Alvoceva

Alvoceva Adverse Reactions

erlotinib

Manufacturer:

Remedica

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Non-small cell lung cancer (ALVOCEVA administered as monotherapy): In a randomized double-blind study (BR.21; Erlotinib administered as second line therapy), rash (75%) and diarrhoea (54%) were the most commonly reported adverse drug reactions (ADRs). Most were Grade 1/2 in severity and manageable without intervention. Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in erlotinib-treated patients and each resulted in study discontinuation in 1% of patients. Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively. In study BR.21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days.
In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas. For patients who are exposed to sun, protective clothing, and/or use of sun screen (e.g. mineral-containing) may be advisable.
Adverse reactions occurring more frequently (≥3%) in erlotinib-treated patients than in the placebo group in the pivotal study BR.21, and in at least 10% of patients in the erlotinib group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4.
The following terms are used to rank the undesirable effects by frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) including isolated reports.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 4.)

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In two other double-blind, randomized, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Erlotinib was administered as maintenance after first-line chemotherapy. These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy, no new safety signals were identified.
The most frequent ADRs seen in patients treated with erlotinib in studies BO18192 and BO25460 were rash and diarrhoea (see Table 5). No Grade 4 rash or diarrhoea was observed in either study. Rash and diarrhoea resulted in discontinuation of Erlotinib in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460. Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 8.3% and 3% of patients, respectively, in study BO18192 and 5.6% and 2.8% of patients, respectively, in study BO25460. (See Table 5.)

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In an open-label, randomized phase III study, ML20650 conducted in 154 patients, the safety of erlotinib for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients.
The most frequent ADRs seen in patients treated with erlotinib in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention. Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively. No Grade 4 rash or diarrhoea was observed. Both rash and diarrhoea resulted in discontinuation of erlotinib in 1% of patients. Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 11% and 7% of patients, respectively.
Pancreatic cancer (ALVOCEVA administered concurrently with gemcitabine): The most common adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving erlotinib 100 mg plus gemcitabine were fatigue, rash and diarrhoea. In the erlotinib plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients. The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively. Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving erlotinib plus gemcitabine.
Adverse reactions occurring more frequently (≥3%) in erlotinib 100 mg plus gemcitabine-treated patients than in the placebo plus gemcitabine group in the pivotal study PA.3, and in at least 10% of patients in the erlotinib 100 mg plus gemcitabine group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 6.
The following terms are used to rank the undesirable effects by frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) including isolated reports.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 6.)

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Other Observations: Safety evaluation of erlotinib is based on the data from more than 1500 patients treated with at least one 150 mg dose of erlotinib monotherapy and more than 300 patients who received erlotinib 100 or 150 mg in combination with gemcitabine.
The following adverse reactions have been observed in patients who received erlotinib administered as single agent and patients who received erlotinib concurrently with chemotherapy.
Very common ADRs from the BR 21 and PA 3 studies are presented in Tables 4 and 6, other ADRs including those from other studies are summarized in Table 7.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 7.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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