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d%> d= _ d=> [Functional Treatment]
Gleevec is used to treat the chronic phase, accelerated phase or blast phase of Philadelphia chromosome-positive chronic myelogenous leukemia (+). For the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors, the safety and efficacy information for the following indications mainly comes from foreign research data. Data on the Chinese population are limited: - For the treatment of adult patients with recurrent or refractory gastrointestinal stromal tumors. Philadelphia chromosome-positive acute lymphoblastic leukemia (+). - For the treatment of hypereosinophilic syndrome and/or chronic eosinophilic leukemia.d/. Adult patients with -fusion kinase. Imatinib mesylate is the world's first approved tumorigenesis-related signaling inhibitor for chronic myelogenous leukemia and gastrointestinal stromal tumors. Treatment should be initiated initially by a physician experienced in treating chronic myelogenous leukemia. The recommended dose of imatinib mesylate for patients in blast phase and accelerated phase is /day. For patients in chronic phase who have failed interferon therapy, the recommended dose is once daily. It should be taken orally with a meal and drink a large glass of water. If effective, you should continue to take it. If the blood picture permits and there are no serious adverse drug reactions, the dose may be considered to be increased from / day to / day or from / day to / day (orally)
Starting dose: for the blast phase and accelerated phase of chronic myelogenous leukemia The recommended dose of imatinib mesylate for patients is/day. The recommended dose for patients in the chronic phase who have failed interferon therapy and for patients with malignant gastrointestinal stromal tumors that cannot be surgically removed or metastasized is/day, which is taken orally once daily. Medication should be taken with a meal and a large glass of water and should be continued for as long as it is effective.
If the blood picture permits and there are no serious adverse drug reactions, the dose may be considered to be increased from / day to / day or from / day to / day (taken in divided doses) under the following circumstances: disease progression, failure to treat after at least one month Satisfactory hematological response was obtained. The hematological response that had been achieved disappeared again.
The dose must be adjusted in the following circumstances: If serious non-hematological adverse reactions (such as severe water retention) occur during treatment, the drug should be discontinued until the adverse reactions disappear, and then the dose should be adjusted according to the severity of the adverse reactions.
Adjustment of dosage in case of severe liver toxicity: If the increase in bilirubin exceeds the upper limit of the normal range or the increase in transaminases exceeds the upper limit of the normal range, the drug should be discontinued until the above indicators drop to . or . times the upper limit of the normal range respectively. the following.
Dose adjustment in neutropenia or thrombocytopenia: Acceleration or blast phase: If severe neutropenia and thrombocytopenia occur (neutrophils less than./ and/or platelets less than/) dose reduction is recommended To / day. If the blood cells continue to decrease for weeks, the dose should be further reduced to / day. If the blood cells continue to decrease for weeks, it is advisable to stop the drug until neutrophils / and platelets /. When used again, the dose is / day.
- Interferon treatment Patients in the chronic phase after failure: When neutrophils are less than ./and/or platelets are less than//, it is advisable to stop taking the drug only when neutrophils are less than ./and/or platelets/, then resume the drug at a dose of /day if neutrophils or platelets are reduced again. When the above values are reached, the dose is reduced to /day when the drug is resumed.
Dosage in patients with liver failure: The plasma concentration of imatinib mesylate can be increased in patients with liver dysfunction, so when these patients take this drug Caution: There are no clinical data on the use of imatinib mesylate in patients with hepatic impairment to make recommendations for dose adjustment.
Dosage in Renal Failure and Elderly Patients: Creatinine clearance is known to decrease with aging. Age has no significant effect on the pharmacokinetics of imatinib mesylate. Since no clinical trials have been conducted in patients with renal impairment, no dosage adjustment recommendations can be made.
[Adverse Reactions]
Most patients will experience some adverse reactions while taking imatinib mesylate, but the vast majority are mild to moderate. Considering that the disease itself also produces symptoms, it is often difficult to determine their causal relationship. During clinical trials, due to drug-related Adverse reactions resulting in drug discontinuation accounted for only % of patients in the chronic phase of chronic myeloid who failed interferon treatment, accounted for approximately % in the accelerated phase, and accounted for % in the blast phase of chronic myeloid. The most common adverse events related to drug treatment are mild nausea (- %) Adverse events such as vomiting, diarrhea, myalgia and muscle cramps are easy to deal with. The incidence rates of edema and water retention were reported in all studies to be -% and -% respectively, with severe cases being -% and -% respectively. Most patients The edema is manifested as periorbital and lower limb edema. Pleural effusion, ascites, pulmonary edema and rapid weight gain are also reported. At this time, medicinal diuretics are usually suspended or certain supportive treatments are given. Some patients are in serious or even life-threatening conditions. There are cases of chronic granuloma Patients with acute crisis died due to complex clinical conditions complicated by pleural effusion, congestive heart failure and renal failure. The incidence of these adverse reactions is related to the dose and is more common at () hours per day. The classification and frequency of occurrence will vary according to system organ classification. Adverse reactions that only occur in individual patients are listed below. Frequency is defined as very common% common% ( ) % occasionally.% ( ) %rare.% ( ) .% very rare ( ) .% (classification method). Systemic Sexual abnormalities are common: water retention (%) and generalized edema (% of both). Common: fever, fatigue, weakness, chills, and weight gain. Uncommon: malaise, bleeding, and weight loss. Communicable diseases/infections are uncommon : Sepsis, pneumonia, herpes simplex, herpes zoster, and upper respiratory tract infections. Blood and lymphatic system abnormalities are common: neutropenia (%), thrombocytopenia (%), and anemia (%). Common: febrile neutropenia, pancytopenia. Metabolic and nutritional imbalances are common: loss of appetite. Uncommon: Dehydration, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, increased appetite. Psychiatric disorder less common: depression. Nervous system abnormalities are common: headache (%). Common: dizziness, dysgeusia, paresthesias, and insomnia. Uncommon: hemorrhagic stroke, syncope, peripheral neuropathy, hypoesthesia, salivation, migraine. Common eye abnormalities: conjunctivitis, increased tearing. Uncommon: Eye irritation, blurred vision, conjunctival hemorrhage, dry eyes, periorbital edema. Ear and labyrinth abnormalities are less common: dizziness. Cardiac abnormalities are less common: heart failure, pulmonary edema, tachycardia. Vascular abnormalities are less common: hematoma, hypertension, hypotension, flushing, coldness of extremities. Abnormalities of the respiratory tract, chest and mediastinum are common: pleural effusion and epistaxis. Uncommon: dyspnea, cough. Digestive system abnormalities are common: nausea (%), vomiting (%), diarrhea (%), indigestion (%). Common: abdominal pain, bloating, flatulence, constipation, dry mouth. Uncommon: gastrointestinal bleeding, melena, ascites, gastric ulcer, gastritis, gastroesophageal reflux, oral ulcer. Hepatobiliary abnormalities are uncommon: jaundice, elevated liver enzymes, hyperbilirubinemia. Skin and subcutaneous tissue abnormalities were common: generalized edema (%), dermatitis/eczema/rash (total %). Common: facial swelling, periorbital swelling, itching, erythroderma, dry skin, hair loss, and night sweats. Uncommon: ecchymosis, hyperhidrosis, urticaria, nail breakage, photoallergic reaction, purpura. Abnormalities of skeletal muscle, connective tissue and bone are common: myospasm, painful myospasm (%), skeletal muscle pain including joint swelling (%). Uncommon: Sciatica. Renal and urinary system abnormalities are less common: renal failure, elevated creatinine. Reproductive system and [prohibited word] abnormalities are uncommon: male [prohibited word] feminization, [prohibited word] enlargement, scrotal edema. Laboratory abnormalities All studies reported cytopenias, especially neutrophil and thrombocytopenia, with a high incidence at high doses ()/day (phase studies). However, the incidence of cytopenias also clearly depends on the stage of the disease or The incidence rates of severe neutropenia (/) and thrombocytopenia (/) in the blast phase and accelerated phase are -% and -% respectively, while in the chronic phase they are only -% and -% respectively. The former is - times the latter. . The incidence rates of neutropenia (/) and thrombocytopenia (/) were only % and % respectively. The median duration of neutropenia and thrombocytopenia were - and - weeks respectively, with only a few cases requiring long-term drug discontinuation. Severe elevation of transaminases or bilirubin is rare (% of cases often require dose reduction or discontinuation (median duration is approximately 3 weeks)), and less than .% of patients discontinue medication for a long time as a result. A patient in the accelerated phase died of Acute liver failure, but the drug interaction between high-dose paracetamol and imatinib mesylate cannot be ruled out in this patient.