equipoise vs deca

The mechanism of action equipoise vs deca is a human monoclonal antibody (isotype IgGl), specifically binds to an epitope that includes both small and large molecules extracellular loop.  Molecule is a transmembrane phosphoprotein that is expressed on B lymphocytes, starting from pre-B cells to mature B cells, as well as on the cells of B-cell tumors. B-cell tumors include chronic lymphocytic leukemia  and non-Hodgkin’s lymphoma. Upon binding to the antibody molecule CD20 remains on the cell membrane is equipoise vs deca not removed from the surface (shedding) and enters into the cell (internalization). Binding equipoise vs decaa with located near membrane specific epitope  is binding and complement activation on the cell surface, leading to developing complement-dependent cytotoxic reactions and lysis of the tumor cells. It has been shown that the expressed equipoise vs deca causes cell lysis, accompanied by high levels of expression of protective proteins of the complement. Furthermore, the binding equipoise vs decaa cause cell death by a mechanism and antibody-dependent cellular cytotoxicity. It was also shown that equipoise vs deca causes cell lysis with both high and low expression equipoise vs deca, as well as cells resistant to rituximab. Pharmacodynamic properties of patients with hematological neoplastic diseases content of B cells in the blood decreased after the first injection equipoise vs decaa. In patients with refractory CLL equipoise vs deca average reduction of B cells in the blood after the first injection was 23%, and after the introduction of the eighth – 92%. In most patients, blood B cells remained low throughout the course of treatment and then gradually increased (however, 3 months after the end of treatment equipoise vs decaom average grade of B cells was 68% lower than their concentration before treatment). ImmunogennostProtein drugs such equipoise vs decau may elicit an immune response, but the formation of antibodies against equipoise vs decaa may be less intense than usual as equipoise vs deca is, firstly, a human antibody, and secondly, it causes the death of B cells. The main clinical study of antibodies to equipoise vs decau been identified; moreover, equipoise vs decaa  concentration in blood were very low, making the detection of such antibodies is unlikely.

Pharmacokinetics Absorption The maximum concentration in serum equipoise vs decaa usually observed at the end of the introduction or immediately after it. Data on the pharmacokinetics were obtained from 146 patients with CLL resistant to prior therapy. The geometric mean for C max (maximum plasma concentration) after the first injection (300 mg) was 63 pg / ml after eight weekly administration (the 7th administration of 2000 mg) geometric mean for C max is equal to 1482 g / ml, and geometric mean for AUQ Reputation (0-∞) (area under the curve “concentration-time”) amounted to 674.463 micrograms-hour / mL; after the introduction of the twelfth (fourth monthly administration at a dose of 2,000 mg), the geometric mean for the C max is equal to 881 mg / ml, and the geometric mean of the AUC (0-∞) was 265.707 g-h / ml. Distribution The volume of distribution is small equipoise vs decaa. The mean value of the volume of distribution at steady state (OASIS), depending on the dose and numbers of administration in different studies ranged from 1.7 to 5.1 liters. Metabolism equipoise vs deca – a protein for which the normal metabolic pathway consists in breaking down into peptides by proteolytic enzymes and individual amino acids.Therefore it is not generally accepted research conducted drug biotransformation. Excretion equipoise vs deca removed from the body in two ways: non-target, and all the other IgG molecules, and due to the interaction with the target, namely, binding to B cells. Already after the first injection equipoise vs decaa a rapid and sustained reduction in the number of the CD20 + B cells, so the further administration of the drug, he will have to communicate with a much smaller number of the CD20 + cells. As a result, the subsequent introductions equipoise vs decaa its clearance value (CL) will be lower and the value of half-life (t1 / 2) – much higher than in the first administered; after repeated weekly injections of the AUC and C max increased in a greater extent than expected for the estimated accumulation equipoise vs decaa calculated on the basis of data obtained from its first introduction. In studies conducted in patients with CLL, the mean values of TC and t1 / 2 were 64 ml / h (range: 4,3-1122 ml / h) and 1.3 days (range 0.2-6.0 days) after the first injection, 8.5 ml / h (range 1,3-41,5 ml / h) and 11.5 days (range: 30.6 2.3 days) after the fourth administration of 9.5 ml / hr (range 2,2-23,7 ml / h) and 15.8 days (range 8,8-61,5 days) after administration of the eighth and 10.1 ml / h (range: 3,3-23, 6 ml / h) and 13.9 days (range:. 9,0-29,2 days) after the introduction of the twelfth individual patient groups Elderly (65 years and older): as shown in cross-population pharmacokinetic analysis of patients aged 21 to 86 years across studies, age had no significant effect on the pharmacokinetics of equipoise vs decaa. Children and adolescents (under 18 years):data on the pharmacokinetics of equipoise vs decaa in this age group are not available. Gender: under cross-analysis showed that the floor has a moderate impact (14-25%) on the pharmacokinetics of equipoise vs decaa – women with max and AUC were slightly higher (in the test group, 41% of patients were male and 59% – women). These differences were considered to be non-clinical significance, so adjust the dose depending on the sex of the patient is not recommended. Renal function: in cross population analysis in patients with creatinine clearance, varying in the range from 33 to 287 ml / min, it was shown that clinically significant relationship between the value of the creatinine clearance, before the introduction of certain equipoise vs decaa, and pharmacokinetics of the last missing. As a correct dose for patients with mild or moderate renal severity of failure (creatinine clearance of> 30 ml / min) is not recommended. For patients with severe renal impairment (creatinine clearance <30 mL / min), the pharmacokinetics data for equipoise vs decaa absent. Abnormal liver function: data on the pharmacokinetics of the drug in patients with impaired liver function no. However, as equipoise vs deca, and all the other molecules of IgGl, catabolized by the most conventional proteolytic enzymes, the prevalence of which is by no means limited to the tissues of the liver, liver function abnormalities are unlikely to have any impact on the rate of removal from the body equipoise vs decaa.

Indications for use

Treatment of patients with chronic lymphocytic leukemia (CLL) after failure of prior therapy with the inclusion of fludarabine and / or alemtuzumab.

Contraindications for use

 

  • Hypersensitivity to equipoise vs decau or other ingredients;
  • children and adolescents up to 18 years;
  • severe renal dysfunction (creatinine clearance less than 30 mL / min);
  • Pregnancy and lactation.Precautions
    Hepatitis B is a history of loss of lung function and heart disease in history.Dosage and administration:
    equipoise vs deca should be entered under the supervision of a physician who is experienced in the use of anticancer drugs. In connection with the potential development of anaphylactoid reactions, infusion equipoise vs decaa is carried out under immediate availability of equipment and medicines needed to provide emergency assistance in such situations.
    The drug is administered as an intravenous infusion, and before use should be diluted. The concentrated solution should be mixed only with 0.9% sodium chloride intravenous solution (see. Use Method ). Do not mix in the container equipoise vs deca for administration with other drugs. Premedication 30 minutes – 2 hours prior to administration to patients need to hold equipoise vs decaa premedicated according to the following dosing scheme.

    Number injection (dose) The dose intravenous corticosteroids The dose of analgesic The dose of antihistamine
    1 (300 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    2 (2000 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    3-8 (2000 mg) Equivalent 0-100 mg prednisolone a) An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    9 (2000 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    10-12 (2000 mg) The equivalent of 50-100 mg prednisolone b) An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine

     

    a) If the second injection is completed without the development of serious adverse reactions, dose, at the physician’s discretion, can be reduced.
    b) If the ninth completed without the introduction of serious adverse events, dose, at the physician’s discretion, can be reduced to the equivalent of 50 mg of prednisolone.

    Dosages
    The recommended dose is 300 mg equipoise vs decaa for the first injection and 2,000 mg equipoise vs decaa- for all subsequent injections. Administration scheme provides 8 consecutive weekly injections, and after 4-5 weeks -. 4 consecutive monthly (i.e. every 4 weeks) administration of the first and second introduction initial speed injection at the first and second introduction should be 12 ml / h ( cm. use method ).During the introduction of the speed should be gradually increased so that every 30 minutes, it was doubled and increased to a maximum of 200 ml / hour (see. The method use). Subsequent introduction If a second administration is terminated without developing serious adverse reactions associated with the introduction of all other administration can be carried out at an initial rate of 25 ml / h, which should gradually increase, doubling every 30 minutes to a maximum of 400 ml / h (cm. The method of use). Changes in dose and resumption of treatment of adverse reactions associated with the introduction equipoise vs decaa, It may cause the need to reduce the rate of administration.

    In the case of mild or moderate adverse reactions administration should be discontinued and, if the patient’s condition is stable, again to resume at a rate equal to half of that at which the introduction was interrupted. If at the time of cessation of equipoise vs decaa because of adverse reactions did not manage to increase the speed of the original, equal to 12 ml / hour, then the resumption of its introduction should be done with a standard initial velocity of 12 ml / h. In the future, the rate of introduction, taking into account the tolerance of the drug to patients and the physician’s discretion, can be increased in the normal way (so that the speed was doubled no faster than once every 30 minutes).

    In case of serious adverse reactions administration should be discontinued and, if the patient’s condition It remains stable, to resume again at a rate of 12 ml / h.Subsequently, rate of administration, based on patient tolerability and the physician’s discretion, can be increased by the standard procedure (so that the doubled speed no faster than once every 30 minutes).

    Method of Use
    1) Before dilution equipoise vs decaa

    Before breeding check equipoise vs decaa concentrate for the presence therein of the particles and discoloration. Do not use equipoise vs deca if its color changed. The concentrate may contain a small amount of visible (clear or whitish) amorphous particles equipoise vs decaa. These particles are removed by the filters included in kit for administration. Do not shake the vial before performing equipoise vs decaom described test. 2) How to make a solution for intravenous administration Prior to administration equipoise vs decaa concentrate should be diluted in 0.9% sodium chloride solution for intravenous administrationunder aseptic conditions . The dose of 300 mg – 3 use vial (total of 15 ml, 5 ml vial):



  • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml and remove Collect 15 ml;
  • from each of the 3 vials equipoise vs decaom Collect 5 ml of concentrate (15 ml total) and enter them into a container volume of 1000 ml;
  • not shake the container – mix the contents by gentle inversion.
    A dose of 2000 mg

    The dose of 2000 mg of 5 ml vials The dose of 2000 mg of 50 ml vials
    For a dose of 2000 mg vials using 20 (total – 100 ml, 5 ml vial): For a dose of 2000 mg using 2 vials (total – 100 ml, 50 ml vial):
    • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml Select and delete 100 ml;
    • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml Select and delete 100 ml;
    • from each of the 20 vials equipoise vs decaom Collect 5 ml concentrate (vsego 100 mL) and enter them into a container volume of 1000 ml;
    • From each of two vials equipoise vs decaom Collect 50 ml of concentrate (total – 100 ml) and enter them into a container volume of 1000 ml;
    • not shake the container – mix the contents by gentle inversion.
    • not shake the container – mix the contents by gentle inversion.

    3) Introduction of
    equipoise vs deca should not be administered intravenously or fast bolus.
    For intravenous use attached to the drug infusion system with built-in filters.
    Concentrate equipoise vs decaa for solution for infusion does not contain preservatives, so its cultivation should be under aseptic conditions. The prepared solution for infusion should be stored at a temperature no higher than 25 ° C and use within 24 Chov after cooking. After this period, the remains of the solution should be destroyed. equipoise vs deca should not be mixed or administered simultaneously with other drugs or solutions for intravenous administration. To avoid this, before and after the introduction of equipoise vs decaa necessary to flush the system for the administration of 0.9% sodium chloride solution.The first and the second administration of the drug should be administered within 6.5 hours after an infusion or through an indwelling catheter in accordance with the following scheme. The scheme for the introduction of 1 and 2 administrations equipoise vs decaa

     

    Time, min infusion rate in ml / h
    0-30 12
    31-60 25
    61-90 50
    91-120 100
    More than 121 200

    If the second introduction passed without the development of serious adverse reactions , other administration (12.3) should be done within 4 hours via an infusion system or through an indwelling catheter in accordance with the following scheme.

    The scheme for the introduction of administrations equipoise vs decaa from 3 to 12 , min infusion rate in ml / h 0-30 25 31-60 50 61-90 91-120 100 200 More than 121 400 Special patient groups ChildrenSafety and efficacy in children younger than equipoise vs decaa 18 not been studied. elderly patients any significant effect of age on the efficacy and safety of the drug has been noted. Taking into account the available data on the efficacy and safety of the drug in the elderly, no dose adjustment in this group is not required. Patients with renal impairment No specific pharmacokinetic studies equipoise vs decaa in patients with impaired renal function have not been conducted. However, it is unlikely that patients with impaired renal function need to adjust the dose of the drug. Patients with impaired hepatic functionThere are no specific studies equipoise vs decaa pharmacokinetics in patients with hepatic impairment have been conducted. However, it is unlikely that patients with impaired liver function will need to adjust the dose of the drug.

    Side effects

    Adverse events reported below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency is defined as follows: very common (≥1 / 10), commonly (≥1 / 100 and <1/10), uncommon (≥1 / 1000 and <1/100), rare (≥1 / 10,000 and <1/1 000), very rare (<1/10 000, including isolated cases), not known (frequency can not be determined on the basis of available data). Frequency categories were formed on the basis of clinical trials of the drug. On the part of hematopoiesis Very common: neutropenia, anemia. Common: febrile neutropenia, thrombocytopenia, leukopenia. Uncommon: Agranulocytosis, coagulopathy, lymphopenia, erythrocyte germ cell aplasia. On the part of the immune reactions, including anaphylactic shock. On the part of metabolism and nutrition Infrequent: . tumor lysis syndrome, Cardio-vascular system Common: tachycardia, hypertension, hypotension. Respiratory system, organs of the chest and mediastinum Common: pain gortanno- pharyngeal region, shortness of breath, cough, bronchospasm, discomfort in the chest, nasal congestion, hypoxia. On the part of the gastrointestinal tract Common: nausea, obstruction of the small intestine, diarrhea. skin and subcutaneous tissue Very common: rash. Common: pruritus, urticaria, “hot flashes.” The general reaction is often: fatigue, chills, rash, release syndrome cytokines, pyrexia, back pain.Secondary infections Very common: bronchitis, pneumonia. Common: sepsis, septic shock, infection by Herpes zoster , infektsiimochevyvodyaschih ways. It is not known: progressive multifocal leukoencephalopathy, hepatitis B.

    Overdosing

    results of clinical tests did not contain any data about equipoise vs decaa overdose cases.

    Interaction with other medicinal products
    There were no drug-drug interaction studies between equipoise vs decaom and other drugs have not been conducted.
    In a joint application with drugs equipoise vs decaa having immunosuppressive activity, may increase the risk of infectious diseases.

    Special instructions and precautions for the use of
    infusion reactions

    when using equipoise vs decaa may experience infusion reactions, requiring the temporary discontinuation of treatment or it is canceled. Reactions to weaken premedication may, however, even in this case, the reaction may develop, mainly during the first injection. Reactions to the introduction may include: anaphylactic reactions, adverse events with the cardiovascular system, chills, cough, cytokine release syndrome, diarrhea, dyspnoea, fatigue, “tides”, increased or decreased blood pressure, nausea, pain, fever, rash and hives. Cases of serious reactions to the introduction of equipoise vs decaa, including cytokine release syndrome, have been described even with the use of sedation. In case of serious reactions to the administration should immediately suspend the administration of the preparation and conduct symptomatic treatment (recommendation to change the speed of drug administration after the development of responses to the introduction given in section “Dosage and administration”).
    The most common reactions to develop in the day of the first administration, and their severity decreases with subsequent administrations. In patients with impaired lung function in history may be at increased risk of complications from the respiratory system caused by the development of serious reactions to the introduction, so during the introduction equipoise vs decaa for respiratory function should be carefully monitored. Tumor lysis syndrome In patients with CLL when administered equipoise vs decaa can develop tumor lysis syndrome (SLO). Therapeutic measures at the Arctic include the correction of electrolyte balance, monitoring of renal function, maintenance of water balance and symptomatic treatment. Progressive multifocal leukoencephalopathy in patients with CLL treated with cytotoxic drugs, may develop progressive multifocal leukoencephalopathy (PMOLEP), including those leading to death. Diagnosis PMOLEP be excluded in all patients who report on the development of their neurological symptoms or change in the nature of neurological symptoms that existed previously. If you suspect a PMOLEP equipoise vs decaom treatment should be discontinued and consult a neurologist. VaccinationSafety vaccination with live attenuated or inactivated vaccines, and the ability to develop primary or secondary immune response to them equipoise vs decaom were not investigated at the time of treatment. Since the quantitative content of B cells is reduced, the response to vaccination can be attenuated. Before vaccination of patients undergoing treatment equipoise vs decaom, you must weigh the risks and benefits of vaccination in these patients. Due to the risk of infection to avoid the introduction of live attenuated vaccines during or after therapy equipoise vs decaom to normalize the number of B-lymphocytes. Hepatitis BPatients receiving equipoise vs deca, there is an increased risk of infection with hepatitis B virus due to immunosuppressive therapy effect (HBV) infection and its reactivation, which may, inter alia, lead to death.Before treatment equipoise vs decaom should identify patients at high risk of disease caused by HBV. Carriers of HBV during treatment ofatutumabom and within 6-12 months after it is necessary to carefully monitor the laboratory and clinical signs of active HBV infection. Treatment equipoise vs decaom those patients who develop viral hepatitis, should be discontinued and appropriate to conduct their anti-viral therapy. Data regarding safety equipoise vs decaa use in patients with active hepatitis are insufficient to make a definitive conclusion. Cardiovascular disease The state of patients with heart disease history should be carefully monitored. If patients develop severe or life-threatening cardiac arrhythmias, treatment should be discontinued equipoise vs decaom. Intestinal obstruction in patients treated with anti-CD20 monoclonal antibodies, in particular equipoise vs decaom sometimes noted the development of bowel obstruction. Patients with complaints of abdominal pain, especially developing at the beginning of the course equipoise vs decaom treatment should be evaluated and assign them the appropriate therapy. Laboratory tests Since equipoise vs deca binds to all CD20-positive lymphocytes (both tumor and normal), during treatment equipoise vs decaom necessary at regular intervals carry out the control hemogram; if patients develop cytopenia, a study should be done more often. With the development of cytopenia is necessary to carry out the appropriate therapy.

     

    Effects on ability to drive vehicles, machinery
    Research equipoise vs decaa influence on the ability to drive a car or work not performed on automatic equipment. Based on the pharmacology equipoise vs decaa, reasons to suspect that the adverse effect of the drug on these kinds of no activity. When considering the possibility of the patient to perform activities that require high concentration and psychomotor speed reactions must be taken into account his clinical condition and the profile of adverse reactions equipoise vs decaa.

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