Bula do remedy Cellcept

the package insert of the medicine Cellcept. Active principles Mycophenolate Mofetil.

what For?

CELLCEPT is indicated for the prophylaxis of organ rejection and for treatment of rejection refractory organ in patients receiving renal transplant alogênicos. CELLCEPT should be used concomitantly with cyclosporine and corticosteroids.

Contraindications

When should I not use?

allergic Reactions to CELLCEPT have been observed. Therefore, CELLCEPT is contraindicated in patients with hypersensitivity to mycophenolate mofetil or acid micofenólico.

Dosage

How to use?

Dose for rejection prophylaxis: initial dose of CELLCEPT should be administered orally within 72 hours after the transplant. The dose of 1.0 g administered twice daily (daily dose of 2 g) is recommended in patients undergoing renal transplantation. Despite the dose of 1.5 g twice a day (dosa daily 3-g) have been used in clinical studies have been shown to be effective and secure, you can’t establish an advantage in terms of effectiveness. Patients receiving 2 g per day of CELLCEPT demonstrated a safety profile overall better than the patients who received 3 g per day of CELLCEPT. Should be used concomitantly with cyclosporine and corticosteroids. Dosage for the treatment of rejection refractory: A dose of 1.5 g administered 2 times a day (daily dose of 3 g) was used in clinical studies for the initial treatment of rejection refractory, and as a maintenance dose. Therefore, it is recommended that the use of 3 g per day for these patients. CELLCEPT should be used concomitantly with cyclosporine and corticosteroids. Instructions space of dosage: If there is the development of neutropenia (absolute neutrophil count < 1.3 x 10 3/ml),treatment with CELLCEPT should be interrupted or the dose reduced. Renal dysfunction severe: In patients with renal dysfunction chronic and severe (speed of glomerular filtration.

Side Effects

What are the evils that can cause me?

The profile of adverse effects associated with the use of immunosuppressive drugs is often difficult to be established due to the presence of the disease and the concomitant use of several medications. The main adverse effects associated with the use of CELLCEPTincluem diarrhea, leukopenia, sepsis and vomiting, and there is evidence of an increased frequency of certain types of infections. The adverse reactions reported in 3 10% of patients treated with CELLCEPT® in the three controlled studies of phase III for the prevention of rejection and in the controlled study phase III for the treatment of rejection refractory are shown in the following: Systemic: Sepsis, infection, abdominal pain, fever, chest pain, pain, headache, increase in the level of the drug, back pain, asthenia. Blood and lymphatic system: Anemia, leukopenia, thrombocytopenia, anemia hipocrônica, leukocytosis. Urogenital: urinary tract Infection, tubular necrosis renal failure, hematuria. Cardiovascular: Hypertension. Metabolic and nutrition: hypercalcemia, hyperglycemia, hipofosfatemia, hypokalemia, hipercolesteremia, peripheral edema, edema. Digestive: Diarrhea, vomiting, constipation, nausea, nausea and vomiting, dyspepsia, f-oral. Respiratory: Infection, dyspnea, pharyngitis, increased cough. Skin and appendages: Herpes simplex, acne. Nervous system: Dizziness, insomnia, tremor. In the three controlled studies for prevention of rejection, patients receiving 2 g per day of CELLCEPT demonstrated a better overall profile of safety in relation to patients who received 3 g per day of CELLCEPT. Sepsis, usually viremia cytomegalovirus (CMV), was slightly more common in patients treated with CELLCEPT than in patients in the control group. In the digestive system, the occurrence of diarrhea was higher in patients receiving CELLCEPT in relation to the group of patients treated with azathioprine or placebo. There was also a discrete increase in the frequency of vomiting. Urinary tract infections were common in all the treated groups, but with a mild increase in patients receiving CELLCEPT compared to those treated with azathioprine or placebo. Leukopenia was more common in patients treated with CELLCEPT than in the control group, was more common in patients who received 3 g per day of CELLCEPT. The safety profile of CELLCEPT in patients treated for rejection refractory was similar to that observed in three controlled studies for prevention of rejection with doses of 3 g per day. Diarrhea and leukopenia, followed by anaemia, nausea, abdominal pain, sepsis, nausea and vomiting, and dyspepsia were the adverse effects of the predominant reported more frequently in pacientas receiving CELLCEPT compared to patients treated with asteroids iv. Invasive disease of the tissue by cytomegalovirus (CMV) was more common in patients receiving CELLCEPT® 3g per day than in those receiving CELLCEPT 2 g per day or the control therapy in three controlled studies for prevention of rejection. Similarly, the incidence of candidemia and candidiasis and aspergillosis tissue invasive was slightly higher in patients receiving CELLCEPT® 3 g per day compared to patients receiving CELLCEPT® 2 g per day, or control therapy for the prevention of rejection. In patients treated with CELLCEPT® for rejection renal refractory, similar results were observed. There was a greater incidence of invasive disease tissue by CMV in patients treated with CELLCEPT® compared with those treated with high doses of asteroids iv. In three controlled studies for prevention of rejection, the percentages of similar fatal infections (< 2%) occurred in patients receiving CELLCEPT or control therapy in combination with other immunosuppressive agents. The incidence of malignancies among the 1,483 of which the patients involved in the three controlled studies for prevention of rejection, which were followed for more than 1 year, was similar to the incidence reported in the literature for receivers of renal alogênicos. There was a small increase in the incidence of lymphoproliferative disease in patients treated with (0,6% – 1,0%) in comparison with the placebo group (0%) and the group azathioprine (by 0.3%). The incidence of malignancy observed after the treatment in controlled studies for the treatment of rejection in renal refractory allogeneic was 2.8% in patients receiving intravenous steroids, and 2.6% in patients receiving CELLCEPT. Disorders, lymphoproliferative were the only malignancies observed. In up to 2% of the pacientas receiving CELLCEPT for the prevention of rejection, and 3% of patients receiving CELLCEPT for the treatment of rejection refractory developed neutropenia, severe (absolute neutrophil count < 500/ml). The following adverse events, not mentioned above, were reported in a ratio of 3% in patients treated with CELLCEPT Systemic: Cysts, accidental damage, hemorrhage, hernia, malaise, abdominal distension, chills and fever, flu symptoms, pelvic pain, swelling of the face. Blood and lymphatic system: Polycythemia, ecchymosis. Urogenital: Disorders of the urinary tract, albuminúria, hydronephrosis, pyelonephritis, dysuria, pain, impotence, urinary frequency. Cardiovascular: Thrombosis, angina pectoris, atrial fibrillation, hypotension, dysfunction peripheral vascular, cardiovascular disorder, postural hypotension, tachycardia, palpitation, vasodilation. Metabolic and nutritional: Increased gamaglutamil transpeptidase, dehydration, increase of SGOT and SGPT, hipervolemia, acidosis, hypocalcemia, increase of the enzyme lactic, hypercalcemia, increased alkaline phosphatase, hypoproteinemia, hyperuricemia, weight gain. Digestive: Hemorrhage, gastrointestinal, smooth, gastritis, gastroenteritis, esophagitis, hepatitis, infection, tests abnormal liver function tests, f-gastrointestinal dysfunction rectal, anorexia, flatulence, hyperplasia, gingival, gingivitis, ulceration of the mouth. Respiratory: pulmonary Edema, sinusitis, dysfunction of the pulmonary, asthma, pleural effusion. Skin and appendages: Carcinoma of the skin, ulceration of the skin, herpeszoster, neoplasm benign, of skin, hypertrophy of the skin, sweating, alopecia, hirsutism, dermatitis, fungal, itching. Nervous system: Depression, drowsiness, paresthesia, hypertonia, anxiety. Endocrine: Diabetes mellitus, dysfunction of the parathyroid. musculoskeletal: Arthralgia, myalgia, disorders of the joints, leg cramps, myasthenia. Sensory organs: Cataract (non-specific), conjunctivitis, amblyopia.

Warnings and Precautions

what should I know before using?

as Well as in patients using regimens immunosuppressive agents with a combination of drugs, patients receiving CELLCEPT as part of a scheme imunossupressivo have a higher risk of developing lymphomas and other malignant tumors, particularly of the skin. The risk seems to be more related to the intensity and duration of immunosuppression than to the use of a specific agent. Suppression of the immune system can increase susceptibility to infections. CELLCEPT has been administered in combination with the following agents in clinical studies; globulin antitimócita, OKT3, cyclosporine and corticosteroids for the prevention of episodes of rejection, and with cyclosporine, corticosteroids, globulins antilinfócitos, globulins antitimócitas or OKT3 for treating episodes of rejection refractory. Lymphoproliferative disease or lymphoma developed in patients receiving CELLCEPT in conjunction with other immunosuppressive agents in approximately 1% of patients in controlled studies in prevention of rejection, and 2,6% of patients in controlled studies for the treatment of rejection in renal refractory. In the three controlled studies for prevention of rejection, and the occurrence of fatal infections was similar (< 2%) for patients receiving CELLCEPT or control therapy in combination with other immunosuppressive agents. In up to 2% of patients receiving CELLCEPT for the prevention of rejection, and 3% of patients receiving CELLCEPT for the treatment of rejection refractory, developed severe neutropenia (absolute count of neutrophils< 500/ml). Patients in treatment with CELLCEPT should be monitored for neutropenia. The development of neutropenia pruning to be related to CELLCEPT, concomitant medications, viral infections, or any combination of these causes. Control laboratory: Patients in treatment with CELLCEPT should perform cbc weekly during the first month, fortnightly in the second and third months of treatment, and monthly during the first year. In case of neutropenia (absolute neutrophil count less than 1.3 x 10 3/ml) the administration of CELLCEPT should be interrupted or the dosage should be reduced and the patient should be observed carefully. Was observed bleeding of the gi-tract in approximately 3% of patients treated with CELLCEPT®. Perforation of the gi-tract (colon and gallbladder) has been observed rarely. Due to the CELLCEPT® be associated with the increased incidence of adverse effects on the digestive system, including cases little frequent ulceration of the gastrointestinal tract, hemorrhage and perforation. should be administered with caution to patients with dysfunction, with active serious digestive system. Individuals with renal dysfunction severe chronic (speed of glomerular filtration.

Overdose

what to do if someone use a larger amount than is recommended?

Not if you have experience with overdose of mycophenolate mofetil in humans. mpa can not be removed by hemodialysis. however, in plasma concentrations was high (>100 mg/ml), small amounts of mpag are removed.

by Increasing the excretion of the drug, mpa can be removed by sequestrantes of bile acids, such as colesteramina.