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Recommended Dose and Dosage Adjustment: The recommended daily dose of APO-GEFITINIB (gefitinib tablets) is one 250 mg tablet with or without food. Higher doses do not produce a better response and lead to increased toxicity.
Dosage Adjustment: No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity or renal function. However, data are limited in patients with severe renal impairment (creatinine clearance ≤20 ml/min) (see Pharmacology: Pharmacokinetics: Special Populations and Conditions under Actions) and caution is advised in these patients.
For patients unable to tolerate treatment after a therapy interruption for toxicity, APO-GEFITINIB should be discontinued and another treatment option should be considered.
Dosage Adjustment due to Toxicity: Poorly tolerated diarrhoea: Patients with poorly tolerated diarrhoea (sometimes associated with dehydration) may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg daily dose once toxicity has resolved.
Skin adverse drug reactions: Patients with 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 once toxicity has resolved.
Eye symptoms: Patients who develop eye symptoms should be evaluated and managed, including interruption of therapy with APO-GEFITINIB. Reinstatement of the 250 mg/day APO-GEFITINIB dose should be considered when symptoms and eye changes have resolved.
Respiratory symptoms: If patients present with acute onset or worsening of respiratory symptoms such as dyspnoea, cough and fever, APO-GEFITINIB should be interrupted and prompt investigation initiated. If Interstitial Lung Disease (ILD) is confirmed, APO-GEFITINIB should be discontinued and the patient treated appropriately (see Respiratory under Precautions; Adverse Reactions).
Hepatic Impairment: An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment due to cirrhosis was observed in a phase I hepatic impairment study (see Hepatic Impairment under Precautions; Pharmacology: Pharmacokinetics: Special Populations and Conditions under Actions). This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
No dose adjustments are recommended for patients with moderate to severe hepatic impairment (Child Pugh B or C) however, these patients should be closely monitored. No dose adjustments are recommended for patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases. These patients should be closely monitored for adverse events.
In patients with impaired liver function secondary to liver metastases, gefitinib exposure was similar for patients with moderate hepatic dysfunction compared to normal hepatic function. Data from four patients with severe hepatic dysfunction due to liver metastases suggested that steady state exposures in these patients are also similar to those in patients with normal hepatic function.
In the pivotal trial IPASS, patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times upper limit of normal (ULN) with no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases were excluded due to potential hepatic concerns associated with the carboplatin/paclitaxel doublet. Consequently, the IPASS study does not contribute any data in this patient population.
Missed Dose: If a dose of APO-GEFITINIB is missed, it should be taken as soon as the patient remembers, as long as it is at least 12 hours before the next dose is due. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
