The recommended daily dose of QUALITINIB 250 is one 250 mg Tablets with or without food. Lesser doses do not give a better response and cause increased toxicity.
Dosage Adjustment: Patients with poorly tolerated diarrhea (sometimes associated with dehydration) or skin adverse drug reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg daily dose.
In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever), Gefitinib therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed, Gefitinib should be discontinued and the patient treated appropriately.
Patients who develop onset of new eye symptoms such as pain should be medically evaluated and managed appropriately, including Gefitinib therapy interruption and removal of an aberrant eyelash if present. After symptoms and eye changes have resolved, the decision should be made concerning reinstatement of the 250 mg daily dose.
In patients receiving a potent CYP3A4 inducer such as rifampicin or phenytoin, a dose increase to 500 mg daily should be considered in the absence of severe adverse drug reaction, and clinical response and adverse events should be carefully monitored.
No dosage adjustment is required or the basis of patient age, body weight, gender, ethnicity, or renal function; or in patients with moderate to severe hepatic impairment due to liver metastases.
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