of cases there is a transformation of a positive status into a negative one.

Composition and active ingredient

The composition of the package includes the antitumor agent itself and the solvent. The lyophilizate is completely dissolved by the solvent to a colorless or yellowish liquid. The bioanalog (150 or 440 mg) is packaged in a different dose of vials. One package consists of 1 unit of "Gercadia" and 1 unit of special dissolving liquid.

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1 bottle of the drug consists of:

  • "Trastuzumab" (the basis of the drug) in a dose of 150 or 440 mg;
  • excipients.

Dosage and how to take it right?

The diluted drug is injected into the vein by a drip. Any other methods are unacceptable. Preparation for the procedure should be carried out with the implementation of all standards of asepsis.

Method of preparation of a concentrated solution of "Trastuzumab" for infusion:

  1. The solvent is injected into the GERTICAID using a sterile syringe and the stream is directed to the lyophilizate. It is important to adhere to the right concentration. For a dose of 440 mg, 20 ml of solvent will be needed. Accordingly, for 150 mg of the dose is sufficient, ml of a sterile solution.
  2. Further, without shaking the glass container, it is slowly twisted and shaken until the content is completely dissolved.
  3. When the lyophilizate is completely dissolved, the concentrate should be allowed to stand for 4-6 minutes before use to completely foam the foam.
  4. If everything is done correctly, a colorless or slightly yellowish liquid should turn out.

Such a concentrate can be stored in the refrigerator for no longer than 28 days without losing its basic properties.

If Gertikad is dissolved with sterile water for injection, it should be used within the first 24 hours after preparation.

Features of the preparation of the substance:

  1. To assign a loading and preserving effect of therapy, the volumes of the substance "Trastuzumab" are used different. The loading dose is as follows: volume of solution = body weight * dose (4-8 mg / kg) / 21 (concentration ratio of solution). Preservative effect of the dose: volume of solution = body weight * dose (2-6 mg / kg) / 21.
  2. Then take the necessary amount of solution and enter into the infusion bag, in which there is already 250 ml of sodium chloride,%.
  3. The contents of the package must be mixed gently by shaking them, without creating a foam.
  4. If the solution has not changed color and does not contain impurities, you can start the procedure.

The medical staff is obliged to closely monitor the patient's condition during the administration of the drug, and also to react quickly to adverse reactions of the body.

Dosage for metastatic breast cancer:

  1. 4 mg / kg solution is administered once in 7 days, the procedure is carried out for an hour, the loading dose.
  2. After 7 days after the loading, a dose-preserving dose of 2 mg / kg was injected once, administered for 30 minutes.
  3. Alternative: once for 21 days - 8 mg / kg of the weight of the solution, injected for an hour, invasively (loading dose).
  4. Alternative: the maintenance dose is administered for half an hour once a day for 6 days - 6 mg / kg. It is carried out after 3 weeks after the loading.
  5. Combined treatment with other antitumour agents. They are used immediately after the introduction of "Gertikad" or after a day.
  6. Use of the aromatase inhibitor in combination therapy: "Anastrozole" is administered after the infusion of "Gertikada".

With metastatic breast cancer and neoplasm of the stomach, the drug is used until the appearance of positive results. It is not recommended to use more than 12 months.

At an early stage of a tumor of a mammary gland therapy spend time in 3 weeks under the resulted scheme.

Gertikad is used to treat tumors in the early stages in conjunction with Docetaxel and Carboplatin. The procedure is carried out once a week in parallel with chemotherapy.

Neoadjuvant chemotherapy involves the use of "Gercardi" once in three weeks, so it takes 10 cycles:

  1. During 1-3 cycles - the drug is used in parallel with an antibiotic with antitumor activity "Doxorubicin" and an antitumor agent of plant origin "Paclitaxel".
  2. During 4-7 cycles - application of "Paclitaxel" once a week.
  3. During 7-10 cycles - the use of "fluorouracil "cyclophosphamide as well as "Methotrexate" - on days 1 and 8 every 4 weeks.

Adjuvant therapy after surgical treatment lasts 12 months at a frequency of 1 every 3 weeks.

Mechanism of action

With the timely use of "Gertikad" blocks the action of the protein HER2, slows down, and in some cases stops the growth of education. According to statistics, 25% of patients with tumors in the chest have increased test results for the level of specific protein, and this is a fairly large number of women. Overall survival is increased by 40%.

Contraindications

"Trastuzumab" has a number of contraindications that should be considered before starting treatment:

  • shortness of breath, requiring oxygen therapy, or against the background of metastases to the lungs;
  • in the early stages of cancer, if there is a history of infarction, angina, heart failure, heart disease, hypertension;
  • the use of anthracyclines;
  • pregnancy and lactation;
  • age to 18 years;
  • hypersensitivity to the components of the drug.

Side effects

  • development of infection;
  • progression of neoplasms;
  • deterioration of the blood formula;
  • allergic reactions;
  • weight loss;
  • depressive conditions;
  • tremor, headaches;
  • increased or vice versa - reduced teardrop;
  • hearing impairment;
  • violation of blood pressure indicators;
  • diarrhea, constipation, nausea;
  • pain in the liver;
  • rash on the skin, swelling;
  • kidney disease.

During clinical studies, no cases of overdose have been observed, but do not exceed recommended doses.

What do you need to pay attention to during the treatment of cancer "Gercadia"?

Before the start of treatment, it is necessary to conduct a test for the status of the HER2 gene.

All manipulations should be performed under the supervision of a physician. Trastuzumab's solution is prepared by medical personnel with special knowledge and skills.

The doctor should warn the patient about both positive and possible negative consequences.

The drug is only available on prescription.

Analogues

Analogues are: "Trastuzumab" and "Herceptin". Studies have shown that the therapeutic effect of the drug in cancer is equivalent to its bioanalogues. "Gerticad" (trastuzumab) is manufactured by the international innovative company BIOCAD. The price for it is significantly lower than that of imported analogues and ranges from 3, 00 to 7, 00 rubles, depending on the dosage.

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It is important to know:

. Vinorelbine in cancer.
. Topotecan with cancer.
. The drug "Gemzar depending on the type of cancer.
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