Description overdue on 30.07.2014
- Latin name: Herceptin
- ATC code: L01XC03
- Active substance: Trastuzumab (Trastuzumab)
- Manufacturer: Roche, Basel, Switzerland
- Composition
- Product form
- Herceptin (Herceptin): pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions on Herceptin: method of use and dosage of the drug
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- Reviews
- Price, where to buy
Composition
Besides the active substance in the composition include Herceptin L-histidine and L-histidine hydrochloride . 1-O-α-D-glucopyranosyl-α-D-glucopyranoside (or α, α-trehalose), non-ionic surfactants polysorbate 20.
Product form
The drug is available in clear glass vials as a lyophilized powder for infusion solution. Each vial bottle equipped with a solvent which is in its composition comprising benzyl alcohol bacteriostatic water.
The amount of active substance in one vial of lyophilizate can be:
- 150 mg;
- 440 mg.
Herceptin (Herceptin): pharmacological action
Herceptin is a group of medical immunobiological preparations, used for the treatment of malignant tumors.
Active substance formulation Trastuzumab - Is synthesized in Chinese hamster ovary cells and having antitumor action of the drug which is used in targeted therapy Breast Cancer .
The substance is a so-called monoclonal (i.e. produced by the same immune cells) antibodies that have the ability to detect and block the HER-2 receptors, are localized on the cell membrane surface of tumor cells. This in turn provides the termination of their continued growth and - in some cases - reducing the size of a cancerous tumor. This trastuzumab has no effect on healthy tissue.
Herceptin, acting on the genetic mechanisms of malignant transformation of cells, blocking them and significantly reduces the susceptibility of cells to the excesses of the membrane protein HER-2 overexpression is directly related to the likelihood of Breast Cancer . This process slows down the process of division of cancer cells and the effect of eliminating the so-called overproduction.
Pharmacodynamics and pharmacokinetics
Associated with the growth of cancer cells HER-2 protein is protooncogene or, in other words, a common gene that at the confluence of certain conditions (mutations enhance the expression, for example) can cause cancer. Its overexpression occurs in about every third or fourth case, when the patient is diagnosed primary mammary cancer . It identifies and considerable variability of HER-2 in respect of advanced gastric cancer.
HER-2 protein is located on the shell certain cancer cells. He created a special gene, which is known as the HER-2 / neu, is a receptor for a particular growth factor, which is called human epidermal growth factor. Attached to the HER-2 receptors on breast cancer cells, the latter stimulates their growth and actively dividing. Some cancer cells are characterized by an increased number of the HER-2 receptor, that allows to identify the cancer as the HER-2 positive. Neoplasms of this type diagnosed in one in five women with breast cancer .
Part of the Herceptin Trastuzumab providing blocking action on the proliferation of abnormal cells in patients with overexpression of HER-2. Use of a preparation as monotherapy in the treatment of HER-2 positive metastatic breast cancer, ongoing therapy as second and third line, allows to achieve 15 tiprotsentnoy total frequency response and increase the median survival of patients up to 13 months.
The use of Herceptin is combined with docetaxel . anastrozole or paclitaxel in women with metastatic breast cancer increases:
- the total frequency response;
- Median time interval until disease progression (in some cases almost double);
- survival period;
- common frequency effect;
- the frequency of clinical improvement.
In appointing the drug after surgery or auxiliary (adjuvant) therapy after surgical treatment of patients who are diagnosed early stage breast cancer is greatly enhanced:
- the duration of survival without the onset of symptoms;
- Survival without recurrence of the disease;
- Survival without the occurrence of distant metastases.
Antibodies to trastuzumab detected in one of the 903 women, however, while an allergic reaction to the drug no.
Herceptin pharmacokinetic parameters are dose dependent: the higher it is, the more the average half-life Trastuzumab and the smaller the clearance of the drug.
Pharmacokinetic parameters did not change, while the appointment with Herceptin anastrozole . Also, the distribution of Trastuzumab in the body. Pharmacokinetic studies of the drug in patients of advanced age, suffering from kidney and / or liver failure, to date, have not been conducted.
Indications
The drug is indicated for the treatment of Metastatic Breast Cancer in patients with a determined overexpression of HER-2. The effectiveness of Herceptin is celebrated as when used as monotherapy after the procedure Chemotherapy And in combination with other drugs. As a rule, complex therapy in the absence of prior chemotherapy involves the simultaneous appointment with Herceptin paclitaxel or docetaxel . In patients with positive estrogen and / or progesterone receptors are also allowed use of the drug in combination with drugs, aromatase inhibitors.
In the early stages of the disease, which is not characterized by the presence of a patient with the HER-2 positive metastatic breast cancer, the drug is prescribed as an adjuvant:
- Following the surgery ;
- upon completion of the course Chemotherapy (as adjuvant and neoadjuvant);
- upon completion of the course radiation therapy .
Contraindications
The main contraindication to Herceptin is hypersensitivity patient to the active agent or any of the ancillary components of the preparation (including benzyl alcohol ).
With careful preparation is encouraged to nominate:
- women suffering from coronary heart disease ;
- patients with resistant high blood pressure and Heart Failure ;
- patients who have undergone treatment cardiotoxic drugs (eg, anthracyclines or cyclophosphamide );
- if breast cancer Concomitant diseases of the lungs;
- if the tumor is given Metastasis the lungs;
- children (because the effectiveness and safety of treatment with Herceptin in this group of patients has not been studied).
Also in compliance with the precautionary measures prescribed medication to patients in the early stages of HER-2 positive breast cancer, which states:
- congestive heart failure (in history);
- resistant to therapy arrhythmia ;
- requiring medical treatment angina ;
- heart disease Characterized clinical significance;
- transmural myocardial infarction According to an electrocardiogram;
- stable high blood pressure, resistance to treatment.
Side effects
Like most anti-tumor agents (Wikipedia confirms this fact) a drug to a certain extent has toxicity can provoke adverse reactions, and in some cases death. The most likely side effects of Herceptin, which develop during the treatment it is:
- various kinds of infusion reactions (usually they occur after the first injection and expressed as chills . fever . shortness of breath , Rash onset, increasing weakness, etc.);
- general reactions (fatigue, breast tenderness, flu-like symptoms etc.);
- dysfunction of the digestive system ( nausea, vomiting Symptoms gastritis, disorders stool etc.);
- dysfunction of the musculoskeletal system (pain in the limbs, arthralgia etc.);
- skin reactions (rash, itching, hives etc.);
- dysfunction of the heart and circulatory system (congestive heart failure . vasodilatation . tachycardia etc.);
- disorders of the hematopoietic system ( leukopenia . thrombocytopenia etc.);
- dysfunction of the nervous system (headaches, paresthesia , Increased muscle tone, etc.);
- disorders of the respiratory organs ( breathlessness Cough, nosebleeds, sore throat and larynx, etc.);
- disorders of the genitourinary system ( cystitis . urogenital infections etc.);
- disruption of vision and hearing;
- Side effects caused by hypersensitivity to the drug ( angioedema . anaphylactic shock Allergic reaction).
Instructions on Herceptin: method of use and dosage of the drug
Instructions for use of Herceptin warns that the drug is intended solely for intravenous drip. Bolus is prohibited.
Duration intravenous drip infusion is 1, 5 hours (or 90 minutes) at load (maximal) dose of Trastuzumab Of 4 mg per 1 kg body weight of the patient.
If there during injection side reactions, which may be expressed as fever or chills, dyspnea, wheezing appearance etc., infusion suspended and resumed only after the complete disappearance of unpleasant clinical symptoms.
During the maintenance therapy dose Trastuzumab reduce by half (up to 2 mg per 1 kg of body weight of the patient). This multiplicity of procedures infusion of 1 times a week.
With good endurance preceding dose of Herceptin is administered by drip for half an hour, until disease progression.
Overdose
Clinical studies revealed no drug overdoses Herceptin. Introduction of a single dose, which would exceed 10 mg Trastuzumab per 1 kg of body weight was conducted.
Cooperation
Specific drug interaction studies with other drugs have not been conducted in humans. Clinically significant interactions with other drugs Herceptin, have been used in patients at the same time with him has been identified.
We can not allow dilution or mixing the infusion solution with other drugs. In particular, it must not be made glucose Because the latter provoking protein aggregation .
Herceptin is characterized by good compatibility with the infusion packages of polyvinyl chloride, polyethylene or polypropylene.
Terms of sale
Vacation Herceptin carried out with a prescription.
Storage conditions
The product is stored at temperatures between 2 and 8 ° C. Ready infusion solution at such temperature condition is stable their pharmacological properties, for 28 days. This is due to the content of preservative in bacteriostatic water used as a solvent for the lyophilized powder and therefore reusable concentrate solution. At the end of 28 days, the solution should be disposed of.
When the freeze-dried dilution with water containing no preservatives, the concentrate should be used immediately.
Put the solution in an infusion package Herceptin be stored for 24 hours under the condition that respect the above temperature, a solution was prepared under strictly aseptic conditions.
Shelf life
The drug is considered usable for 4 years.
Analogs
MabThera
The analogue is the drug Herceptin Trastuzumab (Trastuzumab).
Reviews of Herceptin
Reviews of Herceptin left by women who have been treated it leads to the conclusion that in most cases the drug was well tolerated. As a general rule, difficult to pass only the introduction of its first loading, dose, subsequent dropper not provoke pronounced adverse reactions, and sometimes not accompanied by any adverse events.
At the same time commended Herceptin put not only women leading the fight against breast cancer But their doctors.
Price Herceptin
The product does not belong to the category of cheap medicines. Thus, the price of Herceptin 440 mg is about 70 thousand Russian rubles. In the course of the year the patient c HER-2 positive breast cancer requires 17 infusions over 12 months (ie, once every three weeks). However, typing in the search text " selling Herceptin "You can find ads of women who have left stocks of the drug after treatment, of which they are ready to get rid of half the price.
Buy in Moscow, the drug can be licensed pharmacy chains, as well as in specialized oncology pharmacies (so-called pharmacies onco-assistance ).
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