Felomika (Felomika)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMycophenolic acidMycophenolic acid
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    • Dosage form: & nbspenteric coated tablets
    Composition:

    1 tablet enteric, coated, 180 mg contains:

    Tablet core composition:

    Active substance: mycophenolate sodium - 192.4 mg (corresponding to mycophenolic acid - 180.0 mg).

    Excipients: polyethylene glycol (macrogol) - 40.0 mg; povidone - 57.5 mg; hypromellose (hydroxypropylmethylcellulose) - 13.6 mg; Silica colloidal dioxide - 3.25 mg; magnesium stearate - 3.25 mg.

    Composition of the tablet shell: hypromellose phthalate - 42.0 mg; titanium dioxide - 2.68 mg; ferric oxide yellow oxide - 0.12 mg; triethyl citrate 4.2 mg.

    1 tablet enteric, coated, 360 mg contains:

    Tablet core composition:

    Active substance: mycophenolate sodium - 384.8 mg (corresponding to mycophenolic acid - 360.0 mg).

    Excipients: polyethylene glycol (macrogol) - 80.0 mg; povidone - 115.0 mg; hypromellose (hydroxypropylmethylcellulose) - 27.2 mg; Silica colloidal dioxide - 6.5 mg; magnesium stearate - 6.5 mg.

    Composition of the tablet shell: hypromellose phthalate - 65.0 mg; titanium dioxide - 4.16 mg; dye iron oxide yellow - 0.17 mg; ferric oxide red oxide - 0.17 mg; triethyl citrate 6.5 mg.

    Description:

    Tablets 180 mg: tablets of round shape, biconvex, covered with a coating from light yellow to yellow, with a risk on one side.

    Tablets of 360 mg: tablets of the oval form, biconcave, covered with a shell from pink to pink with a grayish shade of color, with a risk on one side and engraving "NPD" on the other side.

    Pharmacotherapeutic group:Immunosuppressive remedy
    ATX: & nbsp

    L.04.A.A.06   Mycophenolic acid

    Pharmacodynamics:

    Mycophenolic acid inhibits the synthesis of guanosine nucleotides by selectively inhibiting the key enzyme for the purine synthesis of inosine monophosphate dehydrogenase.

    Due to this mechanism it effectively suppresses the proliferation of T and B lymphocytes, and to a much greater extent than other cells, since the proliferation of lymphocytes depends mainly on the synthesis of purines de novo.

    Suppression of proliferation of T and B lymphocytes with mycophenolic acid supplements the action of inhibitors of calcineurin, which disrupt the production of cytokines and affect T-lymphocytes in the phase of resting the cell cycle.

    Pharmacokinetics:

    Suction

    After oral administration of sodium mycophenolate is intensively absorbed.Due to the presence of enteric film coating, the maximum concentration of mycophenolic acid (MPA) is reached after approximately 1.5-2 hours. In studies in vitro it was shown that the special composition of the enteric film coating of the FELOMIC preparation prevents the release of MFC in an acidic medium similar to that of the stomach acid.

    In patients with a stable functioning kidney transplant receiving basic immunosuppressive therapy with cyclosporin in the form of a microemulsion, the degree of absorption of IFC from the gastrointestinal tract (GIT) is 93%, and the bioavailability is 72%. In the dose range from 180 to 2160 mg, the pharmacokinetics of mycophenolic acid have a linear dose-dependent character. The area under the "concentration-time" curve (AUC) with fasting mycophenolic acid did not differ from that when taking the drug with a high fat diet (55 g fat, 1000 calories). However, the maximum concentration of MFC (CmOh) is reduced by 33%.

    Metabolism

    IFC is mainly metabolized with the participation of glucuronyltransferase to form the main pharmacologically inactive metabolite of phenol glucuronide MFC (HMFC).In patients with a stable functioning kidney transplant receiving basic immunosuppressive therapy with cyclosporine in form of a microemulsion, about 28% of the oral dose of mycophenolic acid is metabolized in HMFC when "first passed" through the liver.

    Distribution

    The volume of the IFC distribution in the equilibrium state is 50 liters. Both IFC and GMPC show a high degree of binding to plasma proteins, 97% and 82%, respectively. With a decrease in the number of binding sites with proteins (with uremia, hepatic insufficiency, hypoalbuminemia, simultaneous use of drugs with high binding to blood plasma proteins), an increase in the concentration of free MPA in plasma is possible.

    Excretion

    The half-life of IFC is 11.7 hours, the clearance is 8.6 l / h. The IFC is excreted mainly with urine in the form of HMFC, and very small amounts (<1.0%) are unchanged. The half-life of HMFC is 15.7 hours, the clearance is 0.45 l / h. GMPK is also secreted with bile into the intestine, where it is cleaved (by deconjugation) by the intestinal flora. The resulting IFC cleavage can then be reabsorbed.Six to eight hours after the administration of mycophenolic acid, a second peak of the concentration of MPA is observed, which corresponds to a re-absorption of the deconjugated MPA.

    Pharmacokinetics in patients who underwent kidney transplantation and are on basic immunosuppressive therapy with cyclosporin in the form of a microemulsion

    The table presents the average values ​​of pharmacokinetic parameters after administration of mycophenolic acid. Values ​​of pharmacokinetic parameters of mycophenolic acid with single dose administration allow predicting possible values ​​of these parameters during repeated and prolonged dosing. Mean values AUC and Cmax IFC, measured in the early post-transplant period, was approximately 50% of the values ​​determined 6 months after transplantation.

    Table. Mean values ​​of pharmacokinetic parameters after oral administration of mycophenolic acid in patients after kidney transplantation and receiving basic immunosuppressive therapy with cyclosporin in the form of a microemulsion.

    Adults

    Single dose (n=24)

    Dose

    (ingestion)

    TmOh (h)

    FROMmOh (μg / ml)

    AUC0- ∞ (μgxh / ml)

    720 mg

    2

    26,1 (12,0)

    66,5 (22,6)

    Adults

    Repeated doses x 6 days (2 times per day) (n=12)

    Dose

    (ingestion)

    TmOh (h)

    FROMmOh (μg / ml)

    AUC0- ∞ (μgxh / ml)

    720 mg

    2

    37,0 (13,3)

    67,9 (20,3)

    Adults

    Repeated doses x 28 days (2 times per day) (n=36)

    Dose

    (ingestion)

    TmOh (h)

    FROMmOh (μg / ml)

    AUC0- ∞ (μgxh / ml)

    720 mg

    2,5

    31,2 (18,1)

    71,2 (26,3)

    Adults

    Long-term therapy (2 times a day) (n=48)

    Dose

    (ingestion)

    TmOh (h)

    FROMmOh (μg / ml)

    AUC0- ∞ (μgxh / ml)

    14 days after transplantation

    720 mg

    2

    13,9 (8,6)

    29,1 (10,4)

    3 months after transplantation

    720 mg

    2

    24,6(13,2)

    50,7(17,3)

    6 months after transplantation

    720 mg

    2

    23,0 (10,1)

    55,7 (14,6)

    Children

    Single dose (n=10)

    Dose

    TmOh (h)

    FROMmOh (μg / ml)

    AUC0- ∞ (μgxh / ml)

    450 mg / m2

    2-2,5

    31,9 (18,2)

    76,2 (25,2)

    FROMmOh - maximum concentration in blood plasma

    TmOh - Time to reach the maximum concentration in the blood plasma

    AUC - area under the curve "concentration-time"

    Renal insufficiency

    The pharmacokinetics of IFC does not depend on the function of the kidneys. AUC GMPK, in violation of kidney function, on the contrary, increases, because. in patients with anuria AUC GMPC is approximately 8 times higher. Hemodialysis does not affect the clearance of IFC and GMPC. In renal failure, the concentration of free MPA in the blood plasma can be significantly increased, which is probably due to a decrease in the binding of IFC to proteins under conditions of high urea concentration in the blood.

    Liver failure

    In patients with alcoholic cirrhosis of the liver, no effect of this disease on the IFC glucuronation reaction was observed. The presence or absence of the effect of liver disease on the pharmacokinetics of IFC may depend on the nature of the disease (primary lesion of the parenchyma or biliary system, or the like).

    Childhood

    The experience of using mycophenolic acid in children is limited. The table shows the average values ​​of pharmacokinetic parameters in children with stable kidney transplant receiving a microemulsion of cyclosporine as an immunosuppressive therapy. The values ​​of CmOh and AUC for IFC in children compared with older patients were more variable. When taking a usual single dose of mycophenolic acid 720 mg in children AUC was higher than that in adults. The average value of the IFC clearance was about 7.7 l / h. It is expected that when the dose of mycophenolic acid is 200-300 mg / m2 AUC will be from 30 to 50 μgxh / ml.

    Floor

    Clinically significant differences in pharmacokinetic parameters were not found depending on the sex of patients.

    Elderly age

    Based on preliminary research data, it is assumed that the concentration of IFC does not change clinically with age.

    Indications:

    Prevention of acute graft rejection in patients with allogeneic kidney transplants receiving basic immunosuppressive therapy with cyclosporine in the form of a microemulsion and glucocorticosteroids.

    Contraindications:

    - Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil (mycophenolic acid derivative) or any component of the drug.

    - Childhood (effectiveness and safety not studied).

    - Pregnancy.

    - Breastfeeding period.

    Carefully:

    - Congenital insufficiency of hypoxanthine-guanine-phosphoribosyl-transferase (including Lesch-Nayhan syndrome and Kelly-Sigmiller syndrome).

    - Diseases of the gastrointestinal tract in the phase of exacerbation.

    Use in children

    The efficacy and safety of mycophenolic acid in children have not been studied. There are limited data on the pharmacokinetics of IFC in children who underwent kidney transplantation. At the moment, no specific recommendations on the dosage regimen in children have been developed.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    With the use of mycophenolic acid during pregnancy, there was an increased risk of miscarriage, incl. spontaneous abortion, as well as the development of congenital anomalies. According to the American National Pregnancy Registry for Women after Transplantation (National Transplant Pregnancy Registry, NTPR), mean the incidence of congenital malformations in children born to women who underwent organ transplantation is 4-5%. Although controlled clinical studies on the use of mycophenolic acid in pregnant women have not been conducted, according to NTPR in the use of mycophenolate mofetil in combination with other immunosuppressants during pregnancy, an increased incidence of congenital malformations - 22% (4 children from 18 newborns) compared with the average frequency. The most frequent use of mycophenolate mofetil during pregnancy in children was anomalies in the development of the inner ear, extremities, craniofacial area, including clefts of the upper lip and palate, congenital diaphragmatic hernia, heart, esophagus and kidney defects.The use of mycophenolate mofetil during pregnancy is accompanied by a high risk of spontaneous abortion. Since ingestion or intravenous administration of mycophenolate mofetil is converted to mycophenolic acid, all the information presented above should be taken into account when using FELOMICA.

    In experimental preclinical studies, the animals exhibited a teratogenic effect of mycophenolic acid.

    It is not recommended to begin therapy with FELOMICA before a negative pregnancy test result is obtained. In case of pregnancy, the patient should immediately consult a doctor.

    Before the beginning of therapy with FELOMICA, effective methods of contraception should be used throughout the therapy and for 6 weeks after its completion. It is not known whether IFC is excreted in breast milk. In connection with the fact that there is a potential risk of developing serious adverse events in the breastfed child, it is necessary to resolve the issue of either stopping the use of FELOMICA or, given the importance of therapy with this drug for the mother,on the cessation of breastfeeding throughout the therapy and for 6 weeks after its termination.

    Dosing and Administration:

    Inside, the tablets are swallowed whole, without chewing; do not break the pill. It can be taken on an empty stomach or together with food.

    Mycophenolic acid therapy in patients who did not receive it before, begin in the first 48 hours after transplantation. The recommended dose is 720 mg (4 tablets of 180 mg or 2 tablets of 360 mg) 2 times a day (daily dose of 1,440 mg). In patients receiving mycophenolate mofetil (MMF) in a dose of 2 g, MMF can be replaced with mycophenolic acid in a dose of 720 mg 2 times a day.

    Use in elderly patients

    Correction of the dosing regimen in elderly patients is not required.

    Use in patients with impaired renal function

    In patients with delayed recovery of renal transplant function, a change in the dose of mycophenolic acid is not required. Careful observation of patients with chronic severe renal dysfunction is necessary (glomerular filtration rate is less than 25 ml x min-1 x 1.73 m-2).

    Use in patients with impaired liver function

    Patients with severe liver disease associated with primary lesion of the parenchyma do not require correction of the dose of mycophenolic acid.

    Episodes of rejection reaction

    Reaction rejection of the graft does not lead to a change in the pharmacokinetics of mycophenolic acid. In these cases, changes in the dosing regimen are not required.
    Side effects:

    The following adverse events were observed in two studies of the safety of mycophenolic acid and MMF in 423 patients with a recently transplanted kidney who had not received previous maintenance therapy (patients with a kidney transplant de novo), and in 322 patients with kidney transplant who had previously received maintenance therapy. The incidence of adverse events was similar in both groups of patients.

    When using mycophenolic acid in combination with cyclosporine and glucocorticosteroids, undesirable phenomena such as leukopenia (19.2%) and diarrhea (23.5%) were very often (≥ 10%).

    In elderly patients, the risk of side effects is generally higher due to immunosuppression.

    Malignant neoplasms. In patients receiving immunosuppressive therapy with several drugs, including IFC, the risk of developing lymphomas and other neoplasms, in particular, of the skin, is increased.During the study, malignant tumors developed against the background of mycophenolic acid at the following frequency: lymphoproliferative diseases or lymphomas developed in two patients with a renal transplant de novo (0.9%) and in two patients (1.3%) with a transplanted kidney who received maintenance therapy for up to 1 year; Non-melanoma skin carcinomas developed in 0.9% with a renal transplant de novo and 1.8 % patients with kidney transplant who had previously received maintenance therapy with mycophenolic acid for up to 1 year; other malignant neoplasms developed in 0.5% of patients with a renal transplant de novo and 0.6% of patients with kidney transplant who received maintenance therapy.

    Infectious diseases (opportunistic infections). In patients with recent transplanted kidney that received mycophenolic acid for 1 year as part of complex immunosuppressive therapy, the most frequently observed cytomegalovirus (CMV) infection, candidiasis and infection caused by the herpes simplex virus. In the course of studies, it was shown that CMV infection (confirmedserological viremia, or clinical data) was observed at a rate of 21.6% in patients with a recently transplanted kidney and 1.9% in patients with a stable graft functioning with prolonged maintenance therapy.

    Other undesirable phenomena

    Below are the undesirable events detected with mycophenolic acid at a dose of 1440 mg / day for 12 months in combination with a cyclosporine microemulsion and glucocorticosteroids in two clinical studies in patients with a kidney transplant de novo and in patients with kidney transplant who received previous maintenance therapy. These phenomena had a possible or probable cause-and-effect relationship with the administration of mycophenolic acid. Undesirable phenomena are given in accordance with the classification of organs and systems for MedDRA (medical dictionary of the terminology of regulatory activities) and listed by frequency. The frequency of unwanted reactions is estimated as follows: very often ≥ 10%; often ≥ 1% and <10%; infrequently ≥ 0,1 % and <1%; rarely ≥ 0.01% and <0.1%; very rarely <0.01%, including individual messages.

    Infectious and parasitic diseases

    Very often: viral, bacterial and fungal infections, urinary tract infections, herpes zoster, candidiasis of the oral mucosa, sinusitis, gastroenteritis, herpes simplex, nasopharyngitis.

    Often: infections of the upper respiratory tract, pneumonia.

    Infrequent: wound infections, sepsis *, osteomyelitis *.

    Violations of the blood and lymphatic system

    Very often: leukopenia.

    Often: anemia, thrombocytopenia.

    Infrequent: lymphocele *, lymphopenia *, neutropenia *, lymphadenopathy *.

    Disorders of the psyche

    Often: irritability.

    Infrequently: delusional perception *.

    Disturbances from the nervous system

    Often: dizziness, headache.

    Infrequently: tremor, insomnia *.

    Disturbances from the respiratory system, chest and mediastinal organs

    Often: cough, shortness of breath, shortness of breath with physical activity.

    Infrequently: interstitial lung disease, including fibrosis of the lung with a lethal outcome, "stagnant" lung *, stridor *.

    Disorders from the gastrointestinal tract

    Very often: diarrhea.

    Often: bloating, abdominal pain, constipation, dyspepsia, flatulence, gastritis, loosening of the stool, nausea, vomiting.

    Uncommon: abdominal wall tension, pancreatitis, belching, halitosis * (halitosis), ileus *, esophagitis *, peptic ulcer * subileus *, gastrointestinal bleeding, dry mouth, * ulceration lip * blockage ductless parotid gland *, gastroesophageal reflux disease *, gingival hyperplasia *, peritonitis *.

    General disorders and disorders at the site of administration

    Often: fatigue, peripheral edema, pyrexia.

    Uncommon: flu-like illness, swelling of lower limbs *, pain, thirst *, weakness *.

    Disorders from the metabolism and nutrition

    Very often: hypocalcemia, hypokalemia, hyperureukemia.

    Often: hyperkalemia, hypomagnesemia.

    Uncommon: anorexia, hyperlipidemia, diabetes mellitus *, hypercholesterolaemia, hypophosphatemia *.

    Disturbances from the skin and subcutaneous tissues

    Infrequently: alopecia, bruises *, acne.

    Disturbances from the liver and bile ducts

    Often: abnormalities in the results of functional liver tests.

    Heart Disease

    Infrequent: tachycardia, pulmonary edema *.

    Vascular disorders

    Very often: increased blood pressure, lower blood pressure.

    Often: increased severity of hypertension.

    Disturbances on the part of the organ of sight

    Infrequently: conjunctivitis *, "blurring" of vision *.

    Disturbances from musculoskeletal system and connective tissue

    Often: arthralgia, asthenia, myalgia.

    Infrequent: back pain *, muscle cramps.

    Benign, malignant and unspecified neoplasms

    Infrequent: skin papilloma *, basal cell carcinoma *, Kaposi's sarcoma *, lymphoproliferative disorders, scaly-cell carcinoma *.

    Disorders from the kidneys and urinary tract

    Often: increased levels of creatinine in the blood.

    Infrequent: hematuria *, necrosis of renal tubules *, urethral stricture.

    * this undesirable phenomenon was registered only in one patient out of 372. The profile of adverse events was not different in patients with a transplanted kidney de novo and in patients who previously received maintenance therapy, but the incidence of adverse events was lower in the second group.

    The following are undesirable phenomena revealed during post-marketing observations (the frequency is unknown)

    Disturbances from the skin and subcutaneous tissues: rash.

    Side effects, observed against the background of the use of mycophenolic acid derivatives ("class effects"):

    Infectious and parasitic diseases: severe current, sometimes life-threatening infectious diseases (in some cases, with a fatal outcome), including meningitis, infective endocarditis, tuberculosis, atypical infections caused by mycobacteria. The development of poliomavirus nephropathy (especially associated with VC virus) has been reported.

    With the use of mycophenolate mofetil, cases of development of progressive multifocal leukoencephalopathy associated with JCa virus, in some cases with a fatal outcome.

    Violations from the blood and lymphatic system: agranulocytosis, neutropenia, pancytopenia. When using mycophenolic acid derivatives in combination with other immunosuppressants, cases of development partial red cell aplasia of the bone marrow.

    Disorders from the digestive system: colitis, esophagitis (including CMV-colitis and CMV-esophagitis), CMV gastritis, pancreatitis, perforation of the intestinal wall, gastrointestinal bleeding, stomach and / or duodenal ulcer, intestinal obstruction.

    Overdose:In case of an overdose of mycophenolic acid, there may be signs of hyperimmunosuppression and increased susceptibility to various infections, including those leading to death, as well as sepsis. Although the inactive metabolite of GMPA is excreted by hemodialysis, it should not be expected that this method will effectively excrete clinically significant amounts of active IFC. This is largely due to a high degree (97%) of binding of MPC to plasma proteins. Kolestyramine and other bile acid sequestrants disrupt the absorption of IFC from the intestine and, therefore, can lead to a decrease in its concentration in the blood.
    Interaction:

    Azathioprine. Since no special studies have been conducted on the interaction of mycophenolic acid and azathioprine, these drugs should not be taken concomitantly.

    Live vaccines. Do not use live vaccines in patients with a compromised immune response. With the use of other vaccines, the production of antibodies can be reduced.

    Acyclovir. In patients with impaired renal function, blood concentrations of both HMFC and acyclovir may increase.Perhaps, both drugs compete when excreted from the body (a similar way of excretion - tubular secretion). Such patients require careful observation.

    Antiulcer drugs (including antacids and proton pump inhibitors)

    Antacid preparations, containing magnesium hydroxide and aluminum. With simultaneous use with antacids, absorption of sodium mycophenolate is reduced, resulting in AUC MFC is reduced by 37% and CmOh - by 25%. Caution should be exercised while using the preparation FELOMICA with antacid preparations containing magnesium hydroxide and aluminum.

    Proton pump inhibitors. In healthy volunteers with simultaneous application of mycophenolate mofetil in a dose of 1000 mg and pantoprazole at a dose of 40 mg 2 times a day, there was a decrease AUC and CmOh mycophenolic acid by 27% and 57 %, respectively. However, when using mycophenolic acid together with pantoprazole in these patients, there was no change in the pharmacokinetic parameters of mycophenolic acid.

    Kolestyramin and drugs that affect the intestinal-hepatic circulation. In connection with its ability to bind bile acids in the intestine colestramine can reduce the concentration of IFC in the blood and AUC. In connection with the possible decrease in the effectiveness of the drug FELOMICA, care should be taken when it is used simultaneously with colestyramine and preparations that affect the intestinal-hepatic circulation.

    Ganciclovir. The addition of ganciclovir does not affect the pharmacokinetics of IFC and HMFC. When the therapeutic concentration of MFC is reached, the clearance of ganciclovir does not change. However, with the simultaneous use of mycophenolic acid and ganciclovir in patients with impaired renal function, correction of the ganciclovir dosage regimen may be required, and careful monitoring must be made for such patients.

    Tacrolimus. In patients with stable kidney transplant, a pharmacokinetics of mycophenolic acid in the equilibrium state was studied in a cross-sectional study when it was used simultaneously with Sandimmun® Neoral® and tacrolimus. Mean values AUC IFC with simultaneous use of mycophenolic acid and tacrolimus were 19% higher than with the simultaneous use of mycophenolic acid and Sandimmune® Neoral®, and the values ​​of CmOh IFC - 20% lower. For HMPA values AUC and CmOh were 30% lower when taking mycophenolic acid with tacrolimus than when taking with Sandimmun® NeoRal®.

    Oral contraceptives. Oral contraceptives are metabolized through oxidation reactions, while mycophenolic acid by glucuronation. The effect of oral contraceptives on the pharmacokinetics of mycophenolic acid is unlikely, and, therefore, it is hardly possible to expect any clinically significant interactions. On the other hand, if we take into account the fact that the effect of prolonged therapy with mycophenolic acid on the pharmacokinetics of oral contraceptives has not yet been studied, the probability of a decrease in the effectiveness of contraceptives can not be ruled out.

    Cyclosporine. In studies in patients with stable renal transplant, it was shown that the pharmacokinetics of cyclosporine did not change on the background of equilibrium concentrations of mycophenolic acid.

    Special instructions:

    Mycophenolic acid therapy should be performed only by qualified doctors-transplantologists.

    In patients receiving combined immunosuppressive therapy, including including mycophenolic acid, the risk of developing lymphomas and other malignant neoplasms, especially the skin, is increased.There are data on the genotoxic effect of mycophenolic acid. This risk is most likely associated not with the use of the drug, but with intensity and duration immunosuppressive therapy. To reduce exposure to sunlight and ultraviolet radiation to reduce the risk of skin cancer, it is recommended to protect the skin with clothing and use sunscreens with a high protective factor.

    Patients receiving mycophenolic acid therapy should be instructed to immediately notify the physician of all cases of infection, sudden appearance of bruising, bleeding and any other manifestation of bone marrow depression.

    Excess immunosuppression increases the likelihood of developing infections, including opportunistic infections, as well as sepsis and fatal infections.

    In patients receiving immunosuppressive therapy with mycophenolic acid derivatives, reactivation of the infection caused by hepatitis B and C viruses was observed. Infected patients should be monitored for clinical symptoms and laboratory indicators of the activity of the infectious process.In patients treated with mycophenolic acid derivatives, cases of progressive multifocal leukoencephalopathy (PML) associated with JCa virus, in some cases with a fatal outcome. Cases of PML development in the background of treatment with mycophenolic acid derivatives (mycophenolate mofetil and sodium mycophenolate) were observed mainly in patients with risk factors for PML, including therapy with immunosuppressive drugs and immune disorders. Doctors should consider the possibility of developing PML on the background of drug therapy in patients with reduced immunity and, if necessary, refer patients with neurologic disorders to a consultation with a neurologist. The development of polyomavirus nephropathy, especially associated with VC virus, should be taken into account in the differential diagnosis of the causes of liver dysfunction in patients receiving immunosuppressive therapy. When developing PML or polyomavirus nephropathy, a doctor should consider decrease in the intensity of immunosuppressive therapy.However, in patients after transplantation, a decrease in immunosuppression may increase the risk of graft rejection.

    In patients receiving therapy with mycophenolic acid, the development of neutropenia, caused either by the action of the mycophenolic acid itself, or by concomitant medications, viral infections or a combination of these factors, is not excluded.

    In patients receiving mycophenolic acid, a general blood test should be performed regularly (to detect neutropenia or anemia): during the first month of therapy - weekly, during the second and third months - twice a month, then, during the first year - 1 once a month. With the development of neutropenia (absolute number of neutrophils <1.5 x 103/ mm3) or anemia therapy with mycophenolic acid is advisable to interrupt or discontinue.

    When using mycophenolic acid derivatives (mycophenolate mofetil and sodium mycophenolate) in combination with other immunosuppressants, cases of development partial red cell aplasia of the bone marrow. At present, there is no known mechanism for the development of partial red cell aplasia of the bone marrow against the background of therapy with mycophenolic acid derivatives, as well as the role of other immunosuppressants and their combinations.However, it should be borne in mind that mycophenolic acid derivatives can cause neutropenia and anemia. In a number of cases, with a reduction in the dose or discontinuation of therapy with mycophenolic acid derivatives, the patient's condition was normalized. The change in the dosage regimen of the FELOMIC preparation should be carried out only under proper control of the patient's condition in order to reduce the risk of rejection of the transplant.

    Patients should be cautioned that during vaccination with mycophenolic acid derivatives, vaccination may be less effective and that use of live attenuated vaccines should be avoided. Vaccination against the influenza virus should be conducted in accordance with the recommendations of local health authorities regarding vaccination against influenza.

    Since the reception of mycophenolic acid may be accompanied by adverse reactions from the gastrointestinal tract (ulceration of the gastrointestinal mucosa, gastrointestinal bleeding, gastrointestinal perforation), care must be taken when it is used in patients with digestive tract disease in the acute stage.

    Mycophenolic acid was used in combination with the following drugs: antitumocyte globulin, basiliximab, ciclosporin (in the form of a microemulsion) and glucocorticosteroids. The efficacy and safety of mycophenolic acid in its application with other immunosuppressive drugs has not been studied.

    Effect on the ability to drive transp. cf. and fur:

    The effect of taking mycophenolic acid on the ability to drive vehicles and work with mechanisms has not been established. The mechanism of action of mycophenolic acid, its pharmacodynamic effects and recorded undesirable effects indicate a low probability of such an effect. Nevertheless, patients should be warned about possible undesirable effects of the drug and the need for caution in work that requires concentration.

    Form release / dosage:

    Tablets are enteric, coated, 180 mg, 360 mg.

    Packaging:

    For OOO NANOFARMA DEVELOPMENT

    For 10 tablets in a three-layered OPA / A three-layered foill/ PVC and aluminum foil or PVC / PVDC film and aluminum foil.

    At 30, 50, 60, 100, 120, 150 or 250 tablets in cans, sealed with a lid with or without a first opening, of high pressure polyethylene.

    For OOO Izvarino Pharma

    For 10 tablets in a three-layered OPA / A three-layered foill/ PVC and aluminum foil.

    At 30, 50, 60, 100, 120, 150 or 250 tablets in cans, sealed with a lid with or without a first opening, of high pressure polyethylene.

    On 1 bank or on 3, 5, 6, 10, 12, 15 or 25 contour cellular packages together with the instruction on medical application in a pack from cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2.5 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004610
    Date of registration:21.12.2017
    Expiration Date:21.12.2022
    The owner of the registration certificate:Nanopharma Development, LLCNanopharma Development, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.01.2018
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