Myfortic 360mg Novartis tablet for patients with genetic kidneys (12 blisters x 10 tablets)

Dosage form Box of 12 blisters x 10 tablets
Specifications Mycophenolic acid

Ingredient

Composition informationContent
Mycophenolic acid360mg

Uses

indications

Myfortic 360 mg drug is indicated:

Coordinate with ciclosporin micro -form and corticosteroids to prevent acute pieces in patients with genetic kidney transplant.

Pharmacokinus

mycophenolic acid (MPA) inhibits the proliferation of T T -lymphocytes and B lymphocytes stronger than other cells, because it is different from other cells that can use the process of purin, lymphocytic proliferation depends mainly on new synthesis. Thus, the mechanism of action is to complement the calcineurin inhibitors, the interventions in the cytokin transcription and hold in the resting state of T lymphocytes.

Pharmacokinetics

absorption

After drinking, sodium mycophenolat is very strong. Suitable according to the tablet design in the intestine, the time for MPa concentration to reach a maximum of about 1.5 to 2 hours. In vitro studies prove that the intestinal pills of Myfortic prevent the release of MPA in acid conditions as in the stomach.

Patients with stable kidney transplantation thanks to the immunosuppressive effect of ciclosporin micro emulsion form, the absorption through the gastrointestinal tract of MPa is 93% and the absolute bioavailability is 72%. The pharmacokinetics of Myfortic, proportional to the dose and linear dosage within the research range from 180 to 2160 mg. Compared to hunger, using Myfortic 720 mg with a high -fat meal (55 g of fat, 1000 calories) without affecting the body contact of MPA (AUC); It is the PK parameters that are most related to efficiency. However, the maximum concentration of MPa (CMAX) decreased by 33%.

Distribution

The distribution of MPa in a stable state is 50 liters. Both mycophenolic acid and glucuronid of mycophenolic acid are highly connected to protein, in order of 97% and 82%. Free MPA levels can increase in the condition that is associated with decreased protein (hematoma, liver failure, reducing blood albumin, and simultaneous use of drugs also highly associated with protein). This can make patients at high risk with adverse effects related to MPa.

Metabolism

MPa's disposal time is 11.7 hours and the clearance is 8.6 liters/hour. MPA is metabolized mainly by glucuronyl Transferase to form the mpa's glucuronid, glucuronid of mycophenolic acid (MPAG). MPAG is the main metabolite of MPA and does not see biological activity.

In patients with kidney transplantation stabilized in immunosuppressive state inhibitors due to micro emulsion ciclosporin, about 28% of oral doses of myfortic are converted into mpag due to the transformation before the circulatory system. MPAG's waste time is longer than MPA, about 15.7 hours and the clearance is 0.45 liters/hour.

Elimination

Although only a negligible amount of MPa is present in the urine (

Dynamic pharmacokinetics

In patients with kidney transplantation, the immunosuppressant is inhibited due to micro -cical ciclosporin:

indicated in Table 1 is MPA's average pharmacokinetics parameters after using Myfortic. MYFORTIC pharmacokinetics used the one -times dose of pharmacokinetics used many times and used for a long time. In the early stages of transplantation, the average AUC of MPa and MPa's average CMAM is approximately half the measured value at 6 months after grafting.

Special subjects

Renal failure

MPA's

pharmacokinetics does not change within the scope of kidney function from normal to no. In contrast, MPAG exposure increases as the kidney function decreases; The MPAG exposure is approximately 8 times higher when the anuria is higher. The clearance of both MPA both MPAG is not affected when hemorrhage. Free MPA also significantly increases when kidney failure. It may be due to mpa cohesion to plasma proteins decreasing as urea concentration in the blood increases.

People with liver failure

In volunteers with alcoholic cirrhosis, the process of mpa glucuronid in the liver is relatively not affected by liver parenchyma. The effects of liver disease on this process may depend on each separate disease. However, liver disease has mainly damaged in bile, such as primary bile cirrhosis, which can manifest another effect.

Children

There is no document on safety and efficiency in children. The existing pharmacokineticocytes on using Myfortic for children are limited. In the above table, the average value (SD) of MPA pharmacokinetics parameters for stable kidney transplantation is inhibited with micro -ciclosporin.

MPA's

MPA and AUC hyperplasia is recorded in these patients compared to adult patients with kidney transplantation. The average AUC of MPa at this dose is higher when measuring in adults taking the dose of 720 mg of myfortic. The average apparent clearance of MPa is about 7.7 liters/hour. A dose of Myfortic 200 - 300 mg/m2 can achieve the AUC of MPa 30 - 50 micrograms.

Gender

There is no clinical difference according to the pharmacokinetics of MyFortic.

Elderly

Based on preliminary documents, the MPa contact has not changed to the point of clinical significance by age.

Ethnicity/Race

Use a single dose of 720 mg Myfortic for 18 Japanese and healthy white people, Japanese people are lower than white people in concentration (AUCinF) MPa is 15% and MPAG is 22%. The peak concentration (CMAX) of MPAG is similar to the two groups of objects, however, the Japanese have CMAX MPA higher than 9.6%. These results do not show any related clinical differences.

Before taking Myfortic 360mg Novartis tablet for patients with genetic kidneys (12 blisters x 10 tablets)

How to use

Do not crush Myfortic tablet to maintain the intactness of the intestinal melted membrane.

Dosage

recommended dose is 720 mg (2 tablets 360 mg), 2 times a day (daily dose 1440 mg).

In patients using Mycophenolate Mofetil (MMF) 2 g, the treatment can be replaced with 720 mg of Myfortic 2 times (daily dose 1440 mg).

General target audience

MYFORTIC treatment should be started and maintained by experts with appropriate level implants.

MYFORTIC treatment should be started in newly transplanted patients within 48 hours after transplantation.

Myfortic can be taken with food or not.

Special subjects

kidney failure

No need to adjust the dose in patients undergoing a slow period of renal function after surgery. Patients with severe chronic kidney failure (glomerular filtration rate below 25 ml/min/1.73m2) should be carefully monitored.

Hepatic failure

No need to adjust the dose for patients with kidney transplant with severe liver parenchyma disease.

Children

Safety and effectiveness in children have not been determined. The existing pharmacokineticocales for kidney transplant patients are limited.

Elderly

No need to adjust the dose in the group of these patients.

Treatment in categories

The discharging of the transplant kidney does not change the pharmacokinetics of mycophenolic acid (MPA), so there is no need to reduce the dose or stop using Myfortic.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

In cases of overdose that have adverse effects have been reported, these adverse effects fall into the known safety properties group. The overdose of Myfortic can cause an overcurrent of the immune system and may increase the sensitivity to infections including opportunistic infections, death infections and blood infections. If blood disorders occur (for example, neutropenia with absolute neutrophilic amounts

Although the separation can be used to eliminate the MPAG -active metabolites, it is not sure that it is possible to eliminate the clinical significance of half of the half MPA. This substance accounts for a large amount due to the very high plasma protein of MPa 97%. By intervention into the intestinal circulation of the

What to do when forgetting a dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The following unwanted effects include the harmful reactions of drugs from two control clinical trials. Test evaluating the safety of Myfortic and Mycophenolate Mofetil in 423 new cases and 322 kidney transplant patients in the maintenance phase (random 1: 1); The ratio of adverse effects is similar to each other between therapies in each group.

The adverse reactions of the drug are very common (≥ 10%) when using Myfortic in combination with ciclosporin with emulsion and with corticosteroids is leukopen and diarrhea.

Malignant disease: Patients treating combined immunosuppressive drugs, including MPA, increases the risk of developing lymphoma and other malignant diseases, especially common on the skin. The general rate of malignant diseases observed in clinical trials with Myfortic is as follows: Lymphoma or lymphoma disease appears in two new patients (0.9%) and 2 patients in the maintenance stage (1.3%) using Myfortic for over 1 year; Dark skin carcinom is 0.9% of new patients and 1.8% of patients who are using Myfortic maintenance for more than 1 year; Other malignant diseases are seen in 0.5% of new patients and 0.6% of patients in the maintenance stage.

Mest infections: All transplant patients have an increased risk of opportunistic infections; The risk of increasing along with the total output of exemption inhibitors. The most common chance of infections in new kidney transplant patients with Myfortic in combination with other immunosuppressive drugs in clinical trials are controlled by kidney transplant patients monitored for 1 year, CMV, Candida fungus and herpes. The general ratio of CMV infection (in serum, hematoma or CMV disease) is observed in clinical trials with Myfortic reported in 21.6% of new kidney transplant patients and 1.9% in the maintenance phase.

Summary table of adverse reactions of drugs from clinical studies

The adverse reactions (Table 2) are classified under the title of the frequency, the first is the most common frequency, using the following convention: Very common (≥ 1/10); Common (≥ 1/100,

Table 2 below includes harmful reactions due to the drug that can or are almost certainly related to Myfortic reported in two multi -centralized clinical trials with control, double blindness, random phase III: 1 is in new patients with kidney transplantation and 1 is in patients with kidney transplant in the maintenance phase, in which MyFortic is used by 1,440 mg/day for 12 months, together with micro -micro -corticoids and cohandooids. This table is compiled according to the agency classification according to the Med Dra system.

Table 2. The adverse reactions of the drug may or have the ability to be related to the Myfortic reported in two important phase III tests

viral infections, bacterial infections and fungal infections.

Common

Upper respiratory infection, pneumonia.

]

Skin papilloma, stomach cell cancer, Sarcoma kaposi, lymphocytic hyperactive disorders, cell cancer.

leukopenia.

Common

Ophthalism.

Lymphocytes, lymphocytes, neutropen leukemia, lymph nodes.

Hypercalcemia, hypokalemia, hyperuricemia.

Common

Hemorrhage hyperkalemia, lowering blood magnesium.

Anorexia, hyperlipidemia, diabetes, hypercholesterolemia, hypoglycemia.

Mental disorders

Common

anxiety.

illusion.

Common

Dizziness, headache.

Run, insomnia.

visual disorders

Conjunctivitis, vision.

heart disorders

Tachycardia, pulmonary edema.

Hypertension, hypotension.

Common

Serious hypertension.

Common

cough, difficulty breathing, difficulty breathing.

Interstitial lung disease includes fatal fibrosis, lung congestion, wheezing.

diarrhea.

Common

Abdominal distention, abdominal pain, constipation, indigestion, flatulence, gastritis, loose stools, nausea, vomiting.

sensitive abdominal pain, pancreatitis, belching, bad breath, intestinal obstruction, esophagitis, digestive ulcers, gastrointestinal bowel, dry mouth bleeding, lip ulcer, hand garuine obstruction, gastrointestinal tea disease, hyperplasia, peritonitis.

Common

Abnormal liver function test.

Hair loss, bruising, acne.

Common

joint pain, weakness, muscle pain.

back pain, cramps.

Common

Hyperglyinine hypernipation.

bleeding, kidney necrosis, urethral stenosis.

Common

Fatigue, peripheral edema, fever.

Diseases like flu, edema, pain, chills, weak people.

The results are similar in the group to take the drug at the beginning of the transplant (de Novo) and the group used in the post -graft maintenance phase, although the rate tends to be lower in patients during the maintenance stage.

The following adverse drug reactions from Myfortic Marketing Experience through spontaneous reports and medical cases. Because these reactions were voluntarily reported from a group of unknown -scale population, it could not be estimated to be reliable, so the classification was unclear. The adverse reactions of the drug are listed based on the organ classification system in Meddra. In each organ system, the adverse reactions of the drug are presented in the order of severity.

Disorders of skin and subcutaneous tissue

The rash has been identified as a adverse reaction from clinical trials after approved, surveyed after circulation and spontaneous reports.

The following adverse effects are attributed to mpa derivatives

Infections and parasites

Severe infections, sometimes life -threatening, including meningitis, endocarditis due to infections, tuberculosis and non -typical Mycobacterium infection. Kidney disease caused by polyma virus (PVan), especially due to BK virus infection. Cases of progressive multi -noco white brain disease (PML) are sometimes reported.

Blood and lymphatic disorders

Loss of granulocytes, neutropenia, reducing all types of blood cells. Cases of simple red blood cell property (PRCA) have been reported in patients treated with MPA derivatives combined with other immunosuppressive drugs.

Stomach disorders

Colonitis, esophagitis (including colitis and esophagitis caused by CMV), CMV gastritis, pancreatitis, intestinal perforation, gastrointestinal bleeding, gastric ulcer, duodenal ulcer, bowel obstruction.

Elderly patients

In general, elderly patients may have an increased risk of harmful reactions due to immunosuppressive drugs. Elderly patients use MyFortic as part of a combined immunosuppressive regimen that does not manifest increasing the risk of adverse effects compared to young people in clinical trials with Myfortic.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

MyFortic 360 mg is contraindicated in the following cases:

Myfortic is contraindicated in patients sensitive to sodium mycophenolat, mycophenolic acid or mycophenolate mofetil or any excipient.

Be cautious when using

Patients with hypoxanthin deficiency - Guanin - Phosphoribosyl - Transferase (HGPRT) inherited rare

Myfortic is an IMPDH inhibitor (inosin monophosphate dehydrogenase). Therefore, theoretically, avoiding patients with Hypoxanthin deficiency - Guanin - Phosphoribosyl - Transferase (HGPRT) due to rare genetics such as Lesch syndrome - Nyhan and Kelly - Seegmiller.

Malignant diseases

Patients treating immune inhibitors including Myfortic increases the risk of developing lymphoma and other malignant diseases, especially in the skin. The risk of appearing is more related to the intensity and duration of the use of immunosuppressive drugs rather than the use of a unique substance.

General advice to reduce the risk of skin cancer is to limit exposure to the sun, ultraviolet lights by wearing protective clothing and using sunscreen with high protection index.

Infections

Patients using Myfortic should be instructed to notify immediately when there is any bacterial manifestation, abnormal bruises, bleeding or any manifestations of bone marrow.

Excessive inhibition of the immune system increases the sensitivity of infection, including opportunistic infections, fatal infections and hemorrhage.

Rhetoring hepatitis B (HBV) or hepatitis C (HCV) has been reported in patients treated for immunosuppressive treatment, including mycophenolic acid (MPA) that conducts myfortic and MMF substances. Recommended monitoring of infected patients on clinical signs and tests of HBV or HCV infection.

Cases of progressive multi -nocococcal white brain disease (PML), sometimes fatal, reported in patients treated with MPa derivatives, including mycophenolate mofetil and sodium mycophenolate. The reported cases often have PML risk factors including the treatment of immunosuppressive drugs and immune function damage. In patients with immunosuppressive inhibitors, physicians should pay attention to PML in diagnosis for patients with neurological symptoms and should consider consulting with a neurologist when clinically indicated.

Kidney disease caused by polyoma virus (PVan), especially due to BK virus infection, must be taken into account in the distinctive diagnosis in patients with immunodeficiency with impaired renal function. It is necessary to consider reducing the total amount of immunosuppressive drugs in PML or PVan development patients. However, in patients with transplantation, reducing immunosuppressive inhibitors can risk the transplant.

Blood diseases

Bệnh nhân dùng Myfortic nên được theo dõi kiểm tra các rối loạn về tạo máu (ví dụ như giảm bạch cầu trung tính hoặc thiếu máu, điều này có thể liên quan đến chính MPA, dùng các thuốc phối hợp, nhiễm trùng do vi khuẩn hoặc do một số kết hợp của những nguyên nhân này. Bệnh nhân dùng Myfortic phải kiểm tra công thức máu toàn phần hàng tuần trong tháng đầu điều trị, 2 lần/tháng trong tháng thứ hai và tháng thứ ba điều trị, sau đó mỗi tháng 1 lần trong năm đầu tiên. If there is blood disorders (for example, neutropenia with a total neutropenia

Cases of simple red blood cell property (PRCA) have been reported in patients treated with MPA derivatives combined with other immunosuppressive drugs (see the adverse effect). The mechanism of mpa derivatives causing Prca is not known; The relationship of other immunosuppressants and the combination of these drugs in an immunosuppressive treatment regimen is not known. However, MPA derivatives can cause blood disorders (see above).

In some cases, Prca found a recovery when reducing the dose or suspending therapy with MPA derivatives. However, in patients with transplantation, reducing immunosuppressive inhibitors can risk the transplant. Changes with Myfortic therapy on the recipient should only be conducted under the appropriate supervision to reduce the minimum risk of disposal.

vaccination

Patients should be advised that during MPA treatment, vaccination may be less effective and avoid vaccinations to reduce poison. The vaccination of influenza vaccines can be effective. Doctors should refer to the national instructions on influenza vaccination.

Gastrointestinal disorders

Due to the derivatives of MPa related to increasing the proportion of harmful effects on the digestive system, including rare cases of ulcers and hemorrhage and puncture of the gastrointestinal tract; Should be careful when using Myfortic for patients who are suffering from severe digestive systems.

Coordinate with other drugs

In Myfortic clinical trials, it has been used in combination with the following drugs: Globulin anti -thyroid cells, Basiliximab, Ciclosporin micro -form and corticosteroid. The efficiency and safety of Myfortic when coordinated with other immunosuppressive drugs have not been studied.

The ability to drive and operate machinery

without information.

Pregnancy

Using Myfortic during pregnancy often increases the risk of miscarriage including natural miscarriage and congenital deformities.

Myfortic treatment should not start in women who are likely to become pregnant until the results of negative pregnancy tests are available. Pregnant women must use highly effective contraception before starting, during Myfortic treatment and after 6 weeks after the last dosage of Myfortic.

The period of breastfeeding

It is not known whether MPa will be excreted in breast milk.

Do not use Myfortic during breastfeeding.

Because many drugs are excreted in breast milk, and because of the likelihood of serious adverse effects in infants to breastfeed/young children, it is necessary to decide to avoid breastfeeding during treatment and for 6 weeks after stopping treatment or avoiding the use of the drug, paying attention to the importance of the drug for the mother.

Male patient

Men are capable of sexual activity should use condoms during treatment, and in 13 weeks after the last dose of Myfortic. In addition, the partner of these men should use contraception highly effective during treatment and in 13 weeks after the last dose of Myfortic.

Drug interaction

The observed interactions from the use at the same time do not recommend

azathioprin

It is not recommended to use myfortic simultaneously with azathioprin because of the same use that has not been studied.

Live vaccine

Vaccination vaccines are not used for patients with damaged immune response. Antibody response to other vaccines may be reduced.

Observed interactions need to be considered

aciclovir

The higher concentrations in the plasma of both MPAG (glucuronid of mycophenolic acid) and aciclovir may occur when kidney failure. Therefore, these two drugs have the ability to compete in the renal tubules, increasing the concentration of both MPAG and Aciclovir. In this situation, patients need to be carefully monitored.

Stomach protection drugs

antacids containing magnesium and aluminum hydroxide: The absorption of sodium mycophenolat is reduced when used with antacids. Simultaneous use of Myfortic and antacids with magnesium and hydroxyd aluminum reduces 37% of the body's contact with MPA and reduces 25% of MPA's maximum concentration. Caution should be used when combined with antacids (containing magnesium and aluminum hydroxyd) with Myfortic.

Proton pump inhibitors: In healthy volunteers, simultaneous use of mmf 1,000 mg and pantoprazole 40 mg twice a day, resulting in a 27% reduction of MPa AUC and a 57% cmax of MPa. However, in the same study, it does not observe the pharmacokinetic changes of MPA when using simultaneously Myfortic and Pantoprazole.

ganciclovir: The pharmacokinetics of MPa and MPAG are not affected when using ganciclovir. The clearance of ganniclovir does not change in the situation of MPa exposure in treatment. However, in patients with renal failure, used in combination with Myfortic and Ganciclovir, the recommendations of the dose of ganciclovir are to control and monitor patients carefully.

tacrolimus: In a diagonal transfer study using Calcineurin in stable kidney transplant patients, Myfortic pharmacokinetics in a stable state were measured in treatment with both Neoral and Tacrolimus. The average AUC of MPa is 19% higher and CMAX is about 20% lower. In contrast, the average AUC of MPAG and CMAX is about 30% lower when treated with Tacrolimus compared to when treating Neoral.

ciclosporin A: Research in kidney transplant patients has stable, pharmacokinetics of ciclosporin A is not affected by the dosage in the stable state of Myfortic.

Expected interactions are considered

cholestyramin and drugs that affect intestinal circulation - liver

Due to the ability to block the circulating round - the liver of the drug, Cholestyramin can reduce the body contact of MPA. Caution should be used when combining cholestyramin or drugs that hinder the circulation of intestines - liver because it can reduce the effect of Myfortic.

Oral contraceptive pills

Oral contraceptives are metabolized by oxidation while Myfortic metabolizes the glucuronid pathway. The clinical effect of oral contraceptives on the pharmacokinetics of Myfortic is not predicted. However, it is still not known for the effect of long -term use on the pharmacokinetics of oral contraceptives, which may be the effect of oral contraceptives that are probably affected in a disadvantage.

Storage

Cool dry storage, avoid light, temperature below 30⁰C.

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