As can be learned from the instructions of “Copaxone”, this medication is an acetic acid salt of artificial polymer peptides formed by the L-forms of lysine, tyrosine, alanine, and the amino acid glutamine. Chemically, the substance is as close as possible to the key protein myelin. The drug changes the immune response, affecting immunocompetent cells. Enters competition with the myelin key protein, oligodendrocytic glycoprotein, binding to the molecular complex of tissues.
Technical information
As can be seen in the instructions, "Copaxone" is a drug produced in the form of a solution. The substance is injected into the patient. The main active ingredient of the drug is glatiramer acetate. The product is made in the form of a colorless liquid or slightly tinted in a yellowish tint, but fairly light. Visual inspection reveals slight opalescence. One milliliter of the drug contains 40 mg of the active ingredient. As auxiliary substances, mannitol and specially purified water, which is acceptable for injective administration, are introduced into the pharmaceutical product.
The drug is packaged in disposable glass syringes that do not have color. The volume of one syringe is one milliliter. One package contains four packages, each of them contains three syringes. The drug is packaged in a cardboard box, accompanied by instructions drawn up by the manufacturer. The cost of a medicinal product is from 15 to 30 thousand rubles. The price depends on the characteristics of the packaging, the amount of the drug, the trade policy of a particular pharmaceutical point of sale. When planning an acquisition, you first need to make sure that the product is suitable. Production date and storage duration are indicated on the outside of the package.
Pharmacology
The Copaxon instructions mention that this pharmaceutical product belongs to the class of immunomodulators. The tool is intended for the treatment of multiple sclerosis. The modulating immunity effect of glatiramer acetate against the background of multiple sclerosis has not yet been adequately studied. As suggested by scientists, this substance corrects the processes occurring in the immune system. It is believed that they are especially important in the pathogenesis of the disease. Confirmation of the assumption is due to specialized studies aimed at identifying the pathogenesis of EAE. The abbreviation stands for experimental allergic encephalomyelitis. EAE often becomes a model of sclerosis for experimental trials. Using animals, scientists organized research. Specific experiments were performed involving people who have already been diagnosed with multiple sclerosis. The results prove: the administration of a glatiramer compound affects peripheral induction, the activity level of specific type T lymphocytes.
PPP sclerosis
Relapse-prone relapsing remitting multiple sclerosis has been the subject of scientific research, which took quite a long time. Information on their results can be found in the instruction of “Copaxon”. As the annual observation with the placebo control group showed, the drug really has a reliable and strong effect if it is used three times a week for administration under the skin at a dose of 40 mg. Such medical practice, as proven by tests, can reduce the frequency of relapses.
Organized registration experiments in a clinical setting. The event was conducted with the involvement of people with a diagnosis of PPP sclerosis. One relapse per year is documented, two in two years. For a period of 1-2 years, one relapse was recorded in the presence of one contrast-accumulating zone and the presence of at least one lesion visualized in T1-type images during MRI examination.
Initially, research activities were organized to estimate the number of relapses officially confirmed for patients. The secondary objective of the event was to determine the total number of new and larger foci detected in T2 images obtained with MRI. The task of the doctors was to determine the total number of foci that can accumulate contrast and are reflected in the T1 images.
Kinetics
In the instructions for the use of "Copaxone", the manufacturer indicates the absence of specific studies designed to identify the kinetic characteristics of the drug in the human body. In laboratory conditions, studies have been conducted to make certain conclusions on this subject. In addition, there is limited information gathered by involving healthy people. With subcutaneous use of the drug, the drug is soon absorbed. The main percentage of the volume received in the body in a short time is transformed into subcutaneous tissue. The process is accompanied by the generation of small fragments.
Preclinical studies were conducted to determine the safety of the pharmaceutical product, the ability to poison with repeated administration. Experiments were carried out to assess the toxicity of genes, the negative impact on human reproductive ability. The ability of the drug to provoke cancer was tested. As shown by the results of such preclinical trials recorded in the instructions for use of "Copaxone", the drug is not peculiar to especially dangerous for a person features. Doctors do not have information about kinetics, so it is not possible to assess what the maximum concentration limits are. Conducted experiments involving monkeys, rats. Animals received the medicine in a six-month and longer course.
Animal experiments: interesting features
Organized a two-year test of the drug in rats. No accumulation of immune complexes in the glomeruli of the kidneys was detected.
Tests involving sensitized animals were conducted. As such, mice, guinea pigs were used. After the use of the drug, suffocation was recorded. As far as this is relevant for a person, there is no official information yet.
The toxic effect in the area of ​​administration is fixed upon repeated use. This reaction is one of the widespread.
When and how?
The main indication mentioned in the “Copaxone” instructions for prescribing is PPP-sclerosis. The drug is injected. One dose is 40 mg. Such a quantity of medication is contained in one syringe packaged by the manufacturer. The medicine is used three times a week. You can not pause between administrations for less than two days. It is forbidden to introduce a pharmaceutical product into a vein or into muscle tissue. Reliable information on the permissible duration of the therapeutic course is not yet available. Is it worth it to use the drug for a long time, the attending doctor determines, focusing on the patient's condition.
Independence and risks
The instruction of “Copaxon-Teva” recommends that the patient be trained to inject himself. The first introduction is done strictly under the supervision of a qualified doctor. The patient should remain in the specialist's field of vision for about half an hour to control the body's reaction. To minimize the irritating reaction, to ease the pain in the area of ​​application, each time the medicine is injected into a new area of ​​the body.
Prescribing this drug to children and adolescents should be avoided. No special studies have been conducted that would confirm the safety, reliability, effectiveness of the use of the pharmaceutical product by minors.
There have been no special studies to evaluate the effectiveness of the drug for the treatment of elderly people. The safety of the drug for this group of people has not been studied. No relevant trials were organized for individuals suffering from poor functioning of the product.
Recommendations and rules of use
The instruction of “Copaxon-Teva” draws attention: each syringe with a medicine is used once. Before starting the administration of the drug on your own, you need to make sure that you have all the necessary items in the access area. The patient will need a syringe with the drug, a container for the disposal of used syringes, a cotton swab treated with alcohol. Before setting the injection, the syringe is removed from the package, a piece of paper provided by the manufacturer for protecting the product is removed. Maintain the drug-filled product at room temperature for at least a third of an hour, then rinse your hands with an antibacterial soap. The syringe is carefully examined to check fluid quality. If suspended particles are visible, the color of the drug has transformed, it is necessary to dispose of the damaged product.
If the drug is in order, select the injection zone. You can independently put an injection in the thigh, buttocks, upper limbs. You can inject the drug into the stomach near the navel - in a radius of five centimeters. If any part of the body hurts, pigmentation is lost, it turns red, nodules or tight formations appear, they do not give an injection to such a place. Each injection zone is large enough to be enough for several injections. It is advisable to draw up a diagram for yourself, which is always kept at hand. To inject the drug into the arm or buttock, you may need to ask the help of an outside person.
Introduction: Continuing the Procedure
As indicated in the instructions for use of "Copaxone" 40 mg, the next stage of using the product on its own is to remove the protection from the syringe needle. The skin is treated with cotton wool soaked in alcohol, then the skin fold is easily collected using the first two fingers of the brush. The needle is placed perpendicular to the injection zone, the skin is pierced and the piston is evenly pressed, introducing a medication under the skin. Then the needle is removed by moving the syringe perpendicular to the injection site. The used syringe is placed in a special container for such products.
If for some reason a person forgot to administer a medication on time, they give an injection right away, they barely remembered it. Introducing double volume at a time is strictly prohibited.
What patients are talking about
Reviews on the effectiveness of the tool is not very much. This is due to its high cost. Almost none of the patients with PPP sclerosis can buy such a medication on their own. As you can see from the reviews, the instructions for the use of "Copaxone" are simple and understandable, so the people who used the tool did not experience any special problems with it. Mostly these are people to whom the drug was paid from the budget.
As many have noted, if a person is sick with sclerosis and does not tolerate interferon medications, the drug in question becomes for him hardly the only option for drug treatment. Doctors also note the pros and cons of this drug. On the one hand, it is really reliable in its effect, on the other hand, it requires regular administration, which creates certain inconveniences.
Is there an alternative?
If you pay attention to the documentation accompanying the product, you can name, based on the instructions, analogues of Copaxone in which the main ingredient is glatiramer acetate. Such a product is contained in the product "Timexon". The cost of one package of medicine starts from eight thousand rubles. The similar composition is different for the product “Axoglathiran FS”. According to the instructions, the composition of “Copaxone” and the analogue “Glatirate” are similar: both of them contain glatiramer acetate. True, not every product is as easy to get as Copaxon. Many products with similar compositions are presented only in a very limited number of outlets.
Do not look for yourself, focusing on the instructions, analogues of the drug "Copaxone". The tool chosen by the average person may turn out to be completely ineffective in case of PPP sclerosis, and the time lost and the money spent in vain will not be returned. When planning a replacement for some reason, you need to check with your doctor what exactly from the pharmacy assortment will suit a particular patient. Sometimes you can resort to funds that do not coincide in composition, but belong to the same category of immunomodulatory drugs. Based on the instructions for use, “Genferon” and “Genferon Light” can be reckoned as analogues of “Copaxon”. These funds are more than affordable - one package costs only about a hundred rubles. To the same class of immunomodulatory drugs belong Derinat and Wobenzym, which cost 250-350 rubles. About 350 rubles in pharmacies are asked for one package of the Polyoxidonium medication, which is also, to some extent, as one can conclude from the instructions, an analogue of Copaxone. There are a lot of reviews about this tool, mostly they are positive, but you can not expect the same effect as from glatiramer acetate.
Undesirable effects: is there?
As you can learn from the instructions for use of “Copaxone” 40 mg, information on the safety of the drug is mainly due to the use of the pharmaceutical product “Copaxone-Teva” 20 mg (this medication is used daily). We conducted four placebo-controlled trials for such a product, and one release test containing 40 mg of the active ingredient in 1 ml of the drug (using three times a week).
When using a less saturated product, undesirable local reactions at the injection site were most often observed. Worried about soreness, redness of the skin, swelling of the zone, seals appeared, the area became very sensitive. The appearance of a focus of inflammation is possible.
It is known that the introduction of the drug can provoke a decrease in breathing, a violation of the rhythm and frequency of contractions of the heart, chest pain and vasodilation. Such phenomena may appear in the first few minutes after the introduction of funds.
Trials and Placebo
Copaxon-Teva research was conducted. Their results are given in the accompanying product instructions. It is clarified that the placebo groups and people who received the drug were compared. Four trials were organized with the registration of the result in a double-blind format with a placebo control. They recruited 512 people who needed injections of the medicine every day, and 509 people who received placebo for 36 consecutive months.
In three trials, 269 people with PPP sclerosis took part. They received the drug in question every day, the duration of the course was 35 months. In opposition, they studied a group of 271 people. These individuals received a placebo. The fourth trial was organized with the involvement of 243 patients who recorded the first clinical relapse of the disease, as well as 238 people who were given a placebo. The duration of the test work was 36 months.
Adverse reactions: what?
The composition specified in the instructions for use of Copaxone (the main ingredient is glatiramer acetate) is accompanied by a list of possible negative reactions that this substance can provoke. These include influenza, infectious diseases, bronchial, ear, kidney inflammation. There is a danger of herpetic diseases, candidiasis, furunculosis. Perhaps the appearance of polyps, cysts. Benign processes were detected relatively often. In a small percentage of patients, cancer processes have developed against the background of drug treatment. Relatively often detected lymphadenopathy, much less often diagnosed with thrombocytopenia, leukopenia, splenomegaly, leukocytosis. There are cases when the morphological features of lymphocytes have changed. Some patients were diagnosed with goiter, hyperthyroidism. There is a danger of an allergic reaction.
Even with the dosage indicated in the instructions, “Copaxone”, used with pauses of at least 48 hours between doses, can cause anorexia, weight gain, gout, excess sodium and a decrease in blood lipids. Intolerance to alcoholic beverages is possible. Some became depressed, others became nervous, anxious. There may be aggression, mania, personality disorders, suicidal tendencies, hallucinations, euphoria. Cases of deterioration in hearing and vision were noted. Many had a headache, speech worsened. Possible paralysis, mydriasis. There is a possibility of extrasystole, varicose veins, tachycardia. Cases of cough, runny nose, shortness of breath, lung dysfunction are known. Many were sick.
Frequency and risks
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Sometimes you can’t
The contraindications listed in the Copaxon instructions include a ban on the use of the drug with increased sensitivity to the main ingredient. Sensitization is possible against the background of receiving mannitol, therefore, with an increased susceptibility of this drug, the drug is not prescribed. The tool is not used to treat pregnant women, children and adolescents.
Very carefully, the drug is prescribed if a person is prone to allergies, if impaired renal function or a disease of blood vessels, heart.
Security features
There have been no special studies that could have been used to say that Copaxone is safe for pregnant women. There is not even an approximate idea of ​​the risks associated with the use of the drug by women carrying the fetus. Studies involving animals. The results of such work are insufficient, they do not allow to determine the dangers inherent in man. There is no idea yet whether the active component of the Copaxone drug affects the processes of development, fetal formation, the birth of a child and the development of an infant.
There is no information on the ability of the main active ingredient to be excreted in the milk of a nursing mother. If during lactation there is a need to use "Copaxone", it is necessary to assess what are the potential risks, compare with the obvious benefits, only then make a final decision. A woman should be aware of the dangers associated with such treatment.