Post by Deanne Jenkyns on Apr 20, 2007 18:23:41 GMT 1
Dosing information
Dosage and administration
The recommended daily dose of Tarceva is 150 mg.[1]
Tarceva should be taken orally at least one hour before or two hours after the ingestion of food.[1]
Tarceva is available in strengths of 150 mg, 100 mg and 25 mg.*[1]
*25-mg tablet not available in all countries.
Precautions with Tarceva
Women of childbearing potential must avoid pregnancy while on Tarceva.[1]
Current smokers should be advised to stop smoking, as plasma concentrations could be reduced.[1]
Modifications with dosing
When dose adjustment is necessary, reduce in 50-mg steps.[1]
Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively.[1]
The Tarceva pivotal trial specified the following dose modification guidelines for Grade ¡Ý3 rash or diarrhea that could not be medically managed:[2,3]
hold the dose until symptom returned to Grade ¡Ü1 [2]
reduce the dose by a 50-mg step [1]
Favorable tolerability profile
The most common adverse drug reactions in patients receiving Tarceva were rash and diarrhea. In the pivotal trial, Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, of
Tarceva-treated patients.[1]
Patients with mild/tolerable (Grade 1), moderate/tolerable (Grade 2) or severe/intolerable (Grade ¡Ý3) reactions may be appropriate for treatment with medically managed supportive care.[2,3]
Patients with Grade ¡Ý3 reactions or those that cannot be managed medically may require a dose reduction or temporary interruption of Tarceva treatment.[2,3]
In the pivotal trial, most patients tolerated the 150-mg dose. Rash and diarrhea each resulted in study discontinuation in 1% of Tarceva-treated patients.[1]
Concomitant use with CYP3A4 inhibitors and inducers
Co-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by 69%. Alternate treatments lacking CYP3A4 inducing activity should be considered.[1]
Co-treatment with the potent CYP3A4 inhibitor ketoconazole increases erlotinib AUC by 86%. Caution should be used when administering or taking Tarceva with ketoconazole or other strong CYP3A4 inhibitors.[1]
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment.[1]
Acknowledgment
www.tarceva.net/DosingInfo.htm
Dosage and administration
The recommended daily dose of Tarceva is 150 mg.[1]
Tarceva should be taken orally at least one hour before or two hours after the ingestion of food.[1]
Tarceva is available in strengths of 150 mg, 100 mg and 25 mg.*[1]
*25-mg tablet not available in all countries.
Precautions with Tarceva
Women of childbearing potential must avoid pregnancy while on Tarceva.[1]
Current smokers should be advised to stop smoking, as plasma concentrations could be reduced.[1]
Modifications with dosing
When dose adjustment is necessary, reduce in 50-mg steps.[1]
Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively.[1]
The Tarceva pivotal trial specified the following dose modification guidelines for Grade ¡Ý3 rash or diarrhea that could not be medically managed:[2,3]
hold the dose until symptom returned to Grade ¡Ü1 [2]
reduce the dose by a 50-mg step [1]
Favorable tolerability profile
The most common adverse drug reactions in patients receiving Tarceva were rash and diarrhea. In the pivotal trial, Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, of
Tarceva-treated patients.[1]
Patients with mild/tolerable (Grade 1), moderate/tolerable (Grade 2) or severe/intolerable (Grade ¡Ý3) reactions may be appropriate for treatment with medically managed supportive care.[2,3]
Patients with Grade ¡Ý3 reactions or those that cannot be managed medically may require a dose reduction or temporary interruption of Tarceva treatment.[2,3]
In the pivotal trial, most patients tolerated the 150-mg dose. Rash and diarrhea each resulted in study discontinuation in 1% of Tarceva-treated patients.[1]
Concomitant use with CYP3A4 inhibitors and inducers
Co-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by 69%. Alternate treatments lacking CYP3A4 inducing activity should be considered.[1]
Co-treatment with the potent CYP3A4 inhibitor ketoconazole increases erlotinib AUC by 86%. Caution should be used when administering or taking Tarceva with ketoconazole or other strong CYP3A4 inhibitors.[1]
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment.[1]
Acknowledgment
www.tarceva.net/DosingInfo.htm
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